BCS® XP System Reagent Management Online Training

Describe how BCS® XP system components and software interact to load, transfer, and store reagent data Welcome to the BCS® XP system Reagent Management online education support tool. Upon successful completion of this course, you will be able to: Select Next to continue. Congratulations! You’ve completed the Reagent Management Online Education Support Tool. In this course, you’ve been introduced to the reagent data management tasks summarized below. Describe how system components and software interact to load, transfer, and store reagent data The external BCS® XP database stores reagent and assay definitions and procedures. To make changes to the database, close the BCS® XP program, and then open an auxiliary program called the Data Definition Tool. The Data Update CD contains reagent and assay definitions. Use the EasyLoader XP driver to install CD contents into the BCS® XP database. The Lot Data CD contains all valid lot numbers, reference values, master curves, and validation curves and is released every two months by Siemens Healthcare Diagnostics. Use EasyLot XP driver to install CD contents into the Lot File. The Barcode Reader scans reagent barcodes and sends data to BCS® XP software, which compares scanned data to the BCS® XP database. If the database is not current, missing data are transferred from the Lot File to the database. The Lot File is a database that stores valid (in use/not expired) Siemens Healthcare Diagnostics reagent lot numbers. Relevant lot data are transferred from the Lot File to the BCS® XP database. Identify key areas of the Lot numbers dialog box In the BCS® XP program, use the Lot numbers dialog box to enter and edit reagent lot numbers and reference values, or import new lot lumbers from the Lot Data CD. To open the Lot Numbers dialog box, on the Definitions menu, click Lot info. In the BCS® XP software, lot numbers are also called Product codes. Standards and calibrators are examples of reagents that have reference values. Refer to the Table of Assigned Values included with every reagent lot for current reference values. Identify key areas of the Reagent Overview screen In the BCS® XP program, use the Reagent Overview screen to view inventory statistics for all reagents onboard the instrument. Compare the reagent volume required to process all jobs on the Job List to the reagent volume currently onboard the instrument. Also, view reagent stability times. Identify key areas of the Reagents dialog box In the Data Definition Tool, use the Reagents dialog box to define reagent settings. Demonstrate how to load barcoded reagents, manually enter reagent data, and check reagent inventory Loading barcoded reagents When loading barcoded reagents, make sure you load reagents in the proper location, as defined in the Data Definition Tool for each assay, for example: Should the reagent be stored in a cooling lane or at room temperature? Does the reagent require stirring? The barcoded rack number identifies the type of rack to the system. All racks are previously defined using the Rack definition dialog box, which you can access from the Definitions menu in the BCS® XP program. Manually entering reagent data After the barcode reader scans the barcoded rack number, it scans the barcode label on each reagent vial to ensure that the reference number (reagent ID) and lot number match the data currently stored in the BCS® XP database. If the barcode reader cannot identify all reagents in the rack, the analyzer ejects the rack, and the Loading screen automatically appears, which you can use to manually identify the reagent to the system. Checking reagent inventory After loading reagent racks, the BCS® XP system immediately checks the available reagent loaded onboard the analyzer and updates the Reagent Overview screen. Select Next to continue. Understanding how, why, and where reagent data are updated and stored in the BCS® XP system will help you manage reagent data much more effectively so that you can process all the jobs on the Job List without interruption. Why is it important to keep reagent data updated and stored in a secure location?  Because reagent data include assay definitions, reagent definitions, and assay procedures-and without current definitions and procedures, no assay can be processed and no result calculated. Now, let’s learn how and where reagent data are handled on the BCS® XP system. Select the link below to explore a diagram that shows how system components and software interact to load, transfer, and store reagent data.  Here’s a study hint: On the diagram, do you see that all data that enter the system—either through CD, barcode reader, or you—eventually end up in the BCS® XP system lot file or database?       Handling Reagent Data Learn how and where reagent data are handled on the BCS® XP system. Base ImageHotspotsText BlocksImage File Database:  Storage file for Siemens Healthcare Diagnostics reagent and assay definitions and procedures; pre-loaded during BCS® XP installation Barcode Reader: Scans reagent barcodes and sends data to the BCS® XP software, which compares scanned data to the database.  If the database is not current, missing data are transferred from the Lot File to the database. Lot File:  Database for valid (in use/not expired) Siemens Healthcare Diagnostics reagent lot numbers.  Relevant lot data are transferred from the Lot File to the database. Data Definition Tool: External program that defines reagents specific to each lab and sends data directly to the database.   Use the BCS® XP program Lot info dialog box  to manually enter reagent lot numbers and reference values directly to the database. Lot Data CD:  Siemens Healthcare Diagnostics CD-ROM with all valid lot numbers, reference values, master curves, and validation curves.  Released every two months.  Use the Easy Lot XP driver to install CD contents into the Lot File. Data Update CD: Siemens Healthcare Diagnostics CD-ROM with reagent and assay definitions.  Use the EasyLoader XP driver to install CD contents into the database.   You’ve just learned that all BCS® XP reagents, assays, and assay procedures are defined by settings that are stored in the BCS® XP database. The BCS® XP database is stored outside the BCS® XP software. Its contents are very important. To make changes to reagent or assay settings in the database, use the Data Definition Tool. Access to this external program is user-level defined and password protected If the BCS® XP software is running, the Data Definition Tool is only available to read and print data, or to create new definitions and duplicate existing definitions. Let's explore a few areas of the BCS® XP software that allow us to manage reagent data. Select Next to continue.   You can manage reagent lot data using the Lot numbers dialog box in the Definitions menu, where you enter and edit reagent lot numbers and reference values. To open the Lot Numbers dialog box, on the Definitions menu, select Lot info. Note: Lot data can be found in the Table of Assigned Values enclosed with each box of Siemens Healthcare Diagnostics reagents.     Lot Numbers dialog box Learn more about the Lot Numbers dialog box. Base ImageHotspotsText BlocksImage File Reagent ID Select Info to edit or enter reference values. Select New to add new lot numbers or values. Select Delete to delete unused lot numbers; e.g., expired lots.   Note:  You can delete reagent lots only if they are not currently in use or loaded on the analyzer. Select Import to add new lot numbers from the Lot Data CD. Lot number for the reagent "batch."  Also called Product code. Test method associated with the reagent. Known value of analyte being assayed.  Used as reference to measure samples.  Standards and calibrators have known reference values, for example.  Refer to the Table of Assigned Values included with every reagent lot for the current reference values.  Why do some reagents have multiple reagent IDs? Learn why some reagents have more than one reagent ID. Why do some reagents have more than one reagent ID? Because of the way barcodes are handled, only 99 lots can be produced per reagent ID. To produce more than 99 lots, you must start with a new reagent ID-even though the reagent is the same. When complete, select the X in the upper-right corner to close the window and continue How do you enter a missing lot number? Learn how to enter a missing lot number. How do you enter a missing lot number? From the Definitions menu, click Lot info to open the Lot numbers dialog box.  Note that every reagent in the list has a 4-digit reference number (or Reagent ID). Select the reagent wit the missing lot number, and then click New on the toolbar to open the Lot no. entry dialog box. In the Product code text box, type the new 6-digit reagent lot number.  All lot numbers begin with the 4-digit reference number. Click Save to store the new lot number into the BCS® XP database. When complete, select the X in the upper-right corner to close the window and continue. To ensure an efficient workflow, keep track of reagent inventory—what’s loaded and what’s needed based on your work load. In the BCS® XP program, the Reagent Overview screen allows you to view inventory statistics for all reagents onboard the instrument. For example, you can: Compare the reagent volume required to process all jobs on the Job List to the reagent volume currently onboard the instrument Observe the onboard stability time   Reagent Oveview screen Learn more about the Reagent Overview screen. Base ImageHotspotsText BlocksImage File Reagent name Select the Filter button to view an inventory of only missing reagents or change the reagent sort order by rack or reagent name. Reagent Lot number. The first four digits indicate the reference number (or Reagent ID); the last two digits represent the lot number (or Product code).Displays the lane where the reagent rack is loaded in the analyzer, and the position in the rack where the reagent is located. Barcoded rack number Available reagent volume per vial Total reagent volume per reagent Required reagent volume to complete test requests on the Job List Remaining stability time for onboard reagent Roll your mouse over data in this column to view a screentip that displays onboard stability times defined for each reagent at <15°C and >15°C, as applicable. Stability time Learn more about stability time. What is stability time? When defining reagents, you can specify if the reagent should be loaded in a cooled (< 15 °C) or uncooled (≥ 15 °C) lane. You can also specify the total time that a reagent should be stable if it is stored onboard the instrument at this temperature. When you first load the reagent onboard the instrument, the total stability time appears on the Reagent Overview screen. Then the BCS® XP system starts a timer that displays the remaining onboard stability time. If the stability time expires, on the Analyzer screen, blue dots (which represent reagents, deficient plasmas, standards, or controls loaded in racks) change to red dots. The analyzer will not use reagents with expired stability times. If you remove a rack, the stability timer pauses and the BCS® XP system stores the stability data for an hour. The system resumes the timer if the rack is reloaded within an hour. Otherwise, the stability data is lost and the BCS® XP resets the onboard time to zero for all reagents in the rack. When complete, select the X in the upper-right corner to close the window and continue. Congratulations. You have completed the Stratus® CS 200 System Update Applications Online Training course. Listed below are the key points that have been presented. Take time to review the material before you proceed to the final quiz. You’ve already learned that reagent definitions are stored in the BCS® XP database. The BCS® XP system strictly follows reagent settings and definitions. For example, you can define the following settings: After dispensing reagent, wash the reagent probe with wash solution Dispense reagent using the reagent probe Store onboard reagent cooled or uncooled Onboard reagent time expires after 48 hours if stored at < 15 °C; after 24 hours if stored at ≥ 15 °C To make changes to BCS® XP database definitions and settings, you must close the BCS® XP program and then start the Data Definition Tool. In the Data Definition Tool, use the Reagents dialog box to define reagent settings. New definitions can be created while the BCS® program is still running.   Reagents Dialog box Learn more about the Reagents Dialog box. Base ImageHotspotsText BlocksImage FileLists all reagents defined in the BCS® XP systemSelect New to clear all fields and define a new reagent. Defines reagent name that appears in the Lot numbers dialog box Defines if the reagent probe requires cleaning (intensive, special, extra, high, normal, or low) with washing solution after dispensing reagent to prevent possible carryover from reagents containing thrombin, for example. Defines if a control measurement should be performed automatically with each reagent bottle change. Defines if enzyme blank value (EBV) measurement should occur if a reagent vial is changed. Used for enzyme-based reagents (e.g. ATIII thrombin), where loss of activity still yields valid assay results. Defines if the sample probe will pipette reagent. Used for reagents treated as samples, e.g., calibrators, controls, and deficiency plasmas. Defines if the reagent will be stored onboard in a cooled or uncooled rack; defines how long reagent is stable when stored in either area; sets rule to create an error message if the reagent is loaded in Lanes 1 or 2. Defines if reagent needs to be stirred. For stirred reagents, defines if duration (sec), interval (min), or continuous stirring is required. Defines new reagent ID.  All reagent IDs must be 4-digit unique numbers.  Some reagents display a list of predetermined reagent IDs.  Let’s head to the virtual lab and practice loading reagents using the Loading screen. During the exercise, see if you can identify situations where the system is transferring reagent data to the database.After completing this exercise, you’ll be able to: Load barcoded reagents Manually enter reagent data Check reagent inventory   Loading Reagents Learn how to load reagents. Slide NumberText BlocksCalloutsAudio ScriptImage File1 Welcome to the virtual Hemostasis Lab! Let’s see how the BCS® XP handles various reagent management tasks as we load reagents. Note: The global examples shown in this exercise might vary from the specific assay profiles defined for your laboratory or commonly used in your country. Select Next to continue. Note: If audio does not automatically start, select the play arrow in the top left to begin.Welcome to the virtual Hemostasis Lab! Let’s see how the BCS® XP handles various reagent management tasks as we load reagents. 2Loading Barcoded Reagents Loading barcoded reagents is easy. All you need to know are: Which racks are designated for which reagents? Which racks are designated for which lanes? Then…just load and go! Select Next to continue. Slide QuestionAnswer TextTrue or False: Lanes 1 – 4 are cooling lanes designated only for reagents dispensed by the reagent probe.False! You can also use Lanes 3 and 4 to load diluent, such as NaCl and other reagents dispensed by the sample probe.Loading barcoded reagents is easy. All you need to know are: •Which racks are designated for which reagents, and •Which racks are designated for which lanes. Then…just load and go! 3Loading Barcoded ReagentsIn our virtual lab, we have loaded barcoded reagents into racks and inserted the racks into appropriate lanes on the analyzer.You’ll get used to the following sights and sounds as you load each rack: Push each rack all the way up to the stop cam. You’ll hear the switch in the lane being thrown. The red LED flashes rapidly until the barcode scanner successfully reads all positions and the BCS® XP begins to check reagent volume levels. The scanner’s transport mechanism moves the rack from the rack storage unit to the processing unit.Select Next to continue.Slide QuestionAnswer TextWhat information is obtained when the BCS® XP reads the reagent vial barcode? By reading the reagent vial barcode the analyzer is able to identify the reagent, to read and manage the lot numbers and to recognize the bottle size. Select each number to review the corresponding text.CalloutsStop camLEDPush each rack all the way up to the stop cam. You’ll hear the switch in the lane being thrown: Then you’ll hear the sound of the barcode scanner scanning barcode labels on reagent vials. After reading all barcode labels, the scanner’s transport mechanism moves the rack from the rack storage unit to the processing unit. Here’s what it sounds like:4 Loading Barcoded Reagents Racks are available in several configurations. Each type of rack is designated for different types of reagents, such as reagents that require stirring, or reagent vials that require adapters. Select Next to continue. Racks are available in several configurations. Each type of rack is designated for different types of reagents, such as reagents that require stirring, or reagent vials that require adapters.5 Loading Barcoded Reagents How can the BCS® XP system tell which type of rack is loaded? All racks are defined to the system using the Rack definition dialog box, which you can access from the Definitions menu. Important rack settings include: Rack number Probe depth STAT rack designation The rack number is a barcoded number that identifies the type of rack to the system. Let’s take a closer look at barcoded rack numbers… Select Next to continue. All racks are defined to the system using the Rack definition dialog box, which you can access from the Definitions menu. 6 Loading Barcoded Reagents Let’s examine barcoded rack numbers: The first two digits indicate the rack type. Rack no. 30 is designated for cooled reagents. The next two digits indicate the sequential number of the rack. The last two digits are the check digits. In the example shown here, the barcode reader would scan the rack barcode and “tell” the BCS® XP system that a rack for reagents to be cooled has been loaded. Select Next to continue.   Slide QuestionAnswer TextCan you load rack type no. 30 anywhere besides Lanes 1 – 4?No. To prevent loading errors, the rack does not fit in any other lanes.Examine the barcoded rack ID shown here-rack number 30 is designated for cooled reagents.7Loading Barcoded Reagents All Siemens Healthcare Diagnostics reagents have barcode labels. After the barcode reader scans the barcoded rack number, it scans the barcode label on each reagent vial loaded in the rack. Select Next to continue.  Slide QuestionAnswer Text What reagent data management task is being performed when the barcode scanner reads the reagent barcode label? The barcode reader compares the scanned reference number (reagent ID) and lot number data to the reagent data stored in the BCS® XP Data File for this reagent. Do they match? If yes, no Data File updates are necessary. If no, then the barcode reader queries the Lot File for this data, and then updates the Data File with the new reagent ID and lot number. Special information for this reagent is also updated, if applicable. All Siemens Healthcare Diagnostics reagents have barcode labels. After the barcode reader scans the barcoded rack ID, it scans the barcode label on each reagent vial loaded in the rack.8 Resolving Barcode Read Errors Oh dear!  In our virtual lab, the barcode reader could not identify all of the reagents in the rack! If this happens, the analyzer ejects the rack and the Loading screen automatically appears. On the Loading screen, you can identify the position of the reagents that need to be manually identified. You can see that positions 2 and 5 indicate unknown reagents. Select Next to continue. Oh dear! In our virtual lab, the barcode reader could not identify all of the reagents in the rack! On the Loading screen, you can identify the position of the reagents that need to be manually identified. 9Resolving Barcode Read Errors Let’s investigate why the barcodes were not read properly… On position 5, the vial is turned so that the barcode scanner could not read the barcode. To resolve the problem, we can turn the reagent vial in position 5 so that the barcode shows through the rack window, and then reinsert the rack.  But, why didn't the barcode reader read the reagent in position 2? Select Next to continue.   Tip: When resolving barcode read errors, make sure you examine the correct reagent position! Position 1 goes into the analyzer first; position 5 goes in last.Let’s investigate why the barcodes were not read properly…perhaps the barcode labels were smudged….or…look! On position 5, the vial is turned so that the barcode scanner could not read the barcode. That’s easy to resolve…but why didn’t the barcode reader read the reagent in position 2? 10 Resolving Barcode Read Errors We can see that that barcode label for the Pathromtin SL (PSL) reagent in position 2 is scratched. To resolve the problem, you can: Print a new barcode label. Identify the reagent to the system manually. Let’s identify the reagent manually… Select Next to continue. Hmm…we can see that that barcode label for the Pathromtin SL (PSL) reagent in position 2 is scratched. Let’s identify the reagent manually… 11 Manually Identifying Barcoded Reagents To identify a barcoded reagent manually, examine the barcode label to confirm the reference number (reagent ID) and lot number: The first four digits represent the reagent ID. The fifth and sixth digits represent the lot number. The seventh digit represents the vial size. The last digit is a check digit. We need to manually identify PSL with reagent lot number 523719 to the system. Select Next to continue. To identify a barcoded reagent manually, examine the barcode label to confirm the reference number (this is the reagent ID) and lot number.12 Manually Identifying Barcoded Reagents On the Loading screen, in the Racks area on the left, click rack position 2 with the unidentified reagent. On the Loading screen, in the Racks area on the left, select position 2 with the unidentified reagent.13 Manually Identifying Barcoded Reagents In the Loading info area on the right, select the PSL reagent with reagent lot number 523719.   Slide QuestionAnswer TextWhat happens if the reagent lot number is missing from the list?Reagent lots that do not appear in the Loading info area, have never been loaded onto the analyzer before. You must use the Lot numbers dialog box to enter the new lot number manually, or import it from the Lot File database.  Please refer to the Customizing the BCS® XP System online training course for more information about using the Lot numbers dialog box to enter a new lot number.Tip: Do you see that rack position 2 is outlined and highlighted? This shows that it is selected. In the Loading info area on the right, select the PSL reagent with reagent lot number 523719.14Manually Identifying Barcoded Reagents This reagent is a GW5 vial. What should you do next?Slide QuestionAnswer Text What should you do next? Hint: Click the Adapter arrow (this has already been done for you), and then click with to indicate that the reagent is a GW5 vial loaded into a rack position with an adapter. This reagent is a GW5 vial. What should you do next?15 Manually Identifying Barcoded Reagents Everything looks good…click Insert.   Slide QuestionAnswer Text What reagent management task is being performed when you identify a reagent to the system manually? When you click Insert, the system stores the data directly in the data file. Now the BCS® XP system can read appropriate reagent settings to provide accurate reagent inventory statistics.Everything looks good…click Insert.16Manually Identifying Barcoded Reagents Then, insert the rack into the analyzer so you are ready to process the samples on the “virtual” Job List screen. Select Next to continue. Note: After loading reagent racks, the BCS® XP immediately checks the available volume for each vial loaded onboard.Then, insert the rack into the analyzer so you are ready to process the samples on the “virtual” Job List screen.17Checking Reagent Inventory In our virtual lab, we are viewing the Job List screen waiting for results… While we wait, let’s check reagent inventory. What should you do? Slide QuestionAnswer TextWhat should you do? HintClick the Reagent Overview button in the navigation bar.In our virtual lab, we are viewing the Job List screen waiting for results… While we wait, let’s check reagent inventory. What should you do? 18 Checking Reagent Inventory The Reagent Overview screen allows you to manage reagent volumes so that you can process all the samples on the Job List as efficiently as possible. You’ll find the following information about each reagent: Reagent volume available per vial Total reagent volume available in all vials of the same reagent and the same lot Total reagent volume required to process all tests on the Job List that require that reagent. Remaining onboard stability time per reagent vial Select Next to continue.The Reagent overview screen allows you to manage reagent volumes so that you can process all the samples on the Job List as efficiently as possible.19Checking Reagent Inventory Bravo! You are now ready to process the samples on the “virtual” Job List screen. Select Next to continue.  Note: After loading reagent racks, the BCS® XP immediately checks the available reagent loaded onboard the analyzer and updates the Reagent Overview screen. Bravo! You are now ready to process the samples on the “virtual” Job List screen.20Congratulations You’ve just learned how to perform the following reagent loading tasks: Load barcoded reagents. Resolve barcode read errors. Manually identify barcoded reagents using the Loading screen. You also identified reagent data management tasks while loading reagents, such as manually identifying barcoded reagents and checking reagent inventory.When complete, select the X in the upper-right corner to close the window and continue.Congratulations You’ve just learned how to perform several reagent loading tasks and reagent data management tasks. Reagent Loading Tips Learn about reagent loading tips. Reagent Loading Tips If you placed more than one reagent vial from the same lot on the instrument, the vial that expires first will be used up first. If possible, load one empty reagent rack. You can then use this rack to load new reagents-no waiting time! You must place cooled reagents that are dispensed by the sample probe in Lanes 3 or 4, such as sodium chloride or SCS cleaner for ATIII. When complete, select the X in the upper-right corner to close the window and continue.  Quick Guide: Reagents, Racks & Lanes Learn about the Quick Guide for loading Reagents, Racks, and Lanes. Quick Guide: Loading Reagents  Refer to the following chart when loading reagents. Reagent Rack Type Loading Lanes Cooled reagents no. 30 Lanes 1 – 4 Other reagents no. 50 Lanes 5 - 14 Standards, controls, deficient plasmas no. 50 Lanes 5 – 14 Diluent no. 30 Lanes 3 or 4 Stirred reagents no. 30 position 4 Lanes 1 - 4 no. 50 position 2 Lane 5   When complete, select the X in the upper-right corner to close the window and continue.