CentraLink Data Management System ™ CentraLink™ Data Management System Operator’s Guide 11222683 Rev. A 2016-11 © 2016 Siemens Healthcare Diagnostics. All rights reserved. No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Siemens Healthcare Diagnostics. ADVIA, ADVIA Centaur, ADVIA WorkCell, Aptio, BCS, CentraLink, CLINITEK Atlas, Dimension Vista, INNOVANCE, LabCell, and VersaCell are trademarks of Siemens Healthcare Diagnostics. syngo is a trademark of Siemens Healthcare GmbH. The HCV (aHCV) assay is developed, manufactured, and sold by Siemens Healthcare Diagnostics for Ortho-Clinical Diagnostics, Inc. All other trademarks and service marks used in this document are the property of their respective owners. 11222683 Rev. A 1 Introduction Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Using the Electronic Version of this Guide . . . . . . . . . . . . . . . . . . . 9 System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Lab Information Systems (LIS). . . . . . . . . . . . . . . . . . . . . . . . . . . . Lab Automation Systems (LAS) . . . . . . . . . . . . . . . . . . . . . . . . . . . Automation System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Manager Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Recommended Startup Sequence . . . . . . . . . . . . . . . . . . . . . . . . . 11 11 12 12 12 13 Logging On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Using the Workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using the Toolbar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using ToolTips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using Browser and Editor Windows . . . . . . . . . . . . . . . . . . . . . . . Selecting and Deselecting Records . . . . . . . . . . . . . . . . . . . . . . . . Using Double-Select and Context Menus . . . . . . . . . . . . . . . . . . . Sorting Columns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scrolling to a Data Item . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tips on Using the CentraLink Software . . . . . . . . . . . . . . . . . . . . . 2 14 16 17 17 17 17 18 19 21 21 System Operation Viewing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53 CentraLink System and the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . Uploading QC results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . Multiple LIS Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Uploading QC results to Multiple LIS . . . . . . . . . . . . . . . . . . . . . . . Physicians, Patients and Patient Locations . . . . . . . . . . . . . . . . . . CentraLink System and the LAS . . . . . . . . . . . . . . . . . . . . . . . . . . . LAS Test Availability Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 57 59 61 62 63 66 Result Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67 Accessing the Review and Edit Window . . . . . . . . . . . . . . . . . . . . 67 Using the DiffPad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Accessing the Hematology Review and Edit Window . . . 123 Sample Information Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124 11222683 Rev. A page 3 Image Result Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 Customizing Test Group Column . . . . . . . . . . . . . . . . . . . . . . . . . 128 Result Comments Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 Flags Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Manually Entering a Workorder . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Accessing Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Accessing Physician Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 3 Quality Control Understanding Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . 139 4 System Configuration Configuring Test Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 179 Creating a Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198 Creating a Tool Button or Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . 199 Configuring a LIS Channel . . . . . . . . . . . . . . . . . . . . . . . . . . 203 General Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203 Patients Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204 QC Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206 FTP Settings Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207 Defining a LAS Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207 Connecting CentraLink to an Aptio Automation System . . . . . . 207 Configuring the LAS System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 Configuring LAS Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 Relative Routing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209 Instrument Targeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215 Configuring Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216 Creating or Modifying Instrument Groups . . . . . . . . . . . . . . . . . 234 Configuring Instrument Tests (Methods) and Flags . . . . . . . . . . 235 Configuring Menus Using MISPL . . . . . . . . . . . . . . . . . . . . . . . . . 254 Setting Up Coding Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255 Configuring Patient Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . 259 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260 Sample Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260 QC Population Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260 QC Lot Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261 QC Result Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261 page 4 11222683 Rev. A The Report Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Generating Enhanced (Jasper) Reports . . . . . . . . . . . . . . . . . . . . Configuring Colors on Browsers and Windows . . . . . . . . . . . . . . Defining Print Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 System Management Setting Up Users and Security . . . . . . . . . . . . . . . . . . . . . . . . . . . Assigning Roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Auditing Database Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checking Log Files and Starting and Stopping the Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using the Log Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Understanding the Watchdog Service and Dashboard . . . . . . . . Configuring the Watchdog Service and Dashboard . . . . . . . . . . Checking Database Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scheduling Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Backing Up and Restoring the Software . . . . . . . . . . . . . . . . . . . Selecting and Adding Languages . . . . . . . . . . . . . . . . . . . . . . . . Printing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Customizing the Toolbars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 262 268 270 270 273 279 283 288 289 292 298 305 308 310 312 314 315 Troubleshooting Siemens Remote Service. . . . . . . . . . . . . . . . . . . . . . . . . . . 321 Accepting a Request for Remote Control Session . . . . . . 321 Disconnecting a Siemens Remote Service Connection . . 322 Appendix A: Contacts . . . . . . . . . . . . . . . . . . . . . . . . . 323 Appendix B: Open Source Copyright Information . . 325 Copyright Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 Appendix C: Effects of Control Reported Decimals on Instrument QC Results . . . . . . . . . . . . . . . . . . . . . . . . 331 Numeric Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331 String Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Uploading Patient Samples to the LIS . . . . . . . . . . . . . . . . . . . . . Mean and SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Target Value and Target Deviation . . . . . . . . . . . . . . . . . . . . . . . 11222683 Rev. A 331 332 335 336 page 5 Appendix D: Using the CentraLink System with Aptio Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337 Aliquot and Recapper Modules . . . . . . . . . . . . . . . . . . . . . . 337 Support for LIS Aliquot Requests . . . . . . . . . . . . . . . . . . . . . . . . . 338 LIS Aliquot Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339 The Rack Output Module . . . . . . . . . . . . . . . . . . . . . . . . . . . 339 The Slave Input/Output Module . . . . . . . . . . . . . . . . . . . . . 340 Aptio Desealer Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 340 Setting Automatic Deseal Time . . . . . . . . . . . . . . . . . . . . . . . . . . 340 The Bulk Input Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341 Aptio and ADVIA 2120i System Integration . . . . . . . . . . . . 342 Disabling ADVIA 2120i System Tests . . . . . . . . . . . . . . . . . . . . . . 342 Sample Tube Workflow Overview . . . . . . . . . . . . . . . . . . . . . . . . 342 Scheduling and Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343 Unreadable Barcode MISPL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343 Processing STAT Tubes on the ADVIA 2120i System . . . . . . . . . . 344 Workflow for ADVIA Autoslide Slide Maker Stainer. . . . . . . . . . . 345 Sysmex CS Instrument Connectivity. . . . . . . . . . . . . . . . . . 345 Configuring QC Lots for Sysmex CS Instruments . . . . . . . . . . . . 346 Transmitting Tube Inspection Module Information to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346 Rebooting the CentraLink Server . . . . . . . . . . . . . . . . . . . . 346 Automatic Enabling and Disabling Methods . . . . . . . . . . . 347 Disabling a Method in CentraLink to Prevent Reagent Updates from Re-enabling the Method . . . . . . . . . . . . . . . 348 Appendix E: ISLH Consensus Rules . . . . . . . . . . . . . . . 349 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349 Three Parts of the Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349 Configurable Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 350 Optional Configurable Parameters . . . . . . . . . . . . . . . . . . . . . . . 350 Key Implementation Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 352 Appendix F: UIW Driver for ADVIA XPT Systems . . . . 355 page 6 11222683 Rev. A Dilution Download for Centaur XPT . . . . . . . . . . . . . . . . . . . . . . 355 Dilution Download for Chemistry XPT . . . . . . . . . . . . . . . . . . . . . 355 Ordering Dilutions in the CentraLink User Interface . . . . . . . . . . 355 Rerunning a Test with a Dilution . . . . . . . . . . . . . . . . . . . . . . . . . 356 Manual Dilutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 356 Preliminary Results Limitations and the ADVIA Centaur XPT System 357 Preliminary Results and the ADVIA Chemistry XPT System . . . . . 358 Preliminary Results and the CentraLink System . . . . . . . . . . . . . 359 Retransmission of Results (Centaur XPT). . . . . . . . . . . . . . . . . . . 359 Unresulted Test Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 360 Patient Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 360 Instrument Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361 System Features Not Supported . . . . . . . . . . . . . . . . . . . . 361 Support for Infectious Disease Testing . . . . . . . . . . . . . . . 362 ELF Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364 11222683 Rev. A page 7 page 8 11222683 Rev. A Introduction 1 Introduction Intended Audience This CentraLink ™ Data Management System Operator’s Guide is to be used for the following tasks. • Daily tasks such as reviewing instrument data from a workstation, managing automated data review, and releasing results of patient test samples. • Configuring and monitoring the software. Using the Electronic Version of this Guide 1. Select Help on the CentraLink system help menu. Adobe Reader opens and displays the operator’s guide. The Table of Contents displays in the left pane on the window. 2. Access the full text search feature by selecting the binocular icon. 11222683 Rev. A page 9 Introduction System Overview The CentraLink system is a multi-system data manager for instruments and lab automation systems (LAS). It consolidates data from connected instruments so that you can review and manage patient and quality control results from a single location. Figure 1-1: 1 2 3 4 5 CentraLink System Components Lab Automation System (LAS; 1 or more) Lab Information System (LIS; 1 or more) CentraLink workstations Connected instruments CentraLink Server The CentraLink system receives workorders from the LIS and downloads them to the LAS. The instrument queries the CentraLink system for specific bar-coded sample IDs containing specific test requests. When tests are completed for a sample, the instrument sends the results to the CentraLink system. Normal results can be automatically validated and sent to the LIS. page 10 11222683 Rev. A Introduction Lab Information Systems (LIS) You can configure the CentraLink system to communicate with 1 or more Lab Information Systems (LIS). See Configuring a LIS Channel on page 203. You can also configure each LIS communication to have 1 or 2 channels. • In a two-channel configuration, one connection is designated for downloading test orders from the LIS and the other is designated for uploading results from the CentraLink software. • In a one-channel configuration, data is uploaded and downloaded using a single connection. Use the LIS software to manage: • Order entry • Long term result storage • Reporting • Sample location information Lab Automation Systems (LAS) After downloading workorders from the LIS, the CentraLink software automatically downloads these workorders to the LAS. Upon sample checkin to the LAS, and during the physical routing of samples to the instruments, Sample Managers, and Cold Storage for archiving, LAS status update messages are uploaded to the CentraLink software to provide accession and sample location information. You can also manually query the LAS for sample location information. When multiple LAS are configured, the system downloads all workorders and queries to both LAS. If one LAS is temporarily not accepting orders, the CentraLink system sends the orders after the connection is reestablished. The CentraLink software receives updates from both LAS upon a LAS status update. System Specific Information The CentraLink system supports ADVIA® Automation systems and Aptio ™ Automation systems (LAS). If you are using CentraLink software within an ADVIA Automation system, your lab can have several different workstations each running different applications. Operators can perform daily operations using other applications within these automation systems. 11222683 Rev. A page 11 Introduction Communications protocols support messaging between the CentraLink software and ADVIA or Aptio Automation systems, and indicate whether a configured test is currently available on a particular instrument. Automation System Software Use the automation software to: • Identify and resolve samples that have processing problems on automation system. • Correct routing status. • Manage sample tray input and output: • Direct sort trays to offline laboratories to complete processing. • Determine where sample trays are stored after processing. • View tray and rack contents • Query for the current location and the processing status of samples. • Handle errors and troubleshooting. • Manage which components are currently online and offline. • Manage CentraLink software to automation computer status. Operator Functions • Reviewing data for multiple instruments from any CentraLink system workstation • Managing automated data review and result release of patient test samples • Customizing laboratory-specific criteria for flagging, delta check, and auto-reflex and repeat testing • Viewing ADVIA Hematology system cytograms and histograms • Performing manual result entry • Managing Quality Control (QC) • Generating QC reports System Manager Functions page 12 • Verifying that initial settings are properly configured for instruments, tests, patients, physicians, QCs, and related data • Adding new users • Setting up security for all users • Customizing CentraLink software toolbars • Monitoring communication with the LIS, LAS, and instruments 11222683 Rev. A Introduction • Monitoring instrument and QC status • Backing up and restoring the system • Managing locked-out users Note MISPL is a programming language included with the software which allows you to customize and automate CentraLink system functionality. Consult with your local technical support provider to determine how to best implement MISPL functionality. Recommended Startup Sequence Siemens recommends that you start the CentraLink software services by using Start > System management > Services > Startup. If you manually start the CentraLink services, do so in this order: 1. Service Controller 2. Watchdog service 3. Report Builder Service (if applicable) 4. Message Queue without depending Queue Processors (if applicable) 5. Java Communications Engine (if applicable) 6. Internal services 7. Translators 8. Task scheduler services 9. Queue processors (if applicable) Logging On and Off 1. Double-select the CentraLink icon on the desktop. The Login window displays. 2. Enter your user ID and password in the Login window. See your CentraLink system administrator to obtain a user ID. If the CentraLink software is already running at a workstation, the current user name displays on the status bar. Note When you log in for the first time you must select a role. For more information see Assigning Roles on page 280. 3. To log off the system, select Start > Exit. 11222683 Rev. A page 13 Introduction Note If you do not interact with the system within the 15-minute timeout period, your session expires and you must log back in. You can change this setting in the Authorization Timeout field of the User window. Using the Workspace Figure 1-2: CentraLink Workspace 1 Menu bar 2 Editing toolbar 3 Function toolbar 4 Workspace 5 Status Bar The Menu Bar displays the CentraLink software menus. Menu items vary depending on the windows open in the workspace. For example, the Record menu is not active until a window, such as the Samples window, is open. The items on the Edit menu (Cut, Copy, Paste) are active for an open window. The Editing toolbar contains icons for common tasks (Open, Save, Find Data) that apply to an open window. The Resize active window icon enables you to resize windows and browsers. For more information, see Resizing Windows on the Workspace on page 15. The Function toolbar contains icons for commonly used functions. Each function opens a window. The first group of functions on the toolbar are also on the Start > Routine menu. page 14 11222683 Rev. A Introduction The Workspace Area is where open windows are displayed. You can work on multiple open windows simultaneously with other users on other workstations. The Status bar displays messages, the workstation name, and the current user. Resizing Windows on the Workspace 1. Select the title bar of the window you wish to resize. 2. Select Resize active window. The title of the window changes and a border displays. Drag the black border box to the required size. To resize a column, select the column header border and drag to the required size. 3. To save the changes after you resize the window, select the Resize active window icon. The resized windows maintain the new size specifications between CentraLink sessions for that user. To restore the default window size, double-select the frame title bar. 11222683 Rev. A page 15 Introduction Using the Toolbar When you start the CentraLink system, only the menus and toolbars display. Use the toolbar to start your work, such as reviewing and editing results or checking QC. The toolbar contains the most frequently used functions. You can also create toolbar icons for specialized functions. For more information, see Creating Tools on page 198. Scroll the mouse over the toolbar to view the name of each operation. Figure 1-3: page 16 CentraLink System Toolbar 1 Instruments 2 Tests 3 Order Entry 4 Patients 5 Physicians 6 Samples 7 Review and Edit 8 Results Entry Grid 9 QC Across Controls View 10 System Manager Functions 11222683 Rev. A Introduction Using ToolTips ToolTips provide quick help on any toolbar button, field, or window button. Rest your mouse pointer over any item to activate a ToolTip. Using Menus The menus on the top of the CentraLink system window contain functions that you can use as an alternative to using the toolbar. A menu item with a right-arrow indicator contains submenus. Note After selecting a specific menu option, you might have to select Related prior to seeing the display of your menu choice. After you select a menu item or toolbar icon, the workspace displays a window appropriate for the function you selected. The main functions for routine operations can also be initiated as on the menu bar by selecting Start > Routine. Using Browser and Editor Windows The CentraLink system displays two types of windows: • Browser windows display information in a list format. You cannot enter data in browser windows. • Editor windows contain fields that allow you to enter data. Click OK to submit this data. You cannot enter data in greyed fields. A browser window is updated by inputting data to its corresponding editor window. Shortcut keys are associated with different types of windows. For more information, see Using Keyboard Shortcuts on page 20. Selecting and Deselecting Records To select one or more records: 1. Navigate to each record individually, highlight the record with your cursor, and select the record by pressing the keyboard’s space bar. When you select a record, the greater-than symbol, (>), populates the left-most column. 2. On the Editing toolbar, select Select All. 3. On the Menu bar, select Record > First to current. The first record in the list to the highlighted record are selected. 11222683 Rev. A page 17 Introduction 4. On the Menu bar, select Record > Current to last. This selects from the current highlighted record in the list to the last record. To deselect one or more records: 1. Navigate to each record individually, highlight the record with your cursor, and deselect the record by pressing the keyboard’s space bar. 2. On the Editing toolbar, select Deselect All. On certain browser windows, you can update multiple records at the same time by selecting the appropriate records and executing a given command or function. If you attempt to execute a command or function on multiple selected records in a browser window and another row is highlighted, but not selected, a message displays warning that the current record is not selected. If you select Yes to continue, the selected records are updated; the highlighted record is not updated. This warning message is not displayed if you attempt to execute a multirecord set command or function at the Review and Edit window or at the QC Across Controls View window. Configuring Browser Colors See Configuring Colors on Browsers and Windows on page 270. Using Double-Select and Context Menus • For additional information about an item, double-select it. For example, if you double-select a sample in the Samples window, the Order Entry window displays. • To take additional action on an item, right-select the item and choose a function from the context menu. Note Functions on the right-select menu also display on the main CentraLink system context menu. Depending on the window that is open, a different menu may display in place of the context menu. If a window is not open, the context menu is empty. page 18 11222683 Rev. A Introduction Sorting Columns You can sort columns on many system windows and browsers. To sort columns in ascending order, select the column-header. To sort in descending order, double-select the column-header. A column that has been sorted in descending order displays a downward-pointing arrow, and if sorted in ascending order displays an upward-pointing arrow. Some columns cannot be sorted. When you select on a column that cannot be sorted, an informational message displays. Using the ? Symbol Placeholder The ? (question mark) symbol can have different meanings depending on the field and window in which it displays. Before making changes to a field that contains the ? symbol, ensure that you understand the acceptable values. To use the ? symbol placeholder: 1. Rest your mouse on a field that contains the ? symbol. 2. If your cursor changes to a hand shape, double-select the ? symbol. Another window opens with a list of acceptable data for the field. For example, when you double select the Method test field on the QC Population window, the Tests browser window displays. When you double-select the appropriate test, the Instruments for test window displays. Once the appropriate instrument is selected, the QC Population editor window re-displays, and the Method test field contains the selected test and the Method instrument field contains the selected instrument. 3. If your cursor changes to an I-beam shape, you can type into the field. An example of this is the I-beam cursor in the Sample ID field of the Order Entry window. If the field is not required, the ? symbol is a default value, and you do not have to change it. In some cases, such as search queries, the ? symbol is an indication that the system does not use the field to filter results. Note In some cases, the ? symbol is necessary if no entry is made in a field. Removing the ? symbol and leaving the field blank can cause warnings to be displayed. 11222683 Rev. A page 19 Introduction Using Keyboard Shortcuts Window Any Browser Editor Field Reference Fill-in Log Viewer page 20 Keyboard Keys to Press F10 F4 F2 ESC INSERT F5 F6 CTRL + F <Space> ENTER, <double-select> TAB SHIFT + TAB F7 SHIFT + <Arrow> CTRL + C CTRL + X CTRL + V CTRL + F F6 <Up arrow> <Down arrow> CTRL+ E CTRL+ R CTRL+ G Description of Action Places active keyboard control on the Start selection of the main menu Displays the right-select menu Submit and proceed Cancel and proceed Call editor for create Refresh current query Call editor for update Call Find dialog Toggle selection In lookup mode: return record, otherwise call editor for update Advance to next field or button Backup to previous field or button Go to the first empty field Select Copy selection Cut selection Paste selection Call browser for lookup Zoom (call Editor) Previous alternative Next alternative Deletes the text after your cursor Recall (Undo CTRL + E) Jump to line 11222683 Rev. A Introduction Scrolling to a Data Item If you know the name or ID of a sample, patient, physician, or other data item, you can display the information by typing it into a field on the appropriate window rather than scrolling through a long list: 1. Open the appropriate window. For example, select Patients on the toolbar. The Patients browser window displays. 2. Put your cursor in Last Name on the Patients browser window. Do not select the entry. 3. Type the data item that you want to access. For example, type Smith to access a patient named Smith. As you type, the browser scrolls to the first match. Tips on Using the CentraLink Software • If you initiate a database query and the system remains unresponsive, you can cancel the query by pressing CTRL+BREAK. This action may stop the database and close the CentraLink software. WARNING Do not press CTRL + ALT + DEL. To shorten query time, restrict the search parameters by providing the known search criteria. 11222683 Rev. A • If several windows are open, use the Active Window to Foreground and Active Window to Background icons on the toolbar to display the appropriate window. • Use the Find function (the Binocular icon on the toolbar) to find a specific test, sample type or other data. You can enter only alphabetical text in the Find window; numbers are not accepted. page 21 Introduction page 22 11222683 Rev. A 2 System Operation This chapter outlines many common practices you may be required to perform while running tests and evaluating data. Viewing Samples Each sample consists of one or more test requests. The status of a sample is the same as the lowest status of a test request within the sample. For example, if a sample has 10 tests and one test request has a status of Pending, the sample status is Pending. Understanding Sample ID and Patient ID Sample IDs and patient IDs must be unique for all LIS connected to the CentraLink system. A Patient ID common to more than 1 LIS must reference the same patient. Note If sample IDs are reused without first being deleted from the system, the results for the new physical sample merge with the results of the original, different physical sample. Sample IDs must be deleted from the database before they are reused. See Understanding the Sample Reuse Period on page 25. The first step in ensuring that sample IDs are deleted before reuse is to purge the database. Purging the Database Select Start > System management > Database > Purge data, or select Purge on the Sample Status overview screen. CAUTION Do not perform a manual purge unless absolutely necessary. System performance may be significantly degraded. It is strongly recommended to automatically purge on a regular basis. Contact your local technical support provider to schedule a purge task when the system is least busy or not processing results. Purging the sample database removes: 11222683 Rev. A • Samples marked for deletion. • Samples with status Uploaded, Omitted, and Unknown. • Temporary files which exceed the Maximum temporary file age defined in the General tab of the Options window. page 23 System Operation Samples in Pending, Rerun, Scheduled, Validated and Review status have active workorders and outstanding test requests, and their sample IDs should not be purged. Note If your site processes more than 10,000 samples per day, contact your local technical support provider to configure the purge command to run more than once. If you select Purge data, samples marked for deletion are removed first. Note The Purge data button, like many other CentraLink functions, can be protected so that it is restricted to certain users. Marking Samples for Deletion To mark a sample for deletion, right-select it and choose Mark for Deletion. Samples which have been marked for deletion will display a red flag icon with an X in the center if you open them in the Review and Edit, Hematology Review & Edit or Order Entry windows. This sample is immediately available to be purged. When a sample is marked for deletion: • If an instrument sends a result message, then the existing sample will be deleted and the SID in the message will be treated in the normal manner (as an unsolicited sample). • If an instrument queries for the sample, then the query will not pick up the sample. The sample will not be deleted. • If the LIS sends a new order for an SID or updates an SID which is marked for deletion, the existing sample will be deleted and a new order will be created. • If the LAS sends any type of message which references this sample, then the existing sample will be deleted and a new one will be created with the same SID. • Even if the sample needs dispatching to the LAS it will not be eligible for an actual dispatch. The sample will not be deleted. Purging Patient ID and Retaining Unique Patient IDs You can set up automated Patient ID purging. For details on manual purging, see Manually Purging Data from the Database on page 307. page 24 11222683 Rev. A System Operation The LIS is considered the master system from which the most current data originates, so the CentraLink software always accepts updates to patient records from the LIS. Every patient demographic update that is downloaded from the LIS to the CentraLink software must be identified by a unique patient ID that references the same physical patient. WARNING Do not reuse patient IDs. If you reuse a patient ID, patient demographic updates downloaded from the LIS overwrite the original associated patient details. An erroneous mix of patient details would coexist in the same record of the CentraLink database with patient details unrelated to the original physical patient. Upon download, the LIS should always send valid, populated values within the following fields: Patient Age, Patient Gender, and Patient Name. Note Physician, Patient and Patient Location fields cannot be edited without first specifying an LIS Channel. The LIS must be able to assign different sample IDs to different sample types for the same patient, and send them to the CentraLink system as different workorders. The LIS must also be able to separate different sample types into different workorders. Most often, the LIS specifies the sample type in the workorder. If the sample type is not included in the workorder, the CentraLink system applies the sample type for the first test in the workorder to the entire workorder. Understanding the Sample Reuse Period The sample reuse period is the number of days in which you retain a sample in your lab after the first sample result is generated, or test is ordered. The CentraLink software does not accept or save results for existing sample IDs after their sample reuse period expires. A comment is added to the sample indicating that the reuse period has been exceeded. The sample must be deleted from the CentraLink database before any results are accepted for that SID. Note Only 1 comment is recorded for a sample whose reuse period has expired. For example, if a sample has 3 test requests, and a comment has been added for the first result, none are added to the remaining tests. 11222683 Rev. A page 25 System Operation If your lab requires that you reuse a sample ID for a sample which exceeded the sample reuse period, upload the sample results to the LIS. This changes the sample status to Uploaded. The next time the Purge function is initiated, the sample ID is deleted from the database along with other sample IDs in status Uploaded, Omitted, and Unknown, as well as those that were marked for deletion. After the sample reuse period has elapsed and the sample ID is purged from the system, it can be reused in the CentraLink software. Note If an instrument query occurs after the sample reuse period expires, the orders will still be downloaded. For more information about sample reuse period, see Configurable Sample Reuse Period on page 99. To ensure the proper maintenance of the unique sample ID and patient ID environment, define a relevant sample reuse period and contact your local technical support provider to configure and schedule regular Purge and Omit tasks. Automatically Generating a Sample ID Select SID on the Order Entry screen to automatically generate Sample IDs. This button is only active when the SID-generator is active. When you select SID: 1. The Sample ID is checked for uniqueness. • If it is unique, it is accepted • if it is not unique, it is rejected, and a new Sample ID is requested. 2. If no Sample ID is specified then 2 possible scenarios apply: • SID-generation is not active, and the input will be blocked until a valid SID has been entered manually. • SID-generation is active, the CentraLink system will commit the order for the sample and generate a unique Sample ID. After committing the sample to the database, a message displays: SID '<generated SID>' has been generated The message is for informational purposes only and includes an OK button. When you select OK or Enter, the message disappears. The following message at the bottom of the CentraLink screen displays whenever an order is entered manually: Sample with Identifier <SID> committed page 26 11222683 Rev. A System Operation During data entry, you can always view the last 2 SIDs that have been entered, in the message area at the bottom of the CentraLink window. Sample Status Life Cycle The status of a sample is the same as the lowest test status within the sample. In the following example, the sample must be sent to 2 instruments: • Upon receiving an order from the LIS, all requests in the sample record are created in status Pending. The sample status is set to Pending. • The sample is transported to its first target instrument. The instrument queries the CentraLink system and receives part of the original workorder in return. Some requests are promoted to Scheduled, but the overall sample status remains Pending. • The first instrument uploads results. The scheduled requests are promoted to Review status, but the sample status remains Pending. • Some requests are automatically validated based on low severity assignments. These requests are promoted to Validated status, but the sample status remains Pending. • The sample is transported to its second and final target instrument. Upon query to the CentraLink system from the instrument, all requests still in Pending status are promoted to Scheduled status. When all requests are scheduled, the sample status is promoted to Scheduled. • The second instrument uploads results. Upon result upload, the sample status is changed to Review. • During a Review and Edit session, all requests still in Review status can be validated and then uploaded to the LIS. Once all requests are validated and uploaded, the sample status is promoted to Uploaded. Browsing All Samples To view a list of all samples in the database by sample ID, patient ID, collection date/time and physician ID, access the Samples browser window: • On the menu bar, select Start > Routine > Samples > Browse. or • 11222683 Rev. A Select the Samples icon on the toolbar menu (at left) and then select OK on the Sample query window. page 27 System Operation Viewing the First, Previous, Next, and Last Sample Use toolbar buttons to move through the selected set of samples and display the corresponding Review and Edit window for each sample: Name Description First Review and Edit: Displays the first sample record. Browser: Positions the cursor on the first sample and highlights it. Previous Review and Edit: Displays the previous sample record. Browser: Positions the cursor on the previous sample and highlights it. Next Review and Edit: Displays the next sample record. Browser: Positions the cursor on the next sample and highlights it. Last Review and Edit: Displays the last sample record. Browser: Positions the cursor on the last sample and highlights it. Note When the Auto-skip feature is enabled, sample records that would otherwise appear with no test requests on the Review and Edit window due to restrictions set by specifying a filter view are skipped when you select the Next page/Previous page or Next record/Previous record icons on the toolbar. For more information, see Auto Skipping Unmatched Sample Records on page 95. Viewing Previous Samples of Patient For an overview of the previous samples for the same patient which have some or all tests in common, on the Samples browser right-select a sample and choose View previous samples of patient. The following restrictions apply: page 28 • This function cannot be executed when there is no patient associated with the selected sample. • Samples without a collection time are excluded. • Only samples with the same sample type as the selected sample or without a sample type are displayed. 11222683 Rev. A System Operation • Only tests that have been performed on the selected sample will be displayed. Tests that were performed on any of the previous samples, but not on the selected sample, will not be shown. Viewing Previous Runs To see an overview of the previous runs of the selected sample, right-select the sample and select View previous runs. Only local results will be displayed. The Previous result origin setting is not taken into account. All tests requested on the selected sample will always be displayed for all runs on the screen even if there was no result during a run. The header and footer that are used for the overview are taken from the report model that is also used for the Sample: Report function. The Validation user and Validation time will only be displayed if there are validated results to be displayed, and they will only be shown for the current run. Flags that have the Report option unchecked will still be displayed in this screen. The Severity and Status columns will only be displayed for the current run. You cannot print reports from the Sample View Previous Runs or Sample View Previous Samples Patient screens. Note In software version 16 and later, you can view the number of previous runs on the Review and Edit screen in the Number of previous runs (#PR) column. Querying Specific Samples The CentraLink system database may contain 30,000 samples per connected instrument, and you may want to view only a subset of samples based on specified criteria. Use the selection criteria on the Sample Query window to restrict the samples that are displayed. Leaving a ? symbol in a field indicates that the field is not used to filter the record set the query returns. You have the option of viewing your query results in standard data view or alternate data view: • 11222683 Rev. A Selected samples with standard data view. The listed data includes sample ID, priority, patient ID, collection date/time, physician ID, and status. page 29 System Operation • Selected samples with alternate data view. The listed data includes Sample ID, Priority, Patient ID and name, Status, LAS channel, LAS general area, LAS specific area, LAS tray ID/LAS lane, LAS tray position, and LAS time. Regardless of the view in which you want to see your sample result set, you can enter search criteria by setting one or more of the fields on the Basic and Advanced tabs of the Sample Query window. In addition to entering criteria manually on the Sample Query window, your System Manager can create a preconfigured button in the toolbar. For more information, see Creating a Tool Button or Icon on page 199. To access the Sample query editor window from the menu bar, select Start > Routine > Samples > Query. The Basic tab of the Sample query window displays the following fields: Field Description Sample ID When this value is specified, only one sample can be returned by the query. The CentraLink software supports Sample IDs with a maximum of 32 characters. All sample IDs must be unique. LIS Channel This setting allows you to select samples with the specified LIS channel as requesting LIS. LAS Flag reject results This setting allows you to select samples with a sample flag that matches the one specified. At least one test in Status Select this checkbox to select samples with at least one test in a particular status. For example, if you select this checkbox and select REV in the Minimal Status field, all samples with at least one test in REV status appear on the Sample browser window. If you do not select this checkbox, only samples having a sample status that corresponds to the search criteria in the Minimal status and Maximal status fields appear on the Sample browser window. page 30 11222683 Rev. A System Operation Field Description Related Sample Requests Use this drop-down menu to view secondary samples requested from a primary sample (and vice versa). Enter the primary SID and select Aliquots from the Related Sample Requests drop-down menu to view the primary sample and all requested aliquots. Enter the secondary sample SID and select Primary sample from the Related Sample Requests drop-down menu to view the requested secondary sample and the primary sample. Note This functionality only applies to secondary samples created as a result of an LIS aliquot request. 11222683 Rev. A page 31 System Operation Field Description Minimal status and Maximal status This setting restricts the eligible sample statuses to a from and to range. All samples with a status between the Minimal status and Maximal status are returned. For example, if PND and REV are selected in those fields, all samples with PND, SCH, RRN, REV statuses are returned. When the At least one test in Status field is selected and the Minimal status and Maximal status fields are populated, then all samples with at least one test in the status range are returned to the Sample browser window. When you enter a Minimal status value, the Maximal status field is automatically assigned the same value. When you enter a Maximal status value, the Minimal status value is not affected. The Maximal status field value automatically changes to Validated (VAL), when any restrictions are provided on the following: Instrument or Instrument Group; Test or Test Group; Aspiration From and To dates. You can modify this automatically populated value of VAL to any other status value including the ? symbol. No Maximal status value is required when the At least one test in Status checkbox is selected. Note Exercise caution when entering a Maximal status value. If you enter a Maximal status value that is less than the Minimal status value, the query returns 0 samples. No error message displays under these circumstances; recheck the query parameters that you selected when queries return no samples. If you do not want to specify a status, leave the ? symbol displayed in both fields. Minimal priority page 32 Sets the minimum priority that a sample must have to display. The options include the following priorities: • Routine • Stat • ASAP 11222683 Rev. A System Operation Field Description Test group Restricts the result set to samples containing at least one request for a test of the specified test group. When a value is entered into the Test group field, the Test field is disabled. Test Restricts the result set to samples containing at least one request for the specified test. When a value is entered into the Test field, the Test group field is disabled. Collected from and to Restricts the result set to those collected within the specified date-time interval. The first field of each pair is the date. Double-select to display and select from a calendar. The second field is the time in hours and minutes. Species Restricts the result set to a species. Patient identifier Restricts the result set to patient ID. Patient last name Restricts the result set to patient last name. Type Restricts the result set to those of a specified sample type. Instrument group Restricts the result set to those containing at least one request referencing the specified instrument group. Instrument Restricts the result set to those having at least one request for the selected instrument. When searching for test requests or results when a normal instrument is specified, the query searches for the instrument of type normal instrument. When searching for test requests or results when a concentrator is specified, the query searches for the instrument and the parent instrument of type concentrator. For more information about normal and concentrator instrument types, see Configuring Instruments on page 216. Only search targeted samples Select this checkbox to search for all samples which have requests that are targeted for a specific instrument or instrument group. An instrument or instrument group must be specified to perform this procedure. When this option is selected, the query will show all samples that have been targeted. The Minimal status will automatically be set to Pending and the Maximum status will be set to Scheduled. 11222683 Rev. A page 33 System Operation Select the Advanced tab for additional fields: page 34 Field Description Minimal status minutes Entering a time in minutes restricts the result set to those having the specified status for equal to or more than the specified time in minutes. Maximal status minutes Entering a time in minutes restricts the result set to those having the specified status for less than or equal to the specified time in minutes. Physician identifier Restricts the result set to those associated with the physician ID. Physician last name Restricts the result set to those associated with the physician’s last name. Patient location Restricts the result set to those associated with the patient’s location. Slide request Slide request parameters include: • Not Required - No restriction to the result set based on slide when Not required is selected. • Required - Restricts the result set to those with a slide request. • Result Required - Restricts the result set to those with a resulted slide request. For information on slide processing, see Understanding Slide Requirements on page 46. Aspirated from and to Restricts the result set to those with at least one aspiration time within the specified date-time interval. The first field of each pair is the date. Double-select to display and select from a calendar. The second field is the time in hours and minutes. LAS status needs upload If selected, restricts the result set to samples requiring an LAS status upload message to the LIS. Check LAS update required If selected, restricts the result set to samples requiring an update message to the LAS. If enabled, a specific channel can be selected in the LAS Channel field. LAS Channel If selected, restricts result set to samples associated with selected LAS. Use this feature in combination with the field Check LAS update required field. 11222683 Rev. A System Operation Field Description Not reported If selected, restricts the result set to samples for which a report has not been generated. When generating Sample reports, you have the option of tagging samples as Mark as reported to differentiate them as being listed in a generated report. For more information about generating sample reports, see Sample Reports on page 260. Filter A filter restricts the result set to those samples for which which the filter is trying to return. You can select from a list of filters or create a new filter. Note Your local technical support can create a filter to find samples on criteria not listed in the Query options. Max sample count Restricts the maximum number of samples that can be returned by the query. Restricting the number of returned samples can improve response time for queries that result in large test results. Sort criterion Specifies the sorting order of the search results. You have three sort options: • Sample ID default • Priority Creation time • Instrument time After entering all query parameters, select OK to view the search results. Viewing Query Results in Standard View You can view query results in standard data view or alternate data view. To view the query results in standard view, select Start > Routine > Samples > Query. The listed data includes sample ID, priority, patient ID, collection date/time, physician ID, and status. To re-enter other search criteria parameters, select Options to re-display the Sample Query window. Note You cannot use the Options button to redefine the Max sample count and Sort criterion fields. To change these settings, close the Sample query window, open it again, and enter the criterion. Viewing Query Results in Alternate View To view the query results in alternate view, select Start > Routine > Samples > Query (Alternate View). 11222683 Rev. A page 35 System Operation The listed data includes sample ID, priority, patient ID (Last, First), status, LAS Channel, LAS general area, LAS specific area, LAS tray ID/LAS lane, LAS tray position, and LAS time. Note The LAS lane will be displayed if no LAS tray ID was received from the LAS. The LAS tray ID takes precedence over the LAS lane. To re-enter other search criteria parameters, select Options to re-display the Sample Query window. Attaching a Document to a Sample Record You can attach a maximum of 10 documents and 10 MB of data to one sample. 1. Right-select the sample and select Related > Document. The Documents of sample browser window displays. 2. Open Windows Explorer and select the files to add. 3. In the Documents of sample browser window, drag and drop the selected files, or select Insert and navigate to the attachments in the Explorer window, and select them. The selected files are imported, sample document records are created, and an icon showing there is an attachment displays on the Review and Edit and Sample window. To replace an attachment: 1. Select the attachment and select Delete. 2. Drag and drop the replacement document into the Documents of Sample browser window. The CentraLink software will prompt you to ensure you want to replace the file. Displaying Additional Sample Information After a query has successfully returned a sample list, you can obtain additional information about a sample from the Sample browser window in two ways: page 36 • Right-select an entry to access the context menu • Double-select an entry 11222683 Rev. A System Operation Using the Right-Select Menu Options Function Description Check results Applies an automatic check to the results. This function is useful when norms or delta norms were modified after result entry. Note This option re-evaluates norms for all tests on the sample. Certain CentraLink system workflows depend on norm severities. Ensure you understand the impact of this feature. Diff pad Opens the Diff Pad, which allows you to perform a manual diff using the keyboard. For more information, see Understanding the DiffPad on page 115. Dispatch to LAS Sends an updated workorder to the LAS. Normally, updated workorders are sent to the LAS automatically by a task scheduler, which is set up by an administrator. For more information about sample status, see Viewing the Sample Status Overview window on page 43. You can bypass the automatic process with the Dispatch to LAS option. For more information about downloading workorders, see Workorder Download on page 63 and Addressing Perpetual Pending Issues on page 51. For more information about pending issues, see Addressing Perpetual Pending Issues on page 51. Print label Generates and prints a sample label. For more information, see Generating and Printing Sample Labels on page 53. Query LAS status Queries the LAS and provides updated status information on the Sample browser (Alternate View) window and on the LAS tab of the Order Entry and Review and Edit windows. For more information, see Query Download on page 64 and Query LAS Status Function on page 65. 11222683 Rev. A page 37 System Operation Function Description Upload LAS info Manually uploads current LAS information to the LIS. Unschedule requests Demotes the status of test requests for which results are not received from the instrument from Scheduled to Pending or Rerun. For more information about unscheduled requests, see Addressing Infinite Schedule issues on page 50. Set slide suppression Enables the creation or removal of a suppression request for the CentraLink system slide test. For more information, see Setting Slide Suppression on page 48. Review and Edit (Hematology) Displays the Hematology Review and Edit window, divided into four browsers. 3 browsers allow you to select the a test group in the drop down list. Only test groups of type Hematology will be available for selection. The fourth browser (named Other) contains all the tests of the sample which are not displayed in any of the other 3 browsers. Review and Edit Opens the Review and Edit window. For more information, see Accessing the Review and Edit Window on page 67. Revert Rerun page 38 This function allows you to revert all requests of the selected sample to their previous result. • Only requests in status Rerun or Review can be reverted. Other requests will be skipped. • Calculated requests cannot be reverted Reruns all tests in the sample that are capable of being rerun. Note When you manually initiate a rerun by right-selecting the sample or samples, the Dispatch to LAS task must be running for the order to be downloaded to the LAS. 11222683 Rev. A System Operation Function Description Report Generates a report for a sample. An administrator can define report generation to run when all results of a sample are validated. For more information, see Sample Reports on page 260. Release LAS Flag results rejection When a flag is received from the LAS for a sample and this flag has Sample reject results set to Temporary (concerning instrument), you can use this function to clear this flag so that results can again be received for that sample from a particular instrument. Note This function is only applicable to Aptio automation systems. Upload result Allows you to specify the test and LIS Channel for upload. View Previous samples Provides an overview of the previous samples of of patient the same patient as the selected sample which have some or all of the tests in common. View Previous runs • This function cannot be executed when there is no patient associated with the selected sample. • Samples without a collection time are excluded. • Only samples with the same sample type as the selected sample or without a sample type are displayed. • Only tests that have been performed on the selected sample will be displayed. Tests that were performed on any of the previous samples but not on the selected sample will not be shown. Provides information about previous runs of the selected sample. The default maximum number of runs which can display is 3. View image 11222683 Rev. A If a sample has a hematology cytogram image, you can use this function to view it. page 39 System Operation Function Description Upload validated results Use this window to upload validated results to the LIS. Note that the function will work if at least one request is in status Validated. In other words, a partial upload of results is possible. Mark for Deletion/ Unmark for Deletion This function allows to explicitly mark a sample for deletion. Use the Sample function Unmark for deletion to undo this. The Purge data function will purge samples explicitly marked for deletion. Samples marked for deletion display with a red-flag icon in the user interface. Set patient status You can associate a patient status with the sample. Detailed overview Not supported in this version of the software. Related Functions page 40 Related > Species Opens the Species window and displays the species name and description. Related > Type Opens the Sample Type window and displays the sample type name and description. Related > LIS Channel Uploads To view details of an upload, right-select the Sample record and select Related > LIS Channel uploads. This will show upload time and other relevant data. Related > LAS Lane Contains the most recent lane information for the sample from the LAS system. 11222683 Rev. A System Operation Function Description Related > LAS General The general areas of a LAS Channel, including: Area Name: identifies this LAS general area in the application. LAS channel: a reference to the LAS channel to which this general area is linked. This field is read-only and will be filled automatically by the application. Description: description of the LAS general area. Type: indicates the type of the general area: Input, Output, Input-Output. End of route/Cold storage: both of these options indicate that the area is considered to be in storage. A location archive message can be sent to the LIS if a sample is in a General Area with either of these options selected. Related > LAS Channel A reference to the LAS channel to which downloads information has been or will be downloaded. Related > LAS Channel A reference to the LAS channel to which a general area is linked. This read-only field is filled automatically. Related > Instrument Rack A reference to the rack or racks per instrument. This window displays two fields: Instrument: The instrument to which the rack belongs. Name: The name of the rack transmitted from the instrument. 11222683 Rev. A Related > Instrument Last instrument to process the sample. Related > Container type Specifies tube or other container that contains the sample. page 41 System Operation Function Description Related > Logs Displays selected information out of messages received from instruments or the LAS. • Effective time is used to sort the logs. It can be the time transmitted by the instrument or the LAS, or the time of the transmission itself. • Type: indicates the type of the sample log (Unknown, ALL query, Host query, Instrument result, LAS storage, LAS inlabbing, LAS location update, LAS flag, Sample priority upgrade). Note Only the first and last query are logged for ALL queries. • LAS - LAS channel that generated the message • Instrument - Instrument that generated the message or referenced in the LAS update. Related > Source Indicates the source of the sample; typically this is an area of the body. Related > Requesting LIS Specifies the LIS that is requesting the sample. Related > Physician ID If specified, displays physicians. Related > Patient Location If specified, displays patient locations such as ER. Related > Patient Specifies demographic information. Related > Document Allows you to attach documents to a sample. For more details, see Attaching a Document to a Sample Record on page 36. Related > Patient Status This information about the patient can be sent to instruments upon work order download. You can enter information into two fields, Name and Description. Querying Samples on a Specific Instrument You can search for samples targeted on specific instruments by selecting the Search Targeted Samples checkbox on the Basic tab of the Sample Query window. Enter the name of the targeted instrument or targeted instrument group in the Instrument Group or Instrument fields. page 42 11222683 Rev. A System Operation Note You must choose only 1 field: Instrument Group or Instrument; filling in both fields will negate the search. The following limitations apply to searching for samples: • You cannot search for samples that have already resulted. • You cannot change the sample status parameters. These are set automatically to Pending (minimal status) and Scheduled (maximal status). Viewing Sample Details View details about the sample by double-selecting an entry in the list to display the Order Entry window. For more information about the Order Entry window, see Manually Entering a Workorder on page 132. You can obtain an overview of the number of samples in each status category. For more information about sample status, see Viewing the Sample Status Overview window on page 43. Finding a Single Sample To access the Samples browser: 1. On the menu bar, select Start > Routine > Samples > Browse. 2. On the toolbar, select the Find icon. 3. Enter a Sample ID. 4. Click OK. Note You can select within the sample browser list and start typing a sample ID number, and it will be highlighted. Viewing the Sample Status Overview window The Sample Status Overview window allows you to monitor the CentraLink database size to ensure the automatic purge command is running properly. This window also allows you to monitor critical situations, such as tests that have not resulted within a certain time limit. To access the Sample status overview window, on the menu bar, select Start > Routine > Samples > Status Overview. To update the count, select Refresh. 11222683 Rev. A page 43 System Operation User-Defined Counters You can create user-defined counters on the Sample status overview window by selecting the ellipsis (...) at the right of any sample counter. These counters are identified in the window by the My_Counters label and surrounded by a bold rectangle to differentiate them from automatic counters. You can create up to 16 user-defined counters. Name the user-defined counter button by entering text in the field preceding the counter button. This name, or label, is defined on a per-user basis. User-defined counters are saved when you close the Sample status overview window and are re-instated when you re-open the window, if you are logged in with the same user name. If you want to use the same user-defined counter for a different user, you must re-create it for that user. Auto-Refreshing Rows To set a time interval to refresh, select the Time Interval to Refresh checkbox. You must select the checkbox next to each counter to activate automated refresh feature for the specific counter. The default value of each checkbox is not checked; you can activate or deactivate this feature at any time. You can set the auto-refresh interval to any number between 1 and 99, indicating the number of minutes the system waits to refresh the selected counters. This interval value is used for non-user-defined counters and selected counters and is not configurable on a per-row basis; the value is saved and reused the next time you restart the Sample Status Overview window. If you attempt to set a value above or below this threshold, a warning message displays. When you activate the auto-refresh feature, the text box representing the autorefresh interval in minutes becomes read-only. To reset the interval, perform these steps: 1. Deactivate auto-refresh by deselecting the checkbox. 2. Change the interval to a value between 1 and 99 minutes. 3. Reactivate auto-refresh by selecting the checkbox. Note Checkboxes next to each counter must also be selected during a manual refresh. page 44 11222683 Rev. A System Operation After you select these checkboxes, the number of samples in the database satisfying the query parameters displays. This counting operation will be conducted independently from a possible auto-refresh operation. 4. When you have reactivated auto-refresh, select the counter button to display a list of samples that match criteria. The following restrictions apply to auto-refresh: • Auto-refresh can only be used for the counters on the screen. Any Sample Query screens which have been opened by the use of the buttons described are not refreshed. To autorefresh these screens you must select the specific counter button again. • Auto-refresh for user-defined counters is only activated if the appropriate checkbox is checked. Navigating to the Sample Browser List You can navigate to the Sample Browser list from the Sample Status Overview window. Click any counter button to open its associated browser. The window opens using the parameters associated with the button. Note the following regarding the Sample Browser List button: • The button is active only if the value displayed is non-zero. • Clicking the counter button multiple times does not open up additional instances of the Sample Browser list. This action will refresh currently open Sample Browser lists. Prior customization of parameters is retained. Note For more information on the Sample Browser List window, see Viewing Query Results in Standard View on page 35. Purging the Database On the Sample Status Overview window, you can choose Purge. CAUTION Do not perform a manual purge unless absolutely necessary. System performance may be significantly degraded. It is strongly recommended to automatically purge on a regular basis. Contact your local technical support provider to schedule a purge task when the system is least busy or not processing results. For information about accessing the Purge window from the System Management database window, see Manually Purging Data from the Database on page 307. 11222683 Rev. A page 45 System Operation Understanding Slide Requirements The CentraLink system provides support for communication with the ADVIA 2120 system with Autoslide. Slides are implemented as special tests. You have the following slide function capabilities: • Order a slide and communicate this request to the instrument. • Set the Set slide suppression command and communicate this information to the instrument to prevent slides from being generated. • Reorder a slide on the same existing sample without having to generate a new workorder on the sample. • Search the database and retrieve samples that have either a result generated or a request for the slide, regardless of sample status. Defining the Test for Slide Processing Slides are implemented as special tests. By default, the CentraLink system is preconfigured with the slide test defined for slide processing on the ADVIA 2120 system with Autoslide. Whole blood is typically configured as the sample type that allows for processing slide requests and displaying slide information. You can configure only one sample type to the test that is specified as the slide test; for example, define the slide processing test with a sample type of Whole blood. For more information about defining tests, see Configuring Test Settings on page 179. Defining Slide Setup At this point, the slide test is defined for processing and the name of the test, Slide, is assigned to the Slide test field on the More tab of the system Options window. In addition, the slide information is defined on the Slide setup window for processing slide requests. page 46 11222683 Rev. A System Operation To access the Slide setup window: 1. On the menu bar, select Start > Configuration > Slide setup. The Slide setup window displays these fields: Field Description Test Reference to the name of the test defined for representing slide preparation. In the above example, Slide is the name of the slide test. Allow LIS download If selected, the CentraLink system accepts slide requests from the LIS. If not selected, the CentraLink system does not accept slide requests from the LIS. You must enter slide requests manually or through reflex testing. LIS upload mode Select one of the following options: • Suppress Do not allow slide upload information to the LIS. • Allow manual only Allow slide upload information to the LIS from the Review and Edit window via the Upload button or from the Sample window via right-selecting and accessing the Upload result window. • Allow always Allows automatic slide upload information to the LIS. Note The instrument sends the following slide test result values back to the CentraLink system: Req., Prod., and Fail. You can customize the CentraLink system to convert these result values to Requested, Produced, and Failed, for example. Allow Autovalidation If selected, the presence of a slide test within a sample does not prevent auto validation of all other tests within that sample when the slide test is less than validated. If not selected, the presence of a slide test within a sample prevents auto validation of all tests within that sample, until the slide is validated. Note This functionality is not retroactive. If the Allow Autovalidation checkbox is selected or de-selected within the life cycle of a given sample, the changed functionality does not affect the existing slide or its test requests. 11222683 Rev. A page 47 System Operation Defining Slide Requirements When initiating a sample query, you specify your slide requirements through the Slide Request field on the Advanced tab of the Sample Query window. You can specify the following options: • Not Required Result set is not restricted to slide requests or resulted slide requests. • Required Result set is restricted to slide requests. • Result required Result set is restricted to resulted slide requests. After the query is run through the Sample Query window and the sample(s) display on the Review and Edit window, you can append a comment to a slide request as you would to any other test request. To append comments, right-select the selected slide request and select Edit Comments. See Appending a Comment to a Request on page 102 for more information. Setting Slide Suppression You can create or remove a suppression request for the slide test. The Set slide suppression function enables a request for slide suppression in workorders to certain instruments including the ADVIA 2120 Autoslide. On setting slide suppression on a sample, a NoSlide command is sent to the Slide Maker Stainer (SMS) instrument upon instrument query. If a sample meets the slide criteria but a NoSlide command is sent to the instrument within the workorder download message, the SMS instrument does not make a slide for the sample. Note The Set slide suppression function only suppresses slide creation when it is specified prior to instrument query. If Set slide suppression is specified after instrument query for workorders, the requirement is unknown to the instrument and slide creation is not suppressed. Note Additionally, if the sample is run and the instrument does not query the CentraLink system successfully, then the instrument may produce a slide. To set up slide suppression from the Sample browser window, right-select an entry and select Set slide suppression. The Set slide suppression window displays. page 48 11222683 Rev. A System Operation If you select the checkbox, slide suppression is enabled for the current sample. A NoSlide command is sent to the SMS instrument upon instrument query for the respective SID. Even if the sample contains a slide test, the SMS instrument does not make a slide for the sample. If you do not select the checkbox, slide suppression is re-enabled if previously enabled for the current sample. If the sample meets the slide criteria, the SMS instrument can make a slide for the sample. Considering Slide Sample Statuses The following statuses exist for a slide sample: Status Description Pending When a slide request is created. The slide request exists in a workorder from the LIS, or the slide request was created manually. The request was not sent to the instrument. Scheduled The slide request exists and was sent to the instrument. Review The slide request was processed at the instrument. 1 of 3 values (Req, Prod or Fail) is assigned to the slide test request and is sent back to the CentraLink system. Validated The result value assigned to the slide test request is validated. Uploaded The slide request has been uploaded to the LIS. Omitted When a slide request is cancelled. To be eligible for omission, a slide request can be in any status other than Uploaded. When a slide request is Pending and is omitted, the request is not sent to the instrument. When a slide request is Scheduled, exists at the instrument, and is omitted, the slide request is not accepted back at the CentraLink system. Rerun 11222683 Rev. A The slide request is rerun. Slide requests in status Validated or Uploaded can be rerun when the Allow manual rerun all field on the Review tab of the system Options window is selected. Note Your local technical support provider can code a MISPL function to automatically rerun a slide request. page 49 System Operation Resolving Scheduling Issues Addressing Infinite Schedule issues The Unschedule function addresses “infinite scheduling” issues by rerouting of samples for which the CentraLink system never received results. For requests that remain in status Scheduled indefinitely without a result message from the instrument, you can select Unschedule from the context menu of the Sample browser window, the Review and Edit window, or the Request window. By invoking the Unschedule command at the sample level or the request level, the following demotions of Scheduled requests occur depending on the availability of a previous result: • Test requests that do not have previous results are demoted from status Scheduled to status Pending. • Test requests that have previous results are demoted from status Scheduled to status Rerun. • Upon reschedule, the CentraLink system sends an updated message to the LAS, which reroutes the samples to the instrument. You can specifically query the number of Scheduled requests for which results have not been returned for a specified amount of time from the Sample query window. On the Basic tab of the Sample Query window, select: • At least one request in status • Scheduled in the Minimal status and Maximal status fields. On the Advanced tab of the Sample Query window, enter the minimum amount of time for which a request must be in status Scheduled and for which no results are received from the instrument. Test requests that are in status Scheduled for longer than the specified time are displayed through the Sample browser window. Unschedule a test request for which results have not been received from the instrument: 1. On the Sample browser window, right-select the selected entry and select Unschedule. The Unschedule requests window displays. Note On the Request window, right-select and select Unschedule. When invoking the Unschedule command at the Request window, an Unschedule requests window does not display. page 50 11222683 Rev. A System Operation 2. In the Instrument field, specify the instrument for which you want to unschedule requests. If you do not specify an instrument, all scheduled requests for the sample are unscheduled. Addressing Perpetual Pending Issues To address perpetual pending issues, select Dispatch to LAS from the context menu of the Sample browser window or the Review and Edit Request window. Requests that are in status Pending and Rerun are sent to the LAS, and associated samples are eventually rerouted to the instruments. You can specifically query requests that are in Pending status for a specified amount of time from the Sample query window. 1. On the Basic tab of the Sample Query window, select: • At least one request in status • Pending in the Minimal Status and Maximal Status fields. 2. On the Advanced tab of the Sample Query window, enter the minimum amount of time for which a request must be in status Pending. Test requests that are in status Pending for longer than the specified time are displayed through the Sample browser window. When you right-select an entry and select Dispatch to LAS, the Dispatch to LAS window displays these fields: 11222683 Rev. A Field Description LAS Channel Determines to which LAS system the sample workorder is dispatched. Include dispatched If selected, the message to the LAS includes requests that were previously dispatched to the LAS and are not in status Review. Send as new When set, the request dispatched to the LAS will always display action code New. Note that only requests in status Pending and Rerun will be resent to the LAS with action code N. Ignore LAS Priority Bands If checked, then all LAS priority band settings that have been configured for all defined LAS channels will be ignored. This will cause any outstanding requests to be downloaded immediately to all defined LAS systems. page 51 System Operation Addressing Scheduled Twice Issues To address requests that remain in status Scheduled indefinitely, without a result message arriving from the instrument, select Unschedule from the Request menu to demote requests from status Scheduled to Pending or Rerun (depending on the availability of a previous result). For more information, see the Request Scheduling information in Configuring Instruments on page 216. Viewing the Sample Log Records The Sample Log table window contains an audit trail of information from the LAS to the CentraLink system. When samples are purged from the database, all associated data from the Sample Log table is purged. Accessing the Sample Logs Window To access records from the Sample Log table window, right-select an entry and select Logs. The Sample logs window with Sample n displays. If you double-select an entry, a Sample log window displays. Accessing the Sample Log Window To access the Sample log window, double-select the applicable log entry. The Sample log window displays these fields: page 52 Field Description Sample Reference to the containing sample. Type Indicates the Type of the Sample Log; for example, First Host Query. Effective time This value is used to sort the logs. The effective time value can either be the time that is transmitted by the LAS or the actual transmission time. Comment A free text field where you can enter a comment for the result. Instrument/Name Reference to the instrument. Instrument/Rack Instrument rack as received from the referenced instrument. Instrument/Position Instrument position as received from the referenced instrument. 11222683 Rev. A System Operation Field Description LAS Area Values reported by the LAS. Channel, Flag Status, Tray_id, Shelf, Door, Area, Gate, Lane, Event Type Examples of Event types can be Centrifuged, Decapped, Aliquoted, Sealed, Recapped, Removed, Disposed, or Unsealed. Note For Aptio automation, Tray ID, Tray position and Shelf correspond to Rack ID, Rack Position, and Floor. General Area Name, Description The name and description of the LAS which sent the event. Lane Area The name of the LAS lane which sent the event. Generating and Printing Sample Labels Specify sample label text (test tube barcodes) on the Label definition field on the More tab of the Systems Option window. To print a sample label or labels from the Sample editor window, rightselect the entry and select Print label. The Print label window displays these fields: Field Description Preview A preview of the expanded label displays before the sample label is printed. Printer Specifies the printer to which the generated sample label is output. Note Upon sample label print, the dynamic text within the label definition defined on the More tab of the system Options window is expanded and the output is stored in a .lbl file before the label output is sent to the specified printer. Communication The CentraLink software supports two-way communication between: 11222683 Rev. A • The LIS and the CentraLink software • The CentraLink software and the LAS • The CentraLink software and the instruments page 53 System Operation CAUTION The units of measure for a given test must be defined identically at the LIS, in the CentraLink software, and at the instruments. You can configure CentraLink to read the units of measure for test results uploaded from the instrument, and you must predefine them in the software to match the instrument units. If the unit of measure in the test result does not match the unit of measure on the CentraLink system, the result is rejected. If units of measure for results are manually changed on an instrument, you must also change the units of measure for the corresponding test in the CentraLink software. In addition, you must purge all existing results for the test from the CentraLink software. Units of measure are not uploaded to the LIS from the CentraLink software. Unit Checking and the LIS For Numeric tests and results, if you manually enter a mismatched unit in the Review and Edit window, it is automatically converted to the correct unit of measure. For example, if you enter 30 mL (milliliters) but the value currently used in the column is L, (liters) your entry will be converted to L. However, if a mismatched unit value is sent from an instrument, or received from the LIS as a previous result, then the result is rejected by the CentraLink system. A message of this format displays: Not a number; no computation performed. Unit received mL, expected L. Unit Checking for Patient and QC Results If Check units on the Instrument window is selected, the CentraLink system will check the result unit transmitted by the instrument: page 54 • The unit from the instrument must match the Patient Unit or Control Unit value for the test. • If a unit is defined on Method level, the unit transmitted by the instrument must match the Method unit. • If no unit is defined on Method level, the unit transmitted by the instrument must match the Patient Unit value or Control Unit value for the test. • If instrument unit checking is enabled and the unit transmitted by the instrument does not match the unit configured in CentraLink: 11222683 Rev. A System Operation • ○ The result will be registered as an X-ERROR result. ○ A parse comment will be generated in the syntax: Result rejected (<ResultValue received>). Unit '<received unit>' received, expected '<defined unit>' ○ The result rejection will be stored in the log file of the internal service. If instrument unit checking is enabled and the unit transmitted by the instrument does not match any defined unit in CentraLink, the result is rejected, but no X-ERROR displays. If Check units on the Instrument window is not selected, CentraLink system will accept any result from the instrument, using only the unit defined in the CentraLink software. Unit Checking for Previous LIS Results If Check LIS previous result units on the LIS channel window is selected, the CentraLink system will check the previous result unit transmitted by the LIS: If LIS previous result unit checking is enabled and the unit transmitted by the LIS does not match the test unit configured in the application: • The result will be registered as an X-ERROR result. • A parse comment will be generated in the syntax: • Result rejected (<ResultValue received>). Unit '<received unit>' received, expected '<defined unit>' • The result rejection will be stored in the log file of the internal service. CentraLink System and the LIS You can configure the CentraLink system to communicate with 1 or more Lab Information Systems (LIS). The communication details for each LIS are defined in a LIS channel. A LIS channel represents an incoming (work order download) and an outgoing (result upload, LAS status information) connection to a LIS. At least 1 LIS channel must be defined. 11222683 Rev. A page 55 System Operation Within a LIS channel, you can configure connections to that LIS to enable concurrent downloading of workorder data from the LIS to the CentraLink software, and uploading of result data and LAS status information from the CentraLink software to the LIS. While the 2 communication connection configuration is not required, defining separate upload and download connections improves communication efficiency. To configure communication for the 2 connections, a separate Inbound Translator value and an Outbound Translator value is specified on the LIS Channel editor. Select Start > Configuration > LIS Channel, and then double select on the relevant LIS Channel. You can set up a single communication channel configuration for LIS that do not support separate upload and download connections by specifying the same translator for both Outbound and Inbound. For further information, see Configuring a LIS Channel on page 203. Inlabbing (accessioning) information notifies the CentraLink system that the sample is in the lab and is sent by the LAS when sample barcodes are read on the automation system. Inlabbing information can be sent to the LIS from the CentraLink system only once and must be sent before result upload to the LIS. The CentraLink software can be configured to upload to the LIS sample archive and location information for each sample for which it receives information from the LAS. You can upload this sample archive and location information each time the CentraLink software receives updates from the LAS. For more information, see Uploading LAS Information to the LIS on page 58. Single LIS System This section describes communication with a single LIS connection. For information on communication with multiple LIS systems, see Multiple LIS Systems on page 59. For more information see Configuring a LIS Channel on page 203. When only 1 LIS channel is defined, it will automatically be set as the Default LIS channel. To view this information, select Start > System Management > Options > LIS Channels. page 56 11222683 Rev. A System Operation Requesting LIS for a Patient Sample CentraLink software can connect to multiple LIS channels. To control the upload of results, samples have an associated Requesting LIS field that determines the LIS system from which modifications for that sample can be accepted, and the LIS system to which results for that sample can be uploaded. Upload of Patient Samples on Single LIS system When a single LIS channel is defined, samples downloaded from the LIS, samples created manually in the CentraLink system or unsolicited samples received from instruments will be tagged with the Default LIS channel as the Requesting LIS. Results will be uploaded to that channel. Uploading QC results to the LIS To upload QC results from instruments to a specific LIS channel, you must associate the instrument with an LIS channel. In the case of a single LIS connection, you can enable the Dynamically administer QC instrument option in the LIS channel window to upload QC results. Enabling this option sends the QC results from an instrument to the same LIS channels as the patient results from that instrument. You can also manually configure the uploading of these results. Creation of QC result LIS uploads When the application receives a QC result, the application will create QC result LIS uploads for each applicable LIS QC instrument; the application will search all LIS QC instruments where the instrument matches the instrument that sent the QC result. For all of these matches, QC result LIS uploads will be created and used when actually uploading QC results to the LIS. Verifying QC result LIS upload statistics To view details of an upload, right-select on the QC record and select Related > LIS Channel uploads. This will show upload time and other relevant statistics. The Upload time field indicates when the QC result has been uploaded to the LIS channel. A question mark symbol (?) in this field indicates that the QC result is not yet uploaded to the LIS. Note Contact you local technical support provider if you want to upload QC results more than one time. 11222683 Rev. A page 57 System Operation Automatically Uploading Results To automate the upload of QC results to the LIS, define a command as follows: • Table: QCResult • Description: free text (for example, Upload QC results) • Query: Default • Query parameter set: define a query parameter set. • Function: Upload • Function parameter set: define a function parameter set. Specify the LIS channel to which the QC results must be uploaded. When uploading QC Results to the LIS, the application will check all “QC result LIS uploads” that match the specified LIS channel. Link the command to a task, to execute the command on a regular basis. Manually Uploading Results To manually upload QC results to the LIS, use the Upload function on the QC result menu. Uploading LAS Information to the LIS You can upload accessioning information, as well as sample archive and location information, from the CentraLink software to the LIS. While inlabbing information can only be uploaded once, sample archive and location information can be uploaded as many times as the CentraLink software receives cold storage message updates from the LAS. The CentraLink software may receive an additional cold storage update from the LAS, for example, when a sample tube is removed from cold storage, rechecked into the track, and returned to cold storage after sample testing is complete. Upload LAS Info Function The Upload LAS Info function can be configured to automatically upload inlabbing and cold storage information from the CentraLink software to the LIS through upload messages. If available, the archival cold storage information can include Shelf, Door, Area, Tray ID, and Tray Position values. You can specify whether shelf, door, and area information are uploaded via the Upload LAS info window. page 58 11222683 Rev. A System Operation The Upload LAS info window can be configured to specify whether shelf, door, or area information is uploaded in the message. On the Sample browser window, right-select the entry and select Upload LAS info. The Upload LAS info window displays these fields: Field Description Include shelf Determines whether the sample tube’s cold storage shelf is included in the upload message. Include door Determines whether the sample tube’s cold storage door is included in the upload message. Include area Determines whether the sample tube’s cold storage area is included in the upload message. Multiple LIS Systems This section describes communication with multiple LIS connections. When the application needs to communicate with a single LIS system only, see Single LIS System on page 56. LIS Channel A LIS channel represents an incoming (work order download) and an outgoing (result upload, LAS Status Information) connection to a LIS. An LIS channel must be defined for each connected LIS system. For more information, see Configuring a LIS Channel on page 203. The first created LIS channel will automatically be set as Default LIS channel by selecting Start > System Management > Options > LIS. The value of the default LIS channel can be viewed by selecting Start > System Management > Options > LIS Channels. Requesting LIS for a Patient Sample The CentraLink software can connect to multiple LIS channels. To control the upload of results, samples have an associated Requesting LIS field that determines the LIS system from which modifications for that sample can be accepted, and the LIS system to which results for that sample can be uploaded. 11222683 Rev. A page 59 System Operation Workorders from the LIS Each time the CentraLink system receives a sample work order from an LIS, the sample is tagged with that LIS Channel as its Requesting LIS. When results are generated for the sample, the CentraLink system will only upload the results to the Requesting LIS. An operator can manually upload test results to multiple LIS if required. Note Once the sample is tagged in the CentraLink software for a Requesting LIS this also will accommodate add-ons and reruns. All reruns and reflex tests will be uploaded to the Requesting LIS. Samples Manually Created in the Application When manually creating a sample, a LIS channel must be specified. If only one LIS channel is defined, it will automatically be specified in the manual order entry screen. Unsolicited Sample When an instrument sends results for a sample that is unknown in the application, that sample is considered to be an unsolicited sample. For such samples, the requesting LIS is determined as follows: • If a Default LIS channel is defined on the resulting instrument, this will be used as the Requesting LIS. • If this is not defined on the resulting instrument, CentraLink will use the Unsolicited sample LIS channel field to assign a Requesting LIS. • If this is not defined, the Default LIS channel is used. Creation of Sample LIS uploads and Result LIS uploads When the Requesting LIS is defined, the CentraLink software automatically creates Sample LIS upload and Result LIS uploads records. These records are used by the CentraLink software to check which samples and results must be sent to the LIS. By default the following applies: • For each sample, a Sample LIS upload record will be created which refers to the sample's requesting LIS. • For each sample result, a Result LIS upload record will be created which refers to the sample's requesting LIS. Consultation of Sample LIS uploads and Result LIS uploads To view the status of Sample and Result LIS uploads: 1. From a Sample record, select Related > LIS channel uploads 2. From a Request record (Review and Edit), select Related > Results and from the Results browser select Related > LIS channel uploads page 60 11222683 Rev. A System Operation 3. The Upload time field in both Sample and Request LIS uploads indicates when the Sample/Request has been uploaded to a particular LIS channel. A sample is considered as uploaded when all of its requests have been uploaded to all of the LIS channels (when all Request LIS uploads have been processed). Note The Upload time field is not populated until the Sample or Request is uploaded to the LIS Channel. Uploading QC results to Multiple LIS Creation of LIS QC instruments Instruments reference LIS QC Instruments records. Each instrument has a list of LIS channels to which the CentraLink system will transmit results. To view this list, right-select an instrument and select Related > QC Instruments. Dynamically administer QC Instruments is enabled by default upon creation of a new LIS channel in the CentraLink system. WARNING For automatic upload of QC results to the LIS, the CentraLink system sends QC results to every LIS for which an LIS QC Instrument association exists. If manual upload is used, QC results for an instrument are sent to the specified LIS channel, regardless of whether patient results for the instrument have been sent to that channel. Automatic Creation When Dynamically administer QC instruments is enabled in the LIS channel, LIS QC instruments are created automatically. As patient results from an instrument are uploaded to a LIS, the instrument is added to a LIS QC Instruments for that LIS channel, and QC results from that instrument are also uploaded to that channel. Manual Creation To manually create a new record: 1. Right-select on the LIS channel and select Related. 2. Select Instruments for QC. 3. Click Insert in the Instruments to Upload window. 4. Double-select the Instrument field of the LIS instrument QC window and select the relevant instrument from the list. 11222683 Rev. A page 61 System Operation QC results from the selected instrument will then also be uploaded to the LIS channel specified in the newly created LIS QC instrument. Creation of QC Result LIS uploads View upload time and other details by right selecting the QC record and selecting Related > LIS Channel uploads. Upload QC results to the LIS Automated Upload To automate the upload of QC results to the different LIS systems, a command needs to be defined for each LIS channel to which QC results need to be uploaded: Table Description Query Query parameter set Function Function parameter set QCResult free text (for example, Upload QC results to LIS channel X) Default define a query parameter set. Upload define a function parameter set. Specify the LIS channel to which the QC results must be uploaded. When uploading QC Results to the LIS, the application will check all QC result LIS uploads that match the specified LIS channel. The configuration will be identical for each command, except the LIS channel defined in the function parameter set. Link the commands to a task, to execute the commands on a regular basis. Running the command manually will ignore QC Results uploads. Manual Upload To manually upload QC results to the LIS, use the QC result menu Upload function. Note When you upload QC results manually, LIS QC Instruments are ignored. The QC results are uploaded to all LIS channels. Physicians, Patients and Patient Locations Physicians, patients and patient locations are linked to the LIS channel that provided the information. This means that a single patient/physician can occur multiple times in the database (once for each LIS channel that provided the data). The application is not responsible for managing duplicate patient and physician data. page 62 11222683 Rev. A System Operation CentraLink System and the LAS The CentraLink system can download workorders or test status to the LAS or query the LAS for sample location or test status information. LAS location updates are uploaded to the CentraLink system and are available through the Sample browser (Alternate View) window, the LAS tab of the Review and Edit window, and the LAS tab of the Order Entry window. For more information about downloading workorders and queries, see Workorder and Query Download to the LAS on page 63 and to LAS Sample Status Update Upload to the CentraLink Software on page 65. Configuring Multiple Automation Systems Each LAS corresponds to a single LAS channel within the CentraLink system. View LAS Channels by selecting Start > Configuration > LAS Channels. For more information, see Defining a LAS Channel on page 207. The default behavior when multiple automation systems are configured is for the CentraLink software to receive all download orders from the LIS and send all orders to both automation systems. Your local technical support provider can configure a task to delete an outstanding request on one LAS after it is completed on one LAS or completed offline. Typically this function is defined as an automated command run by a task and is assigned to a task scheduler, which initiates the appropriate Dispatch to LAS command at the specific time on all samples requiring LAS update. Workorder and Query Download to the LAS The communication between the CentraLink system and the LAS consists of workorder downloads, query downloads, LAS sample status update uploads, and test availability communication. Workorder Download Workorder messages sent to the LAS do not contain an instrument specification unless an instrument was explicitly specified when initiating an Advanced Rerun or an instrument is specified in the Instrument rerun selection on the method. For information about advanced reruns, see Setting Up Advanced Reruns on page 106. 11222683 Rev. A page 63 System Operation Automatic Dispatch to LAS Typically this function is defined as an automated command and is assigned to a task scheduler, which initiates the appropriate Dispatch to LAS command at the specific time on all samples requiring LAS update. When you manually initiate a rerun by right-selecting the sample or samples, the Dispatch to LAS task does not need to be running for the order to be downloaded to the LAS. Manual Dispatch to LAS You can also manually send an updated workorder to the LAS. On the Sample browser window, right-select an entry and select Dispatch to LAS. The Dispatch to LAS window displays these fields: Field Description LAS Channel Orders are dispatched to all LAS channels defined in this field. Send as new If selected, the sample dispatched to the LAS will always display action code New which allows you to resend a sample to the LAS. Only requests in status Pending and Rerun will be resent to LAS with action code N. Ignore LAS priority bands If selected, all LAS priority band settings for all Defined LAS channels will be ignored and all requests are uploaded immediately to all defined LAS systems. Include dispatched If selected, the message to the LAS includes requests that were previously dispatched to the instrument and are not in status Review. Query Download A query download is a request for the status of samples on the LAS. Note The Record Passed message that displays after a query is run indicates that the sample status query message was sent to the LAS. It does not indicate that an update message was uploaded from the LAS to the CentraLink system. Send a Query Download Message to the LAS You can send a query to the LAS requesting an update on the selected sample records or on the focused sample record. page 64 11222683 Rev. A System Operation From the Sample browser window, right-select an entry and select Query LAS status. The Query LAS status window displays the LAS Channel field, which identifies the channels to which orders are dispatched. Query LAS Status Function After the query is initiated from the Sample browser window, the Query LAS status function sends the status query message to the LAS. You can view updated LAS status information from the following windows: • On the Sample (Alternate View) browser window, refresh the targeted sample record or records. • On the Sample browser window, double-select a record and view the updated LAS information on the LAS tab of the Order Entry window. • On the LAS tab of the Review and Edit window. LAS Sample Status Update Upload to the CentraLink Software A LAS sample status update message consists of the current status of a sample on the LAS. This LAS sample status update message is uploaded from the LAS to the CentraLink system. The LAS sample status update upload is initiated in response to a Query LAS status request or is uploaded automatically as the tube is processed on the automation system. The LAS status information is stored in the Sample Log table and displays through the following windows: • Sample editor window • Review and Edit window at the Advanced tab and the LAS tab • Sample log browser • Sample Query (Alternate View) window LAS Test Availability Messages The CentraLink system can accept test status messages from the LAS and can also download test status updates to the LAS. These updates can be used to enable or disable workorder download for the respective method on the CentraLink system. When a test is disabled or enabled on the LAS the enable work order field of the corresponding method will be checked or unchecked. The enable work orders field is used to inform the CentraLink system which tests are available. 11222683 Rev. A page 65 System Operation You can use the Message actions tab of the LAS Channel screen to specify whether updates are sent or received. Specify Test Availability in one of 4 ways: Transmit and Test status messages are accepted from and Receive downloaded to the LAS. Transmit Only Test status messages are sent to the LAS but updates from the LAS will be ignored. Receive Only Updates from the LAS are accepted but test availability messages are not sent to the LAS. None Test status messages are not accepted from or downloaded to the LAS. Test Availability from LAS LAS systems can send test availability and instrument availability messages indicating that a given test can no longer be executed on a specific instrument or that a given instrument is no longer available to the LAS. Test Availability from the CentraLink System If the CentraLink system cannot send a test availability update message to the LAS then these message are queued internally. They will be sent once the translator is available and before any orders are dispatched to the LAS. Test Availability Alias On a per-instrument method basis, CentraLink software allows a method to be an alias for another method on that instrument regarding test availability using the workorder enabled/disabled function. If you disable a method via a Test Availability update, then the CentraLink software searches for other methods that are an alias of the disabled method. These aliases are also disabled and the LAS is notified. If you enable a method via a Test Availability update, then CentraLink software searches for other methods that are an alias of the enabled method. These aliases are also enabled and the LAS is notified. Configure this Test Availability Alias field on the LAS tab of the Method window. page 66 11222683 Rev. A System Operation Result Management Accessing the Review and Edit Window You can review, modify, and disposition test results from connected instruments through the Review and Edit window, which you can access in several ways. To access the Review and Edit window from the Sample query window: 1. On the menu bar, select Start > Routine > Review & Edit or 2. Select the Review and Edit icon (at left) at the toolbar menu. Note If you do not enter parameters to the Sample query window, by default all samples with a status of Review are accessed and are available for display through the Review and Edit window. The Sample query window displays. For more information about the fields of the Sample query window, see Querying Specific Samples on page 29. 3. After you enter the parameters and select OK, the Review and Edit window displays. Only one sample ID with all of its associated test results displays on the window at any given time. Using the toolbar, you can navigate between samples on the Review and Edit window that match the query criteria entered on the Sample Query editor window. For details about the areas and fields of the window, see The Review and Edit Window Workspace on page 69. Note If more than one user is accessing a sample on the Review and Edit window, the user name who accessed the sample first displays in a red box on the Menu Bar, along with the date/time they opened the sample.The sample will not be locked from editing, but the indication will alert the user to the same sample being accessed by a different user. Directly Editing a Result on the Review and Edit Window Click on a row in the Current (value) column, and then select Edit to edit a result directly on the Review and Edit window. The window header displays this message: ***Direct Edit Mode Enabled*** 11222683 Rev. A page 67 System Operation You can then enter a new result value in the request browser directly. To save the value, select the Enter or Tab keys, or select on any other field or button in the Review and Edit window. The result value is saved into the database as the current result of the request. Note When you enter Direct Edit Mode the Edit icon toggles to the Disable Direct Edit icon (red line-through). Select this icon to disable direct edit mode. To cancel your input, select the ESC key. You can only cancel the input if you have not exited the updated field prior to pressing the ESC key. Select ESC to disable direct edit mode. Direct edit mode is also disabled if you navigate to another sample, after a configurable timeout available under Start > System Management > Options > Review, or by selecting Edit again. You cannot edit a result value for the following requests: • requests with a status higher than Review • requests with a test datatype other than String, Numeric or Enumerated • requests referring to a calculated test You can edit results values for Enumerated tests from a dropdown list. You cannot enter any value for enumerated tests but are limited to the defined result choices. If you need to force an invalid result, the list of choices will be appended with the application default "X-NORESULT.” You can navigate to the next or previous result in the screen via the TAB, SHIFT TAB or ENTER keys: Use the arrows to browse the list of possible result choices. Note Editing results causes ratios to be recalculated when the test is defined as a component of a ratio test. For example, if you manually edit an RBC result, the HCT result is recalculated since the RBC value is a component of the HCT ratio test. page 68 11222683 Rev. A System Operation The Review and Edit Window Workspace The Review and Edit window comprises three areas: the sample Information area at the top of the window, including demographics and LIS information; the tests and results area; and the disposition area at the bottom of the window, which contains buttons for you to display various information and boxes containing additional information. You can customize the standard Review and Edit window. You can swap columns, change the column width, and select specific columns to display. You can configure the i expert button for customized menu options. Restricting Access to Buttons on Review and Edit You can protect buttons on the Review and Edit window from unauthorized user access through the use of privileges. For more information, see Assigning Privileges on page 276. Filtering Results Using the Request Query Option On the Review and Edit window, you can restrict the test results displayed in the Tests and Results area for the current sample set. To limit the display of test results within the current sample set to those that meet specified test request criteria, access the Request Query window from the Review and Edit window. The parameters for this restricted sample result set apply until the current Review and Edit window session ends. To access the Request query window: 1. On the Review and Edit window, select Options. 2. Select Request options. The Request query window displays. For more information about the fields of the Request query window, see Accessing the Request Query Window on page 95. 3. After entering the test request criteria that will restrict the test results within the sample set, select OK. The refreshed Review and Edit window displays. The results that display in the Test and Results area are restricted to meet the request query parameters entered to the Request query window. The parameters for this restricted sample result set apply until the current Review and Edit window session ends. 11222683 Rev. A page 69 System Operation Sample Counter The sample counter in the top right corner of the screen shows how many samples meet your selection criteria. This counter is automatically updated when new samples arrive from an instrument that also meet your selection criteria. When reviewing the last sample in the list, the counter may, for instance, show 3 to indicate that 3 new samples have arrived while reviewing. When more than 100 samples are available, the counter shows >100. The value <CALC> indicates that the application is calculating the number of samples. The sample counter automatically recalculates when: • You select the Validate/Scroll button • You select the Page Down/Up key • You select the CTRL-F or CTRL-L shortcut keys (to jump to the first/last record respectively) • The last refresh was more than 60 seconds ago The following restrictions apply to the sample counter: • If you select Close while the counter is calculating the number of samples, a message appears stating that the system is calculating. When you select OK and the calculation is completed, the screen closes. • If you select Close while a calculation is being processed, this message displays: There are asynchronous calls active on the Application Server which originated from this screen. This screen will be closed automatically upon completion of these calls. If you select OK, all buttons on the screen are disabled. This prevents the initiation of any operations, as the screen could unexpectedly close. To initiate a new action after selecting Close, you must open a new instance of the Review and Edit window. page 70 • The sample counter only displays if you have opened the Review and Edit window from the main toolbar. If you opened Review and Edit from the Sample Query window, the counter does not display. • If the sample contains a request with associated instrument flags, a warning triangle displays in the upper right corner of the section. 11222683 Rev. A System Operation Default Configuration: Basic Hyperlink Note The Review and Edit window is customizable. Selecting the Basic hyperlink displays these default fields at system startup: Field Description Sample ID Identification number of the displayed sample. The CentraLink software supports Sample IDs with a maximum of 32 characters. Priority Displays the priority of the sample: • Routine • Stat • ASAP Age Age is calculated based upon the creation time of the sample in the CentraLink system. Patient ID Patient ID number. Patient name Name of the patient. Sex Sex of the patient. DOB Patient date of birth. Patient location Place where patient is located, for example, ER. Note Physician, Patient and Patient Location fields cannot be edited without first specifying an LIS Channel. Collection Time Date and time of the sample collection. Sample comment Comment associated with the sample. Patient comment Comment associated with the patient. Note If the combined comments for a sample contain more than 32,000 characters and you select Comments, a message displays indicating that CentraLink cannot display the information. To view these comments individually, select each request. 11222683 Rev. A page 71 System Operation Default Configuration: Advanced Hyperlink Selecting the Advanced hyperlink of the Review and Edit window displays these fields. Field Description Physician ID Identification number of the associated physician. Physician name Name of the physician. Species Species associated with the sample or patient. Instrument time Time the sample was last detected on the specified instrument. Creation time Time the sample record was created. Sample type Type of the sample. Instrument Name of the instrument on which the test is performed. Rack Rack location of the sample at the specified instrument. Position Position of the sample within the rack location at the specified instrument. Encounter Patient's encounter at time of sample collection. Note This field is currently not supported. Default Configuration: LAS Tab Selecting the LAS hyperlink of the Review and Edit window displays these fields: Field Description Name The name of the LAS Channel that uploaded LAS information. Time Time the sample was last detected at the LAS. General area, Shelf, Location fields as reported by the LAS. Door, Area, Gate, Tray id, Tray position, Lane page 72 11222683 Rev. A System Operation Tests and Results Area The Tests and Results area consists of request information in a browser format. You can double-select on any test to see detailed information about the request. Displaying and Changing Columns Displayed You can resize, move, or change column width in both the standard and Hematology Review and Edit window. See Configuring and Resizing Columns. Field Description Test Name of the requested test. You can display the requested test name in different colors depending on the severity and status via the Color Manager. For information about using the Color Manager, see Configuring Colors on Browsers and Windows on page 270. Note If a test name that consists of 20 characters was entered at the Test window, the test name value appears to be truncated in the Test field at the Review and Edit window. To verify the entire test name, put your cursor in the Test field and select the right arrow key until each of the remaining characters of the test name display. Avoid entering test names that consist of 20 characters. Sts The status of the request: Pending (PND), Rerun (RRN), Scheduled (SCH), Review (REV), Validated (VAL), Uploaded (UPL), Omitted (OMT). You can display the request status in different colors depending on the severity and status via the Color Manager. 11222683 Rev. A page 73 System Operation Field Description Current Current result value. Every request can have multiple associated results. Each time a new result value is available, either through manual entry or automatic upload from an instrument, a new result record is created to store the value. On the Review and Edit window, the latest two results display. The most current result value is stored in this Current column. The background of the Current field is color coded to indicate the accumulated result severity. The accumulated result severity is the maximum absolute value of the norm, delta norm, instrument, and QC severity values. These individual severities are color coded in the NS, DS, QS, and IS columns respectively. The following colors display in the Current column depending on the absolute value of the accumulated severities: • Yellow Displayed when equal to 2. • Green Displayed when equal to 1. • Red Displayed when greater than or equal to 3. Red also displays when the patient result generates a Type error, which occurs when the patient result cannot be converted to the datatype of the corresponding test. Note If a patient result value contains a comparator and a numeric value, however, the patient result is treated as a numeric value. A datatype error condition does not result. page 74 11222683 Rev. A System Operation Field Current (continued) 11222683 Rev. A Description • Ambiguous result as per comparator Patient result has a comparator that renders the result value ambiguous with relation to the normal range. As per the comparator, you cannot definitively determine whether the result value falls within the normal range or whether it falls outside the normal range. Norm records are checked in sequence according to their evaluation order. If a result falls outside the range defined by the Low and High Limit values, then the Severity value of the Norm is applied to the result. If the result does not fall outside the range, the norm with the next highest evaluation order is checked. For example, if the Low Limit and High Limit normal range values of a test are set from 0.02 to 10.0: – If the result value <0.02, the result value is not ambiguous because the result is definitively outside the norm range. – If the result value >10.0, the result value is not ambiguous because the result is definitively outside the norm range. – If the result value <0.19, the result value is ambiguous because the values may or may not exceed the norm range. The value <0.19 may be on either side of the Low Limit of 0.02. – If the result value >9.99, the result value is ambiguous because the values may or may not exceed the norm range. The value >9.99 may be on either side of the High Limit of 10.0. page 75 System Operation Field Current (continued) Description When a test’s normal range is not properly defined and a result containing a comparator is ambiguous with respect to the normal range, the respective norm is considered violated. In addition to the red color display in the Current column, the result is held in REV status and must be manually validated. Note This feature ensures the laboratory is not accidentally releasing ambiguous results. If you receive an ambiguous patient result, the normal ranges are not specified correctly and should be re-evaluated. Upon display of this ambiguous patient result on the Review and Edit window, the following text populates the Comment field: Check defined ranges. Note This comment is hard coded and cannot be overwritten or deleted. This comment is not uploaded to the LIS and is not printed on patient reports. This comment serves as an internal note for the laboratory. F Flag An asterisk in the Flag field indicates that a flag is available. The expanded text associated with this flag is displayed in the Flag field at the bottom of the window. P Previous An asterisk in the Previous field indicates that the value of a previous result could not be parsed and still appears in the Previous Result field as it was received from the instrument. Prev Run Contains the previous run result value. When you first open the Review and Edit window, this field shows the value of the previous result. If you select Rerun the result value from the Current field moves to the Prev Run field. page 76 11222683 Rev. A System Operation Field Description Prev Run D/T Date and time of previous run for this request. Prev Samp Contains the most recent result value on a different sample for the same patient. This value can be used for delta checking. This field will only be populated if the previous sample was previously run on the CentraLink system, or if the previous sample result was received from the LIS depending on CentraLink system settings. 11222683 Rev. A Prev Samp D/T Contains the date and time in which the Prev Samp value was recorded. Depending on the settings on the Options window, this date/time stamp may originate from the LIS or from the CentraLink system database. Norm Displays the normal range of acceptable values that have a corresponding severity of 1. Note If a normal range is not defined or if the defined range has a corresponding severity value that is not equal to 1, the ? symbol displays in this field. page 77 System Operation Field Description NS, DS, QS, and IS Normal severity, delta norm severity, QC severity, and instrument severity values. Normal Range Severity Suggested values: -3 panic low, -2 very low, -1 low, <blank> normal, 1 high, 2 very high, 3 panic high. For more information, see Setting Test Norms on page 191. The Allow on type error checkbox on the Method window allows you to configure methods to either enable or disable autovalidation upon receipt of type error patient results. Delta Norm Severity The value represents where the current result is positioned with reference to a user-defined percentage or absolute difference of the previous sample result. for the same patient. For more information, see Setting Test Norms on page 191. blank = current result within user-defined percentage or absolute difference of the previous sample result. -N = current result outside on low side of userdefined percentage or absolute difference of the previous sample result. N = current result outside on high side of userdefined percentage or absolute difference of the previous sample result. page 78 11222683 Rev. A System Operation Field Description NS, DS, QS, and IS (continued) Quality Control Severity The QC severity value indicates the level of QC problems on the method associated with that result. It is the highest of these values: • Westgard severity • QC severity on type error • QC severity on invalid reference For information about setting method severities, see Autovalidation Tab on page 246. Instrument Flag Severity blank =No flag exists 1–999 = Flag exists. Severity level is userdefined. The following colors are displayed in the severity columns: • Red is displayed when greater than or equal to 3. Severe severity outside of normal range. • Yellow is displayed when equal to 2. High severity outside of normal range. • Green is displayed when equal to 1. Moderate severity outside normal range. For more information about Severity Columns, see Colors Associated with Review and Edit Severity on page 82. C Comment. An asterisk in the Comment field indicates that a comment is available. The expanded text associated with this comment is displayed in the Comment field at the bottom of the window when the result is highlighted. When a type error result or ambiguous result displays, an appropriate comment value displays in the Comment field. Some comment values can be manually edited; other comments are generated system comments that are hard-coded and cannot be edited. 11222683 Rev. A page 79 System Operation Field Description T Target Instrument. An asterisk in the Target Instrument field indicates that the name displayed in the Instrument field is that of the target instrument. This indication appears if these 3 conditions are true: • the instrument for the request is unknown • the target instrument is known • the status of the request is lower than Review. TAT Turnaround Time. This column displays the TAT calculation for the request. The start and end criteria for Turn Around Time calculation can be defined on the Review and Edit tab of the system Options window. TAT is displayed in year, month, day, hour, and minute. If the end time has not been reached, the TAT value is followed by “...” on the user interface. page 80 #PR Number of previous runs. This column displays the total of manual and instrument results for this test request. The current result is not counted. Unit Unit of the current result. 11222683 Rev. A System Operation Understanding Request Status A test request can have any of these statuses: Status Description 1. Pending (PND) 2. Rerun (RRN) When a test request is created, its status is Pending. A request is demoted from status Review to status Rerun when a manual Rerun is initiated for the request or an automatic rerun is initiated. 3. Scheduled When the request is downloaded to an analysis (SCH) instrument as a workorder in response to an instrument query, it is promoted to status Scheduled. It can also be unscheduled manually or via an automatic command to status PND or RRN. 4. Review A request is promoted to status Review when a result (REV) value gets assigned to it. A request can also be demoted to status Review from status Validated by executing the Invalidate command. 5. Validated A request is promoted to status Validated when its result (VAL) value is validated through manual or automatic validation. Requests in VAL status can be manually rerun if the Allow manually rerun all option is enabled in the Options window. 6. Uploaded (UPL) 7. Omitted (OMT) You can select Advanced Rerun to perform a rerun on tests in Validated Status. A request is promoted to status Uploaded when it is successfully uploaded to all required LIS, either explicitly by the operator or through automatic uploading. Requests in UPL status can be manually rerun if the Allow manually rerun all option is enabled in the Options window. You can select Advanced Rerun to perform a rerun on tests in UPL status, or the customer’s LIS can re-order this test which will return the test to a RRN status. A request enters status Omitted when the Omit command is executed on it. Only the customer’s LIS is capable of re-setting a test from Omitted to Rerun. UNOMIT can only be performed from the LIS. 11222683 Rev. A page 81 System Operation Colors Associated with Review and Edit Severity The following severity columns exist: NS, DS, QS, IS. A value of blank displays in the severity columns when a request result is in normal range. Colors differentiate between different warning levels for test results. Consider the following scenarios: page 82 • If all the severity columns are blank, the test result value is displayed in black. No severity exists for the given test result. • If any of the severity columns contain a value of 1, the result and the severity column are displayed in green. Moderate severity for the given result is indicated. • If any of the severity columns contain a value of 2, the result and the severity column are displayed in yellow. High severity for the given result is indicated. • If any of the severity columns contain a value of 3, the result and the severity column are displayed in red. Severe severity for the given result is indicated. • If a test request has different severity values among the severity columns, the highest severity value determines the color of the test result. Consider the following severity values: NS=0, DS=2, QS=3, IS=0. If a test request has these severity values, the result is displayed in red and the QS column displays in red. Accordingly, the DS column displays in yellow and the NS and IS columns display without color. 11222683 Rev. A System Operation Function Area Actions Description Select, Apply Selecting a status from this drop-down menu and selecting Apply, applies a selection arrow (>) next to each result with the chosen status in the first column of the Tests and Results area. This allows you to disposition all tests with the same status. To disposition all tests in view, select All from the Select field drop-down menu and select Apply. A selection arrow displays next to each result in the first column of the Tests and Results area. To remove the selection arrows from the results in view in the Tests and Results area, select None from the Select field drop-down menu and select Apply. The selection arrows are removed from the first column of the Tests and Results area for each result. To clear selected results, and select unselected results in view in the Tests and Results area, select Invert from the Select drop-down menu and then select Apply. To select a single result in the Tests and Results area, highlight the result and press the space bar. Edit button Select Edit to enter or update the result value for a request directly in the Current column. For more information, see Directly Editing a Result on the Review and Edit Window on page 67. Flags When a result is highlighted that contains an asterisk in the Flag column field of the Tests and Results area, the expanded text associated with this instrument flag displays in this field. The Flags button is activated only when instrument flags are associated with the current sample. Similarly a warning triangle displays in the upper right corner of the Review and Edit window when instrument flags are associated with the current sample. 11222683 Rev. A page 83 System Operation Actions Description Comment When a result is highlighted that contains an asterisk in the Comment column field of the Tests and Results area, the expanded text associated with this comment displays in this field. When a type error result or ambiguous result displays, an appropriate comment displays in this field. For example, when an ambiguous result as per comparator result is highlighted in the Tests and Results area, this text displays in the Comment field: Check defined ranges. Note The Check defined ranges comment is hard coded and cannot be overwritten or deleted. This comment is not uploaded to the LIS and is not printed on patient reports; it serves as an internal note for the laboratory. Other comment values that display on the Comment field can be edited. page 84 11222683 Rev. A System Operation Actions Description Validate (Scroll) Validates results of selected tests, changing the status from Review to Validated. The Validate (Scroll) button serves as both a Scroll button and a Validate button depending on whether all the pages associated with the test results for this sample display. The label on the Validate (Scroll) button displays initially as Scroll. After selecting the Scroll button, the remaining tests display and the label on the Validate (Scroll) button changes to Validate. In this dual function, the Validate (Scroll) button eliminates the need for manual scrolling through all of the pages of test results to activate the Validate button. When the Auto-Next after Validation parameter is selected on the Review and Edit tab of the system Options window, the next sample in the current sample query automatically displays after the current sample is validated. For more information, see Considering Validate Scroll Functionality on page 89. Rerun Submits selected tests for rerun, which changes the status from Review to Rerun. When Allow manual rerun all is selected on the Review and Edit tab of the system Options window, all selected tests including those in status Validated and Uploaded are rerun. When Rerun is executed, the result value from the Current field displays in the Prev Run field. The current result value from the rerun displays in the Current field. For more information, see Rerunning a Calculated Test on page 91. 11222683 Rev. A page 85 System Operation Actions Description Rerun All Reruns all status Review tests that are in view in the Tests and Results area regardless of whether the tests are selected. When the Allow manual rerun all parameter is selected on the Review and Edit tab of the Options window, tests in all statuses including statuses Validated and Uploaded and excluding status Omitted that are in view in the Tests and Results area are rerun. Note LIS driven reruns always permit reruns of results in status Upload. Omitted tests, which do not display in the Tests and Results area, are exempt from rerun. If any test request participating in a calculation is rerun, any dependent calculated result requests are automatically rerun along with it. When Rerun is executed, the result value from the Current field displays in the Prev Run field. The current result value from the rerun displays in the Current field. For more information about rerunning tests, see Rerunning a Calculated Test on page 91. Revert Reverts the result of a selected request back to the result value of a previous run. Only samples in Review status that have previous results can be reverted. Reverting to a previous result actually creates a new result, which is a copy of the original result record. The reverted record, however, contains the following updated field values: • The user and time fields are updated with the reverting user and time values. • The comment field is updated with any auto-generated comments appended with the reverted comment value. You cannot revert calculated results; however, in reverting the inputs to calculated results, these results are automatically recalculated. Validated and uploaded results cannot be reverted. page 86 11222683 Rev. A System Operation Actions Description Upload Manually sends the validated results to the LIS. The Upload button is activated when at least one validated request is visible in the Tests and Requests section. Upon selecting the validated tests and selecting the Upload button, all selected results with a status of Validated are uploaded to the requesting LIS. For more information about uploading validated results, see Accessing the Request Query Window on page 95. You can also initiate the upload function for selected results by right-selecting and selecting the Upload option from the pop-up request menu. Image Displays the cytogram image sent from the ADVIA 120/2120 system. The Image button is activated when the sample has an associated image result; for example, when hematology results contain cytograms. Comments 11222683 Rev. A Displays a window showing all current result comments of a sample. page 87 System Operation page 88 Actions Description Options Displays a drop-down menu from which you can choose Request Options or Window Preferences. • Request Options Displays the Request Query window, which shows the status, status range, test group, and instrument group parameters that restrict the test results displayed in the refreshed Tests and Results area. It can be used to filter the results displayed in the Tests and Results area. • Window Preferences Displays the Review and Edit preferences window with the checkboxes for View flags, View image, and View comments. Select the checkbox(es) to enable these options and display additional windows whenever the Review and Edit window opens, configured for each user. These windows show flags, comments and images associated with sample requests. For more information about viewing Query information, see Accessing the Request Query Window on page 95. Close Closes the Review and Edit window. 11222683 Rev. A System Operation Supplemental Information About Buttons Validating Results of One or More Tests A test can be validated only if it has a status of Review. You can validate all results with a status of Review, or you can select certain results to validate. Note You can also validate samples or requests via MISPL Validate functions. These functions must be fully understood before being implemented. Contact your local technical support provider for more information. Considering Validate Scroll Functionality When more test results for a sample ID exist than are in view in the Tests and Results area of the Review and Edit window, the Validate (Scroll) button is activated, the Scroll label displays, and the scroll functionality is enabled. Upon selecting this button, the next sequential test result associated with the sample automatically come into view in the Tests and Results area. The scroll functionality is enabled until all of the requests associated with a sample display in the Tests and Results area. Once all the requests display, the Validate label of the Validate (Scroll) button displays and the validate functionality is enabled. Upon selecting this button, all selected tests in Review status are validated. CAUTION Use caution when selecting the Validate (Scroll) button. If you accidentally select the button multiple times, you may validate results for the next record. Auto Next on Validate If the Auto Next on Validate checkbox is selected on the Review and Edit tab of the system Options window, then when you select Validate, the next sample in the current sample query displays. Note If the Auto-skip function is enabled, there may be a delay before the next sample displays. For more information about skipping sample records, see Auto Skipping Unmatched Sample Records on page 95. Auto Validation of Delivered Results If a result is obtained from an instrument, the result is said to be delivered by the method identified by the test plus instrument combination. If a result is entered manually, no auto validation rules are applied. 11222683 Rev. A page 89 System Operation When a new result is assigned to a request, it is always subject to automatic range checking and delta checking. This yields the request's norm severity and delta norm severity, respectively. The request's QC severity is copied from the current QC value of the method delivering the result. The request's instrument severity is set to the maximum value of the associated instrument flag’s patient severity. The severities obtained are now compared with severity limits to determine whether or not the result is automatically validated. If a method is available, the method determines the applicable severity limits. If a method is not available and the result is obtained through a calculation, the test determines the applicable severity limits. When a result is entered manually, no severity limits are available. Automatic validation only occurs when the defined severity limits are available. Auto Validation of Calculated Results Auto validation of calculated test results occurs when all input results are validated. The auto validation criteria can be applied to the calculated test result regardless of whether the input tests are coming from two different instruments. When a method is associated with the calculated test, the method’s auto validation criteria is used. Consider the following scenario: If requests in Review status receive a result through a given method and the request's norm, delta norm, QC, and Instrument severities are all below the respective norm severity limit, delta norm severity limit, QC severity limit and instrument severity limit, then the request is automatically validated. If any of the defined limits are left unspecified, no auto validation occurs. When a method is not associated with the calculated test or the inputs for the calculated test come from more than one instrument, the following auto validation levels, which are defined on the Calculation tab of the Test window, are used: norm severity limit, delta norm severity limit, QC severity limit, and instrument severity limit. page 90 11222683 Rev. A System Operation Rerunning a Calculated Test When a test request participating in a calculation is rerun, any dependent calculated result requests are automatically rerun along with it. Consider the following scenarios: • If a test is a component of a calculation defined in CentraLink software, such as Albumin for the A/G ratio, then the component test and the ratio test are both rerun when the ratio is scheduled for a rerun. The ratio test is automatically recalculated upon receipt of all component test results from the instrument. • If a test is a component of a calculation that is defined only at the instrument, the CentraLink system is unaware of any connection between components and calculations and is unable to perform the component test when only the ratio is scheduled for a rerun. • Morphology flags associated with the previous result are updated by the system when the test is rerun, if these tests are not already validated. Upon completion of test reruns, the Current field result value is copied to the Prev Run field. The new result value for the current re-run displays in the Current field. Considering Application Level Settings for Rerun On the Review and Edit tab of the system Options window, you can select the following checkboxes: • Allow manual rerun all Determines whether tests in all statuses, which includes statuses Validated and Uploaded and excludes status Omitted, are eligible for user initiated, manual rerun. Note The CentraLink system always accepts a request from the LIS to rerun a test request with the status Uploaded, regardless of the Allow manual rerun all checkbox setting. • Autovalidate reruns Determines whether the results that are within normal range after a rerun are eligible for automatic validation. If this option is not selected, you must validate rerun results manually. Note Any time a change is made to an application level setting that involves a user interface change, you must log out of the CentraLink system completely and log back in again for the change to take effect. For example, if you select the Auto next on validate option on the Review tab of the system Options window, you must log out and log back in before the CentraLink system automatically displays the next sample in a query when the current sample is validated. 11222683 Rev. A page 91 System Operation Any time a change is made to an application level setting that involves a communication change, the system administrator must stop and re-start services for this change to take effect. Manually Entering a Result Manual result entry is available when you must enter results from a nonconnected instrument. CAUTION It is not recommended to enter manual results at the Result Entry window. Siemens recommends using the standard Review and Edit or Hematology Review and Edit window to enter and edit results. The Result Entry window is used for legacy purposes only. 1. To access the Result entry window, select Start > Routine > Result entry or select the Result entry icon on the toolbar. The Result entry window displays these fields: Field Description Instrument The instrument on which the tests are scheduled. Double-select the Instrument field to display a list of instruments. When an instrument is selected, the Test selection area below the Test field is automatically populated with the tests defined on the instrument. Worklist When an instrument value populates the instrument field and you double-select the ? symbol of the Worklist field, the worklists for the associated instrument display in the Worklists for instrument browser window. Upon double-selecting a worklist, the selected worklist value populates the Worklist field and all of the samples associated with this worklist are listed and display in the Sample selection area below the Sample ID field. Create new page 92 If selected, the tests and samples selected on this window will be stored as a new worklist for the selected instrument. 11222683 Rev. A System Operation Field Description Test The tests scheduled to the instrument. If you double-select the Test field, the tests defined for the associated instrument display in the Test browser window. Upon double-selecting a test, the selected test value populates the test field. Test selection area Displays the tests defined to the instrument. When an instrument value populates the Instrument field, the Test selection area is automatically populated with the tests defined on the instrument. Within this area, you can select the applicable tests. To delete a test from the list, select the test and select Clear. 11222683 Rev. A Clear To clear the Test selection area, select Clear. Sample list Select Sample list to enable sample lookup in the Sample ID field. Sample ID Double-select to display a list of samples. Select a sample ID, then select OK. Repeat as needed to select more samples. Clear button Select to clear the selection in the Sample ID field. Collected from / to Double-select to display a calendar or enter a date and time interval to limit the samples selected in MM/DD/YY format. Max samples Enter a number to set the maximum number of entries in the Result Entry window. Grid type The style in which the result entry grid displays: • Standard: All selected tests display next to each other. • Tiled: New rows are automatically added within the associated area when the number of tests exceeds the space allotted for one row of tests. • Dynamic : Each test displays vertically. The test name displays next to the associated result. page 93 System Operation 2. Select OK. The Result entry window displays. Note The Result entry display type depends on the Grid type selected. You cannot invert selection in grid mode. The entire grid is always selected. 3. To move to any cell, select TAB. 4. Enter the appropriate value in each cell. After you enter a value and select TAB, the value becomes read-only. Continue until all values are entered. 5. Select Close. Printing a Worklist To print a worklist, on the Result entry grid display, select Record > Print from the tool bar. The Worklist printing window displays these fields: Field Description Report type The generated worklist can be of the following types: Full: All rows and columns of the worklist display. Rows: Only rows of the worklist display. Columns: Only columns of the worklist display. page 94 Printer Reference to the printer to which the generated worklist is output. Set as default If selected, the specified Report Type is saved as the default. Preview If selected, a preview of the worklist is displayed on screen prior to printing. 11222683 Rev. A System Operation Accessing the Request Query Window On the Review and Edit window, access the Request query window: 1. Select Options, and then select Request Options. The Request query window displays these fields: Field Description Status from and to Restricts the result set to a specific status range. For example, if you are not interested in viewing requests already validated, specify Pending and Review in the Status from and to fields. To view only omitted results, specify Omitted in both the Status from field and the to field. Test group Restricts the result set to requests belonging to the specified test group. On re-display of the refreshed Review and Edit window, only the test requests within the current sample that belong to this test group display. Instrument group Restricts the result set to requests belonging to the specified instrument group. 2. Select OK. The Review and Edit window displays. The results that display in the Test and Results area are restricted to meet the specified request query parameters. Auto Skipping Unmatched Sample Records When you enter test request criteria to the Request query window, you further restrict the test results that display for the sample(s) that met the sample query criteria entered to the Sample Query window. When the Auto-skip sample feature is enabled on the Review and Edit tab of the system Options window, sample records with result records that do not match the test request query criteria are skipped and the next sample record that contains result records that match the test request criteria displays. By default, the Auto-skip sample feature is enabled on the Review and Edit tab of the system Options window. 11222683 Rev. A page 95 System Operation If the Auto-skip sample feature is enabled, sample records with result records that do not match the test request query criteria do not display as empty sample records on the Review and Edit window. These empty sample records are skipped, and the next sample record that contains result records that match the test request criteria displays. In addition to automatically displaying only those sample records with result records that match the test request criteria entered on the Request query window, the Auto-skip feature also skips the display of empty sample records when you navigate as follows: • Select the Next page/Previous page or Next record/Previous record buttons of the toolbar. • Select Validate on the Review and Edit window. • Select Page Up or Page Dn on the keyboard. If the Auto-skip sample feature is not enabled those sample records with result records that do not match the test request query criteria display as empty sample records on the Review and Edit window. You must manually navigate past these empty sample records by doing one of the following: • Selecting Next page or Next record on the toolbar. • Pressing Page Up or Page Dn on the keyboard. After 5 sample records with non-matching result records are automatically skipped, a message displays informing you of skipped records.You can stop the process of automatically skipping records at any time by pressing CTRL + BREAK. Right-Selecting Functions Viewing Results of Requests Although the most current 2 results display on the Review and Edit window for a given sample, every test request can have multiple result records associated with it. You can view each of the result records associated with a test request on the Results of request window. New result values are uploaded from an instrument, or they can be entered manually. A new result value for a given test request is saved as a new record when it is received within the sample reuse period, which is a configurable time period. To access the Results of request window from the Review and Edit window, right-select a result and select Related > Result. page 96 11222683 Rev. A System Operation The Results of request window displays. Note To view either hematology results that contain cytograms as a cytogram image, right-select a result of the Results of request window and select View result option. Note To see more information about a result, right-select a request and choose Results. A Result browser displays a General tab and a Comments tab, with these fields: General Tab Field Description Unit This field contains the unit of measurement of the result value as displayed in the Review and Edit window. Status The status of the test request: • Pending: Status when a test request is downloaded to an instrument as a workorder in response to an instrument query. A value is expected from the instrument that queried for the sample. • Available: Status when a result value is assigned to a test request. Schedule user Reference to the user who created the result record that exists in status Scheduled. As this is typically performed by a background process, the user is usually set to batch. Schedule time The date and time when the result record was created in status Scheduled. Method Reference to the method record, and thereby the associated instrument and test, through which the result was obtained. For manually entered results, this field is not populated. 11222683 Rev. A Instrument user The name of the user on the instrument which produced the result. Instrument validation Derived from input from the specific instrument; for example, a CellaVision instrument. page 97 System Operation Field Description Aspiration time Date and time the sample was aspirated at the instrument. Note Not all instruments report this value. If they do not, this field is defined by the time of result receipt on the CentraLink system. Test completed time Date and time in which the test was completed at the instrument. Availability user Reference to the user who entered the result record. For values obtained from instruments by a background process, the user is typically set to batch. Availability time Time when the result value was stored to the database. Value Raw text value supplied by the user or by the instrument. Unlike the string value associated with the request record, no rounding or expansion is applied to this value. Auto dilution coefficient Dilution coefficient uploaded by the instrument with the result. This field displays dilution coefficient for instruments which support dilutions with CentraLink systems, and displays dilution percentage for Sysmex® CS instruments. Auto dilution condition Dilution condition uploaded by the instrument with the result. Manual dilution coefficient Value by which results are multiplied after a manual dilution. QC severity QC severity value of the associated method, at the time the value was copied from the method. Reagent Information To display a table of the reagents used for this result, right-click on the result and select Related > Reagent Used. A table with the Reagent Lot Number, Reagent Serial Number, Reagent Name, Creation Time, Creation User, Expiration time, ID, Last Update Time, Last Update User, Start Time, and version displays. This displays only if the instrument sends reagent information with the result. page 98 11222683 Rev. A System Operation Comments Tab Field Description Instrument comment Comment uploaded by the instrument along with the result value. Parse comment Comment generated by the result value parser. Range comment Comment generated during automatic application of norms and delta norms. User comment Comment a user added to the Edit request comment window. Configurable Sample Reuse Period The value for this configurable time period is expressed in days and is defined in the Sample reuse period field at the More tab of the system Options window. If no day value is specified and the Sample reuse period field value is populated with the ? symbol, the default value of 30 is used. The sample reuse period values can range from 1 to 365. When the CentraLink software receives a new result, it verifies whether the sum of the last posted result date and the Sample reuse period value is greater than the date of the new result, using this formula: (Last result date) + Sample reuse period > Date of new result • If the last result date + Sample reuse period is greater than the date of the new result, then the new result value is saved. The last result date is updated with the current date. You can view the new result value in the Results of request window; the last result date does not display on the window, but is stored in the Sample table. • 11222683 Rev. A If the sample never received a result, then the clock starts counting. page 99 System Operation • If the sum of the Sample reuse period and the last result date is equal to or less than the date of the new result, the new result is not saved. An error message is logged in the instrument Service log. The following comment is added to the sample specifying that results were discarded due to results extending beyond the Sample reuse period: Results discarded – sample reuse time has elapsed for sample <sample_identifier> (<instrument_name><CurrentDateTime>). This comment displays in the Sample Comment field of the Review and Edit window. Note Only 1 sample comment is recorded for a sample whose reuse period has expired. For example, if a sample has 3 test requests and the sample reuse period has expired, once a sample comment has been added for the first result, no additional comments are added for the remaining tests. Omitting a Test The omit function allows you to cancel any further processing, including reporting, for the selected test. The test result status changes to Omitted. You cannot omit records that were uploaded. If a request participating in a calculation is omitted, the calculated result request is automatically omitted. If a component test is omitted, the ratio test is automatically omitted. If a ratio test is omitted, the component tests remain available. Access the Omit window from the Review and Edit window: 1. Right-select the selected test and select Omit. The Omit window displays. 2. On the Omit window, type a comment into the Note field to record the reason the test was omitted. 3. Select OK. Note An LIS can un-omit a test. You can only omit on multiple samples from Display patient samples on QC Results (Across Controls View). If you try to perform multiple omits on different samples on the Display patient samples between 2 QC points window, only the sample of the last request omitted will be dispatched immediately to the LIS. page 100 11222683 Rev. A System Operation Viewing Omitted Results To view omitted results: 1. Open the Review and Edit window for the sample with omitted results. 2. Select View > Query > Reopen on the menu bar or select Options on the lower left of the Review and Edit window. The Request Query window displays. 3. On the drop-down menus at the Status From and To fields, select Omitted and select OK. The results display on the Review and Edit window. Viewing the Omission Note through the Request Window To view the omission note via the Request window: 1. On the Review and Edit window, double-select the omitted test. The Request window displays. 2. Select the Audit tab. The text populates the Omission note field. Invalidating Results To change the status of a request from Validate back to Review, select one or more results with status Validate, right-select on the Review and Edit window, and select Invalidate. If any request participating in a calculation is invalidated, the calculated result request is automatically invalidated with it. Viewing Results Graphically The View Result function allows you to view hematology results that contain cytograms as a cytogram image. Viewing QC Results for a Test When reviewing a sample, you can investigate a quality control severity by navigating from the Review and Edit window to the QC Results window. To see the QC results of a selected test on the Review and Edit window: 1. Access the QC Results (Across controls view) window. 11222683 Rev. A page 101 System Operation 2. Right-select the selected test and select View QC. The QC Results window displays the relevant QC results. The top of the window displays test origin information, the middle of the window displays a history of results, and the bottom of the window displays comments and flags. For more information about viewing QC results, see Accessing the QC Results (Across controls view) Window on page 156. Example: A QC severity error on a glucose test for an ADVIA 1650 instrument displays on the Review and Edit window. The glucose test is defined in the CentraLink system with three different QC levels for glucose. Since the last closeout, these three levels were run twice each. To investigate the quality control implications, select this glucose test on the Review and Edit window, right-select and select View QC. The QC Results Across Controls View window displays all the QC results for this glucose test on the ADVIA 1650 instrument since the last closeout. You can view the entire control history for this assay and instrument. See Understanding Quality Control on page 139 for information on Quality Control functionality. Appending a Comment to a Request You can add or edit a user comment for the result associated with the request. The comment can be either a free text comment or a coded comment, which when updated through the Edit Comment for Request window is expanded into the text associated with the comment code. The comment field is dynamic-text enabled and is linked to the Request table. Dynamic text is the mechanism used by CentraLink software to dynamically expand text segments by substituting MISPL content or references to text records. Text records are reusable text modules that can be referenced from any dynamic text enabled field. For a comment code to expand into text, you must define the text for a comment and associate it with the comment code: 1. On the menu bar, select Start > System Management > Texts > By Mnemonic. The Text Record browser window displays. page 102 11222683 Rev. A System Operation 2. Select the New icon. The Text editor window displays the following fields: Field Description Mnemonic The code that uniquely identifies the comment text. The maximum number of characters for the Mnemonic field is 60 characters. For example, enter the code RR. This is the code that is associated with the text: Rerun Request. Class Classification string for use in queries. Description Describes the text. Table Refers to the table to which the comment text is linked. Mandatory field entry. Text This is the comment text that is associated with the comment code, otherwise referred to as the mnemonic, and displays as a comment through the Comment field of the Review and Edit window. For example, enter the text: Rerun Request. This is the comment text that is associated with the code RR. The maximum number of characters for the Text field is 31,921 characters. Start / End Dates Dates specifying the time period in which the code and associated text can be used. 3. To associate the comment text with the comment code, select OK. Append a Coded Comment to a Test Result To append a coded comment to a test result, on the Review and Edit window: 1. Right-select the test and select Edit Result Comment. 2. In the comment field of the Edit Comment window, enter a forward slash:(/) followed by the comment code, which was entered to the Mnemonic field of the Text editor window. From the example above, enter the value ‘/RR.’ The forward slash is the mechanism through which the CentraLink system recognizes that a coded comment follows. 11222683 Rev. A page 103 System Operation 3. When you select Update, CentraLink software queries the table defined in the Text window and accesses the text associated with the coded comment. The expanded comment text displays in the Comment field of the Review and Edit window. The Edit Comment window displays the following: {<RR}. The coded comment is stored to the database. Once the comment text is expanded in the Edit Comment window, you can add free text before or after the comment. You can view this expanded comment through the Comment tab of the Request window by double-selecting the request. Settings for Comment Upload to LIS For information on LIS Channel Configuration and comments upload, see Patients Tab on page 204. Specifying a Dilution Factor To specify an auto dilution coefficient and auto dilution condition: • for requests in Pending or Rerun status, use the Set auto dilution window. • for requests in Review, Validated and Uploaded status, use the Advanced rerun window. Note Right select a test name on the Review and Edit window to open the Set auto dilution and Advanced rerun windows. If you specify auto dilution coefficient or auto dilution condition values on these windows, the corresponding values assigned to the request from the LIS are overwritten. You cannot revert back to the LIS values unless you manually re-enter the values through the Set auto dilution window. When an auto dilution coefficient or auto dilution condition value or both are specified, these values are downloaded upon workorder download in response to the instrument query as long as dilution download is supported by the instrument protocol. When specified, the workorder message contains the auto dilution coefficient or auto dilution condition values from either the LIS or those manually entered through the Set auto dilution or Advanced rerun windows. Note Do not use the Set Auto Dilution or Advanced Rerun with dilutions functions with the ADVIA Centaur® CP system. page 104 11222683 Rev. A System Operation Setting Up Auto Dilution You enter parameters to the Set auto dilution window for those tests in which you want the initial test run to be diluted. Unlike a dilution that might occur during an advanced rerun on a test that was processed at least once, an auto dilution configured on the Set auto dilution window is a dilution that occurs the first time the test request is processed. For requests in Pending and Rerun status, you can specify an auto dilution coefficient and auto dilution condition through the Set auto dilution window. On the Set auto dilution window, the specified auto dilution coefficient and condition parameters apply only to the highlighted test request that exists in Pending or Rerun status on the Review and Edit window and from which the Set auto dilution window is accessed. These parameters do not apply to multiple records. Instead the parameters are test request specific and are set at the request level. As such, the parameters apply only to the highlighted test request on the Review and Edit window, not to all of the selected records. Note Your local technical support provider can implement a MISPL site function to automatically apply a dilution, based on your workflow. Note The Auto Dilution function cannot be used with many instruments. For a list of supported instruments, contact your local service provider. To access the Set auto dilution window, right-select the test on the Review and Edit window and select Setup auto dilution. These fields display: Field Description Dilution Coefficient Depending on the instrument, leave as the default ? symbol or enter the desired dilution coefficient to be included in the workorder downloaded to the instrument. This field is used for instruments which support dilutions with CentraLink systems, and for dilution percentage for Sysmex CS instruments. Dilution Condition 11222683 Rev. A Depending on the instrument, leave as the default ? symbol or double-select to select from a list of pre-defined Dilution conditions to be included in the workorder downloaded to the instrument. page 105 System Operation Setting Up Advanced Reruns You enter parameters to the Advanced rerun window for those tests that have already been processed at least once. Unlike a first time auto dilution that would be configured on the Set auto dilution window, an auto dilution configured on the Advanced rerun window is a dilution that is defined for a test request that was processed at least once and is being rerun. For requests in Review status, you can specify an auto dilution coefficient and auto dilution condition through the Advanced rerun window. The advanced rerun feature allows for entry of a manual or automatic dilution factor and for instrument-specific reruns. Note These parameters apply to all selected records on the Review and Edit window, not just to the highlighted test request. Manual Dilution To enable manual dilutions for reruns, specify Manual in the Dilution type field of the Advanced Rerun window. For the test request, enter a dilution coefficient, also known as a factor. The condition field is not used for a Manual Dilution and the field displays containing a gray ? symbol. For manual dilutions, the Dilution coefficient field is not downloaded to the instrument with the workorder. The dilution must be performed manually at the instrument to reflect the dilution coefficient field value entered on the Advanced Rerun window. The actual dilution completed on the sample must correspond to the manual dilution coefficient value. When the CentraLink system receives a result for a manual dilution test from an instrument, the received result is multiplied by the manual dilution coefficient value that was entered on the Advanced Rerun window. WARNING If you manually dilute a sample by a certain amount at the CentraLink system and the operator does not dilute the sample tube, CentraLink software will still multiply the result by the amount of the specified dilution, resulting in erroneous results. Auto Dilution To enable automatic dilutions for reruns, specify a Dilution type of Auto at the Advanced Rerun window. page 106 11222683 Rev. A System Operation If you select Auto, dilution occurs automatically at the instrument without manual intervention. The actual dilution completed on the sample directly corresponds to the dilution coefficient value that was downloaded from the CentraLink software. When the result is uploaded from the instrument to the CentraLink system, the result is not altered by the CentraLink system. In addition, your local technical support provider can implement a MISPL site function to automatically apply the desired dilution based on your workflow. You can also specify automatic dilutions on first dilution requests through the Set auto dilution window. See Setting Up Auto Dilution on page 105. Note Use the Instrument field to specify the instrument where the rerun is to be performed on ADVIA Automation and Aptio Automation systems. On the Advanced rerun window, the specified auto dilution coefficient and condition parameters apply to each test request in Review status that is selected on the Review and Edit window prior to accessing the Advanced rerun window. Note In an automation system, the instrument field can be used to target the rerun at a specific instrument. 11222683 Rev. A page 107 System Operation To access the Advanced rerun window from the Review and Edit window, right-select a test and select Advanced Rerun. The Advanced Rerun window displays these fields: Field Description Instrument Instrument to which you explicitly target the rerun. This instrument overrides the default LAS rerun routing. Dilution type page 108 Select one of the 3 dilution types: • Manual - Manual dilution is specified. When the result is uploaded from the instrument after a manual dilution, the CentraLink software multiplies the instrument result by the dilution coefficient value. • Auto - Auto dilution is specified. For auto dilutions, a dilution factor Is downloaded to the instrument with the workorder. The dilution occurs automatically at the instrument without manual intervention. When the result is uploaded from the instrument after an auto dilution, the CentraLink system does not modify this instrument result value. • None - While no dilution is specified, the rerun is targeted to occur on the instrument specified in the Instrument field. The instrument targeted rerun occurs without dilution. 11222683 Rev. A System Operation Field Description Dilution coefficient Manual Dilution When dilution type of Manual is specified prior to rerun, the dilution coefficient value indicates how much the sample must be diluted. After rerun, this value is multiplied against the result received from the instrument to correct the result for dilution. For example, you enter the value 2 for the manual dilution coefficient. Prior to rerun, the sample must be manually diluted with an equal amount diluent. After rerun, the incoming instrument result is automatically multiplied by 2 to correct for dilution. The specified manual dilution coefficient is not communicated to the instrument for automatic onboard dilution. The dilution coefficient must be at least 1. Upon entering a change to the Dilution coefficient field for a manual dilution, a message displays warning that after upload from the instrument, the result will be multiplied by the Manual dilution coefficient. You are prompted to select Yes to confirm that after upload from the instrument, the result will be multiplied by the Manual dilution coefficient. Auto Dilution When dilution type of Auto is specified, the dilution coefficient value is downloaded with the workorder to the instrument. The instrument dilutes the sample as per the value in the dilution coefficient field without manual intervention. When the result is uploaded from the instrument after an auto dilution, the CentraLink system does not modify this instrument result value. This field displays dilution coefficient for instruments which support dilutions with CentraLink systems, and dilution percentage for Sysmex CS instruments. 11222683 Rev. A page 109 System Operation Field Description Dilution condition This field is enabled when you select Dilution type, Auto. Certain instruments require the use of a dilution condition. Depending on the instrument in which the dilution occurs, double-select in the Dilution condition field and select from a list of available values for the auto dilution condition. Comment Allows for entry of free text comments or coded comments. You can also view manual and auto dilution data by double-selecting the request on the Dilution tab of the Request window. Setting a Target Instrument Target initial test requests to a specific instrument using the Set target instrument function. CAUTION If an order has already been dispatched to the LAS, Set target instrument functionality will not update this order on the track. Siemens recommends that you consult with a service representative to configure a MISPL function to set the target instrument based on LIS order content. Setting a Request as Informational Informational requests are used to send down additional information to an instrument in conjunction with the order download. This functionality is currently used to send down Additional Cell Counts and Abnormality Flags to the CellaVision Instrument. To set a request as Informational, rightselect the request and select Set As Informational. Select the Informational checkbox, and then select OK. • In both the standard and Hematology Review and Edit window you can run Set As Informational on multiple selected requests. • You can also automatically set requests as informational via MISPL. Contact your local technical support provider for more information. Viewing Test Request Information To view the details of a test request on the Review and Edit window, double-select a test. The Request window displays test and sample information at the top of the window, and result details at the bottom of the window. page 110 11222683 Rev. A System Operation The top part of the Request window displays these fields: Field Description Test Requested test name. Origin The origin of the request can be External when the LIS downloads the order for the request, Internal when the test was requested through CentraLink manual order entry, reflex testing, or a component from a ratio test, or Unsolicited when a test result was received from the instrument without a request available in the CentraLink system. Status Test request status: Pending, Rerun, Scheduled, Review, Validated, Uploaded, or Omitted. Sample priority The priority of the sample associated with the request: Routine, ASAP or Stat. Instrument The instrument from which the result is expected or the instrument delivering the result. Patient History time This equals the sample collection time, or when the collection time is not available, the sample creation time. The time specified in this field is used for delta checking if, at the application level, the previous result origin is set to local in the CentraLink database. Aspiration time Time when the instrument aspirated the sample. String value Text representation of the result value. Rounding for numerical tests is indicated. Target Instrument Displays the targeted instrument, if specified. Allow autovalidation Specifies whether the test is auto-validated. Autovalidation mode Specifies the autovalidation mode. The bottom part of the Request window consists of six tabs: Result Detail Tab Upon display of the Request window, the Result Detail tab is activated. The Result Detail tab displays associated results by Aspect name and Value. 11222683 Rev. A page 111 System Operation Dilution Tab The Dilution tab displays these fields: Field Description Coefficient The dilution coefficient as requested through the workorder downloaded from the LIS or as specified using the Advanced rerun or Set auto dilution functions. This field displays the dilution coefficient for instruments which support dilutions with CentraLink systems, and the dilution percentage for Sysmex CS instruments. Condition The dilution condition, such as Neat, Down, or Up, as requested through the workorder downloaded from the LIS or as specified using the Advanced rerun or Set auto dilution functions. Result coefficient The dilution coefficient as reported by the instrument. Result condition The dilution condition (Neat, Down or Up) as reported by the instrument. Manual coefficient The manual coefficient is the manual dilution coefficient specified on the Advanced rerun window. When a result for the request is received from the instrument after manual dilution, the manual dilution coefficient is multiplied against the result. This manual coefficient value and the calculated result value are stored in the result record. Then, the manual dilution coefficient value is cleared to prevent it from being applied to subsequent results. Result manual coefficient page 112 Contains the manual dilution value used to obtain the current result value. 11222683 Rev. A System Operation Severity Tab The Severity tab includes these fields: Field Description Norm Displayed when the result is outside the norm ranges. The scale of the severity number reflects your range severity definitions. It is positive when the result is above the high limit, or negative when the result is below the low limit. Delta norm A delta check severity is assigned only if a previous sample result matching the same patient and test can be found and, depending on how the delta norm is defined, if the maximum percent difference or absolute difference is exceeded. QC The QC severity value can equal a warning, moderate or severe control failure depending on how you group and define the severities relative to the available Westgard rules. Instrument Automatically set to the highest severity of the associated patient severity instrument flags. Note A Patient severity value on the Instrument Flag window greater than this value overwrites it. Aggregate An aggregate of the other four severities. It is automatically set to their highest absolute value. If this aggregate value is different from zero, the result in Review and Edit is red. Comment Tab The Comment field of the Comment tab includes free text that is received from the LIS with the request. 11222683 Rev. A page 113 System Operation Audit Tab The Audit tab includes these fields: Field Description Validation time Date and time the result was validated by the validation user. Upload time Date and time the result was uploaded to the LIS by the Upload user. Omission time Date and time the request was omitted by the Omission user. Omission note Contains the reason for omission, if applicable. Validation user User who initiated the validation. Note If batch is the validation user this means that the CentraLink program validated this result due to Auto validation settings. Upload user User who initiated the upload. Note If batch is the upload user this means that the CentraLink program validated this result due to Auto validation settings. Omission user User who initiated the omission. Note If batch is the omission user this means that the CentraLink program validated this result due to Auto validation settings. LIS Previous Res Tab The LIS Previous Res (LIS previous result) tab includes these fields: page 114 Field Description Date/Time Lists the date and time in which each previous result value for the request was transmitted by the LIS. Result value Sorted in order of the most recently received result, lists all previous results transmitted by the LIS for the request. Unit Lists the unit of the previous result sent. 11222683 Rev. A System Operation Understanding the DiffPad The Diff Pad function allows you to use designated keys on the computer keyboard to increment counters for different blood cell types. You can open the Diff Pad, the virtual blood differential counter, from any whole blood Sample browser window or from the Review and Edit window. Figure 2-1: 11222683 Rev. A Diff Pad Window 1 Counter requests area 2 Diffpad Instrument 3 Requests area 4 Image area 5 Result comments 6 Flags 7 Result user comment 8 Sample comment page 115 System Operation Although no physical instrument is in actual use, a differential counter is represented in the CentraLink system by an instrument record. Instrument records become eligible as counters when one or more of their contained methods have their counter key label field set. The CentraLink system comes pre-configured with a single counter-type instrument called Diff Pad. You can add other counter-type instruments. The Diff Pad function can be used whether or not the corresponding tests have already been requested or if the instrument results already exist. If the tests have not been requested, the CentraLink system automatically adds the tests to the request when the Diff Pad is used. Specifying a Diff Pad Instrument If no instrument is specified in the Diff Pad field on the More tab of the system Options window, you must enter an instrument to use the Diff Pad. If you attempt to right-select on a selected sample in the Sample browser window before specifying an instrument in the Diff Pad field, a list of instruments displays from which you can select an instrument counter. If you select an instrument that is not setup correctly for counters, a warning message displays: None of the contained methods have an associated counter key When a Diff Pad value is specified in the Diff Pad field on the More tab of the system Options window, the Diffpad Counter window displays. This window consists of the following two lists, which can be updated: • Contained methods that have counter key labels defined. In the case of the pre-configured DiffPad instrument, it contains the typical white blood cell types. • Contained methods that do not have counter key labels defined. If the counter instrument is properly configured with additional methods, this list can be used to view related results. Upon display of this window, available results are displayed first. These results can include those obtained from a real instrument. You can select Reset to reset all counters to zero. page 116 11222683 Rev. A System Operation To navigate to the Diff Pad: 1. On the Sample browser window, right-select the selected entry and select Diff pad, or on the Hematology Review and Edit window, select the Diff Pad icon. The Diff Pad window displays. 2. While looking through the microscope, use the keyboard to count the different cell types. Select the appropriate key to increment the cell count by one. You can count the number of cells in 2 ways: Formula The counted cells for this test will be added to the total number of counted cells. Separate The counted cells for this test will not be added to the total number of counted cells. They will have to be counted separately. • If you make a mistake or want to restart the count, select Reset on the counter window to set all the counts to zero. • When the count limit of 100 is reached, you hear a signal indicating that sufficient data is available. • Each time this value is reached, or the count cycle, a separate sound is triggered. Note The count limit is configurable. 3. Select OK. Note To see the Diff Pad count reflected on the Review and Edit window, close the Review and Edit window and reopen it. Using the DiffPad The Diffpad (virtual blood differential counter) allows you to use designated keys on the computer keyboard to increment counters for corresponding blood cell types. For example, you could designate the “y” key to use as a counter for Lymph cells. Right select on any sample browser and select Diff Pad from the menu, or select the Diff Pad icon on the Review and Edit window. 11222683 Rev. A page 117 System Operation Preconfigured Diff Pad The CentraLink software has a preconfigured Diff Pad which contains the typical white blood cell types. Configuration Although no physical instrument is in use, a differential counter is represented in the application by an instrument record. Several different counter instruments can be configured, each with its own counter specific setup and methods. Instrument Level Options These Diff Pad options can be set on an instrument level: Type Instrument records become eligible as counters when their type is set to Diff Pad. Counted test Specify the test for which the fractions are being counted via this Diff Pad. When this test is specified, a column displaying the absolute values of the counted fractions is visible in the Counter requests area of the Diff Pad window. Count cycle The CentraLink system generates a sound each time this number of cells has been counted. You can continue counting until the cell count limit is reached. This can be helpful if the user decides that not enough cells have been counted to get a reliable result. If no cell count cycle is specified, the counter stops when the cell count limit (see below) is reached. Count limit page 118 This specifies the maximum number of cells that must be counted in order to obtain realistic statistics (typically 50 or 100). The cell counter stops counting as soon as this limit has been reached, and an audible signal is generated. 11222683 Rev. A System Operation Method Level Options These options can be set for the methods of a Diff Pad instrument: Counter key label This field allows you to specify which key will be used to count the test. You cannot assign the same counter key multiple times for different methods of the same instrument. You can edit the Diff Pad counter key labels. Select the hand icon to edit the label. However, you cannot edit a key label after you have started counting cells. Count method This field has two possible values: Formula The counted cells for this test will be added to the total number of counted cells. Separate The counted cells for this test will not be added to the total number of counted cells and must be counted separately. Usage Unless you specify a Diff Pad instrument in Options, when you open a Diff Pad a list of instruments displays. After you select an instrument, the Counter screen displays these areas: Counter Requests Area This section of the window contains the methods of the selected counter instrument which have a counter key label defined. These keyboard keys can be used to count the different cell types while looking through the microscope. 11222683 Rev. A page 119 System Operation Each cell type has an associated key, which increments the associated cell count by one. The results are stored as percentages. Column or Field Definition Key This column contains the counter key label that is defined for the method. The key codes in this column can be customized (see below). ABS When a Counted test is specified for the instrument, an extra column will be visible displaying the absolute values of the counted fractions. These absolute values are calculated as follows: RequestCounterValue * CountedTestNumericValue / TotalCount. These values are informational only and are not stored in the database. Prev Run Contains the current result value of the corresponding test request. Instrument Contains the instrument that produced the current result value that is displayed in the Prev Run column. Counting Indicates the number of cells that already have been counted, and the count limit. • You can change the count limit while counting cells. • The new limit is user specific and will be used for the next session. • You cannot enter a value lower than the amount of cells that have already been counted. Counted test Indicates the counted test configured for the instrument. Value Indicates the current result value of the counted test. Tips for Using Diff Pad page 120 • Separate count methods (see above) are displayed at the end of the list and will have a slightly different background color. • Use the backspace key to correct (subtract) the counted cells in inverse chronological order. 11222683 Rev. A System Operation • Configuration changes (for example, key codes and count limit updates) are immediately saved when you exit the field. Result updates are saved only when you select OK. • Add result comments in the Result user comment field. Icons on the Diff Pad User Interface Icon Meaning This icon indicates that the sample has sample documents. Click this icon to switch to Edit mode (see below). This icon indicates that the screen is in Edit mode which allows you to enter codes in the key code column of the browser. These new codes are user specific and will be recalled for your next session. Click this icon to confirm your changes. Once counting has started, the key labels can no longer be updated. You can no longer switch to Edit mode. This icon allows you to reset all counters. This icon allows you to edit counter key labels. When a red line intersects the hand, the labels are not editable. 11222683 Rev. A page 121 System Operation Requests Area This area contains the methods of the selected counter instrument for which no counter key label is specified. This list can be used to view related results, if the counter instrument is configured with additional methods. Field Definition Test Name of the test request. This field is a read-only field which displays the test name of the focused test request, for which you can enter result comment. Current Current result value of the test request. This value can be updated. The second field allows you to enter a result comment. Prev Run Previous run value of the test request. Instrument Instrument that produced the current result value of the test request. Sample comment The sample comment will be displayed in this section of the window.You can update the sample comment; the updated comment will only be saved when you select OK. Result user comment Users can manually add result comments in the Diffpad screen. These comments will be saved in the Result.UserComment field. • The test must be a method on the DiffPad Instrument to see any result comments in the Diff Pad window. • If you cancel the Diff Pad window the result comments entered will not be saved. • If you reset the counters, all comments entered for the counters are also reset. Comments are saved in the database concurrently with the counter results. Image Result Area Associated sample images are displayed in this area. The image sent by the instrument may be larger than the provided area. Select this button to expand the image over the entire screen, and to return the screen to its previous setting. page 122 11222683 Rev. A System Operation To configure your system to resize images, in Internet Explorer, choose Tools > Internet Options and select the Advanced tab. Enable Allow active content to run in files on My Computer. You must enable this option for any server and client PC to use the image zoom functionality. This setting is not saved when closing the screen. Note You can click on the image to open it in a separate window, and modify the size of the image in the new window. This functionality is also available in the Hematology Review and Edit window. Flags Area Any instrument flags associated with the current sample are displayed in this area of the window. Result Comments Area Any result comments associated with the current sample are displayed in this area of the window. Note You can use the Diff Pad without having requested the contained tests beforehand. The application will silently add the requests if necessary. Accessing the Hematology Review and Edit Window Review and modify hematology test results from connected instruments on the Hematology Review and Edit window. Open the Hematology Review and Edit window: • Select Start > Routine > Review and Edit (Hematology) > Instrument rack query. • Select Start > Routine > Review and Edit (Hematology) > Sample query. • Right select a hematology based sample and select Review and Edit (Hematology) • Create and configure a Hematology Review and Edit instrument rack or Sample query button on the tool bar. To create and customize a button on the user interface, see Creating Tools on page 198. Note Depending on the size of your monitor, you may have to scroll to view the entire Hematology Review and Edit window. There are six areas of the Hematology Review and Edit window: 11222683 Rev. A • Sample information • Patient information page 123 System Operation • Image results information • Test groups information • Results comments • Flags The basic layout of the Hematology Review and Edit window is as follows: Figure 2-2: Hematology Review and Edit Window 1 Samples toolbar 2 Patients toolbar 3 Test Group Toolbar 4 Hematology image 5 Flags 6 Comments Sample Information Area You can customize the window information and layout in this area. Consult your technical support provider to configure this area for your laboratory’s needs and to change the default settings. page 124 11222683 Rev. A System Operation Sample, Patient and Test Group Icons Enter Edit mode Exit Edit mode Edit result comment Indication of attached sample documents (for example, CellaVision images) Diffpad shortcut Sample Revert/Test Group Revert (depending on context of button) Sample Rerun/Test Group Rerun (depending on context of button) Validate the sample Validate the test group Validate selected requests Generate Sample Report 11222683 Rev. A page 125 System Operation View Previous Sample/View Previous Runs (depending on context of button) Indication of suggested user actions based on customizable rules. Request Groups Request Group codes can optionally be assigned to methods from an Instrument to ensure consistency in the status of all requests assigned to that request group. If an action is performed on one request in the Request Group, then this action will be automatically performed on all other requests assigned to the same Request Group. For example, a Rerun of one request will cause all other requests in the same Request Group to also be Rerun. See Advanced Tab of Method Editor Window on page 243 for more details on request group codes. Note In some cases it may not be possible to maintain status consistency across requests in the same Request Group, i.e. if the other requests are not in the correct status for the function being performed. Depending on the action being attempted this can result in a message to the user stating the requests which could not have the action performed and/or the entire function not being applied. CAUTION Implementation of request group codes can impact existing MISPL rules. Contact your local technical support provider before implementing request group codes functionality. page 126 11222683 Rev. A System Operation Hematology Consensus Rules Note A set of ISLH Hematology Consensus Rules is provided with the software. See also ISLH Consensus Rules. If a condition or set of conditions is met, the drop-down list of the i button displays a list of ISLH Hematology Consensus Rules that were triggered. If you select one of those buttons a recommended action (for example, Slide test reflex) is triggered, or a popup message with instructions displays. Each rule has a default setup that includes, for example, comments, test methods limits, and flag severity triggering levels. Note You can create customized MISPL for i button functionality beyond that of the ISLH Consensus Rules. For more information, contact your local technical support provider. Image Result Area If an image result is associated with the selected sample, it displays in the top right corner of the window in an embedded Internet Explorer window. Note You can click on the image to open it in a separate window, and modify the size of the image in the new window. 11222683 Rev. A page 127 System Operation Customizing Test Group Column Task Visibility Width Position Sorting How to The button in the top right corner of each browser allows you to determine which columns should be displayed/ hidden. The following columns cannot be hidden: >, Test, Current The settings are stored per user and remembered. The width of each column can be changed by dragging the column separator to the left or to the right. The column on the left-hand side of the selected separator will become wider when dragging the separator to the right and narrower when dragging it to the left.The settings are stored per user and remembered. Select the first-from-left button in the top-right corner of each browser to activate or deactivate column swapping for that list. Then select Column swapping active. To move a column, drag it to the desired position. When the left mouse button is released, the column will be repositioned. The settings are stored per user and recalled for each user session. By default, the tests in the test browsers will be sorted by their sequence number. Click on a column header to sort the tests in that browser on this column. The sorting column and order is indicated by means of an indicator in the column header. • Column sorting settings are reset when you switch to another sample or exit the screen. • You cannot sort columns when column swapping is active. Note In system software version 16 you can also customize the standard Review and Edit window. Result Comments Area This area displays all comments associated with the sample results. When this panel is updated, the Hematology Review and Edit window is automatically updated with the new comment. page 128 11222683 Rev. A System Operation Two viewers cannot see each other’s results. For example, User X making updates to a result comment being viewed by user Y will not cause an update of user Y's window. An update to the Hematology Review and Edit window will only occur when you change comments within the same session. Flags Area This area displays all flags associated with the sample results. Configuring and Resizing Columns You can choose which columns to view in the 4 request/test-listings on the screen, and change column width and position in the list. You may also specify which column the list needs to be sorted on. When you close the window, these settings are saved on a per-user basis. Click the Select columns to show icon on the right-most part of the window and select the checkboxes of the columns you wish to display. To change column order, click on the Activate Column Swapping icon (two arrows). Select and drag the column to the desired location. Then click Deactivate column swapping. You can view, hide, resize or reposition these columns: 11222683 Rev. A • > Indicates whether the line is currently part of a multi-selection • Test Name of the performed test. • Current Current value of the result. • Instrument Instrument which generated the result, if any. • Unit Unit of the current result. • Norm Norm-range to which the test must comply. • Sts Status of the performed test. • NS Norm Severity if any. • DS Delta norm Severity, if any. • QS QC Severity, if any. • IS Instrument Severity, if any. • S Severity (highest severity of NS, DS, QS, and IS) • M Manual. Checkbox indicating whether the result was entered manually or not. Please note that this excludes DiffPad results. These are not considered manual results. This is the same behavior as per previous version. page 129 System Operation • C Calculated. Checkbox to indicate whether or not the test is a calculated test. • Prev Run Previous run. Displays the result from a possible previous run (if available). • Prev Samp Previous result for same patient, previous sample, same test. Displays the result from the same test on a previous sample (if available). • F Indicates if there are flags on the request. • P Indicates if there are parse errors for the previous run request value. • Current D/T Current date and time. • Prev Run D/T Date and time of previous run for this request. • Prev Samp D/T date and time in which the Prev Samp value was recorded. • #PR Number of previous runs. • T Target Instrument • TAT Turnaround Time. This column displays the TAT calculation for the request. The start and end criteria for Turn Around Time calculation can be defined on the Review and Edit tab of the system Options window Restrictions and Options • You can change all column widths and positions. • You cannot hide the >, Test, or Current columns. • You can group tests within a hematology selection panel so that if any request within the group is rerun, validated, reverted, invalidated or unscheduled, the action applies to the entire group. • You can include images in Hematology test groups. The Hematology Review and Edit Window Layout The Hematology Review and Edit window contains 4 test browsers. For 3 of these browsers you can decide which tests should be displayed by selecting the appropriate Hematology Test Group in the drop down list of each browser/quadrant. The Other browser contains all the tests of the sample which are not displayed in any of the other 3 browsers. The first time that you open the Hematology Review and Edit window, all tests display in the Other test group.Your preferences are saved when you close the window. page 130 11222683 Rev. A System Operation You can access all Hematology Test Group-based functions (Invalidate, Omit, Rerun, Revert, Unschedule, Upload) by right-selecting in the Name drop down list. Access all request-based functions by right selecting in the tests browsers. The Hematology Review and Edit window has multiple Revert buttons. Sample Revert: If selected, the action does not proceed if at least one request in the sample does not have a Previous Result. Test Group Revert: If selected, the action does not proceed if at least one request in the quadrant does not have a previous result. Request Revert: menu item (via right click on a request) If selected, the system will prompt you to proceed with the revert if one of the selected requests does not have a previous result. Editing Results For information on editing results, see Directly Editing a Result on the Review and Edit Window on page 67. Edit mode is disabled: • When you select the Exit Edit Mode icon (see above). • When you navigate to another sample • When the <esc> key is pressed • When the Hematology Review and Edit window is closed • When a context or connection timeout occurs (see Options) • When the Edit mode time out occurs (see below) Edit Mode Time Out Select Options. On the Review tab, in the Edit mode time out field specify the period (in minutes) after which the Edit mode is automatically disabled for a specific sample. The default value is 1 minute. Editing Restrictions 11222683 Rev. A • You can only edit tests with data type String, Numeric and Enumerated. • The request status should be lower than Validated to update the result value. • You cannot edit calculated tests. • Like other CentraLink functions, you can protect the Edit button to restrict its use. page 131 System Operation Notes Auto-validation warnings are disabled, but the test-scoped Edit warning will be shown if defined. If you receive a Record already modified by someone else error, refresh the request view to view the most recent value, then re-edit it if still necessary. If you manually modify Diff Pad results, keep in mind that there is no 100% check. To avoid problems, use the Diff Pad function. Manually Entering a Workorder • Create a new workorder. • Supplement the order entry process from the LIS. You can order requests by panel (Profile) or as a single test. • Correct a workorder. Creating a New Workorder 1. On the menu bar, select Start > Routine > Order entry. You can also select the Order entry icon on the toolbar. The Order Entry window displays Sample ID and status information at the top of the window, and sample origin information at the bottom. 2. Type the Sample ID. The maximum Sample ID length is 32 characters. The Requesting LIS field is pre-populated with the default LIS channel specified in the Options window. This field must be populated, and determines which patient ID, patient location and physician IDs are restricted to whatever are associated with that LIS channel. Note Physician, Patient and Patient Location fields cannot be edited without first specifying an LIS Channel. You can enlarge the size of the Sample browser window or Review and Edit window to increase the Sample ID field and display the full Sample ID value. For information on resizing windows in the CentraLink software, see Using the Workspace on page 14. Note The Sample ID value originates from the LIS, the barcode on the container, or the Order Entry form. This field entry is mandatory. page 132 11222683 Rev. A System Operation 3. Enter the tests that you are ordering in Requests: If Then You know the code or mnemonic for a test You can enter it directly and select ENTER to add it to the list. You can also enter a list of known codes separated by commas and select ENTER. You want to enter tests from a list Double-select the Requests field to open the Requestables browser. Each test mnemonic is listed as Smp (simple) or Pan (panel) in the Type column to indicate that it is a single test or a group of tests. To limit the display to simple or panel display, select Options and select the type. You want to learn more about a test before ordering it Select the test on the Requestables window and right-select to display additional information. You want to enter a single test on the order Double-select the test line on the Requestables window. You want to enter multiple tests Select each test and press the spacebar. Select OK to transfer the selected list to the Order Entry editor. When a test is selected, the left-most column displays a > character. Note Requesting LIS, Sample ID and Requests are the only required fields on the window. Note If a test name that consists of 20 characters was entered at the Test window, the test name value appears to be truncated in the Requests field of the Order Entry window. To verify the entire test name, put your cursor in the Requests field and select the right arrow key until each of the remaining characters of the test name display. Avoid entering test names that consist of 20 characters. 4. Enter the Collection D/T. These date/time values are automatically populated in the Collection D/T field for the next manual work order. You can override or clear the value in the Collection D/T field, however, for each new manual work order created. Once the Order Entry window is closed, the value in the Collection D/T field is cleared. 5. Double-select Sample types to display a list of sample types. 6. Double-select Container type to display a list of container types. 11222683 Rev. A page 133 System Operation 7. Double-select Patient ID to display a list of patients. 8. On the list of patients, double-select the appropriate patient to enter patient information on the order in most of the remaining fields. Note If the patient is not on the list, you can manually add the new patient information. When you select OK to submit the order, the system prompts whether you want to create the new patient record. If a patient record already exists with the Patient ID that you are specifying, a popup window prompts you to confirm whether you want to update the patient record. If you select Yes, the patient record is updated and all sample records that reference the patient record are updated. If you select No because you do not want to update the patient records, a message window prompts that the specified patient data conflicts with stored patient data. Select OK. Note Depending on the size setting in use for the Review and Edit window, the patient name may not display in full. To display the full patient name either enlarge the size of the Review and Edit window or right-select on the request and select Related > Patient. 9. Double-select Patient location to select from a list of patient locations. Note The Encounter field is reserved for future use. 10. Select the More tab to add a comment about the order. 11. Select OK. Merging Workorders with Existing Unsolicited Samples If the manual work order you submit has the same sample ID as another work order, the system displays a duplicate sample ID warning. If the manual work order you submit has the same sample ID as another work order and that work order is unsolicited and was received from an instrument rather than the LIS, the CentraLink system displays a message that you can merge the orders. In this case, select Merge on the Order Entry window. Note When you select OK or Merge to submit an order, the Order Entry window remains open to accept another order. To close the window, select Cancel. If you entered a new patient record for the work order, the system prompts you on whether to create the new patient record. If you select Yes, the patient record is updated and all sample records in the CentraLink database that reference the patient record are updated. If you select No, the patient record is not updated. page 134 11222683 Rev. A System Operation To add demographics and updates to orders that were created by unsolicited result upload from an instrument, use the manual order entry and then select Merge. Note You cannot merge with orders created by LIS download or manual order entry. If you attempt this, you will receive a duplicate sample ID warning. Manually Adding Tests to an Existing Workorder 1. Double select the order in the request field and select the test you want to add. 2. Select OK. Ratio and Component Tests Ordered Manually A ratio test is a test whose result is calculated from the results of other test results. A component test is a test whose result can be used in the result calculation of a ratio test. A test is set up as a ratio test by your administrator. An example of a ratio test that could be defined is HCT, where RBC and MCV are the component tests used to calculate the ratio test. If you order a ratio test manually, the component tests are automatically ordered. If you omit a component test from the order, the ratio test is automatically omitted. If you omit a ratio test from the order, the component tests remain in the order. LAS Tab The LAS tab on the Order Entry window displays read-only fields that contain details that are uploaded from the LAS. More Tab The More tab on the Order Entry window displays read-only fields that contain details about the LIS and instruments. The Comment field is editable: 11222683 Rev. A • Instrument is the last known instrument that received the sample. • Instrument rack is the last known rack. • Instrument position is the last known position of the sample in the rack. page 135 System Operation • Instrument time is the date and time of the last sample track (instrument, rack and position) information. • Centrifuged date time is the date and time of the last centrifuge notification. • Comment is free text and is dynamic text-enabled. Accessing Patient Records Depending on the security parameters defined by your administrator, you may have limited access to patient information. 1. On the menu bar select Start > Routine > Patients > By birth date / By ID / By Lastname, Firstname. You can also select the Patients icon on the tool bar. The Patients browser window displays. 2. Double-select a patient to access the Patients editor window. The Patients editor window displays. 3. Modify information in the editor and select OK. Note Depending on the size setting for the Review and Edit window, the full patient name may not display. To display the full patient name either enlarge the size of the Review and Edit window or right-select on the request and select Related > Patient. Accessing Physician Records 1. On the menu bar select Start > Routine > Physicians > By ID / By Lastname, Firstname. You can also select the Physicians icon on the toolbar. The Physicians browser window displays. Double-select a physician to open the Physician editor window. The Physician editor window displays the following fields: Field Description Physician ID Identification number that uniquely identifies the physician. Last name, First name, Physician name and address information. Title, Address Phone page 136 The phone number at which the physician can be reached. 11222683 Rev. A System Operation Field Description Fax The fax number to which reports are sent. Note This fax number value serves as the default to which files are sent when the Via fax checkbox on the Report window is selected. For more information about generating sample reports, see Sample Reports on page 260. Report model The name of the report template to be used with samples associated with this physician. Language The language used when printing reports for samples for this physician. Selecting a Report Format for a Physician Requesting physicians may have different report preferences. You can respond to these preferences by associating a specific report model with a physician name. When such an association is made, the report model is used whenever a workorder contains the physician’s name. 1. In the Physicians browser window, double-select a physician. The Physician editor window displays. 2. Double-select in the Report model field. The Report models window displays. Note Report models are initially configured by your system administrator. 3. Double-select the report model name in the Report models browser window that you want associated with the physician. The name of the selected report model displays in the Report model field. For more information, see Setting used only when Output type is set to FAX. on page 265. 4. Select OK. 11222683 Rev. A page 137 System Operation page 138 11222683 Rev. A 3 Quality Control Understanding Quality Control The Quality Control (QC) function allows you to view and print the QC data collected from all connected instruments. The data can represent control samples or patient samples. In either case, each group of QC results pertaining to a given sample is represented by a dedicated QC population to which you can apply Westgard rule-based control checking and define hold upon failure criteria. Westgard rules are configured per method and can be triggered in 4 ways: • across a lot • within a lot • within and across a lot • neither within or across a lot For more information, see Configuring Westgard Rules on page 251. You can view the QC results of a sample in numerical-tabular format or Levey-Jennings graphical format through the QC Results (Across controls view) window and through the QC Populations window. You can generate printed reports that contain graphs and numerical data and statistics by lot or by population. Note Westgard Rules continue to apply after a lot has been closed out. For example, A 10x rule applies across closed-out and non-closed-out points of a population. Control-Based QC Results Control-based QC results are obtained from tests on samples drawn from QC material. They are received in populations identified by instrument and QC lot. For each QC lot record that you create, you can create population records to hold the target values and ranges per test, or you can set up the system to automatically create them. Whether creating records manually or automatically, you must specify the target values and ranges per test. You can access other populations using the QC Lot window. QC results are included in Westgard checking when they have a numeric value other than unknown and no instrument flags with QC severity greater than 0. QC results that contain a supported comparator can be configured to participate in Westgard checking, however, these results do not participate in statistics. 11222683 Rev. A page 139 Quality Control Patient-Based QC Results Patient-based QC results, also called moving average results, are obtained by averaging test results from patient samples. They are received in populations defined by instrument and patient species. Moving average populations are created automatically as incoming results are stored. Patient results uploaded from an instrument are used for patient-based QC only when Check moving average on the Method window is selected. When selected, Bull's algorithm smooths the incoming data and generates a new QC result per instrument batch. You can influence the smoothing level by increasing the value of the Moving average batch size field on the Request window. The moving average batch size can be configured per request: the larger the batch, the fewer the number of QC results are generated and the less they vary. Patient results that contain a comparator (a greater than or less than sign) are not used to calculate moving averages. QC Lots The QC Lot window provides access to the QC Lot table, which stores records representing quality control lots. All QC tests performed on the same QC material are grouped into a QC lot. QC lots can be created manually or created automatically upon first reception of results for that QC lot. To access the QC Lot window: 1. On the menu bar, select Start > Routine > Quality control > QC lots > By name, lot number. The QC Lot query window displays the following fields: Field Description Name The name of the QC lot. Include expired If selected, expired QC lots as well as current QC lots are included in the display on the QC Lots browser. If not selected, only current QC lots are included in the display. 2. To initiate the query and populate the QC Lots browser with the relevant QC Lots, select OK. Upon display, the QC Lots browser is automatically sorted by Name followed by Lot Number. page 140 11222683 Rev. A Quality Control 3. To access the QC Lot editor window, double-select a lot on the QC Lots browser window. The QC Lot editor window displays the following fields: Field Description Lot Number Unique identifier of the QC lot. Name Name of the QC lot. Level Value that describes the lot level. Required for Bio-Rad, a manufacturer of control material, and other manufacturers. This alphanumeric field has a default value that displays as the ? symbol. Note This field must be populated with a QC lot level value, if you plan to export QC results using the Bio-Rad point data format. If a level value is not entered, an error message displays informing you that the lot level is empty. See Exporting QC Populations to Text and XML Files on page 151. Description Free text area for describing the QC lot. Start Date Start date before which the lot cannot be used. Expiration Date End date after which the lot cannot be used. You can schedule an internal e-mail notification to be sent when a QC Lot expires or is about to expire within a configurable period. For more information, see Scheduling a QC Lot Expiration Notice on page 309. Adding a New QC Lot Note Depending on the barcode labels used on specific instruments, adding a lot number may require special configuration assistance from your local technical support provider. This is true for customized barcode labels and Sysmex CS instrument QC. 1. On the menu bar, select Start > Routine > Quality control > QC lots > By name, lot number. The QC Lot query window displays. 2. On the QC Lot query window, select OK. The QC Lots browser window displays. 11222683 Rev. A page 141 Quality Control 3. On the QC Lots browser window, select New on the editing toolbar. The QC Lots editor window displays. 4. Enter the lot number. The number must match the number entered at the instrument. 5. Enter the new name, level, description, and dates for the new QC lot. Note You must fill in all fields accurately to avoid unmatched results. Ensure that the Expiration date is later than the Start date. 6. Select OK. Specifying Parameters for a QC Lot Once QC lots are established, you can specify test and instrument parameters for each QC lot. In grouping a QC lot with test and instrument parameters and specifying target values and deviations, you allow for the QC results to be associated with a QC population that accumulates statistics. To specify test and instrument parameters for a QC lot from the QC lots window: 1. Right-select the selected lot that requires test and instrument parameters and select Populations. The QC populations query window displays. 2. Enter the required parameters and select OK. page 142 11222683 Rev. A Quality Control Automating QC Result Upload to the LIS The system can be configured for automatic upload of QC data to the LIS by scheduling this function on all QC lots. The CentraLink system comes pre-configured with an upload command. Regardless, you must define a task and associate the command with a task scheduler. For more information, see Scheduling Tasks, page 308. Your local technical support provider can configure multiple LIS Channels, and certain LIS Channels can be designated for QC Upload only. QC Populations All QC results associated with the same QC test of a specific QC lot or species are grouped in a QC population. The QC population maintains statistics of the values of its contained results. The QC Populations window provides access to the QC population table, which stores records representing statistical populations of QC results sharing the same instrument, test, and either QC lot, if the result is control based, or species, if the result is patient based. To contribute to the statistics, QC results must meet the following criteria: • The result must have a numeric value. • The result value must be within the range defined by the Ignored deviation count. Any result value outside the ignored deviation count value is not used in statistics. • The result cannot be flagged by an undefined flag or by a flag with a severity greater than zero. • The result must not be omitted. You can see a graphical display of these statistics through the LeveyJennings graph. Populations can be manually or automatically created within the CentraLink software. If you do not manually create populations prior to processing controls, populations are automatically created upon receipt of the first QC result for the respective method and control lot being used. If you choose to have your populations automatically created, you must still manually specify the target and reference mean and deviation in order for Westgard checks to be applied and for QC results to affect auto-validation of patient results. QC populations can be accessed from the main menu, from the Method window, and from the QC Lot window. When accessed from the main menu or the QC Lot window, the QC population window displays first. 11222683 Rev. A page 143 Quality Control To access the QC Populations window from the main menu: 1. On the menu bar, select Start > Routine > Quality Control > QC populations. The QC population query window displays. You can also access the QC population query window from the QC Lots window by right-selecting a lot number row and selecting Populations. The following fields display: Field Description Test Limits QC data to a specific test. Double-select the field to select from a list. Instrument group Limits QC data to a specific instrument group. Double-select the field to select from a list. When a value is entered into the Instrument group field, the Instrument field is disabled. Instrument Limits QC data to a specific instrument. Doubleselect the field to select from a list. When a value is entered into the Instrument field, the Instrument group field is disabled. page 144 Type Select one of the following: • Any – does not restrict the result set to type. • Control – restricts the result set to populations referencing a QC lot. Entering a value to the QC Lot field enables additional restriction to the specified QC Lot. • Patient – restricts the result set to moving-average populations referencing a species. Entering a value to the Species field enables additional restriction to the specified species. QC lot Limits QC data to a specific control lot. Doubleselect the field to select from a list. Species Limits QC data to a specific species. Double-select the field to select from a list. MISPL Filter Allows filtering based on MISPL function, and limits QC data to a specific special function. Double-select the field to select from a list. Note Your local technical support provider can provide MISPL filters for you. 11222683 Rev. A Quality Control 2. To submit the entered criteria, select OK. The QC Populations browser displays. Depending on the criteria you entered, this browser displays a range of QC populations. 3. To view the details of one of the listed QC Populations, double-select any entry. The QC Population editor window displays the following fields: Field Description Method Test Method test identifies the test associated with the method to which the population applies. When inserting a new QC population, first specify the test with the instrument field unspecified. Setting the test restricts instrument lookup to only those instruments that support the test. Method Instrument Method instrument identifies the instrument associated with the method to which the population applies. Moving average Moving average indicates whether this is a patient-based population. When selected, this checkbox specifies that a species, not a QC Lot, is grouped with the test and instrument within the QC population. 11222683 Rev. A Target value The target value for the control product. Note When setting the target value to assign population reference values, the specified value should be within the range of the assay. A reference value outside the assay range will cause a severity to be generated for an invalid reference result if a control result with a comparator (< or >) is received. Target Deviation (1SD) The target deviation for the control product. Note If the manufacturer supplies the deviation as 2SD, you must divide that number by 2 to derive the 1SD value. Cumulative N The number of results for this test that were closed out. Current N The number of results for this test that have not been closed out. page 145 Quality Control Field Description Current Days to Keep The number of days, starting from the current date back, for which the current QC result is kept in the database. The number should be between 0 (default value) and 2000. Ignored deviation count If the difference between a new QC result and the reference value is greater than or equal to the ignored deviation count times the reference deviation, the new QC result does not contribute to the population statistics. Example: QC population for test WBC Reference value: 3.4 Reference deviation: 0.225 Ignored deviation count: 2. QC result: 3.9 [3.9 (QC result) - 3.4 (Reference value)] [2 (Ignored deviation count) * 0.225 (Reference deviation)]. page 146 Last close out time The date and time when the population was last closed out. Reference value Used for Westgard checking. This can be set to either the Target value or the Mean. To set this, right-select the editor and select Set Reference. In the Source field, select Target, Current Statistics, or Cumulative Statistics. Note If you choose Current Statistics or Cumulative Statistics, the standard deviation at the time you choose the setting is used from that point forward. Note Reference values should be defined with values within the range of the assay. A reference value outside the assay range will cause a severity to be generated for an invalid reference result if a control result with a comparator (< or >) is received. 11222683 Rev. A Quality Control Field Description Reference deviation Used for Westgard checking. You can set either the Target deviation or the Standard deviation. To set this, right-select the editor and select Set Reference. In the Source field, select Target, Current Statistics, or Cumulative Statistics. QC Choice List A list of QC choices which reflect the nonnumeric values for a QC result. To access QC choice lists, at the main menu select Start > Configuration > QC choice lists. Copying QC Populations To copy a QC population from one instrument to another, select Copy from the QC Populations window and the Instrument to which you want to copy the population record. The following fields will always be copied: • Test • Lot • Moving Average • QCPopulation Species • Ignored Deviation Count The following fields will be automatically populated depending on the target instrument of the copy operation: • Method (Method of target instrument matching the test will be selected) On the Copy to Another Instrument window, the following fields must be specified. The value must differ from the current value, and is mandatory: • Instrument: target instrument to which the QC population is to be copied • The following check boxes are optional: • Copy target ?: if enabled, the target value and target deviation will also be copied • Copy references ?: if enabled, the reference value and reference deviation will also be copied Note All other fields of the QC Population table will not be copied and will receive their default values. If a QC lot does not exist, one is created using the Lot number supplied from the instrument. 11222683 Rev. A page 147 Quality Control Automatic QC Lot and QC Population Creation If a valid QC point is received and the lot does not exist, then it will be automatically created. Viewing QC Results for a Population To view QC results from the Results of QC Population window, rightselect the selected population and select Related > Results. The Results of QC population window displays. From this window, you can investigate the date and time the QC was assessed, the QC value, and the QC severity. Note If the result is omitted, an X displays in the Omitted column. Viewing a Levey-Jennings Graph To view a Levey-Jennings graph from the QC Populations window, rightselect the selected population and select Levey-Jennings graph. The Levey-Jennings graph displays. Figure 3-1: 1 2 3 page 148 Levey-Jennings Graph Tool bar Current request name and instrument Test result graph 11222683 Rev. A Quality Control About the Levey-Jennings Graph The Levey-Jennings graph displays all QC results in chronological sequence that were obtained in the date interval specified using the Since and Until fields. These QC results are displayed at equidistant X axis intervals. Levey-Jennings graphs display the following: • comparator results with a half-open straight line. • instrument log events associated with an instrument and a method and for which a QC population exists with a dotted vertical line. Refer to Instrument Logs on page 229. Note To prevent legibility issues, limit the amount of text for display on the Levey-Jennings graph. The graph area is color-coordinated to QC standard deviations (SDs): • Green band: the green band lies between +/- 2 SD of the reference value. • Yellow band: the yellow band lies between 2 to 3 SD and -2 to -3 SD of the reference value. • Red band: the red band lies above 3 or below -3 SD of the reference value. Plotting characters are color-coordinated to reflect severity: • Green plotting dots are for values that have not violated a Westgard rule; that is, the severity check of a QC result is zero. • Red plotting dots are for values that have violated a Westgard rule. • White plotting dots are for values that are omitted. The default Westgard rules are as follows: 11222683 Rev. A 1-2s A control result exceeds the reference value (mean) plus or minus 2 SDs. 1-3s A control result exceeds the reference value mean plus or minus 3 SDs. 2-2s Two consecutive control results fall on the same side of the reference value plus or minus 2 SDs. 4-1s Four consecutive control results fall on the same side of the reference value plus or minus 1 SD. 10-x Ten consecutive control results fall on the same side of reference value. R-4s Two consecutive control results that are on opposite sides of the reference value plus or minus 2SD. page 149 Quality Control TIP Rest your mouse on a plotting dot to see detailed information about it. • X = sequential number of the value • Y = value of point • Test • Assessed time • Severity • Cumulative Westgard errors up to that point The target value and target deviation displayed are values defined on the QC population window. The cumulative and current N, Mean, SD, and CV% displayed are the actual calculated statistics. To change the date interval: 1. Enter a start date in the Since field using the format M/D/YY. 2. Enter an end date in the Until field using the same date format. 3. Select Draw to display the new data for the new date range. Note Double-selecting either of date fields opens a calendar from which you can select the date. The Levey-Jennings Graph Toolbar Modify the Levey-Jennings Graph using these tools: Button page 150 Name Description Print Displays a print window from which you can select a printer, set print options, and print the graph. Zoom in Double the zoom factor of the graph. Zoom out Divide the zoom factor of the graph by 2. Reset zoom Restore the zoom factor to 1:1. Free zoom The mouse cursor changes into a magnifying glass, and if you select somewhere in the drawing area, the screen is zoomed around that point. 11222683 Rev. A Quality Control Button Name Description Zoom window The mouse cursor changes into a drawing cross and you can draw a rectangle on the screen. When the mouse button is released, the graph is zoomed to that rectangle. Group/split the data sets Not applicable in the CentraLink system. X options Displays a window where you can set all X axis options. Y options Displays a window where the user can set all Y axis options. General options Displays a window where the user can set all general options. Show/Hide the legend Toggles the display of the legends. About Displays the About box. Exporting QC Populations to Text and XML Files You can export QC population data as an XML file or as a text file in either the Bio-Rad point data or summary data format to ensure that the QC data is recognized by most third party QC software. You can select one control population or multiple control populations at a time for export. All information for a control population, which includes lot number, expiration date, target, target deviation, and test value, can be exported in one step. Note You can group Bio-Rad text formats by instrument, lot number, and test, and you can sort them by date and time and by lot level. 11222683 Rev. A page 151 Quality Control To access the Export window from the QC Population editor window: 1. Right-select the selected population and select Export. The Export window displays the following fields: Field Description Accessed From/ The starting time frame and ending time frames from which QC data is accessed for export. Accessed To On the dropdown menu, specify a date value or choose from among listed relative date values. Select Other to customize your own entry by entering a number, a time interval of day, week, month, quarter, or year, and by specifying whether this is in the past or the future. Note The Accessed To value must be more recent than the Accessed From value. An invalid date range prevents successful QC data export. Include omitted page 152 If selected, omitted results are exported with the QC population data. If not selected, omitted results are not exported with the data. 11222683 Rev. A Quality Control 11222683 Rev. A Field Description Folder Target folder for the output files. The files are named automatically and include a prefix, (dependent upon the Format), and a time stamp. page 153 Quality Control Field Description Format Select from the following options: • XML – All summary data (lot number, expiration date, target, target deviation, and test value) are exported at the same time as the point data. An output file can contain multiple population records each with multiple result records. Note If the Accessed From value is more recent than the Accessed To value and you choose XML as the format type, the export process initiates upon selecting OK, an output file is created, but it does not contain QC results. No error message displays. • Bio-Rad point data – Results are output one per line with the following data per result: Instrument Name, Lot Number, Test Name, AssessmentDate, AssessmentTime, Lot Level, QC String Value. Non-numerical results are skipped. Note To successfully export data in the Bio-Rad point data format, a lot level must be specified on the QC Lots editor window. Note If the specified Accessed From value is more recent than the specified Accessed To value and you choose Bio-Rad point data as the format type, the following error message displays when you select OK: Nothing to Export • page 154 Bio-Rad summary data – This data is always generated to cover a user-defined period of time. The mean, standard deviation, and number of points is exported as opposed to the QC string value of the point data. In this format, populations are output one per line, with the following data per population: Instrument Name, Lot Number, Test Name, Minimal Assessment Date, 12:00, Lot Level, Selection Mean, Selection Standard Deviation, Selection Numeric Count. Non-numerical results are skipped. 11222683 Rev. A Quality Control 2. To initiate the export, select OK. 3. Upon export completion, a confirmation message displays. Evaluating QC Results You can obtain QC results in the following ways: • Results can be uploaded directly from instruments. These results are associated with a method and with a QC lot. • Results can be calculated from uploaded results. These results are associated with a method on a calculated test and with a QC lot. Note To be used in a calculation, input QC results must share instrument, QC lot, and assessment time. • Results can be generated by the patient Moving Average algorithm. These results are associated with a method and with a species. QC Results have the following three associated severities: • Westgard severity • Instrument severity • Method severity To investigate a QC issue, you might have to consider several QC populations. Querying provides you with a comprehensive view of QC results because you can access results from across different populations, control lots, or species. Results are displayed on the QC Results (Across controls view) window. You can also access a specified result set through the QC Results window. QC Blocking Using the QC Blocking field, you can define test groups so that when a QC result sets the QC severity of a test's method, the methods of the other tests in this group are set to the same QC severity. At the Test Group window, define a group of type QC Blocking. This definition will apply to all tests in the group if they have a method on the same instrument and a QC population for the same QC lot as the triggering QC result. Note A test cannot belong to more than one QC Blocking test group. 11222683 Rev. A page 155 Quality Control Accessing the QC Results (Across controls view) Window You can navigate directly to the QC Results (Across controls view) window from the Review and Edit window, from the QC icon of the QC menu, or from Start > Routine > Quality control > QC results . You can also right-select a result and select View QC. When you navigate from the Review and Edit window, the method and instrument are preassigned since you navigate from a selected test and instrument. When navigating from the QC icon or the Start menu, the fields on the QC Results (Across controls view) window are not populated. Enter criteria in the Query Parameters fields and select Apply, to display results matching the entered criteria. QC Result Parsing QC results with a supported comparator are parsed into a numerical value and a comparator as is done with patient results. QC results with a comparator are handled as numeric results and can be configured to participate in Westgard checking. Consider the following examples: • Result sent by instrument is “<0.02”: This value is saved to the database as NumericValue = 0.02, StringValue = <0.02 and Comparator = <. • Result sent by instrument is “>10.0”: This value is saved to the database as NumericValue = 10.0, StringValue = >10.0 and Comparator = >. Note Patient results with an associated comparator are not eligible to contribute to the moving average. Note If a connected instrument sends a comparator result to the CentraLink system, for example, < 7 the CentraLink system stores the space between the comparator and the value in the string value field, but removes the space in the numeric value field, which is displayed in the Review and Edit window. Listing All Patient Samples Between 2 QC Result Date Ranges Use this function to display all samples of a specified request that were received between two selected QC Results. In the QC Results (Across controls view) window, select two QC results from the same population and right-select, and choose Display patient samples from the drop-down menu. page 156 11222683 Rev. A Quality Control A window displays, Patient Samples from DDMMYYYY to DDMMYYYYY where DDMMYYYY represents the day, month and year. This window displays the following data: • Sample ID • Sample priority • Sample collection date/time • Test • Request status • Validation user • Result associated with the request • Availability time of the result • The Display previous results checkbox indicates whether or not the result displayed is the current result or a previous result. If a large time-frame is chosen then it could take quite some time for the list to appear. If you select only one QC result and choose Display patient samples, all samples from the time of the selected result until the current time are displayed. If more than 2 QC results are selected then the first 2 results that were selected are used for the date range. You can only omit on multiple samples from Display patient samples on QC Results (Across Controls View). From the Patient Samples window, you can then perform the same function on all requests which were received during the date and time defined by the two QC results. An example of a function which could be performed is Omit. Note If the Omit function is performed from this window, the cancel messages to LAS are not dispatched immediately. In this case, use the Dispatch to LAS to send the cancel messages to the LAS. Type Error QC Result A type error QC result occurs when the type of the result value cannot be converted to the type of the corresponding test. On receipt of an unexpected non-numeric value, the Westgard severity is set to 0, the Method severity is set to the value in the QC severity on type error field on the Autovalidation tab of the Method window, and Type error is selected at the QC Results window. 11222683 Rev. A page 157 Quality Control Invalid Reference QC Result A QC Result is considered an invalid reference when the QC result numeric value contains a comparator and the QC result is not definitively on the same side of the population reference value. The population reference value and reference deviation must be specified for a QC result to be considered an invalid reference. On receipt of an unexpected invalid reference QC result with comparator, the Westgard severity is set to 0, the Method severity is set to the value in the QC severity on invalid reference field on the Autovalidation tab of the Method window, and Invalid reference is selected at the QC Results window. Consider the following example for a QC population with reference value of 0.495 and a reference deviation defined. • QC result value <0.5 is considered an invalid reference because the actual value may be on either side of the reference value. Note It is the reference value rather than the reference deviation that determines if a result is an invalid reference. • QC result value <0.1 is not considered an invalid reference because it always falls on the low side of the reference value. Although QC results that contain a comparator can be configured for inclusion in Westgard checking, these results are not included in statistics. Accordingly patient results that contain a comparator are not included in moving averages. Levey-Jennings graph displays comparator results with a half-open straight line. To access the QC Results (Across controls view) window: 1. On the menu bar, select Start > Routine > Quality control > QC results. You can also select the QC icon on the toolbar. The QC Results (Across controls view) window, comprising 3 areas, displays a Query parameters area at the top of the window, a results browser in the middle, and statistical information at the bottom. page 158 11222683 Rev. A Quality Control Query Parameters Area In the Query Parameters area of the QC Results (Across controls view) window you can enter search criteria that restricts the result set that is displayed in the result browser area: Field Description Test This field restricts the result set to those referencing the specified test. This value also restricts a specified instrument to those having the specified test available. Instrument This field restricts the result set to those referencing the specified instrument. This value also restricts a specified test to those available on the specified instrument. When a value is entered into the Instrument field, the Instrument group field is disabled. Instrument group This field restricts the result set to those referencing the specified instrument group. When a value is entered into the Instrument group field, the Instrument field is disabled. 11222683 Rev. A From and To These values restrict the result set to those assessed between the specified dates and times. These fields have the calendar functionality and time fields. Type The type of control result. The options are as follows: • Control – Restricts the result set to those obtained from QC material, which references a QC lot. • Patient – Restricts the result set to only those obtained from a moving average of patient results, which references some species. • Any – No type restriction imposed on the result set. Lot Restricts the result set to only those referencing the specified QC lot. Species Restricts the result set to those referencing the specified species. page 159 Quality Control Field Description Include Closed Out Determines whether results that have already been closed out are included in the result set. Sort by Determines the relative order of importance of the following fields for sorting the result set in the browser: test, instrument, assessment time, and lot number. The last sort by value you specify is applied automatically in your next session. Select from the following sort by selections: • Test-Lot-Assessed-Instrument • Test-Instrument-Assessed-Lot • Test-Lot-Instrument-Assessed To initiate the query and populate the result set in the QC Results browser, select Apply. Result Browser Area The Result Browser area of the QC Results (Across controls view) window displays the results that match the search criteria entered in the Query Parameters area: page 160 Field Description Test This column is highlighted when the associated method is determined to be critical as per processing the result. Instrument This column is highlighted when the associated method is determined to be critical as per processing the result. Lot/Species Either the QC lot or the species displays. Assessed Date and time the result was processed. C Contains an asterisk when a comment is associated with the result. The expanded comment is displayed at the bottom of the screen when the result is highlighted in the browser. 11222683 Rev. A Quality Control Field Description GH GH indicates that a QC severity has caused other methods to have their severity set, placing a Group Hold on the results. For more information, see QC Blocking on page 155. String Value This column is highlighted when the associated method severity is above the QC auto validation level. The String Value field contains the comparator and numeric value. QC results with a supported comparator are parsed into a numerical value and a comparator as is done with patient results. F 11222683 Rev. A Contains an asterisk when a flag is associated with the result. The expanded meaning of the flag is displayed at the bottom of the screen when the result is highlighted in the browser. page 161 Quality Control Field Description MS This Method Severity field value is set to the highest absolute value of the following QC severities: • Westgard severity • QC severity on instrument flag Note If a QC result has an associated flag and the instrument flag control severity is greater than zero, Westgard checks are not performed and no Westgard severities are applied. In this case, the Method Severity field value is set to the instrument flag control severity even if the flag has a lower severity than the Westgard severity for the violated Westgard rule. • QC severity on type error • QC severity on invalid reference Type errors occur when the received result value cannot be converted to the result type of the corresponding test. On receipt of an unexpected non-numeric value, the Westgard severity is set to 0 and the QC severity on type error is applied. Invalid reference error occurs when the QC result numeric value contains a comparator and the QC result is not definitively on the same side of the population reference value. QC results with an associated flag where the instrument flag control severity is greater than the value specified within the QC maximal instrument severity field on the More tab of the system Options window are automatically omitted. This MS value can be reset. See Resetting QC Severity on page 166. See Understanding Color Display in the Result Browser on page 163 for details on color assignments. page 162 11222683 Rev. A Quality Control Field Description Levey-Jennings These columns display the relative position of the -3, -2, -1, 0, +1, +2, +3 value with respect to its population's reference value and reference deviation. Colors have the same meaning as in the QC Population LeveyJennings graph: • The backgrounds between the -2 to +2 deviation columns display in green. • The backgrounds between the -2 to -3 deviation column and between the 2 to 3 deviation column display in yellow. • The backgrounds of the -3 deviation column and of 3 deviation column display in red. The deviation values are represented as either dots or arrows. Arrows are used for outliers farther than 4SD from reference. The dots and arrows are either displayed as solid or outlines. An outlined dot or arrow is displayed when a result is omitted. Understanding Color Display in the Result Browser The method QC severity column (MS) has the same color coding specifications as the severity columns on the Review and Edit window. The colors differentiate between different severities assigned to the test results. Consider the following severity and color coding specifications: • When the QC severity of the method is 1, the background of the MS column displays as green. Green signifies moderate severity. • When the QC severity of the method is 2, the background of the MS column displays as yellow. Yellow signifies high severity. • When the QC severity of the method is 3 or greater, the background of the MS column displays as red. Red signifies severe severity. When the method QC severity of a QC result exceeds the method QC severity limit, the following column backgrounds display in red: test, instrument, and string value. Red also displays within the Current column of the Review and Edit window with a type error QC result or an invalid reference QC result with comparator. 11222683 Rev. A page 163 Quality Control • A type error QC result occurs when the type of the result value cannot be converted to the type of the corresponding test. • An invalid reference QC result occurs when a comparator of a numeric result is inconclusive regarding the relative position of the value with respect to the population reference value. When the QC severity exceeds the QC severity limit, the test, instrument, and string value columns continue to display in red until the QC problem is addressed and the Reset Severity function is executed. Statistics Area The Statistics area at the bottom of the QC Results (Across controls view) window allows for you to see population statistics for the QC result selected within the Result Browser area. To contribute to the statistics, QC results must meet the following criteria: page 164 • numeric value • empty comparator field • not omitted • exist inside the range defined by the QC population Ignored deviation count 11222683 Rev. A Quality Control Field Description Comment Any comment that has been associated with the selected control result. Note When a comparator QC result does not contribute to Westgard checks, 1 of 2 comments displays depending on whether the Include comparator QC results checkbox is selected for the individual Method on the Method window or globally on the Setup Westgard window: • When a QC Result is a comparator result and the Include comparator QC results checkbox is not selected, the following comment displays: Comparator result; not participating in WG checks. • When a QC Result is a comparator result and Include comparator QC results is selected, but the result is determined to be an invalid reference, the following comment displays: Undefined reference result; not participating in WG checks. Either of these additional comments are added to the existing comments. Neither of these additional comments is uploaded to the LIS nor is it listed on reports. Refer to Westgard Tab on page 247. 11222683 Rev. A Flags The expanded meaning associated with the flagged result displays in the Flag field when the result is highlighted in the QC Result browser. Target Value The target value of the QC population for the selected QC result. Note The evaluation of the QC result for Westgard checks is performed against the QC population reference value and deviation and not the Target value and deviation. page 165 Quality Control Field Description Target Deviation The target deviation value of the QC population for the selected QC result. Note The evaluation of the QC result for Westgard checks is performed against the QC population reference value and deviation and not the Target value and deviation. N The number of QC results contributing to the statistics of the QC Population of the selected QC result. Mean The mean value of the statistics of the QC Population of the selected QC result. SD The standard deviation of the statistics of the QC population of the selected QC result. CV % The coefficient of variation of the statistics of the QC population of the selected QC result. Current This row displays the current statistics of the QC population of the selected QC result. Cumulative This row displays the cumulative statistics of the QC population of the selected QC result. Date range When a date range is specified in the From / To fields of the Query Parameters section, this row displays the statistics of the QC results that correspond to the entered date and time for the QC population of the selected QC result. Resetting QC Severity The Reset Severity function is initiated when the problem that caused the method’s QC severity is addressed. Once initiated, the reset severity function resets the method’s QC severity field to zero and triggers a new QC result action record that is associated with the QC result record referencing the method. After the method QC severity of a given QC result exceeds the method QC severity limit, the test, instrument, and string value columns of all subsequent QC results remain red until the QC control problem is addressed and the Reset Severity function is executed. page 166 11222683 Rev. A Quality Control Once a method displayed in red is highlighted, the Reset Severity button is selected, and the method QC severity of the new QC result does not exceed the method QC severity limit, the test and instrument columns no longer display in red. Instead the columns display with a white background. The string value column, however, retains the red background as a permanent indication of the QC result’s method QC severity exceeding the method QC severity limit. The MS column background also retains the red background. Note Failure to reset a QC severity to zero results in the continued reporting of a QC severity error on all subsequent instances of that test on the affected instrument. Resetting the QC Severity To reset the QC severity from the QC Results (Across controls view) window: 1. Select Reset Severity. The Reset QC Severity window displays and is automatically populated with the Instrument and Test value of the QC result highlighted in the QC Results browser and is the instrument and test reference for the method for which you are clearing the severity. 2. Enter a comment. Note If the current QC severity is not equal to or higher than the QC severity limit, the comment will not be stored in the CentraLink database. 3. Select OK. Note The change is not automatically reflected in the QC Results (Across Controls View) window. To display the reset severity, select F5 to refresh the window or close the window and reopen it. Resetting the QC Severity from the Instruments Browser: 1. Select the Instruments icon on the toolbar. The Instruments browser window displays. 2. Right-select the selected instrument that has the associated QC severity that you want to reset and select Related > Tests. 3. Select the test that has the associated QC severity you want to reset. 4. Right-select the selected test and select Reset QC Severity. 11222683 Rev. A page 167 Quality Control 5. Enter a comment and select OK. The QC severity of the selected test on the selected instrument is reset to zero. Right-Selecting Functions The following functions can be displayed if you right-select on the QC Results (Across controls view) browser. Viewing QC Results You can access the result record of any QC result that displays in the QC Result browser. The result record provides detail information on result values, severity flags and includes the tabs Failed Westgard checks, Comments. You can access the QC Results window from the QC Results (Across controls view) section and from the QC Population window. To access the QC Results window from the QC Results (Across controls view) section: 1. Double-select a QC result. 2. From the QC Population editor window, right-select a result at the QC Population editor window and select Related > Results. 3. On the Results of QC Population window, double-select a QC Result. The QC Result window displays with the Failed Westgard Checks tab selected. page 168 Field Description Population QC lot The QC Lot value indicates that the result is part of a control population. Specifies the QC lot from which the result was obtained. Population species The species value indicates that the result is part of a patient moving average population. Assessment time The date and time when either a control-based, QC lot result was assessed on the instrument or a patient-based, moving average result was generated. String value The string representation of the result value. It can contain non-numeric QC values. Numeric value The numeric representation of the result value. Original value The original value transmitted by the instrument. 11222683 Rev. A Quality Control Field Description Unit The result unit for a given test, for example, mU/L. This will show what unit value was received from a connected instrument. This field can be empty. Type Error The checkbox is automatically selected when a type error QC result occurs. Type error QC results occur when the type of the result value cannot be converted to the Control data type of the corresponding test. Invalid reference The checkbox is automatically selected when an invalid reference QC result with comparator occurs. Invalid reference QC result occurs when the comparator of a numeric result is inconclusive regarding the relative position of the value to the population reference value. The term “invalid reference” suggests that the comparator was used with a numeric value that could be interpreted as a result that may be on either side of the population reference value. Westgard severity Determined by the severity assigned to the Westgard check that was violated for this result. Severities are assigned in the Westgard setup sub-tab of the Advanced tab of the Method window. Note If a QC result has an associated flag and the control severity that was defined for that flag is greater than zero, Westgard checks are not performed and no Westgard severities are applied even if the flag has a lower severity than the Westgard severity for the violated Westgard rule. See Configuring Instrument Tests (Methods) and Flags on page 235 and Configuring Westgard Rules on page 251. 11222683 Rev. A page 169 Quality Control Field Description Method severity The Method severity is the highest QC severity received on a result since the last QC reset. A QC result severity is determined by the highest absolute value of either the Westgard severity, the instrument severity, or the QC severity on type error fields. If the QC severity of a result exceeds the current method severity, this value is copied into the Method severity field. Note If a QC result has an associated flag with a control severity greater than zero, Westgard checks are not performed and no Westgard severities are applied, even if the flag has a lower severity than the Westgard severity for the violated Westgard rule. See Configuring Instrument Tests (Methods) and Flags on page 235. Instrument severity Automatically set to the highest severity of the associated control severity instrument flags. If a result has an associated flag and that flag's control severity is greater than zero, the result is automatically excluded from Westgard checks. For results with an associated flag and the flag's control severity is greater than zero and higher than the value specified in the QC maximal instrument severity field on the More tab of the system Options window, these results are automatically omitted and excluded from the population’s current statistics. Note If the instrument severity flag is not relevant to QC results, set the Control severity at the Instrument Flag window to 0. If the instrument severity flag is relevant to QC results, set the Control severity at the Instrument Flag window to equal the highest value of the Westgard rules applicable to that method. If an unknown flag is received, the field value is set to -5. See Setting Instrument Flags on page 235. page 170 11222683 Rev. A Quality Control Field Description Omitted The checkbox is automatically selected when a result is omitted. Uploaded The checkbox is automatically selected when the result is uploaded to all associated LIS. The Failed Westgard check tab displays these fields: Field Description Across Lot 1-2s, 1-3s, 10-x, 2-2s, 4-1s, R-4s Within Lot 1-2s, 1-3s, 10-x, 2-2s, 4-1s, R-4s Upon receipt of a new QC result, this field displays which Westgard severities have been triggered for this particular result. Upon receipt of a new QC result, this field displays which Westgard severities have been triggered for this particular result. The Comment tab displays these fields: Field Description Instrument comment Comment received with the result from the instrument. Parse comment Comment generated by the system. Multiple parse comments are comments separated by commas. User comment Free text area. Reagent Information To display a table of the reagents used for QC results, right-click on the result and select Related > Reagent Used. A table with the Reagent Lot Number, Reagent Serial Number, and Reagent Name, Creation Time, Creation User, Expiration time, ID, Last Update Time, Last Update User, Start Time, and version displays. Accessing QC Result Flags To access the QC Results Flags window from the QC Results (Across controls view) window: 1. Right-select the selected QC result and select Related > Flags. The Flags of QC result browser window displays. 2. To view the QC Result Flag window, double-select on an entry. 11222683 Rev. A page 171 Quality Control The QC result flag displays these fields: Field Description QC result population QC lot References the applicable QC lot. QC result population species References the applicable species. QC result assessment time References the date and time that the result was accessed. Instrument flag References the instrument flag defined on the instrument. Interpreting Non-Numeric QC Results The system can store non-numeric QC results. They are not eligible for Westgard checking. These non-numeric QC results are excluded automatically from the population’s current statistics. Non-numeric QC results are excluded from the statistics but they are not auto omitted. For non-numeric QC results, if the associated severity of a result choice is 0, a dot will appear in the 0 column of the Across Controls view. If the severity associated with the result choice is non-zero, a left arrow is shown in the -3 column and a right arrow in the +3 column. Defining Non-numeric QC Results You can define a set of QC Result Choices for non-numeric QC results. Define a Result Choice List and associate the list with a QC Population. 1. On the QC Choice List window, enter values for these fields: Name: Unique identifier of QC Choice List Description: Free Text Description Severity: Field not applicable in this version. Note If a non-numeric QC result is received that does not match any result choice codes the 'QC severity on type error' from the method is assigned as the severity to that result. page 172 11222683 Rev. A Quality Control 2. Assign the Result Choices to a list on the QC Result Choice window: List: List to which this choice belongs Seq no: Determines the sequence of choices within the choice list Code: Corresponds to the actual value of a non-numeric QC result Description: Free-text description Severity: Severity applied if a non-numeric QC result value matches this choice code. 3. Associate the QC Choice List with a QC Population. Omitting a QC Data Point You can omit individual QC data points from the Current data set. Omitted data points are not included in the QC statistics (N, Mean, SD, and CV). Note You cannot omit a data point that has already been closed out. Data points that were uploaded cannot be omitted. Data points that were calculated cannot be omitted. 1. In the QC Results (Across controls view) window, display the QC information for the data point that you want to omit. See Accessing the QC Results (Across controls view) Window on page 156 for detailed instructions. 2. Select the data point that you want to omit. 3. Right-select the selected data point and select Omit. 4. In the Omit window, enter a comment. A comment is mandatory whenever you omit a result. 5. Select OK. Reinstating an Omitted QC Data Point 1. In the QC Results (Across controls view) window, display the QC information for the data point that you want to reinstate. 2. Select the data point that you want to reinstate. 3. Right-select the selected data point and select Reinstate. 4. In the Omit window, enter a comment. A comment is not mandatory to reinstate a result. 5. Select OK. 11222683 Rev. A page 173 Quality Control Auditing a QC Data Point You can see a record of all actions that were taken on a QC data point. 1. In the QC Results (Across controls view) window, display the QC information for the data point you want to audit. 2. Select the data point that you want to audit. 3. Right-select the selected data point and select Related > Actions. The Actions on QC Results browser window displays all actions that were taken on the selected data point. Adding a Comment to a QC Data Point You can add a comment to a QC data point. 1. In the QC Results (Across controls view) window, display the QC information for the data point you want to comment on. 2. Select the data point about which you want to comment. 3. Right-select the selected data point and select Edit Comment. 4. Enter the comment you want and then select Update. The comment text displays in the Comment field at the bottom of the window. Uploading QC Results to the LIS You can upload control-based QC data to 1 or more LIS. By default this upload is by population. You can configure it to upload by lot. QC results associated with the QC lot that were not previously uploaded will be uploaded to the LIS. Upload to the LIS is intended primarily for archiving purposes. Any LIS intending to perform its own QC checking on data received from the CentraLink system must take into account that data is uploaded in batches, not in real time, as they come in from the instruments. Upload individual QC results, or results by lot, to the LIS from the QC lots window: 1. Right-select the selected lot or individual results and select Upload results. 2. For individual results, double select the desired LIS Channel. page 174 11222683 Rev. A Quality Control The Upload results window displays the following fields: Field Description LIS Channel The channel to which you want to upload results. Max Days Specifies the maximum number of days back from the current day from which to collect results.This value limits the size of upload messages. If left unspecified, no day limit applies. Note If this is the very first time that QC data are being uploaded, select 1 for 1 day in the Max Days field to limit the amount of QC data uploaded to the LIS and to avoid impacting communication with a large amount of data at one time. Include not closed out If selected, QC results that are not closed out are eligible for upload. If not selected, QC results that are not closed out are not eligible for upload. Group message by lot If selected, a single message containing all eligible QC results associated with the QC lot is sent to the LIS. If not selected, separate messages for each QC population are sent to the LIS. Note If the number of results in one single message is greater than 10,000, selecting this checkbox and grouping the QC result upload on a single message can impact communication performance. If this is the very first time that QC data are being uploaded, it is recommended to group by QC Population. WARNING If the system is configured to upload certain QC points to certain LIS channels, then manually uploading QC will override the restrictions in place. 11222683 Rev. A page 175 Quality Control Closing Out QC WARNING When QC closeout is being performed, you cannot purge, reprocess or close out the same population. Performing the QC Close Out procedure removes all QC data from the Current QC calculations and includes the closed-out data in the Cumulative QC calculations. Consult your local technical support provider to configure QC close out, purging close out results, auto-expanding database, and Online backup on the same task scheduler. Closing Out QC for All Instruments 1. On the menu bar, select Start > Routine > Quality Control > QC Close Out. The following message displays: Do you want to close out all the Daily QC? 2. Select Yes. Closing Out QC for a Single Instrument 1. On the menu bar, select Start > Configuration > Instruments. The Instrument browser window displays. 2. Select the instrument that you want to close out. 3. Right-select the selected instrument and select QC Close Out. The following message displays: Do you want to close out all the Daily QC? 4. Select Yes. page 176 11222683 Rev. A Quality Control Importing ADVIA 120/2120 QC Data 1. Place the ADVIA 120/2120 QC media into the disk drive. 2. On the menu bar, select Start > Routine > Quality Control > ADVIA 120 QC Configuration Import. The ADVIA 120 QC Import window displays. 3. Double-select the Data file field to specify the data file name. The Control file field is automatically populated. Do not change this value. 4. Optionally you can enter the Name of the supplier and a Description. 5. Double-select the Instrument field and select from the list. 6. Select OK at the Instruments window. 7. Select OK at the ADVIA 120 QC Configuration Import window. Note Newer CentraLink server models do not contain a floppy drive. Please contact your local field service representative for alternative import methods. 11222683 Rev. A page 177 Quality Control page 178 11222683 Rev. A 4 System Configuration Configuring Test Settings This section describes how to add a new test and how to configure the CentraLink system settings for the following items: • Units (standard measures) • Dimensions (standard measures) • Requestables (tests or panels that can be selected for a workorder) • Delta Norms (delta checking) • Norms (range checking) • Result choices (alternatives for test results) The Tests browser window displays the tests that are defined in the CentraLink system. Adding a Test Definition 1. On the menu bar, select Start > Configuration > Tests > By name. You can also select the Tests icon on the toolbar. 2. To access the Test editor window, select the New icon. 11222683 Rev. A page 179 System Configuration The Test editor window with the Basic tab activated displays these fields: Field Description Name A unique identifier for the test. Upon entering a change to the Name field, a message displays warning that modifying the Name of the test does not modify the corresponding requestable name. If necessary, update the Name of the corresponding requestable. Note Do not enter a test name value of 20 characters or more. While the test name is accepted by the CentraLink software, the test name value appears to be truncated when it displays at the Order Entry or Review and Edit windows. Sample type Whole blood, serum, plasma, or other. Upon entering a change to the Sample type field, a message displays warning that modifying the Sample type can affect how the test is processed at the instrument. Note If you change the sample type from ? to a known value, it may affect results reporting and the automatic download of orders to Dimension Vista® instruments. page 180 Type This field is reserved for future use. The default value is Simple and cannot be modified. Description Description of the test. 11222683 Rev. A System Configuration 11222683 Rev. A Field Description Patient data type The acceptable patient data type values that apply to patients results include the following: • Numeric - Numeric results are expressed in a given Control Unit and can be used in numerical computation; for example, in comparisons against normal ranges and statistics. • String • Enumerated - Enumerated results must match one of a fixed set of result choices, for example, +, ++, +++. • Image - Image results can reference image data on the file system. • Complex result values are composed of individual pieces of arbitrary labeled information, which allows for loss-less forwarding from the instrument to the LIS. You cannot view or edit these result values. Control data type The acceptable control data type values that apply to QC results include the following: • Numeric - Numeric results are expressed in a given Patient Unit and can be used in numerical computation; for example, in comparisons against normal ranges and statistics. • String • Enumerated - Enumerated results must match one of a fixed set of result choices, for example, +, ++, +++. These results can be defined on the QC Result Choice List window and then associated with a population. See Defining Nonnumeric QC Results. • Image - Image results can reference image data on the file system. • Complex result values are composed of individual pieces of arbitrary labeled information, which allows for loss-less forwarding from the instrument to the LIS. You cannot view or edit these result values. page 181 System Configuration Field Description Patient unit Reference to the unit in which the patient results of numeric tests are expressed. WARNING The units of measure for a given test must be defined identically at the LIS, in the CentraLink software, and at the instruments. Control unit Reference to the unit in which the QC results of numeric tests should be expressed. Alternate unit Set an alternate unit if the unit used in the CentraLink software is different from the one reported by the instrument. Upon entering a change to the Alternate unit field, a message displays warning that modifying the Alternate unit can affect the reporting of new results. Unit coefficient Coefficient (factor) for converting from the standard to the alternate unit. Upon entering a change to the Unit coefficient field, a message displays warning that modifying the Unit Coefficient can affect the reporting of new results. Unit term Constant required to convert from the standard to the alternate unit. Upon entering a change to the Unit term field, a message displays warning that modifying the Unit term can affect the reporting of new results. Seq no page 182 Sequence number. Used to define the sequence of the tests on reports and on the Review and Edit window. Sequence numbers do not have to be unique or consecutive. 11222683 Rev. A System Configuration Field Description Patient reported decimals The number of decimal places used to represent patient results on the Current column of the Review and Edit window, on reports, and that is uploaded to the LIS, is configurable. For new tests, the default value is the ? symbol. Note The ? symbol in this field means that the CentraLink software will display exactly the same number of decimal places uploaded from the instrument up to and including 9 decimal places. Upon entering a change to the Patient reported decimals field, a message displays warning that reported decimals of a numeric test can round both new and existing patient results. If you enter a value less than 2, a message displays warning that the result could be rounded. You must confirm that the value you want to enter is less than 2. The CentraLink software stores the result as it is received from the instrument. If the current result value is reverted, this value will be rounded before populating the Current column of the Review and Edit window. Control reported decimals The number of decimals used to represent instrument, patient moving average, and calculated QC results is configurable. The Control reported decimals value determines the number of decimals to which the QC result is rounded. Upon entering a change to the Control reported decimals field, a message displays warning that reported decimals of a numeric test can round both new and existing QC results. If you enter a value less than 2, a message displays warning that the precision level of QC results being registered will be reduced. For patient moving average QC results, calculated QC results, and instrument QC results, refer to Effects of Control Reported Decimals on Instrument QC Results on page 331. 11222683 Rev. A page 183 System Configuration 3. Select the Advanced tab and identify the following fields: Field Description Strict Targeting This checkbox determines whether instrument targeting is strictly enforced for requests of this test. If Strict Targeting is selected: • The order for that request will only be downloaded to the targeted instrument when that instrument sends a query. If CentraLink receives a query from another instrument, the targeted request will not be downloaded to that instrument. If Strict Targeting is not selected: • The order for that request will be downloaded to the targeted instrument when that instrument sends a query. If another instrument query is received, the targeted request will be downloaded to the non-targeted instrument. The Strict targeting checkbox does not have any impact if a request is not targeted. Default value Edit Warning Trigger page 184 The default value of this field is unchecked, which maintains the same behavior as the previous CentraLink software version. Note If a request is already in Scheduled status, you must unschedule the request, and then set a target instrument in order for Strict targeting to be applied to subsequent instrument queries. This value pertains to morphology flags. When specified, a default value such as negative is automatically assigned to results missing in a message from an instrument with Full sample upload set. If this value is specified, the edit warning is displayed whenever results are manually edited. Note An edit warning is not displayed when a result is manually edited in the Diffpad screen. MISPL program used for reflex testing.Consult your local technical support provider for more information. 11222683 Rev. A System Configuration Field Description On new request A MISPL function triggering a particular event whenever a new request for this test is created. Consult your local technical support provider for more information. If this checkbox is selected, delta norms will be evaluated when a comparator result (for example, ">6") is involved. Delta Norm for comparator results active If this checkbox is not selected, delta norms will not be evaluated for comparator results. The comparator itself will be ignored and the numerical value (for example, "6") will be used. 4. You can also specify if a test is downloaded to the LAS or not. Select the LAS tab and identify the following fields: Field Description Omit on LAS Update Select this for external tests for which no results are expected. Upon receipt of an external test request, the CentraLink system forwards it to the LAS for sorting and subsequently omits it. Allow Download 11222683 Rev. A If only one LAS Order Translator is specified on the LAS tab of the system Options window, the test request is omitted after it is sent to the configured LAS. If you select this, the test is downloaded to the LAS. Changes applied to this field are not retroactive. page 185 System Configuration 5. Select the Calculation tab to set the following fields: Field Description Calculated QC required If this is enabled, the MISPL expression specified in the Calculation field (below) is also applied to QC Results. If this is disabled, the MISPL expression specified in the Calculation field is not applied to QC Results, and the scope of MISPL used includes all sample-scoped functions. Calculation This field specifies a MISPL program used to calculate the result of a ratio test based on the results of the component tests. Your local technical support provider defines this program. The program contains a calculation formula, which you can view in this field. If this formula is changed, only the future ratio tests are affected. The test results available in the database stay the same. Upon entering a change to the Calculation field, a message displays warning that modifying the calculation can affect the reporting of new and existing results. Norm severity limit The normal severity limit, which is one of the values against which auto validation of calculated test results is determined when a method is not associated with the calculated test. Delta norm severity limit The delta normal severity limit is one of the values against which auto validation of calculated test results is determined when a method is not associated with the calculated test. QC severity limit This QC severity limit is one of the values against which auto validation of calculated test results is determined when a method is not associated with the calculated test. Instrument severity limit The instrument severity limit is one of the values against which auto validation of calculated test results is determined when a method is not associated with the calculated test. 6. To enable autovalidation, select the Allow checkbox at the Autovalidation tab. page 186 11222683 Rev. A System Configuration 7. In the LIS tab you can select Allow download, and also determine the upload mode. The upload options are Allow always, Suppress, Manual Only, or Never Upload. 8. After entering the required test information, select OK. The system adds the new test to the list of test definitions. Defining Calculations A calculation is a string-valued MISPL program that is used to calculate the result of a test from the results of other tests. The formula is compiled against the sample class for calculations involving patient results and against the QC result class for calculations involving QC results. Defining Test Groups The Test Group table contains records representing groups of tests. After creating test groups, you can assign tests to the test groups through the Test editor window. Note If referenced by tests or requests, a test group should not be deleted. Deleting a test group that is referenced can result in the generation of empty audit logs. Instead of deleting test groups that are referenced by tests or requests, you should reassign them. 1. On the menu bar, select Start > Configuration > Test groups. The Test groups window displays two fields. • Name is the name of the test group. • Type indicates the type of this test group. Define Type as: Normal: default value. Hematology: Indicates that the test group is oriented for hematology. See Accessing the Hematology Review and Edit Window on page 123 for more information. QC blocking: When a QC result is received which sets the QC severity of the test's method, and this test belongs to a QC blocking test group, the methods of the other tests in this group for the same instrument will be set to the same QC severity, if they have a QC population for the same QC lot as identified for the received QC result. See QC Blocking on page 155 for more information. Note A test cannot belong to multiple QC blocking test groups. Note If a QC severity has already been set, it can never be lowered. Note The required QC populations and QC lots will not be created automatically if they are not available. 11222683 Rev. A page 187 System Configuration Adding a Test to a Test Group 1. On the menu bar, select Start > Configuration > Tests > By name. The Test browser window displays. 2. Select the test to add to the test group. Right-select on the test and select Set Group. The Set Group editor window displays. 3. Double select In the Test Group field, enter the test group name. Note You can enter a test into more than one test group. To display all groups to which a test belongs, right-select on Test > Related Test groups. 4. Select OK. Editing a Test Definition 1. Select the Tests icon on the toolbar. The Tests browser window displays. 2. Double-select the test that you want to edit. The Test editor window displays. 3. After editing the appropriate fields, select OK. WARNING Changing the test name can impact many aspects of CentraLink system operation. Contact your local technical support provider before modifying a test name. Deleting a Test Definition 1. Select the Tests icon on the toolbar. The Tests browser window displays. 2. Select the test that you want to delete. 3. Select Delete on the toolbar. If the test is not in use, the test is deleted. Note Before you delete a test, you must delete any associated patient results, QC results and QC populations. page 188 11222683 Rev. A System Configuration Setting a Test Unit 1. On the menu bar, select Configuration > Units. The Units browser window displays. 2. Double-select the appropriate unit. The Units editor window displays the following fields: Field Description Name This field describes a unique name for the unit, such as mL. This is a required field. Dimension This field describes the dimension of the unit, such as Volume. Double-select to display a list of dimensions and make a selection. This is a required field. If you attempt to change the Dimension field, a message displays warning that modifying units can affect the reporting of new results. Coefficient If the unit being defined is the standard or default unit for this dimension, set the coefficient to 1.0. If this is an alternate unit, set the coefficient to the correct value for converting from the standard unit to the alternate unit. To convert results from the standard unit to an alternate unit, the CentraLink software uses the formula: Result (in alt. units) = Coefficient * Result (in std. units) + Term. This is a required field. Upon entering a change to the Coefficient field, a message displays warning that modifying units can affect the reporting of new results. Term A constant value that may be required in the conversion from the standard unit to an alternate unit. Term = 0 for standard units. Upon entering a change to the Term field, a message displays warning that modifying units can affect the reporting of new results. Assigning a Unit to a Test 1. On the menu bar, select Start > Configuration > Tests > By name. The Test browser window displays. 11222683 Rev. A page 189 System Configuration 2. Select the appropriate test. 3. Double-select the selected test. The Test editor window displays. 4. In the Patient unit field, enter the unit. 5. Select OK. Once a unit is assigned to a test, it cannot be modified. For more information, see Unit Checking for Patient and QC Results on page 54. Setting a Dimension for a Unit A dimension is a measure for a unit that is used in a test. 1. On the menu bar, select Configuration > Dimensions. The Dimensions browser window displays. 2. Double-select the appropriate dimension. The Dimension editor window displays. 3. Edit the name and select OK. Setting Result Choices Result choices are used for discrete alternatives for test results. The alternatives can be coded numerically. The codes represent listed results, not a standard measure of any kind. Delta checking does not exist for this type of test. Access the Result choice window and enter the appropriate code: 1. On the menu bar, select Start > Configuration > Tests > By name. The Tests browser window displays. 2. Select the appropriate test. 3. Right-select the selected test and select Result choices. The Result choices for test browser window displays. 4. Double-select the appropriate result choice. The Result choice editor window displays. page 190 11222683 Rev. A System Configuration 5. Edit the fields of the Result choice editor window as required: Field Description Code This is a unique identifier for the result. Expansion This is a description of the result choice. If an expansion value is defined, it displays on the Review and Edit window and is transmitted to the LIS. Severity Norm severity value that is assigned when this result is received. 6. Select OK. The Result choice window remains open for additional entries. Continue to add or edit entries as required. 7. Upon completion, close the open windows. Setting Morphology Flags Morphology flags are non-numeric result choices typically confined to the alternatives: +, ++, +++, and negative. For this type of test, there is no delta checking. 1. On the menu bar, select Start > Configuration > Tests. The Tests browser window displays. 2. Select the test that has associated morphology flags. 3. Right-select the selected test and select Result Choices. The Result choices for test browser window displays. 4. Double-select the code in the browser window. The Result choice editor window displays. Setting Test Norms Test norms are ranges of normal test values or reference ranges. For a given test, you can assign several different norms including gender, species, and age of the patient. When test results are entered, each result is verified against the normal ranges defined for that test. 1. On the menu bar, select Start > Configuration > Tests. The Tests browser window displays. 2. Select the appropriate test. 11222683 Rev. A page 191 System Configuration 3. Right-select the selected test and select Norms. The Norm for test browser window displays. 4. Double-select the appropriate norm. The Norm editor window displays the following fields: Field Description Evaluation order This field is required when you are adding additional ranges to the default range, and defines the order in which ranges are evaluated. Ranges with higher severity levels are assigned a lower evaluation order so that they are evaluated first. After the first non-zero severity is identified, normal ranges are not evaluated. Method The norm applies only to results obtained from the instrument associated with the method. Sex Patient sex. Species Patient species. Min age Minimum age of patient. Max age Maximum age of patient. Age unit Unit for patient age. Eligible This field is used by MISPL programs to determine if a norm is applied or not, for example, patient location: intensive care. Consult your local technical support provider for information on MISPL. Low limit Low limit of norm. High limit High limit of norm. Severity This field defines the severity level if the test result exceeds the low or high limit. Comment Use this field to define a text comment, which displays on the Review and Edit window when a result falls outside of range. Setting Delta Norms A delta norm specifies the normal variation in results between two successive instances of the same test performed on different samples from the same patient. page 192 11222683 Rev. A System Configuration A delta norm value can be expressed as either of the following: • Percentage change from the earlier result. Each local previous result is verified against any delta norms that were defined for that test when a previous result is available for the same patient and when the time lapse between the two results does not exceed the delta check limit specified for the test. • If the Limit is absolute field is enabled, the absolute value of the difference between the current result value and a previous result value are evaluated. If the absolute difference exceeds the value specified within the Limit field, the Delta norm severity is applied. Access the Delta norms editor window: 1. On the menu bar, select Start > Configuration > Tests. The Tests browser window displays. 2. Select the appropriate test. 3. Right-select the selected test and select Delta norms. The Delta norms for test browser window displays. 4. Double-select the appropriate norm. The Delta norm editor window displays the following fields: Field Description Test This field defines the test for which Delta norm check is configured and based. Evaluation order This field defines the order in which delta limits are evaluated. Limits with higher severity levels are assigned a lower evaluation order so that they are evaluated first. After the first non-zero severity is identified, normal ranges are not evaluated. Species 11222683 Rev. A Patient species. If specified, the delta norm applies only to this species. page 193 System Configuration Field Description Eligible This field is used for MISPL programs. If specified, the delta norm applies only if the site function evaluates as true. Your local technical support provider can configure a GetPreviousLocalResult(0) MISPL that is triggered through the Eligible field of the Delta Norm. For a given patient, this MISPL extends the ability to retrieve the most current previous result for the same test on a different sample. Limit is absolute This determines whether the value in the Limit field is an absolute value, which is expressed in the associated test unit. If Limit is absolute is not selected, the value in the Limit field is a relative value, which is expressed as a percentage. Limit Depending on whether Limit is absolute is enabled, the Limit value is the absolute or relative result value shift since the previous result. When the Limit value is exceeded, a severity value is assigned to the requests delta norm Severity field and a comment value is assigned to the delta norm Comment field. Severity Severity level value is applied when the result value shifts because the previous result exceeds the Limit value set in the Limit field. Comment When a result falls outside of range, the comment defined in this field displays on the Review and Edit window. Day Limit This value specifies the maximum number of days since the previous result of the same patient required delta checking. The number of days between the 2 tests, which cannot be exceeded for delta norm to be eligible for evaluation. If this is set to 2, for example, and the second test is received after 3 days, a delta norm is not calculated. Note The time interval for delta checking is set on the Tests window. For more information, see Configuring Test Settings on page 179. page 194 11222683 Rev. A System Configuration Defining Test Aspects You can define multiple result aspects or characteristics from instruments that send multiple result aspects; for example, the ADVIA Centaur system. The Patient result selector configured on the Basic tab of the Method window is the instrument result aspect that displays on the Review and Edit window. The Control result selector configured on the Basic tab of the Method window is the instrument result aspect that displays on the QC Results window. Although only one aspect displays on the Review and Edit window and on the QC Results window, the CentraLink system can be configured to transmit all defined aspects to the LIS if supported by LIS protocol. To define test aspects for an instrument: 1. Select the Instruments icon. The Instruments browser window displays. 2. Select the appropriate instrument. 3. Right-select the selected instrument and select Aspects. 4. Select New on the toolbar to add a new Aspect. For more information about supported result aspects, see Result Detail Tab on page 111. Creating Panels for Requestables In the order entry process, individual tests and groups of tests, called panels, are selected for each patient sample from the list of requests on the Requestables browser. Simple requestables are mapped to individual tests. Panel requestables containing other requestables of any type are mapped to panel members. If required, the original test request can be omitted through MISPL. Once the original test request is omitted, it must be reordered from the LIS if a rerun is required. To create panels from existing test and panel definitions, open the Requestable window: 1. On the menu bar, select Start > Configuration > Requestable. The Requestable browser window displays. 2. Double-select the appropriate requestable. 11222683 Rev. A page 195 System Configuration The Requestable editor window displays these fields: Field Description Name Unique identifier of the requestable. Explicit When selected, the requestable is visible in the list of requestables on the Order Entry window and can be manually requested. Simple requestables, which are not explicit, can still be requested as part of a panel requestable. Type of Requestable Valid values for this drop-down menu include Simple and Panel. Test Reference to the test which can be requested through this requestable. Create a new panel from the Requestable browser window: 1. Select the New icon. The Requestable editor window displays. 2. Enter the Name for the new panel. 3. Select Explicit. 4. Select Panel from the Type of Requestables field. The Description field displays in place of the Test field. 5. Type a description of the panel, and select OK. The new name is added to the list of requests. 6. In the Requestables browser, select the new panel name. 7. Right-select the selected panel and select As panel requestable > Members. The Panel members browser window displays. 8. Select the New icon on the toolbar. The Panel member editor window displays. 9. Double-select the Requestable field on the Panel member editor window. A new Requestables browser window displays. page 196 11222683 Rev. A System Configuration 10. Highlight the test or panel that you want to include in the new panel and select OK. The newly opened Requestables browser window closes. The selected name displays on the Panel member editor window. 11. To add the name to the Panel members browser, select OK. 12. Repeat steps 9–11 until all panel members are selected. Deleting a Panel 1. On the menu bar, select Start > Configuration > Requestables. The Requestable browser window displays. 2. Select the panel to delete. 3. Right-select the selected panel and select As panel requestable > Members. The Panel members browser window displays. 4. Select the test or panel to delete and select Delete. 5. Select Yes to delete the panel member. 6. Select Close on the Panel members browser to return to the Requestables browser window. Adding Tests to Requestables 1. On the menu bar, select Start > Configuration > Requestables. The Requestable browser window displays. 2. Select the New icon on the toolbar. The Requestable editor window displays. 3. Type the name for the new test panel. 4. Select Explicit. 5. Select Simple. 6. Double-select the Test field. The Tests browser displays. 7. Select the test to add to the list of requests. 8. Select OK to add the name on the Requestable editor window. 9. Select OK on the Requestable editor window to add the test to the list in the Requestables browser window. 11222683 Rev. A page 197 System Configuration Creating Tools Create tools to reduce the number of steps that are required to perform common or repeated tasks. Tools can be associated with, and then accessed from, the start/context menus or the toolbar: 1. Create a tool. 2. Create a toolbar icon. 3. Associate the tool with the icon. 4. Associate the tool with a context menu. Note After you configure a Tool, the same parameters are reused until you define new parameters and associate them with it. Creating a Tool Tools are pre-configured functions which you can create and assign to start menus, context menus and toolbar items, and in general, to reduce the number of mouse clicks required to perform certain routine actions. A tool is always identified with a specific table. To access the Tools browser: 1. Select Start > System management > Scheme > Tables 2. On the Tables browser window, right select a table, and from the menu select Related > Tools. 3. In the Tool browser, select New on the toolbar to add a new tool. At the Tool editor window define the following fields: page 198 • Mnemonic Unique identification for the tool. • Label Multilingual label used for displaying the tool in a menu or toolbar • Tooltip Text that will be shown when hovering over a tool in a menu or toolbar. • Table Read-only field which identifies the table from which the tools browser was opened. • Function table • Function mnemonic • Function parameter set Allows you to assign a function and possibly a function parameter set to the tool. Select the base table (gp_Site for use in Start menu). The "Function table" may differ from the "Table" but there must be a direct link between both tables. For more information, see "Function path" (below). 11222683 Rev. A System Configuration • Function path If Function table differs from Table this field should specify the connection path between the two tables. You must execute a Method-based function: (Function table: Method + Function mnemonic: SetupWorkOrderDownload). To get from QCResult–level to Method-level, use the Function path field using a MISPL–like syntax. Only the scheme-navigation part of MISPL is active. In this case the logical path to follow is “QCResult.population.method.” For this field you do not need to indicate the QCResult-part but you must indicate the Method-part. Note You cannot execute any MISPL-code here. The field is a free-text field but is checked for correctness prior to saving the value to the database. You are notified if incorrect data is entered in this field. • method is a field name on the QCPopulation table, as in MISPL; note that this example also refers to population and not QCPopulation. The database field on the QCResult-table is also named population. When you are configuring the tools, ensure that you select the correct field against which a particular function needs to be executed. • Skip setup If enabled, the function parameter set will not be shown when starting the tool. If disabled, the function parameter set will first be shown on screen (for example, query options) before actually starting the tool, which allows updating the parameters first. 4. On the Tool editor window, select OK to save the new tool. 5. On the Tools browser window, select Close. 6. On the Tables browser window, select Close. Creating a Tool Button or Icon Create a toolbar button or icon, to which you will associate sample query and test request criteria, in one of three ways: 11222683 Rev. A • Select Start > System management > Menu > Toolbar buttons • Right select on the toolbar and select Toolbar. • On the Toolbar buttons window, select Insert to create new toolbar buttons. ○ Row determines the relative vertical position of the button. ○ Sequence determines the relative horizontal position of the button. page 199 System Configuration ○ Tool mnemonic / Tool table: is a reference to the tool that will be activated. ○ Label is the multilingual text appearing on the button. ○ Help text is the multilingual text appearing in the button's tool tip. The help text will be visible when the mouse pointer hovers over the button. ○ Image up, Image down, and Image disabled are the file names (in the <root>/img folder) of the image the button should contain when it is normal, pressed and disabled. Only the first one is mandatory. Images and Label text are mutually exclusive. ○ Insert ruler: adds a vertical separator between the tool bar buttons. To see the buttons you created, log out and log in. Define and Associate Criteria with a Toolbar Icon To define sample query and test request criteria and associate these parameters to the created toolbar icon: 1. On the Actual parameter sets of function browser, highlight the newly created parameter set, right-select, and select Setup. The Review and Edit - Query setup window displays. 2. On the Basic and Advanced tabs, enter the sample query parameters that will restrict the sample set as per your requirements. The Basic and Advanced tabs of the Review and Edit - Query setup window contain each of the fields of the Basic and Advanced tabs of the Sample query window. Note On the Basic tab of the Review and Edit - Query setup window, the status values do not display to the right of the Minimal and Maximal status fields although these values do display on the Basic tab of the Sample Query window. 3. On the Requests tab, enter the test request parameters that will restrict the test results within the restricted sample set. The Request tab of the Review and Edit - Query setup window contains each of the fields of the Request query window. For more information about the fields of the Request query window, see Querying Specific Samples on page 29. 4. After entering all of the sample query and test request parameters at the Review and Edit - Query setup window, select OK. The Actual parameter sets of function browser displays. page 200 11222683 Rev. A System Configuration 5. On the Actual parameter sets of function browser window, select OK. The Toolbar button editor window displays. The Function parameter set field is populated with the Short description field value that you entered at the Actual function parameter set editor window. Defining Remaining Toolbar Icon Characteristics On the Toolbar button editor window, define the remaining fields that characterize the toolbar icon: 1. On the Label field of the Toolbar button editor window, enter the label that will display on the toolbar button. The maximum number of characters for the Label field is 240 characters. For example, you could enter a label that reflects the window accessed upon toolbar icon selection, ReviewCHEM. 2. In the Help text field, enter the text that will display on the toolbar button when the mouse is positioned over the button. The maximum number of characters for the Help text field is 240 characters. 3. On the Image up, Image down, and Image disabled fields, enter the file names of the image the button displays when it is: • active but not selected • selected • disabled Image up is the only mandatory field. These image file names are located in the <root>/img directory. Note Images and text are mutually exclusive. 4. To delineate this toolbar button from other toolbar buttons with a vertical line, select the Insert ruler checkbox. 5. On the Toolbar button editor window, select OK. The Toolbar button browser window displays. 6. On the Toolbar button browser window, select Close. 11222683 Rev. A page 201 System Configuration Associate the Tool with a Context Menu 1. Select Start > System management > Scheme > Tables 2. On the Tables browser, scroll and right-select a table. Then select Menu > Edit 3. In the Menu window, select All to expand the menu tree. Select and highlight a menu option after which you want the new tool to appear. The new tool option will appear in the menu immediately below the highlighted option. Select New on the toolbar to add a new tool to the menu. 4. The Option editor window displays. Define the following fields: • Table Read-only field which identifies the table you are editing the menu of. • Tool is a reference to the tool that will be activated • Label is the caption that will appear as menu option. If you include a '&' character in front of any letter in the label, then this letter can be used as a shortcut key when you're inside the menu. • TTY accelerator is the accelerator used on teletype user interfaces. • Windows accelerator key can contain keys specified as ctrl - <Letter>. To see if your key is working, exit the application and log in again. 5. To save the setting, in the Option editor window, select OK. Log Out and Log In to the CentraLink Software To display the toolbar icon that is preconfigured with the sample query and test request parameters, you must log out and log back in to the CentraLink software: 1. Log in to the CentraLink software. 2. On the toolbar, the new Review and Edit icon displays and is identified by the label or image to which you assigned it. 3. On the toolbar menu, select the newly created toolbar button. The Review and Edit window displays and is populated with the sample set that meets your predefined sample query and test request criteria. page 202 11222683 Rev. A System Configuration Note After selecting the configured toolbar icon and directly accessing the populated Review and Edit window, you can temporarily override the configured parameters by accessing the Request query window, entering new parameters, and reaccessing the refreshed Review and Edit window. The newly entered request query parameters for this restricted sample result set, however, only apply until the current Review and Edit window session ends. After the current session ends and you select the configured toolbar icon, you re-access a Review and Edit window populated with the sample set that meets your predefined sample query and test request parameters. For more information about using the Review and Edit window, see Accessing the Review and Edit Window on page 67. Configuring a LIS Channel Configure LIS channels by selecting Start > Configuration > LIS channels. The LIS channel window displays 4 tabs: General, Patients, QC and FTP settings. General Tab On the General tab of the LIS channel window, define the following fields: 11222683 Rev. A • Name: identifies the LIS channel in the CentraLink system. • Coding system indicates which mapping is to be used between the application codes (tests, etc.) and corresponding LIS codes. If no coding system is specified, the CentraLink system assumes that the LIS understands the codes in the CentraLink system database. • Upload instrument flags causes the CentraLink system to upload instrument flags along with each validated request. • Upload reagent information allows uploading Result-specific reagent information to the LIS. • Expand text on upload determines whether or not text references included in comments will be de-referenced (expanded) prior to uploading them to the LIS on patient result upload or QC result upload. • Upload European numbers causes the CentraLink system to force numeric results into European number format (with a comma as decimal separator) on upload. • Upload validation user causes the CentraLink system to upload the login name of the validating user along with each validated request. page 203 System Configuration • Inbound translator indicates which translator takes care of communication from the LIS to the CentraLink system. For best performance, use different translators for Inbound and Outbound. • Outbound translator indicates which translator takes care of communication from the CentraLink system to the LIS. • Barcode translation field references a logical-valued MISPL function responsible for converting LIS sample identifiers into local sample identifiers if required. Patients Tab The Patients tab displays the following fields: • Upload graphs if checked, uploading results will coincide with uploading graphs to the LIS.The CentraLink software does not currently support connection to any instruments that generate these results. • Full sample download If this option is enabled and a work order is downloaded from the LIS, this is considered a replacement of the work order currently available in the CentraLink system. Test requests not available in the work order will be omitted, and test requests available in the work order message will be added or rerun if applicable. If this option is disabled and a work order is downloaded from the LIS, the test requests not available in the work order maintain their current status and will not be omitted. The test requests available in the work order will be added, or rerun if applicable. Note This only applies when the action code transmitted in the message is set to A. If the action code is set to N for an existing sample, the work order message will be rejected. The table below contains the configurations consistent with the behavior of previous versions of the CentraLink software: LIS Channel inbound translator s79s (Spec79 LIS) Lmxs (LMX LIS) All other translators • page 204 Full sample download Enabled Enabled Disabled Upload images if checked, uploading results will coincide with uploading image results to the LIS. 11222683 Rev. A System Configuration • Upload result aspects If enabled, all related aspect results (including the patient/control result selector defined in the Method) will be uploaded to the LIS on patient result upload. If disabled, only the patient/control result selector will be uploaded to the LIS. the default value is Enabled. Note In case of QC results, the CentraLink system only stores the control result selector in the database. Only the control result selector will be uploaded to the LIS, regardless of this option. This table contains the recommended configuration: 11222683 Rev. A LIS Channel outbound translator Upload aspect results s79s Disabled lmxs Disabled All other translators Enabled • Check LIS previous result units If enabled, CentraLink will check the unit of the previous results transmitted by the LIS. If a unit mismatch is identified, the LIS previous result will be stored as X-ERROR in the CentraLink software and a comment added stating the received unit and the expected unit. If disabled, units transmitted in previous LIS results are not checked. The default value is Enabled. • On end order message is a reference to a Sample-scoped, logicalvalued MISPL function. This function will be run each time an order message has been received and fully processed. • Alternate LIS upload: This field is used to define an additional LIS Channel for result upload in a multiple LIS environment. page 205 System Configuration • Upload comments: Patient determines whether or not patient comments will be uploaded to the LIS on patient result upload. Instrument result determines whether or not result comments from an instrument will be uploaded to the LIS on patient result upload. Result parsing determines if parsed comments are included with Patient result comments uploaded to the LIS. Examples of parse comments, which are automatically generated, are “Not a number; no computation performed” and “Unknown result choice.” Sample determines whether or not sample comments will be uploaded to the LIS on patient result upload. User Result determines whether or not manually entered result comments will be uploaded to the LIS on patient result upload Result range determines whether or not result range comments (e.g. caused by delta norm violation) will be uploaded to the LIS on patient result upload Note You can filter QC comments as well as LIS comments. Filtering Comments Uploaded to LIS You can filter comments which are uploaded to the LIS on a per-commentline basis. At the LIS Channel screen, select Configuration > LIS comment filter. Use the LIS comment filter editor to edit certain comment strings from being uploaded to the LIS. Enter text in the Filter string field: • The string does not need to completely match the line that needs to be removed; a partial match is sufficient. • Punctuation and all characters will be taken into account for filtering. • Filtering is not case-sensitive. • Trailing and leading spaces will be taken into account in the filter string for comparison purposes QC Tab Set the following values from the QC tab: page 206 • Dynamically administer QC instrument can be used to automatically determine the LIS system to which QC results must be uploaded. For more information, see Upload QC results to the LIS on page 62. • Instrument Result determines whether or not result comments from an instrument will be uploaded to the LIS on QC result upload. 11222683 Rev. A System Configuration • User Result determines whether or not manually entered result comments will be uploaded to the LIS on QC result upload • Result Parsing determines if parsed comments are included with QC Result comments uploaded to the LIS. Examples of parse comments, which are automatically generated, are, “Not a number; no computation performed” and “Unknown result choice.” FTP Settings Tab You can configure these settings at the FTP Settings tab to upload images to the LIS via FTP: • FTP host and FTP port indicate where the CentraLink system should upload results and/or images using the File Transfer Protocol. Whether or not these are uploaded with FTP is determined by the Upload images option of the LIS channel. • FTP time-out indicates how long the CentraLink system should try and upload results and/or images in case of a communication failure. Expressed in seconds. If set to "?", no FTP time out limit is applied. • Image prefix is used for generating names for outbound image files. Image file names will have the format <ImageFolder>\w<ImagePrefix><SeqNo>.bmp. <SeqNo> will be an arbitrary 4-digit number that matches the result value of the Hemimage test uploaded with the sample results. It is the responsibility of the LIS to make sure that the image is stored permanently with an unambiguous name. • Image folder determines to which subdirectory of the LIS FTP root images should be uploaded. Defining a LAS Channel This section contains instructions on how to define a LAS Channel within the CentraLink system. Connecting CentraLink to an Aptio Automation System This section details connectivity between CentraLink systems and Aptio Automation systems. 11222683 Rev. A page 207 System Configuration Configuring the LAS System To configure the LAS system, select Start > Configuration > LAS > LAS Channels. The following fields display: • Name: identifies the LAS channel in the CentraLink system. • Coding system: indicates which mapping is to be used between the instrument codes, container codes, sample source codes, sample type codes, species codes, test codes and corresponding LAS codes. If no coding system is specified, the CentraLink system assumes that this LAS understands the codes in the database. • Order queue processor: establishes a link between Message queue system and a specific application or instrument. • Specific priority: this field is mandatory when Priority is set to Specific. It should then hold a reference to a LAS priority band of the LAS channel. Configuring LAS Flags You can configure LAS flags by selecting LAS flags from the LAS channel popup menu. The LAS Flag window contains the following fields: Field Code Description This field should contain the code as it is transmitted from the LAS channel. Note This field is case-sensitive and is only available with Aptio Automation systems. LAS channel This field references the LAS channel on which this LAS flag is available. This field is read-only and is populated automatically. Expansion This field contains the text (full detail of what the flag means) that can optionally be displayed in the sample comment field of the Review and Edit window or uploaded to the LIS. Watchdog This field indicates the type of messages that should notification be transmitted to Watchdog. Upload to LIS You can indicate if the expansion should be added to the sample comment upon upload to the LIS. By default, this option is disabled. To activate this feature, the LIS channel option Upload sample comments must also be enabled. page 208 11222683 Rev. A System Configuration Display expansion This field allows you to indicate if the expansion should be added to the sample comment field in the Review and Edit window. By default, this option is disabled. Sample reject You can indicate whether results should be rejected, results and if so, whether they should be rejected for one specific instrument (indicated in the message), or for all instruments. In case of result rejection, all new results that arrive for a sample will be rejected and saved as "X-NORESULT". Note that manually-entered results will not be rejected if Permanently (all instruments) is selected. By default results will be accepted. When the sample flag Sample reject results is set to Temporary (concerning instrument), this flag can be cleared using the Sample function Release LAS flag result rejection. On receipt You can specify a SampleLog-scoped and Logicalvalued site function that will be executed when this flag is received from the LAS after creation of the SampleLog record in the database. Note For the field Sample reject results you must set the X01 flag to temporary and the X02 flag to permanent. Clearing LAS Flags To clear a flag so that results can again be received for that sample from a particular instrument, set the Sample reject results drop-down menu to Temporary (concerning instrument). This setting does not affect LAS flags that have Sample reject results set to Permanent (all instruments). When setting this option, a list of instruments displays that contain the Sample reject results flag. Selecting an instrument clears the flag for that instrument; by default, all listed instruments are selected. Relative Routing Routing Priority for Tests • 11222683 Rev. A Aptio Automation systems do not support the concept of routing priority associated with each configured method in Automation, as is supported by ADVIA Automation systems. page 209 System Configuration • If the CentraLink system sends an order to an Aptio Automation system that contains normal instrument tests and sort tests, then the instrument tests are processed prior to the sort tests. • You can define preprocessing for both instrument tests and sort tests in an Aptio Automation system. Preprocessing may include centrifugation and/or uncapping before that test is processed by an Aptio Automation system. • Pre-sorting of samples is not supported via sort tests. Samples requiring centrifugation and/or uncapping are managed by Aptio Automation system configuration. Setting Test Route Priority You can prioritize the dispatching of tests from the CentraLink system to LAS by creating Automation Test Groups and Relative Routing Bands. You cannot prioritize the processing of tests which are performed on the same Instrument, but you can identify relative routing priority bands for tests performed on multiple instruments. Priority Bands and Test Groups Users can create LAS Priority Bands and LAS Test Groups, which prioritize the dispatching of tests to connected track systems. Priority Bands You can define unique relative routing priority bands for each connected track system. These bands control the dispatching of requests to each track system. The following rules apply to the creation of priority bands: • You must assign each band a unique name and a unique numeric value, between 0 and 10,000, inclusive. A lower numeric value corresponds to a higher priority; for example, a priority band with a value of 5 has a higher priority than a band with a value of 20. • You cannot assign two bands the same numeric value. • Each band can contain one or more LAS test groups. LAS Test Groups You can define any number of LAS test groups for each connected track system. Each test group may contain one or more orderable tests. A LAS test group defines the completion criteria for all tests associated with that group. The following rules apply to the creation of automation test groups: page 210 • You can assign one or more test group(s) to each LAS priority band. • You cannot assign the same test to multiple test groups. 11222683 Rev. A System Configuration • You cannot assign the same test group to multiple priority bands. • You cannot assign a test directly to a priority band. Defining Priority Bands and Test Groups You can create a LAS Priority Band by selecting Start > Configuration > LAS > LAS Priority Bands and defining Name, Seq Number and LAS channel: Field Name Seq no LAS channel Definition This field identifies the name of the priority band in the CentraLink system. This field identifies the sequence number of the priority band. A value between 0 and 100,000 can be specified. The lower the value, the higher the priority of the band. This field identifies the LAS channel to which the band belongs. Completion Criteria for LAS Test Groups To determine how LAS test groups are completed, set the completion criteria for each group to either Minimal Request Status or LAS General Area. If you select Minimal Request Status then you also must select one of the following status values: • Scheduled (SCH or higher): The test request has been included in a response to an instrument query for work. • Rerun (RRN or higher): A result for the test has been received but the test has since been rerun. • Review (REV or higher): A result for the test has been received in the CentraLink system. • Validated (VAL or higher): A result has been received and validated, either automatically or manually, in the CentraLink system. This means that a valid result has been obtained for the test. • Uploaded (UPL or higher): A result has been received, validated and uploaded to the LIS host. • Omitted (OMT): A User or MISPL rules have decided that the subject test requests in a priority band are no longer required. If you select Minimal Request Status, the LAS test group is considered complete when all tests in that group have reached the minimal request status selected. 11222683 Rev. A page 211 System Configuration You can use the Test Not Available=Continue checkbox to prevent any disabled test from holding up the completion criteria of the group. This option applies only to test groups that have a completion criteria of Minimal Request Status. For example, you may want to have TSH tests done before tests in lower priority bands, but if TSH testing is not available on a connected instrument, then the other test requests can be processed. Note For Aptio Automation systems, always select this checkbox. You cannot select a minimal status of Pending (PND), because that is the initial state of a request. If LAS General Area is selected you can select a single Automation location area from the Automation sort location table. You can optionally determine whether a subsequent Removed Sample Processing Notification message and InLab message is required, after the location is reached, in order to reach the completion criteria for this LAS priority group. If you select LAS General Area the test group is considered complete when the sample based Automation location is the same as the Sample LAS location selected, meeting the following criteria: • The sample has reached the General Area specified. • If defined, the sample has reached one of the Lane(s) specified. • If defined, the sample is within the position range specified for the corresponding lane. • Optionally, a subsequent Removed Sample Processing Notification and Inlab message is received, indicating that the sample has been removed and subsequently returned to the automation track. Note On Aptio Automation systems, the receipt of a Removed Sample Processing Notification and subsequent Inlab message is necessary in cases where a sample is parked for offline processing. This ensures that remaining tests will not be downloaded until the rack has been removed and the sample processed and returned to the track. A priority band is considered complete when each test group defined in that band has reached its completion criteria. This completion of one priority band triggers the sending of the tests requests in the next highest priority band. You can generate a list of overdue requests and (optionally) automatically dispatch them via a filter in the Sample Query window. Contact your local technical support provider to configure this option. page 212 11222683 Rev. A System Configuration MISPL may be used to filter for the subject requests. The list includes requests that have not been dispatched and requests that have been dispatched but not yet been run on an instrument. Note The configuration and use of test groups and priority bands has no impact on the response to instrument queries. A query response includes all pending requests that are available on that instrument regardless of a test’s relative routing priority. These guidelines also apply if you select LAS General Area: • The General Area field must match the Aptio Node-ID name. • The Lane field must match the Aptio RackLane name. • The Position field must match the RackPos in the S001, Sample Location Notification message. • When multiple Lane and Position combinations are specified, the sample is considered complete when any of the specified Lane and Position combinations are reached. • If no Lane and Position combination is specified, then the entire General Area shall be considered as completion criteria. If a position is not specified within a Lane and Position combination, then any Position in the Lane is considered as completion criteria. • You can specify any numeric value between 1 and 100 in the position field. You cannot specify Positions if a corresponding Lane is not specified, for example: ○ You can specify an entry with a name of 'SortA' which is considered complete once the sample reaches any position in lane 7, within General Area 05. ○ You can specify an entry with a name of 'SortB' which is considered complete once the sample reaches lane 5, positions 1 to 12, or lane 6, positions 13 to 24, or any position in lane 8, all within General Area 06. Dispatching Tests to LAS When orders are created, the CentraLink system dispatches only tests which belong to the highest priority (lowest numeric value) priority band. Tests in any lower priority bands are not dispatched at this time. The current priority band is considered complete when all LAS test groups associated with that band meet their completion criteria. When the current priority band completes, the CentraLink system then dispatches only tests which belong to the next highest priority (lowest numeric value) band and are still in a valid status for dispatch (that is, they have not been omitted or had routes deleted). The following applies to test dispatching: 11222683 Rev. A page 213 System Configuration • By default, tests are not associated with any LAS test group or LAS priority band. • Upon CentraLink software upgrade, tests are not associated with any LAS test group or any LAS priority band. • Tests which are not associated with any LAS priority band are dispatched to LAS based upon a configurable option, specific to each configured automation system. You can configure these nonprioritized tests in 3 ways: ○ ASAP Tests are never held by the CentraLink system. This option is the default and remains the default when a customer site is upgraded. ○ Last Tests are dispatched after all tests in test groups associated with defined priority bands have been completed. ○ Specific Tests are dispatched after a specified priority band has completed. Note The CentraLink system displays tests which are not in any routing bands on the LAS Channel prioritization overview window. Display this window by selecting Start > Configuration > LAS prioritization overview. If no LAS priority bands are defined in the CentraLink system, all tests are dispatched to LAS according to existing behavior (that is, they are never held by the CentraLink system). Rerun and Reflex Tests The CentraLink system processes rerun, reflex or unscheduled tests according to the priority routing rules for new orders. If a rerun or reflex test is associated with a higher priority band than the most recent requests sent to the track system, then the test is immediately dispatched and does not wait for the current band to complete. The rerun or reflex test priority band must complete before any requests for lower priority bands are dispatched. Any priority band that is in process before the rerun or reflex tests must also complete before any lower priority bands can be dispatched. If a test is manually rerun, the CentraLink system can immediately dispatch the test to the track system and ignore any previously configured priority bands. By default this option is unchecked. Note If a rerun or reflex test is triggered via MISPL, and you want to override relative routing priority bands, the rule should specify that the test be immediately dispatched to the connected track system. page 214 11222683 Rev. A System Configuration You can manually dispatch requests to a connected track system immediately, via the CentraLink system interface or MISPL, regardless of the test’s priority band, using the Ignore LAS Priority Bands option on the Dispatch to LAS window. If you enable Ignore Bands if Rerun on a test group and a test belonging to this LAS test group is rerun, no release conditions will be checked at all and the test is immediately downloaded to the LAS. None of the priority bands are taken into account in determining when the test should be sent to the LAS. You can dispatch by sample or by selecting multiple requests. Instrument Targeting You can target instruments in CentraLink using three methods: • Set Target Instrument. See Setting a Target Instrument on page 110. • Advanced Rerun. See Setting Up Advanced Reruns, page 106. • Instrument Rerun Selection. See the following section. Note You can also apply strict targeting at the test level. See the Advanced tab under Configuring Test Settings. Instrument Rerun Selection The CentraLink system can define a target instrument for rerun tests in the LAS order download message, and specify the instrument targeted for the rerun test. For rerun tests where a specific target Instrument is not provided in Advanced Rerun, you can define, on a per Instrument method basis, whether the same or different instrument is targeted. You can select more than one method at a time to allow for easier configuration. 11222683 Rev. A page 215 System Configuration This option is called Setup Instrument targeting for rerun and you can choose from the following values: Value Definition ? If you select this option, no instrument is targeted. This is the default setting. Same If you select this option, all reruns of this test are targeted for the same Instrument that generated the last result. Different If you select this option, all reruns of this test are targeted for a different Instrument than the one that generated the last result. The CentraLink system will choose the instrument based on the following criteria: • Test is available and is enabled on the instrument • It is not the instrument which produced the last result • Instrument is assigned to that automation track • Within the remaining candidate instruments the CentraLink system chooses a random instrument to which the rerun is targeted If there is no available instrument for testing, then the CentraLink system does not specify any target instrument when dispatching the request to automation.This is equivalent to setting “?” which may result in the sample returning to the same instrument. If you specify an instrument for a test via Advanced Rerun or the CentraLink user interface, this value overrides the Instrument for rerun option and is sent as the target instrument to the LAS. Configuring Instruments The Instruments editor window defines the instruments connected to the CentraLink system. 1. On the menu bar, select Start > Configuration > Instruments. You can also select the instruments icon on the toolbar. The Instruments browser window displays. page 216 11222683 Rev. A System Configuration 2. On the editing toolbar, select the New icon. The Basic tab of the Instrument editor window displays these fields: Field Definition Name The unique identifier of the instrument. Type This drop-down menu field specifies the type of instrument: Diffpad, Normal or Concentrator. Concentrator: An instrument of type concentrator is a system that facilitates multiple instrument connections; for example, the VersaCell system. When a concentrator configuration is defined, normal instruments must be defined to the concentrator. Test requests are scheduled against the concentrator. The CentraLink software does not know which of the normal instruments connected to the concentrator will receive and execute test requests. One concentrator instrument can have multiple normal instrument connections. A concentrator cannot be a member of another concentrator. Normal: A single instrument. Each of the following instrument parameters must be defined for a normal instrument: flags, methods, aspects, OnEndResultMessage, full sample upload, batch size, barcode Translation. Normal instruments that are eligible for connection to a concentrator can only be a member of one concentrator. A DIffpad instrument is a virtual blood differential counter which allows you to use designated keys on the computer keyboard to increment counters for corresponding blood cell types. Parent Instrument 11222683 Rev. A Only instruments of type Normal can be associated to a Parent Instrument. A Parent Instrument must always refer to an instrument of type Concentrator. page 217 System Configuration Field Definition Coding system References the coding system record, which defines the mapping of tests and other codes between the CentraLink system and the instrument. For more information about coding systems, see Setting Up Coding Systems on page 254. Check units This field ensures that the test result units which are sent from this instrument are checked by CentraLink before they are accepted. LIS Channel Specifies the LIS channel assigned to unsolicited samples from this instrument. Instrument Window Advanced Tab Barcode translation Determines whether an incoming barcode identifies a patient sample, a control sample, or a sample with an unreadable barcode and translates it into either a sample barcode or a QC lot code that matches a database record. Upon entering a change to the Barcode translation field, a message displays warning that modifying the Barcode translation can affect sample identification. Method request If selected, any requests of type image for a groups include images sample will always be included in all request groups defined through the Request group code field, even if there are multiple groups. See Advanced Tab of Method Editor Window on page 243 for more details on request group codes. page 218 11222683 Rev. A System Configuration Instrument Window Communication Tab The Communication tab of the Instrument window displays these fields: Field Description Query Area When the sample record in the CentraLink system does not reference a sample type, this default value specifies the sample type that should be associated with the sample in the workorder message to the instrument. Required only for instruments that must have some sample type in their workorder message. Default sample type Query Area When the sample record in the CentraLink Default container type system does not reference a container type, this default value specifies the container type that should be associated with the sample in the workorder message to the instrument. This is required only for instruments that must have some container type in their workorder message. 11222683 Rev. A page 219 System Configuration Field Description Query Area This field indicates how the application will respond to queries of the instrument (host queries) or to translator-initiated ALL queries. Request scheduling • Multiple: The application will respond to queries of the instrument with any test requests that can be satisfied by the instrument, even if they are already scheduled to another instrument. This also applies when a work list is being downloaded in response to a translatorinitiated ALL query. • Once per instrument: Test requests will be sent to each instrument only once. A scheduled test request will still be sent to other instruments. This is useful for instruments that are not capable of sending specific queries to the application and for which work is downloaded automatically in response to a translator-initiated ALL query. Test requests will be sent to multiple instruments but only once to the same instrument. • Query Area Max previous results page 220 Once: This is the default value. Once a test request is scheduled, it will not be downloaded again to the scheduled instrument or to any other instrument. The request is sent only if it has not been scheduled yet. If selected and if the instrument is capable of performing delta checking, the maximum number of previous results for the same patient for the same test can be sent to the instrument with the workorder. 11222683 Rev. A System Configuration Field Description Query Area CentraLink software supports non-unique patient identifications (PID) from different LIS systems. A patient is uniquely identified by the combination of its PID and the originating LIS channel. However, some instruments cannot handle nonunique PIDs. Patient demographics download In some cases (for example, HIV tests) patient information should be shielded and not be downloaded to the instrument. You can set the following values for patient demographic downloads: Always: Patient data is always sent to the instrument (default value). Never: Patient data is never sent to the instrument. Only if PID unique: Patient data is only sent if the PID is unique across all defined LIS. On ALL Query Area Download by Worklist Activates the workorder download by worklist feature for this instrument. In response to an ALL query from the instrument translator, the CentraLink software returns the contents of the first worklist available for download to the instrument as opposed to returning all eligible samples. Note To resend a workorder request to an instrument, you must first unschedule the request and then resend the unscheduled request to the instrument. On ALL Query Area Match Target 11222683 Rev. A In response to an ALL query without sample identification from the instrument translator, the CentraLink software returns requests targeted to the instrument associated with the translator that generated the query. page 221 System Configuration Field Description On ALL Query Area In response to an ALL query without sample identification from the instrument translator, the CentraLink software returns no more than the maximum number of samples defined in this field. Max Samples When targeting is disabled and multiple, equivalent instruments of the same type exist, this value-enables the distribution of requests among same type instruments. If the ? symbol populates the field, all available requests are downloaded in response to a query from an instrument translator. On ALL Query Area Send order messages Allows you to determine whether or not CentraLink should send orders when receiving an ALL query. On ALL Query Area Not supported in this software version. Send cancel messages On ALL Query Area SID translation On ALL Query Area On ALL Query Sample select page 222 This allows you to allow to manipulate the SID of the sample when an ALL query is received from the instrument or translator. When an AllQuery finds a sample to be selected, this allows you to intervene and not to add the sample to the query. 11222683 Rev. A System Configuration Field Description Result Area Defines whether the Comment code or Comment text should be saved as the result's instrument comment. Comment storage The following options are available: • Code or Text When the code is available in the result message, the code will be saved. If the code is not available, the text will be saved. • Text or Code When the text is available in the result message, the text will be saved. If the text is not available, the code will be saved. • Code only If the code is available in the result message, the code will be saved. If no code is available, no comment will be saved. • Text only If the text is available in the result message, the text will be saved. If no text is available, no comment will be saved. Note This option only applies to Instrument drivers that use the URL (internal ASTM) protocol, not to drivers using the XML protocol. Note Verify for each translator how the instrument message is translated into the internal message protocol. This allows you to determine which comment field you wish to save into the result instrument comment field. Result Area Unknown flag comment If an unknown flag is reported, the result is held in review, and flag severity is raised to -5. All unknown flags from a particular instrument will have this comment appended to it. If this field is left blank, unknown flags will not be identified. Siemens recommends that you populate this field. 11222683 Rev. A page 223 System Configuration Field Description Result Area If selected, a patient result upload is considered final; that is, no additional results for the sample are expected from the instrument. If some results are missing upon result upload, their default values as defined in the test record are automatically assigned. Note Full sample upload does not apply to QC results. Full sample upload Result Area On end result message Reference to a MISPL function, which is executed when a complete result message is received from the instrument. Instrument Window Translators Tab This tab references the translator records, which define communication with the instrument. Multiple translators can be defined for a single instrument (if the instrument supports this functionality). Instrument Window LAS Tab The LAS tab of the Instrument window displays the following fields: Channel Connection active page 224 This field references a LAS channel to which the instrument is linked. This field indicates whether or not the connection to the LAS is active. This field is either set by the LAS channel or can be manually set by the popup menu Setup LAS connection availability function. 11222683 Rev. A System Configuration Instrument Window Diffpad Tab The following Diff pad related options can be set on instrument level: Type Counted test Count cycle Count limit Instrument records become eligible as counters when their type is set to Diff pad. Allows you to specify the test for which the fractions are being counted via this diff pad. When this test is specified, a column displaying the absolute values of the counted fractions will be visible in the Counter requests browser of the Diff Pad window. An audible signal alerts you each time this number of cells has been counted. You can continue counting until the cell count limit is reached. When no cell count cycle is specified, the counter stops when the cell count limit is reached. Allows you to specify the maximum number of cells that should be counted in order to obtain realistic statistics (typically 50 or 100). The cell counter stops counting when this limit has been reached, and an audible signal sounds. Instrument Connections to the CentraLink System Only normal instruments contribute to the total number of connected instruments on the CentraLink system. Concentrator and Diffpad instruments are not counted toward this number. The translator that the normal instrument communicates with is the normal instrument’s connection to the CentraLink system. On the Instrument window, you would define a normal instrument connected to a concentrator as having a parent instrument. This parent instrument value identifies the concentrator to which the normal instrument is connected. As a parent instrument is defined to this normal instrument, the translator is defined on the concentrator. This ensures that when a normal instrument is connected to a concentrator, all communication is managed by the translator of the concentrator. 11222683 Rev. A page 225 System Configuration On the Instrument window, you would define a concentrator instrument as having a Translator. This concentrator translator serves as the translator for the normal instrument, which references the translator indirectly through its specified parent instrument field value. In this scenario, the translator of the concentrator defines the normal instrument’s connection to the CentraLink system. On the Instrument window, a normal instrument that is not connected to a concentrator is defined as having a Translator. In this scenario, this normal instrument translator defines the normal instrument’s connection to the CentraLink system. Workorder Processing with a Concentrator Configuration During workorder download, test requests are scheduled to the concentrator, which sends the order to the connected normal instrument for processing. The test request is processed on the normal instrument, which generates the result. The generated result record contains the result value as well as a reference back to the normal instrument identifier. In order for the generated result record values to be saved as a result to the concentrator, to which the request is scheduled, the normal instrument must be defined to the concentrator. Without a valid normal instrument identifier to which the result values are mapped, the concentrator cannot use the valid result and stores the result value as “X-NORESULT,” or stores it against the concentrator, depending on the type of concentrator. Concentrator Overriding Values The following instrument fields of the concentrator instrument override the setting in the corresponding fields of the underlying normal instruments. • Maximum previous results • Coding system • Default sample type Note When a sample type is not defined for the sample in the CentraLink software, the sample type of the concentrator is downloaded to the normal instrument in the Workorder message. page 226 • Default container • Enable rescheduling parameter 11222683 Rev. A System Configuration Note When replying to a Query message, the Enable rescheduling parameter of the concentrator is used because tests are scheduled against the concentrator. The CentraLink software cannot determine beforehand which of the normal instruments connected to the concentrator will receive and execute a test request. • Download by worklist • On All query match target • On All query max samples Specific Query from Concentrator When the CentraLink software receives a specific query from the concentrator, the CentraLink software downloads a workorder for the sample attaching all methods whose associated tests can be done by any of the normal instruments defined to the concentrator. The CentraLink software does not determine which of the normal instruments connected to the concentrator will receive and execute test requests. The concentrator is responsible for targeting the normal instrument that will receive the workorder, except in cases where the concentrator instrument supports the download of targeted instrument in the order. All Query from Concentrator When the CentraLink software receives an ALL query from the concentrator, the following occurs depending on whether instrument download by worklist is enabled: 11222683 Rev. A • If the instrument download by worklist is enabled, all worklists of the normal instruments connected to the concentrator are transmitted in the workorder to the concentrator. The workorder contains all corresponding sample information in the worklists of the normal instruments and requests that match the target of the normal instrument. If a worklist for the concentrator is available, that worklist is also transmitted to the concentrator. • If the instrument download by worklist is not enabled, the concentrator parameters specified at the Instrument window in the On ALL Query Match Target and On ALL Query Max Samples fields are taken into account and the appropriate workorders are downloaded to the concentrator. • Test requests are scheduled to the concentrator, which targets the connected normal instruments for processing. page 227 System Configuration Test Selection Update The CentraLink software can be configured to automatically download updates to requests for a sample that have already been queried for and downloaded to the concentrator. When the CentraLink software receives a test selection update from the concentrator, it only downloads the add-on, reflex and rerun tests of samples already transmitted to the concentrator at some time in the past. How Results from the Concentrator are Interpreted and Displayed Patient Results On the Review and Edit window, patient results received from the concentrator are associated with the normal instrument from which they were generated, not the concentrator. These patient results display with the normal instrument. The flags attached to the patient results refer to the flags of the normal instrument. Auto validation rules applied to the patient results correspond to those defined on the Method records of the normal instrument. Moving averages Moving averages refer to the normal instrument. To enable moving averages, select Check moving average on the method of the normal instrument. Full Sample Upload Full sample upload refers to the normal instrument. To enable full sample upload, select Full sample upload on the Advanced tab of the Instrument window of the normal instrument. When the concentrator receives results from a normal instrument supporting full sample upload, all test requests scheduled to the concentrator that can be performed by the normal instrument are assigned the default value specified on the corresponding tests. QC Results On the QC Results (Across controls view) window, QC results received from the concentrator are associated with the normal instrument from which they were generated, not the concentrator. These QC results display with the normal instrument. The QC flags attached to the QC results refer to the flags of the normal instrument. QC severities raised for these results correspond to those defined on the Method records of the normal instrument. page 228 11222683 Rev. A System Configuration Normal Instrument Identifier Upload to the LIS The normal instrument identifier is transmitted to the LIS when this upload behavior is supported by the LIS translator. Instrument Logs The Instrument Log window stores event information about activities performed on an instrument, including logging, maintenance, calibration, and reagent change. For those events associated with an instrument and a method and for which a QC population exists, you can associate this instrument log event with a dotted vertical line that displays on the Levey-Jennings graph. To access the Instrument Log editor window: 1. On the Instrument window, right-select and select Related > Instrument logs. Note You can also access this window through the Method window. The Instrument log browser window displays. 2. On the Instrument logs browser window, select the New icon or select Insert. The Instrument logs editor window displays these fields: Field Description Instrument Instrument to which the log applies. When the Instrument log browser is accessed through the Method window, this field is automatically populated with the instrument value on the Method window. LAS Channel LAS channel to which the log applies. Method Reference to a specific method. When the Instrument log browser is accessed through the Method window, this field is automatically populated with the test value on the Method window. Event time 11222683 Rev. A The time in which the activity that was performed on the instrument took place page 229 System Configuration page 230 Field Description Event type The type of activity performed on the instrument: • Log • Maintenance • Calibration • Reagent change Show on qcgraph If selected, a dotted vertical line that corresponds to the event is plotted and displays on the LeveyJennings graph in CentraLink when the event is associated with an instrument and a method and for which a QC population exists. Code Code representing the event that displays on the Levey-Jennings graph. Note To prevent legibility issues, limit the amount of text for display on the LeveyJennings graph. Description Free text description of the event. Comment Free text comment. 11222683 Rev. A System Configuration Automatic Download Targeting Note This is only applicable to instruments which use automatic download of results, such as the Versant 440. The Setup targeting option enables targeting for all associated methods at once. To access the Setup targeting window: 1. On the menu bar, select Start > Configuration > Instruments. The Instrument browser window displays. 2. Right-select the appropriate instrument and select Setup targeting. On this window you can define the following fields: Field Description Enable This checkbox determines whether requests for the instrument's tests can be targeted to the instrument. Seq no This value determines the order, among all eligible instruments, in which the current instrument is considered as target for a matching request. Automatic Download Retargeting Note This is only applicable to instruments which use automatic download of results, such as the Versant 440. When an instrument is taken offline, you have the option of deleting the worklists that are in Ready status for this offline instrument. This allows for worklists that are not yet scheduled and targeted to this instrument to be targeted to another instrument and prevents additional targeting to this offline instrument. When the instrument is brought online, worklists are retargeted to this instrument using the Setup targeting function. To access the Retarget window: 1. On the menu bar, select Start > Configuration > Instruments. The Instrument browser window displays. 2. Right-select the appropriate instrument and select Retarget. On this window you can select the Delete ready worklists checkbox. If selected, all Ready status worklists targeted to the instrument are deleted. 11222683 Rev. A page 231 System Configuration Enabling Moving Average for a Method 1. On the menu bar, select Start > Configuration > Instruments. The Instruments browser window displays. 2. Select the appropriate instrument. 3. Right-select the selected instrument and select Related > Tests. 4. Double-select on the appropriate method. The Method editor window displays. 5. Select the Moving Average checkbox. 6. Enter a Batch size. This field is optional, but must be a positive integer if filled in. Batch size determines the frequency by which a patient result, obtained by this method, should be added as a QC result in the QC population. For example, if this field is set to 5, then the 5th, 10th, 15th, etc. patient results will be added as QC results. 7. Select OK. Note You can set the moving average for more than one method on the Tests on instrument window, by right-selecting the methods and then selecting Setup moving average. At this window, enable the checkbox and enter a batch size. Setting up QC Populations for Moving Average Data 1. On the menu bar, select Start > Routine > Quality Control > QC populations. The QC population query window displays. 2. Select OK. The QC Populations browser displays. 3. Select New on the editing toolbar. The QC Population editor window displays. 4. Enter the Method test. 5. Select Moving average. By selecting Moving average, you are specifying that this is a patientbased population. The selected moving average checkbox specifies that a species, not a QC Lot, is grouped with the test and instrument within the QC population. page 232 11222683 Rev. A System Configuration 6. Enter the remaining data and select OK. For more information about defining QC populations, see QC Populations on page 143. Automatically Creating QC Populations for Moving Average Data If you do not create QC Populations for the moving average data, the populations are automatically created when patient results are received from the instruments. Once these populations exist, you must define the Reference value and Reference deviation for Westgard checks to apply. Note Westgard rules are applied using the Reference value and Reference deviation rather than the Target value and Target deviation. To initially set the Target value and Target deviation as the Reference value and Reference deviation: 1. On the QC Population browser window, select the population for which you want to define the Reference value and Reference deviation. 2. Right-select the selected population and select Set Target. The Set Target window displays. 3. Enter the Target value and Target deviation. 4. Select Set as reference. 5. Select OK. The Target value and Target deviation is also set in the Reference value and Reference deviation fields. Once statistics are available, change the Reference value and Reference deviation to Statistics: 1. Select the population for which you want to change the Reference value and Reference deviation. 2. Right-select the selected population and select Set Reference. The Set Reference window displays. 3. From the dropdown menu select Target, Current Statistics, or Cumulative Statistics. Note If you choose Current Statistics or Cumulative Statistics, the standard deviation at the time you choose the setting is used from that point forward. 4. Select OK. 11222683 Rev. A page 233 System Configuration Creating or Modifying Instrument Groups You can create groups of instruments by right-selecting the instrument and choosing Set Group. An instrument can belong to multiple instrument groups. References to the containing instrument group are automatically created whenever new requests or QC results are created, which improves query performance. When an instrument changes groups, however, requests and QC results are not synchronized. Note Patient results received prior to instrument group creation are not returned in queries for the specified group. To display all groups to which an instrument belongs, right select Instrument > Related instrument groups. Note If referenced by requests, QC results, or other instrument groups, an instrument group should not be deleted. Deleting an instrument group that is referenced can result in the generation of empty audit logs. Instead of deleting instrument groups that are referenced by requests, QC results, or other instrument groups, reassign them. Access the Instruments Groups editor window and enter or modify an instrument group: 1. On the menu bar, select Start > Configuration > Instrument groups. The Instrument groups browser window displays. 2. To create a new instrument group, select the New icon or select Insert. 3. To access an existing instrument group, double-select the appropriate instrument group. The Instrument Group editor window displays. 4. Enter or modify the Name and Description of the instrument group. 5. Select OK. Assign an instrument to an instrument group: 1. On the menu bar, select Start > Configuration > Instruments. The Instruments browser window displays. 2. On the Instruments browser window or the Instrument editor window, right-select the instrument and then select Set Group. The Set Group editor window displays. • page 234 Name is the unique identifier of the group. 11222683 Rev. A System Configuration • Type indicates the type of this instrument group. The possible values are: Normal: default value. Hematology: allows you to define the instruments in this group as hematology instruments. An instrument can belong to multiple instrument groups of the same type or of a different type. Note You cannot configure instrument groups of type hematology without the appropriate hematology license. • Description is a free text field. To display all available Instrument groups, double-select the Group field. 3. Double-select an Instrument group. 4. On the Set group window, select OK. Note Using the right-select Set group function at the Instruments browser, you can assign multiple instruments to a group at the same time. Configuring Instrument Tests (Methods) and Flags Setting Instrument Flags You define Instrument flags for every new instrument configured in the CentraLink system. The CentraLink system only stores flags that are already defined. Instrument flags that are not configured in the CentraLink system are ignored. If the Unknown flag comment field on the Instrument is not empty, an unknown flag received from an instrument will be captured as a result comment. Note QC results received with undefined instrument flags are automatically omitted. An instrument flag has a code, explanatory text (expansion), and two severity flags. You can define the severity that is assigned when an instrument flag is associated with a QC result, and you can define the severity that is assigned when an instrument flag is associated with a patient result. Defining these flags independently allows for more precise instrument severity determinations between QC result and patient results respectively. 11222683 Rev. A page 235 System Configuration Defining Instrument Flags To define instrument flags, access the Instruments window: 1. On the menu bar, select Start > Configuration > Instruments. The Instruments browser window displays. 2. Select the instrument for which you are defining flags. 3. Right-select the instrument and select Related > Flags. The Flags defined on instrument browser window displays. 4. Double-select the appropriate flag. The Instrument flag editor window displays the following fields: page 236 Field Description Instrument This field is automatically filled with the name of the instrument you are modifying. Code Unique identification for the flag. This code must match the code used by the instrument. Expansion Determines the flag description on the Review and Edit window and on reports. Patient severity The overriding patient severity flag value applicable to patient results, which automatically sets the Instrument value on the Severity tab of the Request window to the highest severity. Note If the patient severity flag value is greater than the instrument severity value on the Severity tab of the Request window, then this value overwrites the instrument severity value. 11222683 Rev. A System Configuration Field Description Control severity The overriding QC severity flag value applicable to control samples, which automatically sets the Instrument severity value of the QC results window to the highest severity. If this control severity flag value is greater than the Instrument severity value of the QC results window, then this flag value overwrites the Instrument severity value. Note If the instrument severity flag is not relevant to QC results, set the Control severity at the Instrument Flag window to 0. If the instrument severity flag is relevant to QC results, set the Control severity at the Instrument Flag window to equal the highest value of the Westgard rules applicable to that method. If an unknown flag is received, the field value is set to -5. Upload to LIS If checked, this flag is uploaded to the LIS. Report If checked, this flag is included in printed reports. Edit Marker This field is not supported in this version of the CentraLink software. Setting Instrument Tests (Methods) You must define all the tests performed on an instrument in a Tests on instrument list. The tests on this list are instrument-specific, and the test definitions do not automatically apply to another instrument. You can configure a test on an instrument and specify a different result selector for patient results and control results using the Method window. Note Your administrator or local technical service provider must ensure that the test list for an instrument is accurate. You can add a new instrument to the instrument list by copying settings from an existing instrument using the Deep Copy function. Note You cannot deep copy an instrument of type Concentrator. If you need to deep copy a Concentrator instrument, make a deep copy of the child instruments and then create the concentrator instrument, or use the normal copy function. 11222683 Rev. A page 237 System Configuration Note You can also deep copy coding systems, by right-clicking on the coding system and selecting the check boxes of the codes you wish to copy. 1. On the menu bar, select Start > Configuration > Instruments. The Instruments browser window displays. 2. Select the instrument for which you are defining a method. 3. Right-select the selected instrument and select Related > Tests. The Tests on instrument browser window displays. 4. Double-select the appropriate test. The Method editor window displays. The top portion of the Method window displays these fields: page 238 Field Description Test Reference to the test that can be performed on the instrument. Note If the test is a calculated test, the CentraLink software does not download orders or accept results from the instrument. Instrument This field is automatically filled with the name of the instrument. 11222683 Rev. A System Configuration Basic Tab of Method Editor Window The Basic tab displays these fields: Field Description Patient result selector The Patient result selector determines the instrument aspect that represents the actual result value for patient results. This aspect displays on the Review and Edit window. The ADVIA Centaur system is an example of a system that makes use of this field value. Commonly used aspects are DOSE (concentration) and INTR (interpretation). For information on defining a result selector, see Defining Test Aspects on page 195. Control result selector The Control result selector determines the instrument aspect that represents the actual result value for QC results. This aspect displays at the QC Results window. The ADVIA Centaur system is an example of a system that makes use of this field value. Commonly used aspects are DOSE (concentration) and INTR (interpretation). For information on defining a result selector, see Defining Test Aspects on page 195. Last “Enable-Work Orders” -change by reagent change 11222683 Rev. A This field indicates if the method was enabled/ disabled based upon the reagent status and is important when the CentraLink system is connected to an Aptio Automation system. For more information see Automatic Enabling and Disabling Methods on page 345. page 239 System Configuration Field Description Unit Double-select the field to open the Units for dimension browser. Double-select the unit you want to enter in the editor. Edit this field only if the unit of the method differs from the default unit in the test table. The units must be of the same dimension for proper conversion to take place. Upon entering a change to the Unit field, a warning message displays. The message prompts that you should only modify the Unit on the method if it is necessary to convert the result uploaded from the instrument to match the units reported in the CentraLink software. Modifying the Unit on the method can affect the reporting of new results. If a Unit is defined on the method, it will be used in unit checking functionality, and must match what is defined on the instrument. Low detection limit Linearity Range: If results fall outside the delimited range, they are converted to the detection limit, preceded by a <, and displays on the Review and Edit window. The value displayed on the Review and Edit window is the value uploaded to the LIS. If you change the Low detection limit field, a warning message prompts you that modifying the limit will change new results from the instrument that are less than the Low detection limit to the Low Limit value, preceded by the < symbol. Note This is completed prior to Norm and Delta Norm checks. page 240 11222683 Rev. A System Configuration Field Description High detection limit Linearity Range: If results fall outside the delimited range, they are converted to the detection limit, preceded by a >, and displays on the Review and Edit window. The value displayed on the Review and Edit window is the value uploaded to the LIS. Upon entering a change to the High detection limit field, a message warns you that modifying the High detection limit will change new results from the instrument that are greater than the limit to the High Limit value, preceded by the > symbol. Note This is completed prior to Norm and Delta Norm checks. Note When High and Low Detections limits contain more than 3 significant digits they are rounded to 3 significant digits when displayed in the CentraLink system: • When High and Low Detection Limits are exceeded, the limit will display properly in the CentraLink system if the limit has less than or equal to 3 significant digits. • When High and Low Detection Limits are exceeded, the limit will be rounded to 3 significant digits when shown in the CentraLink system. • Misreported results may occur when more than 3 significant digits is clinically significant and the limit shown in the CentraLink system is rounded to 3 significant digits. • When the High or Low limit is rounded and displayed in the Review and Edit window it will contain the same number of reported decimals as specified on the test configuration window. • The limit shown in the Review and Edit window will be uploaded to the LIS. Enable targeting 11222683 Rev. A Select this checkbox if requests for the method's test are targeted to the method's instrument. page 241 System Configuration Field Description Auto target seq no This field is enabled when Auto target requests on the More tab of the system Options window is selected. If the auto targeting feature is activated, the value in this field determines the instrument that can satisfy the request. Among the instruments capable of satisfying the request, the one with the lowest value is selected as target. Note This field is only applicable to instruments using all query functionality. Enable workorders Select this if workorders for this test are sent to the instrument. If the test is never ordered individually, but only as part of a panel, leave the checkbox deselected. In the LAS environment, this checkbox is deselected if the test is disabled on the ADVIA Automation or Aptio Automation system. When connected to an Aptio Automation system, the enabling and disabling of tests must be performed on the CentraLink system according to Automatic Enabling and Disabling Methods on page 347. Download dilution Select this if the instrument method can accept a dilution coefficient. Moving AverageEnabled Select this if the moving average is calculated for this test. Moving Average-Batch Determines the frequency by which a patient Size result, obtained by this method, should be added as a QC result in the QC population. For example, if this field is set to 5, then the 5th, 10th, 15th etc. patient results will be added as QC results. page 242 11222683 Rev. A System Configuration Advanced Tab of Method Editor Window Field Description Instrument Rerun Selection This setting determines how the CentraLink system selects an Instrument for reruns of this method. The value can be set to Any, Same or Different. This value only applies when no specific Instrument has been selected for the rerun, using the Advanced Rerun function. On QC result processed 11222683 Rev. A Reference to a QC Result-based MISPL function which is executed each time a QC result is processed for the method. page 243 System Configuration Field Description Accept Results for Validated Requests If enabled this option allows CentraLink to accept results for validated or uploaded requests. Incoming results for omitted requests will always be ignored. Upon receipt of a new result for an uploaded request, the request status will be demoted to Review, and the CentraLink system will perform auto-verification rules, if configured. Note If a result is held in review, this option does not apply. Request group code This is a free-text field. You can optionally assign Request Group codes to ensure consistency in the status of all requests assigned to the same code. For example, the Validate of one request will cause all other requests in the same Request Group to also be Validated. You can also specify the Request Group Code for multiple methods simultaneously using the Set request group code function. Note Manually-entered results in CentraLink system have no associated Instrument; request grouping will not be applied to those results. Note When performing a Revert operation on a Request or Test Group in the Hematology Review & Edit window an Ignore Grouping option displays. If you select this option, the Request Group Code configuration will be ignored and only the selected requests will be reverted. page 244 11222683 Rev. A System Configuration Autovalidation Tab The Autovalidation tab includes these fields: Field Description QC severity This field is automatically filled with the highest QC severity of the method since the last QC reset and can be one of the following: Westgard QC severity, instrument flag control severity, QC type error severity, QC severity on invalid reference. For more information, see Resetting the QC Severity on page 167. QC severity on type error The value assigned to the QC severity when a control result is received that cannot be converted to the test's control data type. This integer value defaults to 5. This field can also be used if a non-numeric QC result is received that does not match any choice code defined for the QC population. For information about type errors, see Type Error QC Result on page 157. QC severity on invalid reference QC severity on invalid reference is the value assigned to the QC severity when a control result is received with a comparator that prevents it from being unambiguously positioned with respect to the population reference value. For example: Control result value <10 Population reference value 5 This integer value defaults to 5. For information about invalid references, see Invalid Reference QC Result on page 158. Allow on type error 11222683 Rev. A Allow on type error determines whether automatic validation proceeds when a patient result is received that cannot be converted to the test's patient data type. page 245 System Configuration Field Description Allow on invalid range Allow on invalid range determines whether automatic validation proceeds when a patient result is received with a comparator that prevents it from being unambiguously positioned with respect to the applicable normal ranges. For example: Patient result value <10 Range values 5 to 6 WARNING Do not enable Allow on invalid range. If your normal ranges are properly configured or if you do not have norms defined, you will not receive invalid reference patient results and there is no reason to enable this setting. Severity limits If requests in Review status receive a result through this method and the request's Norm, Delta norm, QC and Instrument severities are all below the respective Norm severity limit, Delta norm severity limit, QC severity limit and Instrument severity limit, then it is automatically validated. If any of the limits are left unspecified, no auto-validation occurs. The following severity limits are used in the auto validation of methods: • Norm severity limit • Delta norm severity limit • QC severity limit • Instrument severity limit Configuring Autovalidation for a Method When results are received from an instrument for a request and the request’s Norm, Delta norm, QC, and Instrument severities are all below the respective Norm severity limit, Delta norm severity limit, QC severity limit, and Instrument severity limit of the method, the result is automatically validated. If any of the limits are left unspecified, no auto validation occurs. Westgard Tab By default, Westgard checks are enabled. You have the option, however, of disabling individual Westgard checks. page 246 11222683 Rev. A System Configuration When any of the fields of the Westgard tab is set to 0, the individual Westgard check is disabled. To the right of a disabled Westgard field, the label “(disabled)” displays. When a Westgard check is disabled, no Westgard comment is added to the QC result and no Failed Westgard comment is uploaded to the LIS. The Westgard tab displays these fields: Field Description *1-2s, 1-3s, 10-x, 2-2s, 4-1s and R-4s Severity assigned to the method QC severity if a QC result obtained through this instrument channel fails the respective Westgard check and if the current QC severity of the method is lower. *for each field there is an Across lot and In lot field. Across lot Upon receipt of a new QC result, previous QC results, for the same test on the same Instrument, from any lot will be taken into account for the determination of violation of Westgard rules. When any of these fields is set to 0, the individual check is disabled, and to the right of the Westgard field, the label “(disabled)” displays. Note In the Method editor, severities can be specified for each Westgard rule, separately for “across lot” or “in lot”. In lot: upon receipt of a new QC result, only previous QC results that originated from the same lot will be taken into account for the determination of violation of Westgard rules. 11222683 Rev. A page 247 System Configuration Field Description Apply Westgard checks Determines whether the method is subject to Westgard checking on numerical tests. Include comparator QC results Determines whether comparator QC results contribute to Westgard checks. • When the checkbox is selected, the comparator QC results contribute to Westgard checks. • By default the checkbox is not selected, and the comparator QC results do not contribute to Westgard checks. The type error severity is raised for the Method, which prevents autovalidation of all patient results for the specified method. This QC result is not taken into account for checks of subsequent QC results. When a comparator QC result does not contribute to Westgard checks, a comment displays in the Comment field of the QC Result (Across controls view) window. This comment is added to existing comments but is not uploaded to the LIS or listed on reports. Refer to the description for the Comment field in the Statistics Area on page 164. For information about enabling this feature for all methods of an instrument or test, see Configuring Westgard Rules for an Instrument on page 251 or Configuring Westgard Rules for a Test on page 252. LAS Tab The LAS tab contains 1 field, Test Availability Alias, which allows you to select the current method's alias for Test Availability messages (for example, a message from the LAS enabling/disabling the Enable Work Orders field of a method). When a method is enabled or disabled through a Test Availability message, it applies to all methods that have this method as alias. For example, if Method A1 and method A2 have method A as test availability alias: 1. When a test availability message is received for method A, the same actions will also be performed for methods A1 and A2. page 248 11222683 Rev. A System Configuration 2. When a test availability message is received for method A1, the same actions will not be performed for methods A and A2. The following restrictions apply to test availability aliases: • If the allow download field is unchecked, the test will be ignored from processing of LAS test availability messages. • A method cannot be its own alias. • Only methods of the same instrument can be selected. • A method that already is an alias cannot be selected. Diffpad Tab of the Method Editor Window Counter key label (method level) Count method (method level) Counter key label Specify the key to be used for counting test results in the Diff Pad. Do not edit the field for tests that do not use the Diff Pad. Ensure that the ? symbol displays in the field. If you enter a change to the Counter key label field, a message displays warning that modifying this label can affect the manual entry of results on the Diff Pad. This field has the following possible values: Formula: The counted cells for this test will be added to the total number of counted cells. Separate: The counted cells for this test will not be added to the total number of counted cells. They will have to be counted separately. Specify the key to be used for counting test results in the Diff Pad. Do not edit the field for tests that do not use the Diff Pad. Ensure that the ? symbol displays in the field. Upon entering a change to the Counter key label field, a message displays warning that modifying the label can affect the manual entry of results using the Diffpad. Setting Autovalidation for a Single Instrument 1. On the menu bar, select Start > Configuration > Instruments. The Instruments browser window displays. 2. Select the instrument for which you are setting limits. 11222683 Rev. A page 249 System Configuration 3. Right-select the selected instrument and select Related > Tests. The Tests on instrument browser window displays. 4. Double-select the appropriate test. The Method editor window displays. 5. To view the currently defined autovalidation limits, select the Autovalidation tab. 6. Right-select on the method window and select Setup autovalidation. The Setup autovalidation window displays. • The Setup autovalidation window is used to define the autovalidation limits, and should not be used to view the method’s defined autovalidation limits. To view the method autovalidation limits definitions, refer to the values displayed at the Autovalidation tab of the Method window. • If you select OK at the Setup autovalidation window and the autovalidation limit fields are set to the default ?, the autovalidation limit fields are changed to a question mark. • If it is not your intent to define the autovalidation limits, select Cancel. 7. Enter the new severity level for each limit. 8. On the Setup autovalidation window, select OK. 9. On the Method editor window, select OK. Configuring Westgard Rules The CentraLink system is preconfigured with standard Westgard checks to apply to QC results. The default QC severity level for each Westgard check is 1. A setting of 0 disables the specific check. To the right of a disabled Westgard field, the label “(disabled)” displays. When a Westgard check is disabled, no Westgard comment is added to the QC result and no Failed Westgard comment is uploaded to the LIS. On the QC Result editor screen, you can distinguish between how Westgard Rules are applied on instruments, methods, or tests: • page 250 Across lot: If you select this checkbox, upon receipt of a new QC result, previous QC results for the same test on the same instrument, and from any lot, will be taken into account for the determination of violation of Westgard rules. 11222683 Rev. A System Configuration • Within lot: If you select this checkbox, upon receipt of a new QC result, only previous QC results that originated from the same lot will be taken into account for the determination of violation of Westgard rules. • If you select neither checkbox, neither set of rules is applied. • If you select both checkboxes, both sets of rules are applied. Configuring Westgard Rules for an Instrument You can simultaneously set up Westgard checking for all methods of an instrument through the Setup Westgard window. To customize the QC severity level for all Westgard checks performed on all results from a single instrument, perform the following steps: 1. On the menu bar, select Start > Configuration > Instruments. The Instruments browser window displays. 2. Select the instrument for which you are setting limits. 3. Right-select the selected instrument and select Related > Tests. The Tests on instrument browser window displays. 4. Double-select the appropriate test. The Method editor window displays. 5. Select the Westgard tab. 6. Enter the new severity level for each Westgard check. When any of the fields of the Setup Westgard window is set to 0, the individual Westgard check is disabled. To the right of a disabled Westgard field, the label “(disabled)” displays. When a Westgard check is disabled, no Westgard comment is added to the QC result and no Failed Westgard comment is uploaded to the LIS. 7. Select Apply westgard checks. If this is not selected, the Westgard rules are not applied to the method. If you select Include comparator QC results, comparator QC results contribute to Westgard checks for all methods of a test. When a comparator QC result does not contribute to Westgard checks, a comment displays in the Comment field of the QC Result (Across controls view) window. For more information, see the description of the Comment field in the Statistics Area on page 164. 8. Select OK. 11222683 Rev. A page 251 System Configuration Configuring Westgard Rules for a Test You can simultaneously setup Westgard checking for all methods of a test through the Setup Westgard window. Configure the system to use other severity values for the Westgard checks performed on a specific test regardless of the instrument on which it was performed by completing the following steps: 1. On the menu bar, select Start > Configuration > Tests. The Tests browser window displays. 2. Select the test for which you are setting limits. 3. Right-select the selected test and select Setup Westgard. The Setup Westgard editor window displays. 4. Enter the new severity level for each Westgard check. When any of the fields of the Setup Westgard window is set to 0, the individual check is disabled, and no Westgard comment is added to the QC result and no Failed Westgard comment is uploaded to the LIS. 5. Select Apply westgard checks checkbox. If this is not selected, the Westgard rules are not applied to the method. 6. If you select Include comparator QC results, comparator QC results contribute to Westgard checks for all methods of a test. When a comparator QC result does not contribute to Westgard checks, a comment displays in the Comment field of the QC Result (Across controls view) window. Refer to the description of the Comment field in Statistics Area on page 164. 7. Select OK. Configuring Westgard Rules for a Method Configure the system to use other severity values for the Westgard checks performed on specific tests on a single instrument by completing the following steps: 1. On the menu bar, select Start > Configuration > Instruments. The Instruments browser window displays. 2. Select the instrument for which you are setting limits. 3. Right-select the selected instrument and select Tests. The Tests on instrument browse window displays. page 252 11222683 Rev. A System Configuration 4. Double-select the appropriate test. The Method editor window displays. 5. Select the Advanced tab. 6. Select the Westgard setup tab. 7. Enter the new severity level for each Westgard check. When any field of the Setup Westgard window is set to 0, the individual Westgard check is disabled. To the right of a disabled Westgard field, the label “(disabled)” displays. When a Westgard check is disabled, no Westgard comment is added to the QC result and no Failed Westgard comment is uploaded to the LIS. 8. Select Apply westgard checks. If this is not selected, the Westgard rules are not applied to the method. 9. Select OK. Method Setup Targeting Function The Setup targeting option from the Method window determines whether matching test requests are downloaded to the instrument. This function is not applicable to methods referring to a calculated test. To access the Setup targeting window: 1. On the Method editor window, right-select, and select Setup targeting. The following fields display: Field Description Enable Determines whether matching test requests can be targeted to the instrument. Seq no Determines the order, among all instruments capable of performing the associated test, in which the associated instrument is considered as target for a matching request. Configuring Menus Using MISPL You can use MISPL to configure customized menus for the Standard and Hematology Review and Edit windows. To access the MISPL menu table, choose Start > Configuration > MISPL menus. 11222683 Rev. A page 253 System Configuration Identifier: This field identifies the window in which the menu items will be visible. This screen also determines the base table of the Visibility and Executable site functions. Base table name: this field is filled automatically by the application in function of the chosen identifier. It indicates the base table (context) for the Visibility and Executable site functions. Sequence: You can determine the sequence of each item in the menu by assigning it a sequence number. Menu label: Determines the label that will be displayed in the menu. Visibility function: This determines the visibility of the menu item. When the function returns FALSE, the menu item will not be displayed. When it returns TRUE, the menu item will be displayed in the menu. Executable function: This determines the action that will be executed when the menu item is selected. Setting Up Coding Systems The CentraLink system typically communicates with many different applications using different names for the same item. To avoid naming conflicts, you can set up coding systems. A coding system is a set of names used by a given application to denote equivalent CentraLink system names. Coding systems are stored in the CentraLink system database and can be modified or expanded at any time. For the changes to take effect, you have to stop and restart the services and translators. Coding systems can contain codes for the following items: page 254 • Tests • Sample types • Container types • Instruments • Species • Sample source • Aspect • Sample Priority • LAS Event • Result Type Codes (Configuration of Result Type Codes is not supported in software version 16 and must not be used. All results in the CentraLink system are treated as final results.) 11222683 Rev. A System Configuration Note With software version 16 you can deep copy coding systems. Using Coding Systems Coding systems work for the following items: • Instruments • LIS • LAS Your local technical support provider configures the LIS and LAS. You may need to add an instrument test code. You can reference coding systems from instruments to denote the coding system used for instrument communication. Multiple instruments can use the same coding system. This typically occurs when you are using several instruments of the same brand and type. Setting Up a Test Code Test codes are instrument-dependent. In general, each test on an instrument must have a unique identifier in the coding system for that instrument on the CentraLink system. An exception is where one test on the instrument is matched to more than one test on the CentraLink system. In this case, each test is uniquely identified on the CentraLink system by the same type. For example, the ADVIA 1650 system uses the same test code for serum and urine tests and they are differentiated by the sample type. Upon entering a change to any field of the Test code window, a message displays warning that modifying Code values can affect the reporting of new results. 1. On the menu bar, select Start > Configuration > Coding Systems. The Coding system browser window displays. 2. Select the appropriate instrument. 3. Right-select the selected instrument and select Related > Test codes. The Test codes in coding system browser window displays. 4. Select New on the toolbar to add a new test code. The Test codes editor window displays. Coding system is populated automatically and refers to the coding system to which the test belongs. 11222683 Rev. A page 255 System Configuration 5. Enter Test. The test value is the CentraLink system test name. 6. Enter an inbound value. This is the value recommendation from the LAS or LIS. Note The combination of coding value, inbound system and sample type must be unique. 7. Enter an outbound value. This is the value sent to the LAS or LIS. The outbound values do not have to be unique. This code is the value recognized by the LIS, LAS, and instrument. 8. Enter a sample type. The sample type value of the test populates the Sample type field. This field is not enabled for entry. This value is a reference to the sample type to which this code is restricted. Note The case-sensitive checkbox should only be used when 2 tests have the same test code and are diferentiated by case. 9. Select OK. Setting up a Sample Type Code In the CentraLink software default setup, the sample type “serum” is identified with the string “Serum.” A LIS might use the abbreviation “Sr” to denote the serum sample type. If this occurs, you can create a sample type code that associates the abbreviation “Sr” with the CentraLink system’s serum. Note If you do not specify a LIS code for serum, the CentraLink system expects the LIS to use and understand the CentraLink system identifier “Serum.” Upon entering a change to any field of the Sample type code window, a message displays warning that modifying Code values can affect the reporting of new results. 1. On the menu bar, select Start > Configuration > Coding Systems. The Coding system browser window displays. 2. Select the appropriate instrument. 3. Right-select the selected instrument and select Related > Sample type codes. The Sample type codes in coding system browser window displays. page 256 11222683 Rev. A System Configuration 4. Select New on the toolbar to add a new sample type code. The Sample type code editor window displays. Coding system is populated automatically and refers to the coding system to which the test belongs. 5. Enter the Sample type. 6. Enter the Value. This code is the value recognized by the LIS, LAS, and instrument. 7. Enter the Match order. Match Order is an integer value used when a single code value is mapped to multiple sample types and unsolicited results are uploaded from the instrument. The CentraLink system picks up the mapping with the lowest match order. 8. Select OK. Setting Up a Container Type Code Container type codes associate container types with coding systems. 1. On the menu bar, select Start > Configuration > Coding Systems. The Coding system browser window displays. 2. Select the appropriate instrument. 3. Right-select the selected instrument and select Related > Container type codes. The Container type codes in coding system browser window displays. 4. Select New on the toolbar to add a new container type code. The Container type code editor window displays. Coding system is populated automatically and refers to the coding system to which the test belongs. 5. Select OK after entering the relevant field values. Setting a Species Code If the LIS does not specify species codes in a workorder, the workorder in the CentraLink system has a question mark in the species field indicating species unspecified. If the lab only handles human specimens, you do not need to specify this code. When a lab processes more than one species, however, you must enter species codes. 11222683 Rev. A page 257 System Configuration Upon entering a change to any field of the Species code window, a message displays warning that modifying Code values can affect the reporting of new results. 1. On the menu bar, select Start > Configuration > Coding Systems. The Coding system browser window displays. 2. Select the appropriate instrument. 3. Right-select the selected instrument and select Related > Species. The Species codes in coding system browser window displays. 4. Select New on the toolbar to add a new species code. The Species code editor window displays. Coding system is populated automatically and refers to the coding system to which the test belongs. 5. After entering the relevant field values, select OK. Defining Sample Sources Note You can define sample sources and set up sample source codes in the CentraLink software. The CentraLink software, however, does not currently support connectivity to microbiology instruments. Configuring Patient Locations The Patient locations browser window lists the locations that can be associated with a patient. 1. From the menu bar, select Start > Configuration > Patient locations. The Patient locations browser displays. 2. To add a new Patient location, select New on the toolbar. The Patient location editor window displays. 3. Enter the appropriate information and select OK: page 258 Field Description Name Unique identification for the location. Description Description of the location. LIS Channel Path to the LIS Channel that will be used to locate the patient record. 11222683 Rev. A System Configuration Reporting You can generate Sample, QC Lot, and QC Population Reports from the Report window. To generate a report, right-select a Sample, QC Lot, or QC Population entry in the respective browser and select Report. The Report editor window displays tabs for General, Printer, File, and Fax settings. Note If you select PDF format at the General Tab, the Jasper Report template field becomes active; you can then select the appropriate Jasper template for your report. Sample Reports Sample reports display results for all requests associated with a sample. The Sample report is divided into a Sample header, patient information, and physician information. A table displays at the bottom of the report with Name/Test, Norm, Severity, Unit, Instrument, Validation Time, Validation User and Value. Any notes associated with the results display below the table. Omitted and shielded requests are not included in Sample reports. Note The default Jasper report template for Sample Reports contains additional information. QC Population Reports QC Populations reports display text, HTML or PDF reports on QC populations. You can generate a QC Population report containing Levey-Jennings graphs, and you can direct its output to screen or to a printer. You can run the report on a selection of more than one population at once. The header section of the report includes the From and To date range when these parameters are specified on the Report window. The N, Mean, SD and CV% statistics are displayed for Date range, Current, and Cumulative. When a date range is not specified on the Report window, the Date Range statistics fields are blank. Depending on the close out data, the Current and Cumulative statistics fields could be blank. In the graph section, the background colors are displayed as follows if target values are defined for the specified population: 11222683 Rev. A page 259 System Configuration • The backgrounds between the -2 to +2 deviation columns display in green. • The backgrounds between the -2 to -3 deviation column and between the 2 to 3 deviation column displays in yellow. • The backgrounds of the -3 deviation column and of 3 deviation column displays in red. A grey dot is displayed in the Levey-Jennings graph when a result is omitted. A dot with a circle around it indicates that the QC result has comments associated with it. A non-numeric QC result displays in the Levey-Jennings graph as a vertical line. The line color indicates the following: • Red: The QC result has non-zero QC choice severity, type error or invalid reference. • Green: The QC result has choice severity of zero and does not have type error or invalid reference. • Gray: The QC result is omitted. In the bottom, tabular section, the comment column contains result comments and action comments like Omit and Reinstate. When applicable, the comments are expanded. QC Lot Reports QC Lot Reports display text, HTML or PDF reports on QC populations by lot. The report includes Target value, Target deviation, and From and To date range when the From and To date range parameters. When the From and To date range parameters are specified on the Reports window, the current, cumulative, and date range statistics are displayed in the report heading. When the From and To date range parameters are not specified on the Reports window, no date range is displayed in the heading and the current and cumulative statistics are displayed at the bottom of the report. QC Result Reports You can generate a QC Result report using the generic print function. This generic print function generates simple multiple-record text reports with dynamic content that is applicable to the selected records. To generate a QC Result report, on the menu bar, select Record > Print. The Report window displays. page 260 11222683 Rev. A System Configuration You can configure the structure of the report by defining the fields in this window. Contact your local technical support representative if you have questions about configuring this content. The Report Window The General Settings tab of the Report window displays these values: Field Description Format Report format can be HTML, text, PDF or XML format. The XML format can be used as a data source for modifying default Jasper report templates. Text is plain ASCIII characters. The text format requires a line width of up to 132 characters. Ensure that your Windows fonts or page orientation are set to avoid text wrapping. Graphs are available in HTML and PDF format only. The graphs might not display properly when scrolling during preview. Note This field is disabled and Text displays when the Output type is set to Fax. Output type Print, Fax, or File. If you select Fax you must also define a Fax header, Fax number and Fax command. Jasper report template When you select PDF for Format, this allows you to manually select from one of the available Jasper templates. Preview 11222683 Rev. A If selected, a screen preview of the generated report is displayed. When the specified format is HTML, a web browser is used for previewing the generated HTML report. Note To preview Jasper reports, a PDF viewer must be installed on your system. page 261 System Configuration Field Description Mark Sample as reported If selected, the sample record is marked as having been reported. If you check the Not reported checkbox on the Advanced tab of the Sample Query window, any record marked as reported is not returned for a query initiated from this window. Select this option for Sample Reports. Note Exercise caution in using this option. The sample is marked as Reported even when you select Cancel on the subsequent Preview window. QC Lot and QC Populations reports only From and To Delimit the from and to dates and time. Only QC results assessed within the specified time frame are used in the report. Enter a range of dates and times or select the dates from the Calendar window. Entering a date range determines whether current, cumulative, and report statistics are displayed in the report heading. Sort by Select Instrument or Test. The Sort by field determines the sequencing of the QC populations displayed in the report. QC Lot reports only Instrument The instrument from which you want to include QC populations in the report. When a value is entered into the Instrument field, the Instrument group field is disabled. Instrument Group The instrument group from which you want to include QC populations in the report. Note You can configure automatic reporting by defining a reporting command, which can be scheduled to run automatically. For details on setting up automatic reporting, contact your local technical support provider. page 262 11222683 Rev. A System Configuration Printer Settings Tab Settings for reports created only when the Output is set to Print. Printer The printer reference applies only when the specified format is Print. References the printer to which the text output is directed. When the specified format is HTML, the Windows environment determines the printer. Copy count Number of copies to be printed. Title Field currently not used by CentraLink. Override Print settings This setting is only applicable to PDF reports. and allows you to override the default print settings: Printer sides, Job sheets, Media tray, Print quality, Sheet collate, Chromaticity. File Settings Tab Settings which apply only when Output type is set to File in the General tab. 11222683 Rev. A Filename The name you assign to the file. You can use dynamic text in this field. Expanded Filename The expanded file name including parameters and full path of the file location. PDF User password Only used when File type is set to PDF. PDF owner password PDF Author PDF Creator PDF keywords PDF subject PDF title You can also choose PDF permission and conformance settings in this area. page 263 System Configuration FAX Tab Setting used only when Output type is set to FAX. Fax number By default when one sample is selected, the fax number specified in the Fax number field at the Physicians window automatically populates this field. You can also enter a different fax number, which overrides the fax number specified in the Fax Number field at the Physicians window. When more than one sample is selected, the ? symbol populates the Fax number field. If you do not enter a fax number value, the fax is sent to the fax number specified in the Fax number field at the Physicians window for the sample. For more information, see Accessing Physician Records on page 136. Note Do not specify special characters, for example, + or -, among the numerical values specified in the fax number field. Spaces are permitted between numbers; for example, 0032 9 220 48 10. Configuring Reports with Report Model Report models allow you to configure header, body, and footer information. If a report model is not defined, a default report style is used. 1. Select Start > Configuration > Report models. The Report model browser window displays. 2. To add a new Report model, select New on the toolbar. The Report model editor window displays the following fields: page 264 Field Description Name Unique identifier for the report model. Comment Full name or explanation of the report model. Fax Header When Via fax on the Report window is selected, this text is added as the fax header. Header Unique identifier or name for the report header/ title. Column Heading List List of column headings separated by commas. 11222683 Rev. A System Configuration Field Description Column type list List of column types separated by commas. The order of the column types corresponds to the order of the headings in the Column heading list field. The following column types are available: • Description: description of test • Name: test name (mnemonic) • Norm: Applicable normal range • Severity: associated severity • Unit: units or measure for the displayed results • Validation User: login name of validating user • Value: result value • Validation Date/Time: date and time of result validation. • Instrument: instrument on which the validation was performed. Footer Unique identification or name for the report footer. Jasper template Path name where the template used for this report is located. Define a report model through the report model editor window by completing the following steps: 1. Enter or modify the Name and Comment. 2. Double-select Header. The Texts based on table browser window displays. You can select from the available header designations. If you need a customized header, contact your local service provider for assistance. Right-select the selected header and select Preview to display the header. 3. Double-select Column heading list. The Multi-lingual text editor window displays. The default language is English but you can select another language from the Language dropdown menu. a. Select New to create a new column heading list or Edit to modify an existing one. 11222683 Rev. A page 265 System Configuration b. Enter or modify the comma-separated list of column headings in the bottom Editor field. The list of headings must be in the same order as the list of column types. c. Select a language. d. Select Save to record the list in the Report model editor. 4. In the Column type list field, specify each column type in a commaseparated list using only the specified types. Note The order of the column types must correspond to the order of the column headings. 5. Double-select Footer. The Texts based on table browser window displays. You can select from the available footer designations. If you need a customized footer, contact your local service provider or distributor for assistance. 6. Select OK. Note For information on assigning a report model to a physician, see Accessing Physician Records on page 136. Setting a Default Report Model on the Options window The CentraLink system generates reports according to a default report model in the list of available models. Every sample or test in the report follows the default report model unless a different model is associated with the requesting physician. To change the default report model: 1. On the menu bar, select Start > System management > Options. The Options editor window displays. 2. Select the More tab. The name of the current default report model displays in Report model. 3. Double-select Report model. The Report models window displays a list of the available models. 4. Select the appropriate report and select OK. Report model is populated with the selected report model name. Reports generated after this change use this report model. page 266 11222683 Rev. A System Configuration 5. For PDF reports you can define default QC Lot and QC Population templates by selecting the Report Builder tab in this window. Determining Which Template is Used The CentraLink system uses the following logic in determining which template to use for a given sample report: • If a sample references a physician and the physician references a report model, then the report model referenced by the physician is used. • If the physician does not reference a report model, the model specified in the Report model field on the More tab of the system Options is used. • If the Report model field of the system Options window does not specify a report model, a default report model is used. Generating Enhanced (Jasper) Reports If you set the Format to PDF for any Sample, QC Population and QC Lot Report: • The data is exported from the application in an XML format. • The XML data is interpreted by a Jasper template file (.jasper file) which defines the report layout. • The Jasper template is used to generate PDF reports. CAUTION The default Jasper report templates can be customized. All such customization by you, or at your request, and any resulting liabilities, are entirely your responsibility. Use caution in modifying these templates prior to incorporating them in your routine environment. XML data can be used in modifying default Jasper report templates. Select XML as the Format and File as the Output Type in the Report window to generate an XML file which can be used as a representative data source for template customization. There are separate folders for QCLotReport, QCPopulationReport, and SampleReport. The default templates are located in: D:\CentraLink\templates\examples 11222683 Rev. A page 267 System Configuration Adding a Logo or Address to the Jasper Report The default Jasper templates for Sample Report, QC Lot Report, and QC Population reports point to a blank jpg image file. You can modify this to add a customer logo or address. Copying the Logo 1. Using Windows Explorer, navigate to D:\CentraLink\templates\examples\SampleReport\images 2. Right-select the Logo_Text.jpg file and select Copy. 3. Right-select in the folder and select Paste. A backup copy of the original file is created. 4. Right-select Logo_Text.jpg and select Edit. The default blank image opens in Microsoft Paint. Adding a Customer Address 1. In the Tools area of the task bar select the Text Tool using the icon labeled A. 2. Select in the upper left-hand corner of the small white rectangle and drag the cursor so that the dotted lines cover the rectangle. This will maintain the default size for the image. 3. Select the Text tab. 4. Select the font type and size, and then enter the text for the customer name and address. 5. Select the down-arrow icon in the upper left corner and then select Save or press Ctrl + S. 6. Close Paint. 7. Using Windows Explorer, navigate to D:\CentraLink\templates\examples\SampleReport\images and copy the modified Logo_Text.jpg file. 8. Paste a copy into the D:\CentraLink\templates\examples\QCLotReport\images and the D:\CentraLink\templates\examples\QCPopulationReport\images folders. 9. At the Copy File window, select Copy and Replace. page 268 11222683 Rev. A System Configuration Adding a Customer logo to the Reports 1. Open the customer logo using Microsoft Paint. Crop a section of the logo that is less than or equal to 789 x 168 pixels in size. Copy the cropped image and save as a jpeg file named Logo_Text.jpg. 2. Save copies of the modified Logo_Text.jpg file in the images folders for SampleReport, QCLotReport, and QCPopulationReport. 3. At the Copy File window, select Copy and Replace. Configuring Colors on Browsers and Windows Use the Color Scheme window to define the foreground and background colors of the samples and requests based on status and priority. Following is an example of how to set colors; in this case, setting STAT samples with a status greater than review to red text with a white background: 1. From the menu bar, select Start > System Management > Customize > Colors. The Color Scheme window displays. 2. From the Select a table drop-down list, select Sample. 3. Select Insert to add a new line. 4. Double select the priority column and set to Stat. 5. Double select the Status column and set to REV. Note These are the minimum values and will affect any status higher than REV which are Stat. 6. If setting status for color, you are setting minimum value status (severity, priority) 7. Double select the Example column and set the foreground color to Red and the background color to White. 8. In the Test Area, set Priority to Stat. Samples of status REV, VAL UPL and OMT will display as red text on a white background. Defining Print Commands When you select Print from the Record menu, the CentraLink software automatically prints a copy of the open browser to the default printer. When you select Print... from the Record menu, the Output options window displays. From the Output options window, you can choose among several print options before printing. 11222683 Rev. A page 269 System Configuration To access the Output options window from the toolbar, select Record > Print.... The Output options editor window displays these fields: Field Description Selection only If this setting is selected, only the selected records are printed. Device type This setting determines the device to which the job will be printed. The options include: File, Terminal, Printer, Clipboard, Excel, or Word. The default setting for printing is Printer. Format This setting determines the format of the print out: Text or HTML. Printer This setting identifies the printer to which output is directed. Set as default If selected, this setting allows you to save the value in the Printer field as the default user printer. Directory This setting determines the target location for generated files. File This setting determines the name of the generated target file. Copies This setting determines the number of copies to be printed. Report Printing Options When printing a report, you can define the following fields: page 270 • Title page references a Text scoped to the current table, yielding the contents of the report's title page. • First page header references a Text scoped to the current table, yielding the contents of the report's first page header. • Header references a Text scoped to the current table, yielding the contents of the report's header. • Body references a Text scoped to the current table, yielding the contents of the report's body • Footer references a Text scoped to the current table, yielding the contents of the report's footer. 11222683 Rev. A System Configuration 11222683 Rev. A • Language type is either User or Site, and determines whether the language of the user or that of the site will be used to translate multilingual content. • Page height is the number of lines per page. • Number of copies determines how many copies of the report will be printed. • Printer is a reference to the destination Printer. • If Set as default is checked, the currently configured parameters will be stored as default for reporting from the current context. • If Don't generate document when no records available is checked, all output (including header and footer) will be suppressed if no records are available. • If Preview is checked, you will be able to preview the report before actually printing it. • If Output to file is checked, a dialog appears allowing specification of a target file. • If One page per record is checked, page breaks will be inserted between successive records. page 271 System Configuration page 272 11222683 Rev. A 5 System Management Setting Up Users and Security You can add users to the CentraLink system and assign different privileges to them. Adding New Users To set up new users with a login name, password, and other settings: 1. Log on as a System Manager. 2. On the menu bar, select Start > System management > Security > Users. 3. Select OK on the User Query window. The Active users window displays. 4. On the toolbar, select the New icon or at the keyboard, select Insert. The User editor window displays Session, User, User Interface, Contact, and Privileges areas. Field Description Initials User’s initials. Last name User’s last name. First name User’s first name. Login name Unique identifier for the user. When a user first logs in to the CentraLink system, the password is the same as this login name. Roles See Assigning Roles on page 279. Session/Enabled Allows current users of the below Session Type access to CentraLink functionality. Session Type Interactive is meant for humans who work with CentraLink through a graphical user interface. Batch is meant for Service processes such as Translator servers and Task schedulers. After selecting a session type, enable either session via the checkbox. Language 11222683 Rev. A User’s preferred language. This setting overrides the site default specified in application-level settings. page 273 System Management Field Description Enabled Determines whether or not a user is allowed to log in. You cannot delete user records. Mandatory field entry. Autologin allowed Allows a user to log on without a password. Minimum password length Minimum number of characters in the logon password. See Setting a User Password. Maximum password age The maximum age of a password, measured in days. This setting overrides the site default specified in application-level settings. It is not applicable to system managers or developers. Mandatory field entry. You can change a password on the date is it due to expire. Start tool A tool that is activated automatically every time you log in. Authorization timeout Maximum time in seconds that a user can refrain from interacting with the application. This setting overrides the site default specified in application-level settings. Mandatory field entry. Context timeout Maximum time in seconds that a user can leave the password dialog unattended. This setting overrides the site default specified in applicationlevel settings. Printer Default printer for the user. E-mail address User’s email address. Mail method User’s preferred mail receipt method. Valid settings are Internal (through CentraLink system built-in mail), External (through Internet), or both. Phone User’s preferred phone number. Setting a User Password If you assign a password to a user, the user must type it in the password field on the Logon window. page 274 11222683 Rev. A System Management At the Security tab of the Options window, you can set the Password strength field to Medium or High using the Password Strength field under the Security tab of the Options window (Start > System Management > Options). If the password strength is set to High, the minimum length is 9 characters (regardless of the Minimum Password Length setting in the User window), and must contain 3 of these 4 characters: upper-case letter (A-Z), lower-case letter (a-z), number (0-9), or special character ($, %, for example). Define a user password on the User browser window: 1. Right-select and select Change Password. 2. Enter the new password. Note You cannot reuse a password until it has been changed 6 times. 3. Enter the password again in the verification field. 4. Select OK. Note Change the password in the User browser window, not the editor window. If a message displays that the record has been changed by someone else, it can be safely ignored. Assigning Printers to a User On the Active user’s browser window, the Printers right-select option allows you to assign printers to a given user. Note Users of type System Manager cannot assign their own printers; however, users of type System Manager can assign printers to other System Managers. Assign a preferred list of printers to a user: 1. On the menu bar, select Start > System management > Security > Users. The Active users window displays. 2. Highlight the user to whom you want to assign printers. 3. On the highlighted user entry, right-select the user and select Related > Printers. The Printer assignment browser window displays. 4. On the toolbar, select the New icon or at the keyboard, select Insert. The Printer assignment editor window displays. 11222683 Rev. A page 275 System Management 5. In the Printer field of the Printer assignment editor window, doubleselect the ? symbol. The Printers browser window displays and lists all of the printers defined to the system. 6. On the Printers browser window, select the printers that will be assigned to the given user. 7. After the appropriate printers are selected, select OK. The Printer assignments window displays and lists each of the printers that is assigned to the given user. 8. On the Printer assignments window, select Close. The Active users window displays. The printers are assigned to the user. When the user accesses the Printers browser window, the Show my printers only checkbox must be selected in order to view the preferred printer list assigned to the user. For more information about working with printers, see Printing on page 314. Assigning Privileges You can create privileges and associate them with operators or roles. You can privilege-protect tables, fields, and functions. Note It is recommended to assign privileges to roles, and only assign user privileges for case exceptions. To assign privileges: 1. Add new operators as type User. 2. Add a new privilege. 3. Define the privilege by adding functions and data to it. This is known as protecting the functions and data. If functions and data are assigned to a privilege, no operator of type User has access to them unless assigned to the privilege. 4. Assign an operator to the privilege, giving the operator access to the functions and data. Note Users of type Guest or Developer are not associated with privileges. Guests are never granted any privileges. Developers never require any privileges. Only for the generic type User and System Manager are privileges taken into account. Each function has a minimal user type assigned to it. This is the minimal authority or experience level a user has to activate that function. page 276 11222683 Rev. A System Management Consider the following table that depicts the relationship among functions, privileges, and users. Functions Privileges Users Order Entry Advanced Marit Sample Validation Manager Steven Result Entry Senior Lieven Physician Functions are assigned to privileges and then users are assigned to privileges. In the above scenario, only a user assigned to “Senior” can validate a sample or edit results. You can assign one function or one user to two different privileges. Adding a Privilege 1. Log on as the System Manager. 2. On the menu bar, select Start > System Management > Security > Privileges. 3. Select New on the toolbar. 4. Enter a Name that is the unique identification of the privilege. 5. Select OK. Privileges are associated with users to grant them special access rights. Privileges are associated with tables, fields and functions to protect them from unauthorized access. Privileges and their associations with data, functions and users are all kept in the database. If no privileges are defined in the database, then no sitespecific data or function protection is in effect. System managers create privileges and associate them with data, functions and users as required. CentraLink software uses the privilege setting only for users of the type user and system manager. CentraLink software treats guests as users without any privilege, and developers as users with full privileges. Note When you add or remove associations between privileges and users or functions, you may have to close the current user session before the new properties take effect. System managers can access the table of privileges by selecting Start > System Management > Security > Privileges. 11222683 Rev. A page 277 System Management The Factory Default Advanced Privilege CentraLink software is shipped with a factory default setting. This factory default can be (re-)established by initializing the database. It consists of a single privilege, Advanced, which is associated with all but the most commonly-used functions. System managers and developers will not see any difference. Users will see significantly simpler menus until they are granted the Advanced privilege. To see which functions are protected by this privilege, use the privilege browser to locate it and select Related > Functions from its popup menu. Note It is recommended to assign a privilege to prevent MISPL functions from being incorrectly modified or deleted. Contact your local technical support provider for more information. Adding Functions to a Privilege You can associate a privilege with data or functions to protect them from unauthorized user access. You can subsequently assign privileges to users to grant them access to the data and functions that the privilege protects. Note Whenever you add a function to a privilege, it is protected from all users; that is, the function is not available to users of type “User” until you assign a user to the privilege. 1. Log on as the System Manager. 2. On the menu bar, select Start > System Management > Security > Privileges. The Privileges browser window displays. 3. Right-select a privilege and select Related > Functions Protected. A list of the currently protected functions displays. 4. To add a function, select insert and it will display in the function privilege table. Within that table, select the appropriate table and function mnemonic. 5. Select OK. Adding Users to a Privilege After you have assigned functions to a privilege, you can assign users to allow them access to those functions. 1. Log on as the System Manager. page 278 11222683 Rev. A System Management 2. On the menu bar, select Start > System Management > Security > Privileges. The Privileges window displays. 3. Select the appropriate privilege. 4. Right-select the selected privilege and select Privileged Users. A list of users currently assigned to the privilege displays. 5. Select New on the toolbar. The User’s Privilege window displays. 6. Double-select User to select from the Users window. 7. Select OK. The next time the user logs on, the privilege is in effect. Assigning Roles Defining Roles Note This option is available for system administrators only. Select Start > System management > Security > Roles. 4 default roles are available and are defined in the UserType field: • Guest • User • System manager • Developer Each user type is linked to specific privileges. Check this field to see if a certain user in his current role can execute a function or not. Note When you log in to the CentraLink application for the first time, and you have more than two possible roles, you must select the role you will assume for the current session. You cannot change roles during a session. The Log maintenance sessions field is enabled for System Managers or Developers, and disabled for Guests and users. It can be enabled for Guest or user, but users logging into the application with this role must input a reason as to why they are logging in. Log types of Maintenance sessions are then created with a description field containing the reason entered at login time. • At least one System manager user must be defined. • A role can not be deleted as long as users are linked to it. 11222683 Rev. A page 279 System Management In the Role Privilege editor window, right select on a user or role context to access the user role assignment table. Assigning Roles Once all roles have been defined, assign the available users to the defined roles. You can assign roles from the User browser or the Role browser, which display all users assigned to a specific role. For example, create a role called NightShift and assign specific privileges to that role. Then, assign users to that role. If more than one role is assigned to you, select the role for a particular session at the Login screen. There must be at least one role assigned of type System administrator. If these users have no assigned roles CentraLink will create a role of type System administrator with no additional privileges and assign it to them. The applicable privileges for a user are the combination of their user privileges and the role privileges of the role chosen at log-in time. Default Functions for All Users By default, users have access to the following basic functions: page 280 • Instrument Tests • Method QCPopulations • Norm AgeUnit, Comment, Eligible, Method, Species, Test • PanelMember Requestable • PanelRequestable Members • Patient Species • Physician ReportModel • QCLot DeepCopy, QCPopulations, Report • QCPopulation LeveyJenningsGraph, Lot, Method, Recalculate, Report, Results, SetReference • QCResult Population • Request CheckResult, EditComment, Invalidate, Patient, Rerun, Results, Revert, Sample, UploadUser, Validate • Requestable PanelMembership • Result AvailabilityUser, AddComment, Method, Request, ViewImage, ScheduleUser 11222683 Rev. A System Management • Sample CheckResults, DiffPad, Patient, PatientLocation, Physician, Report, Requests, Rerun, ReviewAndEdit, Type, UploadResults, ViewImage • Services CheckActivity • Site Calculator, Calendar, InstrumentsByName, OrderEntry, PatientsByLastNameFirstName, QCPopulationQuery, RequestablesByName, ResultEntry, SampleQuery, SamplesByIdentifier, SampleTypesByName, ServicesByName, SpeciesByName, TestsByName, ReviewAndEdit • Species Patients • Test Instruments, Norms, SampleType, ResultChoices, DeltaNorms, Requestables • LIS Channel • LAS Channel • LAS test group System Manager Privileges Although system administrators are not subject to the usual privileges, the CentraLink software can assign special privileges to system managers as well. Contact your local service provider for more details on assigning privileges to system manager logins. Shielding Users from Instruments System Administrator level users with necessary privileges can shield specific instruments from certain users to prevent users from accessing an instrument and viewing any requests or results processed on that instrument. Privileged system managers can administer and change the rights of users at the Main Menu: 1. Select Start > System Management > Security > Users. 2. Right-select and select Related > Shielded Instruments. The Instruments Shielded from User browser displays. 11222683 Rev. A page 281 System Management Note If an instrument of type Concentrator is shielded from a user, all underlying instruments are also shielded. If you want certain instruments below the Concentrator instrument to be shielded and others to be accessible, you cannot shield the Concentrator instrument. The following warning displays when you shield a user: Sample or QC reports printed by <user> may not contain all results of the sample. Results originated from the instrument <instrument name> will not be shown on the printed report. 3. Select Yes to continue and shield the instrument. Using the Default Advanced Privilege The Advanced privilege is shipped with the CentraLink system but must be granted to users before they have access to advanced functions. To display the list of functions associated with the Advanced privilege: 1. Log on as the System Manager. 2. On the menu bar, select Start > System Management > Security > Privileges. The Privileges window displays. 3. Select the Advanced privilege. 4. Right-select to access the list of protected fields, functions, and tables. Protecting Table and Field Data You can associate privileges with individual database tables and fields to protect them from unauthorized viewing, modification, or both. To control access to a table by specifying table and the type of access to restrict: 1. Create or select a privilege to associate with access to the table. 2. Right-select and select Tables protected. 3. Enter the Table. 4. Enter the Type of access to restrict. Note The Privilege field is automatically populated with name of the privilege you are modifying. 5. Select OK. page 282 11222683 Rev. A System Management To control access to a field by specifying the field name, field table, and type of access that you want to restrict: 1. Create or select a privilege to associate with access to the field. 2. Right-select and select Fields protected. 3. Enter the Field name. 4. Enter the Field table. 5. Enter the Type of access to restrict. Note The Privilege field is automatically populated with name of the privilege that you are modifying. 6. Select OK. Auditing Database Tables Auditing provides a means of tracking the history of user actions. When auditing on a table is enabled, each of the modify or delete actions on the table is saved to an audit log file. Note User modify/delete actions are audited; batch actions (actions automatically performed by the CentraLink system, for example, Auto validation and MISPL rules) are not audited. You can specify which tables to audit from a predefined list. The following actions can be tracked: 11222683 Rev. A • Sample deletion • Sample omission • QC result omission • QC result reinstatement • QC severity resetting • QC population modification • QC Lot Modification • Request omission • Request deletion • Result Editing • User account modification • Modifications to the Norms • Modifications to Flags • Modifications to the Delta Norms • Modifications to LAS Channel page 283 System Management • Modifications to LIS Channel • Modification to MISPLs • Modifications to Calculations • Modifications to Texts Table • Modifications to the Coding Systems • Modification to Commands • Modifications to Tasks • Modification to Units and Dimensions • Modification to Aspects • Modification to Container type • Modification to Instrument records • Modification to Instrument Groups • Modification to Test Groups • Modification to Requestables • Modification to Patients • Modification to Patient Location • Modification to Physicians • Modification to Sample Types • Modification to Species • Modification to Specific-Self (Options) • Test and Method table modification • Audit Trail purge Audit Logs Audit logs contain the following information: • Changed fields with From and To values • Date and time the change was made • User who initiated the change • Action performed by the user who initiated the change You must configure the purge of audit information on a regular basis. You can configure an export of this information prior to purge. Contact your local technical representative to configure this functionality. Automated tasks, executed by the user “Batch,” are excluded from auditing. Note User actions are audited; batch actions are not audited. page 284 11222683 Rev. A System Management Viewing Audit Logs You can view a list of the logging activity that pertains to a specified user, table, or both through the Log Entries window. To access the Log entries window: 1. On the menu bar, select Start > System Management > Logging> Audit Overview. The Audit overview query window displays the following fields: Field Description From Parameter that limits the display of audit log entries to those that have a date stamp value equal to or greater than this From date value. This is a required field. Note The number of days between the From date and the To date values cannot exceed 60 days. 11222683 Rev. A To Parameter that limits the display of audit log entries to those that have a date stamp value less than or equal to this To date value. Note The number of days between the From date and the To date values cannot exceed 60 days. User Parameter that limits the display of audit log entries to those initiated by this user. Note Either a User or Table name value must be entered. Table Parameter that limits the display of audit log entries to those applicable to this table. Note Either a User or Table name value must be entered. page 285 System Management 2. After entering the parameters, select OK. The Log entries window displays The audit information that displays is restricted to meet the audit query parameters entered to the Audit overview query window. The parameters for this restricted audit set apply until the current Log entries window session ends. Field Description Creation Time Displays the creation date of a log entry. S Displays the severity of the entry. Login Displays the name of the user. Table Name Displays the name of the table for which the audit log is generated. Name Displays the log type of the audit log. Description Displays the transaction details of the record within the audited table. User name Displays the full name of the user. Log Type Area Name Displays the name of the log type. Enable If selected, indicates whether this type of log is currently enabled. Log Process Area Name The name of the program that initiates the logging process. Final If selected, this checkbox Indicates whether the logging process is closed for the log file and thereby finalized. Creation time Displays the creation time of the log file. Expire date Displays the expiration date of the log file. Disposition Area Limit to selected record page 286 If selected, restricts the displayed list of audit log entries to the transaction records within the current view that pertain to the currently selected record. Note The display of audit log entries is refreshed from the transaction records that display in the current view, not from all applicable transaction records stored in the database. 11222683 Rev. A System Management Field Description Group by record This option is not supported in CentraLink and should not be used. Show subject record If selected, transfers control to the applicable editor window in which the transaction was entered and saved and displays the details of the transaction record within this editor window. Note If the first record of the transaction record grouping is a deleted record and you select Show subject record, the corresponding editor window does not display because the deleted record does not exist. Export to browser If selected, exports the displayed audit log data to an XML-based file that can be printed. Options If selected, displays the Audit overview query window, which allows for you to update the parameters of the query. Upon re-display of the Log entries window, the audit log data is refreshed to reflect records that meet the entered audit criteria. For information about entering auditing criteria, see, Entering Auditing Criteria that Restricts the Log Entries Display on page 287. Close If selected, the Log entries window closes. Entering Auditing Criteria that Restricts the Log Entries Display Through the Audit overview query window, you can restrict the audit information that displays within the Log entries window to that which meets specified audit criteria. Access the Audit overview query window: 1. On the Log entries window, select Options. The Audit overview query window displays. For details on the parameters of the Audit overview query window, see Viewing Audit Logs on page 285. 11222683 Rev. A page 287 System Management 2. After entering the parameters, select OK. The refreshed (Audit Overview) Log entries window displays. The audit information that displays is restricted to meet the audit query parameters entered to the Audit overview query window. The parameters for this restricted audit set apply until the current (Audit Overview) Log entries window session ends. Checking Log Files and Starting and Stopping the Server The CentraLink system maintains log files that track database activity. You can monitor the log files and then stop and re-start the CentraLink software and its databases. In the Log Folder field of the General tab of the system Options window, a root folder directory for all log files is specified. This root folder contains sub-folders for service logs, which are named svc, and translator logs, which are named trl, respectively. These sub-folders are again subdivided in sub-folders dedicated to individual services and translators. You must specify the ? symbol in the Log Folder field of the General tab of the system Options window; the log file folder then defaults to D: \<CentraLink>\log. WARNING Do not change this value under any circumstance. The CentraLink system server is the computer containing the CentraLink databases: • Genro: Generic, Read-only data (for example, scheme info) • CentraLink: Specific, Read-write data (for example, tests, samples, etc.) These databases are installed as part of the CentraLink application and are in Progress database format. Some Progress commands, including the Open Edge Explorer Tool, display in your Start menu. The Open Edge Explorer Tool allows you to manually start or stop the two databases that the CentraLink system uses. During the CentraLink system installation, the databases are set up to automatically start and stop upon system startup and shutdown. However, you may need to manually start or stop the database. For example, you may need to stop the database to upgrade the CentraLink system, and restart it after the upgrade is complete. page 288 11222683 Rev. A System Management In addition to starting and stopping the database servers, other services, such as those used for instrument communication, must be started and stopped. Note Some instruments connected to CentraLink can upload images. These images are stored within the CentraLink database. If changes are made to a translator, for example, you must stop and start the translator for the changes to take effect CAUTION Be sure to stop all the CentraLink system services and the CentraLink databases before making any system changes, such as changing the system date and time. You can start and stop all CentraLink services from the Start menu: • Start > All Programs > CentraLink > Start Services • Start > All Programs > CentraLink > Stop Services Note Use these Start menu options only if you are instructed to do so by Siemens support personnel. Using the Log Viewer You can view one or more log files using the Dual Log Viewer or MultiLog Viewer. Note To open a log in the Log Viewer: • Right select on any translator or service and select View Log which opens the current log for that service or translator. • Right select on a translator and choose View Log of Translator and Service. This will open the current log of the translator and service using the Dual Log viewer. You can view the following types of logs: • Info • Warning • Error • Debug • Trace • Fatal Within the Log Viewer window, you can: • 11222683 Rev. A sort log entries in ascending or descending order by selecting the arrow icon at the top of the column. page 289 System Management • view both Translator and Service Logs in the same window (dual log viewer). • sync logs based by time. • view multiple log files. • jump to line functionality. • view log file updates. • select and paste lines into your system clipboard. Note If you attempt to close the Log Viewer while it is updating, the Log Viewer and CentraLink user interface may freeze. Do not close the log viewer until the progress bar has completed for all updates. If a freeze occurs, contact your local support provider for details on how to regain access from that computer. Using the Open Edge Explorer Tool The Open Edge Explorer Tool allows you to manually start and stop the databases. When you start the tool, you must be connected to the CentraLink system server running the databases. This is the server where AdminService for Progress 11.1 is running. This software is installed on the server during the installation or upgrade process. Manually Stopping the Database 1. On the menu bar, select Start > System management > Services > Shutdown. 2. Exit all interactive CentraLink sessions on the server and on the client workstations. Shut down the AppServer 1. In the menu bar select Start > All Programs > OpenEdge 11.1 > OpenEdge Explorer 2. An Internet Explorer window displays. 3. In the AppServer (5 Items) section select <centralink server name>.CentraLink15 4. Select Broker Control. 5. Select Stop AppServer. In the confirmation message window, select OK. 6. Click Resources in the blue bar at the top of the screen to return to the initial Explorer window. page 290 11222683 Rev. A System Management Shut down the Databases 1. In the Database (2 Items) section click on <centralink server name>.centralink 2. Select Control. 3. Select Stop Database. In the confirmation message window, select OK. 4. Click Resources in the blue bar at the top of the screen to return to the initial Explorer window. a. In the Database (2 Items) section click on <centralink server name>.centralinkgenro b. Select Control c. Select Stop Database. In the confirmation message window, select OK. 5. Close the OpenEdge Explorer window Manually Starting the Database You must start the CentraLink server from the computer on which the CentraLink server software is installed. Do not start the server from any other computer. Start the databases and the AppServer: 1. In the menu bar select Start > All Programs > OpenEdge 11.1 > OpenEdge Explorer 2. An Internet Explorer window displays. 3. In the Database (2 Items) section select <centralink server name>.centralinkgenro 4. Select Control 5. Select Start Database. 6. Select Resources in the blue bar at the top of the screen to return to the initial Explorer window. Start the second database 1. In the Database (2 Items) section select <centralink server name>.centralinkname>.centralinkgenro 2. Select Control 3. Select Start Database. 11222683 Rev. A page 291 System Management 4. Select Resources in the blue bar at the top of the screen to return to the initial Explorer window. Start the App Server 1. In the AppServer (5 Items) section select <centralink server name>.CentraLink15 2. Select Broker Control 3. Select Start AppServer. 4. Close the OpenEdge Explorer window 5. To start the services and translators on the CentraLink session server, on the menu bar, select Start > System management > Services > Startup. This procedure only starts services and translators with the AutoStart attribute selected. Verify that services and translators are selected correctly. You must start any unselected required services and translators individually. Understanding the Watchdog Service and Dashboard You can automatically monitor communication with the LIS, LAS, Task Schedulers and analysis instruments using the Watchdog service and the Watchdog Dashboard. Watchdog Service The Watchdog service is a background program that monitors connectivity and availability. The Watchdog service monitors the following items: • Connection status of translator services and their associated translators • Availability of the LIS FTP service • Status of task schedulers • Quality control issues • LAS error flags • Connection status of the Database server • Availability of space on disk drive used for image storage • Message Queues and queue processing All incoming information is gathered, interpreted, and dispatched to the Watchdog Dashboards. Information related to connectivity and availability is posted as messages in the Message log of the Dashboard and are broadcast as alerts via internal email to system managers. page 292 11222683 Rev. A System Management Watchdog Service Alerts The Watchdog service can be configured to alert every CentraLink system user of type System Manager. Alerts are sent as messages displayed to the Dashboard, as emails, or as both. The Watchdog service name displays in the Options window. To receive alerts as emails, you as system manager must specify the mail server, mail port, and your email address on the Mail tab of the system Options window. Note A system manager receives a Windows messenger alert if the system manager’s login name to the CentraLink software is the same as the system manager’s login name to Windows. The Watchdog service generates alerts: • When a service remains in status Undetermined for more than 50 seconds • When a translator remains in status Disconnected for more than 10 seconds Watchdog Dashboard The Watchdog Dashboard connects to the Watchdog service. Through its graphical interface, the Watchdog Dashboard displays the monitoring results of the Watchdog service. The Watchdog Dashboard displays the Status of Communication with the Task Schedulers, connected translator services and translators and displays log messages. You can filter the displayed Task Schedulers, translator services and translators by name or by instrument group. To send QC severity change messages to the Watchdog Dashboard, select the Send QC Warnings to Watchdog checkbox on the Watchdog tab of the system Options window. To access the Watchdog Dashboard, select the Dashboard icon on your desktop. The Dashboard window displays. Translator services are located on the left side of the Watchdog Dashboard window. The associated translators are located on the right. Filter Watchdog content from translators and services into logical groups using the Service Groups window. Dashboard Toolbar The Watchdog Dashboard window toolbar contains the following: 11222683 Rev. A page 293 System Management • About button - Displays the About dialog box, which displays product version and copyright information. • View button - Allows you to sort the following services and translators from a drop-down menu: • Show all items - Displays all the services and translators. • Hide inactive - Displays only the active services and translators. • Show specific set - Displays services and translators by instrument group. • Setup button - Accesses the Watchdog Dashboard Preferences window. Through the Watchdog Dashboard Preferences window, you can configure the Watchdog Dashboard to connect at Watchdog startup to a specific host and port, which is the default and is recommended, or to search for and display all available Watchdog services on the network upon Watchdog Dashboard startup. • Filter field - As per translator name values entered to this field, you can filter the display of translator service and translator information by translator name. Dashboard Tabs The Watchdog Dashboard window contains the Communication Monitor, Message Log, and Task Scheduler Monitor tabs. Communication Monitor Tab Translator servers and their associated translators display on the Communication Monitor tab of the Watchdog Dashboard. You can filter the display of this translator information by name or by instrument group. On a given row of the Watchdog Dashboard, the left-most rectangle represents the translator service and the rectangles that follow in the same row represent the associated translators. Message Handling and Alert Display Warnings, errors, and alerts display as follows: page 294 • Light bulb icons - Upon receipt of an QC message alert, a light bulb icon displays in the translator service or translator rectangle. When you select the light bulb icon, the message displays in the Information text area at the bottom of the Watchdog Dashboard window. • I icon - Displays when your mouse hovers over the a service or translator on the Communications tab. When you select the corresponding rectangle on which the I icon displays, data in the Information panel is refreshed with information that pertains to the corresponding service or translator. 11222683 Rev. A System Management • Messenger service alert window - Displays upon disconnect of a service, translator, or ftp server and when limited space on the hard drive is detected. Starting and Stopping Translator Services and Translators You can start or shut down the CentraLink application and related services from the operating system Start menu. NOTE: Use these Start menu options only if you are instructed by Siemens support personnel. • To start CentraLink services, translators, the application server and databases: Start > All Programs > CentraLink > Start Application system The CentraLink system automatically starts the databases and application server after a server restart, so this function should only be used if you are instructed by support personnel. • To shut down CentraLink services, translators, the application server and databases: Start > All Programs > CentraLink > Stop Application system With this menu option, you do not need to use the OpenEdge Explorer tool for manual database shutdown. Only use this option if you are instructed by Siemens support personnel, or prior to a shutdown or restart of the server. • To start or shut down CentraLink services, translators and the application server: Start > All Programs > CentraLink > Start Services Start > All Programs > CentraLink > Stop Services If you logged into Windows with a user account that has the privileges to start and stop services, you can start and stop services and translators from the Watchdog Dashboard. On the Watchdog Dashboard, you can start and stop the translator services and translators from the following two areas: 11222683 Rev. A • Translator service and translator rectangle - By right-selecting an individual rectangle and selecting Start or Stop, you can start or stop the corresponding translator service or translator. • Information panel - By selecting a translator service or translator, you can isolate and display the data of individual translator services and translators at the information panel at the bottom of the window. On the information panel, you can start and stop translator services and translators by selecting Start or Stop in the Actions area. page 295 System Management For more information about starting and stopping translator services and translators, see Start and Stop Translator Services and Translators on page 304. Status of Communication The status of communication with the connected servers and translators displays through color codes. Color Service Status / Meaning Translator Status / Meaning Green Active Sent activity confirmation less than 1 minute ago. Active Started and connected to external application. Light Gray Inactive Defined in database, but not started. Inactive Defined in database, but not started. Dark Gray Unknown Status. This should only be a temporary status. Unknown Status. This should only be a temporary status. Gray (right) Green (left) Idle. Indicates intentional disconnection. Red (right) Green (left) Disconnected. Disconnected Started but not connected to external application. Disconnected status is sent if there is failure to (re-)establish the connection (see Idle). Note Translators that use FTP as the low-layer protocol, for example, the LMX LIS translator, do not have a status of Connected or Disconnected. The status of these translators is either Active or Inactive. QC Severity Messages Through the Send QC Warnings to Watchdog checkbox on the Watchdog tab of the system Options window, you can configure sending QC severity change messages to the Watchdog Dashboard. page 296 11222683 Rev. A System Management These QC severity message displays are compatible with both Normal and Concentrator instrument types. For QC messages from a concentrator translator, the value of the sender is the name of the concentrator translator; the warning displays as a light bulb icon on the concentrator translator rectangle. Upon selecting the light bulb icon on the concentrator translator rectangle, the QC message text displays in the Information area of the Watchdog Dashboard and contains a reference to the normal instrument. If the CentraLink QC severity is 0, then the QC message displays as severity information in the Information panel, and also as log messages in the Message Log tab. If the CentraLink QC severity is greater than 0, then the QC message displays as a severity warning in the Information panel, and also as log messages in the Message Log tab. Monitoring Tasks from the Watchdog Dashboard You can monitor tasks and have messages sent to the Dashboard using the Task Scheduler Monitor tab. A grid-displays all current Task Schedulers, as well as the last update message. The information panel at the bottom of the window displays Task Scheduler information and recent messages: • Task Schedulers send messages to Watchdog regarding status and task progress (beginning and completion of task, as well as unrecoverable errors that cause the task to be halted prematurely) • Info, Warning, Alert and Error Watchdog messages • Messages can be displayed as popup alerts, with an appropriate background color to visually distinguish the severity • Info and Warning messages automatically close after 6 seconds. This is the default setting but can be changed. • Alert and Error messages remain open until you close the popup window. This is the default action but can be changed. Turning off Task Scheduler messages You can enable or disable the sending of a Task Scheduler message via the Send Task Scheduler Messages checkbox on the Start window. By default task schedulers send task progress information messages to the Watchdog Daemon. If you turn this option off, task schedulers will only send Active/Inactive status updates to the Watchdog Daemon. 11222683 Rev. A page 297 System Management This option setting is automatically applied the next time the Watchdog Start function is executed. Message Log Tab Log messages and QC messages display in a table format on the Message Log tab of the Dashboard. You can select the header of each column of the log table to sort the log message display. The Log tab lists the most recent posts to the message log. A scroll bar displays as required. By selecting a given log message row, you can isolate and display the data of the log messages at the information panel at the bottom of the window Message Queue and Queue Processing Tab This tab displays Name, Host, Description, Last Updated, Port, and Status of Message Queues and Queue processing within the CentraLink system. Statistics for the message queue display at the bottom of the window. Configuring the Watchdog Service and Dashboard Starting Watchdog Service Independent of Other Services The Watchdog Startup window allows you to configure a control service that communicates with the Dashboard. Unless the control service is started manually, the control service starts automatically when the Watchdog starts. You must manually start the Watchdog service: page 298 • When configuring Watchdog for the first time • When a user is added to the application and needs to receive messages from Watchdog • Every time the service has been stopped due to technical reasons 11222683 Rev. A System Management To start the Watchdog service independent of other services: 1. On the menu bar, select Start > System Management > Services > Watchdog > Start. The Start window displays the following fields: Field Description Control service Mandatory field that references the service that allows the Watchdog to start and stop other services. The Watchdog control service must use the XML-based internal language. Zeroconf service bind In a network with multiple CentraLink servers, this option locates and allows you to determine which Watchdog to connect to. It is recommended that this be set to None. Enable Windows Messenger alerts Enable e-mail alerts Enable internal mail alerts Determines how system managers are notified of Watchdog alerts. Send QC warning If enabled, the application will also send QC warnings to Watchdog. Send task scheduler messages If enabled, Watchdog will also monitor task scheduler activity. The chosen settings can be consulted in the general options of the application being monitored. You can view the current configuration of the Watchdog, which includes the fields and values of the Startup window as well as the Server and Port fields, through the Watchdog tab of the system Options window. These values can only be changed on the Register Watchdog window or the Startup window. Data Storage, System Performance, and Report Monitoring You can monitor data storage via the Storage Monitor tab. You can monitor Progress databases as well as disk space and FTP servers. You can monitor report building from the Report Builder tab. Registering and Unregistering Watchdog Before you can start the Watchdog service, you must register it with Windows. You must register Watchdog on the CentraLink system server. 11222683 Rev. A page 299 System Management To register the Watchdog service, select Start > System Management > Services > Watchdog > Register. The Register Watchdog window displays these options: Field Description Service name Name of the Windows service to be registered. Folder The folder where the Watchdog is installed. The default is the Watchdog subfolder of the application root folder. Server Contains the name or IP address of the CentraLink system server. Port Specifies the TCP/IP port where the Watchdog is listening. User login name Windows user account used to run the service. This account does not need administrator privileges but requires the user right “Log on as a service.” If running in a domain, use <DomainName>\<LoginName>; otherwise, use <ComputerName>\<LoginName>. User password User’s Windows password. Note After registration, always start the Watchdog service to avoid delays in communication with the instrument translators. To unregister the Watchdog service, select Start > System Management > Services > Watchdog > Unregister. Starting and Stopping Watchdog After the Watchdog is registered, you must start and stop it along with AutoStart services and translators. Note After the Watchdog service is registered, you must always start the Watchdog service to avoid delays in communication with the instrument translators. To start the Watchdog service, select Start > System Management > Services > Watchdog > Start. To stop the Watchdog service, select Start > System Management > Services > Watchdog > Stop. Note the following about Watchdog: • page 300 Whenever a new user is added to the application you monitor, you must stop and start Watchdog for the new user to receive messages. 11222683 Rev. A System Management • You must restart any process interacting with Watchdog after the Watchdog license has been activated. • The Watchdog log is stored in one or multiple files located in the folder D:\Centralink\watchdog\log\<timestamp>.log. Configuring Watchdog Dashboard Defining Watchdog Dashboard Preferences By default, the Watchdog Dashboard takes the first available port as the Receiver port, which is the port through which the Watchdog Dashboard receives data from the Watchdog service. If your lab requires incoming socket communication on fixed ports, however, then you can assign a fixed port to the Receiver port. To access the Watchdog Dashboard Preferences window: 1. On the Watchdog Dashboard, select Setup. You can set the following options in the Watchdog Dashboard Preferences window: Enable quality control warnings Set startup mode You can set Watchdog to monitor Quality Control warnings in the application you monitor (Start Watchdog). The dashboard will then display a warning whenever the Quality Control module raises a severity. By default, the dashboard will start in ZeroConf mode (and will automatically detect the services it needs to monitor).To change this setting: In the dashboard, select the Setup icon in the menu. Check the option Always connect to... and enter a host and a port. Click OK. You need to quit and start the dashboard for this option to take effect. 11222683 Rev. A page 301 System Management Copy from connected service Set default filter Allows copying the host and port from the currently connected Watchdog service. This makes the configuration easier, as you can use Zeroconf discovery the first time to detect the correct Watchdog service, and then switch to Always connect to the Watchdog service running on and copy the host and port without having to note them beforehand. You can set a default filter that will automatically apply when launching the dashboard. To set the default filter: In the dashboard, select the Setup icon in the menu. Next to the Default filter option, enter the filter you want to use. Click OK. Set receiver port You must quit and start the dashboard for this option to take effect You can set the receiver port from which the dashboard needs to listen to. In the dashboard, select the Setup icon. Next to the Receiver port option, define the receiver port you want to use. Click OK. You must quit and start the dashboard for this option to take effect. page 302 11222683 Rev. A System Management Purge log items, QC warnings and task scheduler messages To save memory, you can set a preference for how long log items, QC warnings, and task scheduler messages should be retained.The default is to purge these 3 items after 24 hours. To change this setting in the dashboard, select the Setup icon in the menu. Change the hours next to the option Purge log items older than, Purge QC warnings older than, or Purge task scheduler message older than. The minimum delay is 1 hour, and the maximum delay is 48 hours. Purge now allows you to clear all 3 items immediately, without having to quit the application. This will affect the Information panel of a selected translator, but will not necessarily affect the visibility of these 3 items in the Message log tab page. The Dashboard log will automatically be cleared when you quit the application. Note The Purge log items and Purge QC warnings and Purge task scheduler messages options do not affect Watchdog or the logs of the applications you monitor. They only clear the dashboard memory to enhance performance. Note You must quit and start the dashboard for this option to take effect. 11222683 Rev. A page 303 System Management Set pop-up preferences You can set whether or not information, warning, alert and error pop-ups should be shown, and for how many seconds. Entering "0", means that you will have to close the pop-up manually. Note This feature is currently not supported. Note Each of the parameters defined on the Watchdog Dashboard Preferences window is a global setting. The selections made to the Watchdog Dashboard Preferences window affect each Watchdog Dashboard connected to this Watchdog service. If another Watchdog Dashboard is open and active at the time the preferences are reset, however, the other Watchdog Dashboard does not reflect the changed preferences until you exit this Watchdog Dashboard and subsequently reopen this Watchdog Dashboard. Select OK. After you reopen the Watchdog Dashboard, selections made to the Watchdog Dashboard Preferences window take affect. Start and Stop Translator Services and Translators On the Dashboard, you can start and stop the task schedulers, translator services and translators from the following two areas: • Translator service and translator rectangle • Information panel On the translator service or translator rectangle, start or stop services and translators as follows: 1. Right-select the corresponding translator service or translator rectangle. 2. From the dropdown menu, select Start or Stop. page 304 11222683 Rev. A System Management On the information panel, start or stop services and translators as follows: 1. Select the translator service or translator. On the information panel at the bottom of the window, the data of individual translator services and translators displays. 2. In the Actions field on the Information panel, select Start or Stop. Setting Email Alerts in the Watchdog Dashboard You can automatically set email alerts to system administrators from the Options window on the Mail tab. These options are retained when you restart the Dashboard. Select the Enable internal mail alerts toggle box. If enabled, alerts are broadcast to system administrator users by the Watchdog Daemon as internal application mails. If this setting is disabled, no internal application mails are sent by the Watchdog Daemon. This value is automatically retained the next time the Watchdog Dashboard starts. Two factors are important in your ability to set email alerts: • The ability to broadcast alerts to system administrator users via internal application mail depends on the configuration and usage of the Xml Control Service in the CentraLink system, which is also needed to allow Watchdog Dashboards to start and stop translators and services. • Sending internal application mail by the Watchdog is related to the mail method set at user level. If the mail method is set to external for a system administrator, the system administrator will never receive any internal application mail from the Watchdog. If the user mail method is set to internal or both, the user will receive internal application mail from the Watchdog when applicable. Note External email is not currently supported. The internal CentraLink mail system will be used. Checking Database Storage You can manually or automatically check CentraLink software’s database storage size. You can verify disk space availability, database extent usage, and database lock table overflow risk. Disk space availability checking is only available on the CentraLink system server. Note Ensure that Database Storage Check is configured. 11222683 Rev. A page 305 System Management To verify available database storage on the server, on the menu bar, select Start > System management > Database > Check storage. The Check storage window displays the following fields. The system checks local disks only. Field Description Backup maximal days passed A warning is generated when more days have elapsed since the latest Progress database backup than the specified Backup maximal days passed. Disk minimal megabytes free Minimal amount of megabytes that must be available to prevent a warning.The recommended setting is 200. This warning may trigger either before or after the maximal usage value is set. For example, if you set this value to 200 MB, and set the maximal usage to 80%, but only 75% of the disk has been used, this warning is triggered first. Disk maximal percentage used Maximum percentage of used disk space to prevent a warning. The recommended setting is 80. This warning may trigger before or after the minimal disk space value is set. For example, if you set this value to 80% and the disk has 500 MB free, and minimal free megabytes is set to 100 MB, this warning is triggered first. Area minimal megabytes free Minimal amount of megabytes that must be available per storage area to prevent a warning. Area maximal percentage used Maximum percentage of used space per storage area that must be maintained to prevent a warning. Check overflow extent When selected, a warning message displays when the overflow extent is in use. Enables an advanced check on database size. The CentraLink system database consists of 55 extents, each of which has a 2 gigabyte limit. Support email address Sets the system to forward a copy of the warning to the specified address. This feature requires that an Email host and port were configured in the email address field of Mail tab on the system Options window. page 306 11222683 Rev. A System Management Note External email is not currently supported. The internal CentraLink mail system will be used. Warnings are displayed to the current user and mailed to all enabled users of type System Manager. System managers can schedule the storage check function to run automatically. Manually Purging Data from the Database CAUTION Do not perform a manual purge unless absolutely necessary. System performance may be significantly degraded. It is strongly recommended to automatically purge on a regular basis. Contact your local technical support provider to schedule a purge task when the system is least busy or not processing results. Manually purge data from a database in 2 ways: • On the menu bar select Start > System management > Database > Purge data. Note You can purge individual samples by marking them for deletion. See Marking Samples for Deletion, page 24. These samples are purged first. You cannot undo this action, so be cautious when marking individual samples for deletion. You should use the regular Purge functionality to clean your database. If you mark too many individual samples for deletion, this may interfere with the regular Purge function. • On the Sample status overview window, select Purge. For information about accessing the Purge window from the Sample status overview window, see Purging the Database on page 45. The Purge data window displays the following options: 11222683 Rev. A Field Description Days to keep Select the checkbox on the General tab on the Purge data window. The period of time, starting from the current date back, for which the data is not purged. Samples Select the checkbox on the General tab on the Purge data window.When selected, samples with status Uploaded, Omitted or Unknown, that is, those samples without requests, and their dependent data are purged. page 307 System Management Field Description Worklists Select the checkbox on the General tab on the Purge data window. When selected, worklists and their dependent data are purged. Reagents Select the checkbox on the General tab on the Purge data window. When selected, reagent information and dependent data are purged. Patients Select the Patients tab on the Purge data window. When selected, patients outside the Days to Keep parameters, whose records are not associated with any samples or requests, are purged. Patient days to keep Select the checkbox on the Patients tab on the Purge data window. This setting indicates the period of time, starting from the current date back, for which the patient data is not purged. If the patient data has not been updated in this time frame, the record is purged. This value can be any positive number between 0 and 999; the default value is 365. Instrument days to keep This field will be disabled until the Instruments field is enabled. The default value is 365. The specified number of days (backwards from the current date) will be evaluated against the event time of the instrument log. Scheduling Tasks A task specifies that a command is launched automatically at a specific time and perhaps on a recurring basis. Scheduled tasks might include uploading and downloading: • Uploading QC results to the LIS • Automatically uploading patient results to the LIS • Download workorders to the LAS Set up a scheduled task: 1. On the menu bar, select Start > System management > Commands > Commands The Commands browser window displays. 2. Select the appropriate command. page 308 11222683 Rev. A System Management 3. Right-select the selected command and select Tasks. The Task browser window displays. 4. Select New on the toolbar. The Task editor window displays. 5. Enter the Name value, the From value, which is the start date, and the Until value, which is the to date. 6. Specify the Recurrence pattern information to automatically perform the specified command. 7. Select OK. Scheduling a QC Lot Expiration Notice You can schedule an e-mail notice to be sent to alert you when a QC Lot expires or is about to expire. To schedule a QC Lot expiration notice: 1. On the menu bar, select Start > System Management > Options. The Options editor window displays. 2. Select the Mail tab. 3. In the field provided enter the e-mail address where you want the QC Expiration e-mail notice to be sent. 4. Enter values, if necessary, for Server (your email server) and Port (TCP/IP location of mail server). 5. If the specified mail server requires user authentication, check Use server authentication and specify a User name and Password to be forwarded to the mail server. 6. Click OK. The Send expiration notification dialog appears. 7. In the Days in advance field, enter the number of days in advance of an QC lot expiration when you want to receive a notice of expiration. The default value is 3 days. 8. Select OK. If no expiration date is specified for a QC lot, an expiration notification will not be sent. Note External email is not currently supported. The internal CentraLink mail system will be used. 11222683 Rev. A page 309 System Management Backing Up and Restoring the Software Backing Up the Databases Do not shut down the databases before making a backup. You can continue working while the backup is being made. You can launch the CentraLink database backup utility from the CentraLink system. Note The recommendation is to perform a database backup once a day. Contact your local technical support provider to configure automatic backup, based on your lab’s requirements. For regular database backups, see Backing Up the Database Online on page 311. To launch the CentraLink database backup utility: 1. On the CentraLink menu, select Start > System Management > Database > Backup. The CentraLink backup utility window displays. 2. Deselect Write to tape. By default, this checkbox is selected. 3. Select Start. Progress messages display throughout the backup process. WARNING When the possibility of insufficient disk space exists while performing a manual backup, the following message displays: You probably don't have enough disk space on your temporary drive to do the backup. Are you sure you want to proceed? (Y/N) To cancel to backup at this point, you must select No. If you select Yes and sufficient disk space does not exist, the database locks. To resolve the problem, reboot the CentraLink server. A complete backup operation is done in several steps. During a backup, a database image is written to the spare disk on the server. The current step is marked by the yellow arrow. Steps that are completed are marked with a green check mark. A backup is successful when all checkboxes are marked with a green check mark. Steps that failed are marked with a red cross. If a step fails, examine the log at the bottom of the backup window. page 310 11222683 Rev. A System Management Backing Up the Database Online You can configure a task to back up the CentraLink database at regular intervals. You cannot attempt database backup more than once every 6 hours. If the scheduled database backup has not completed for 6 hours or more, the System Manager can back up these CentraLink databases via the Online backup window. Select Start > System Management > Database > Online Backup and set the following fields: • Keep period: number or days to keep the backup in the specified location. The default value is 4; the range is between 0 and 60. • Root backup folder: the location of the backup database • Backup folder prefix: a user-determined prefix, after which a date and time is appended to each backup. • Last backup time: this is for information only and tells the user when the last successful backup was performed. Online backup creates the files CentraLink.bck, CentraLink.st, genro.bck, genro.st, and the text file bckinfo.txt, which includes additional details including the server name, CentraLink version and date/time of the backup. Restoring the Database from the Image The CentraLink software is shipped with a utility that makes it easy to reconstruct the database starting from the backup image that you just restored. 1. On the Windows Start menu, select Run. 2. Type d:\centralink\bin\restore.exe. 3. Select OK. 4. Copy these 3 database backup files from the disk to the default restore path directory: centralink1, centralink.inp and centralink.st. If you use online backup, copy the files CentraLink.bck, CentraLink.st, genro.back and genro.st. Note Typically the default restore path is F:\CentraLink\Tmp\Backup. 5. Ensure that the value in the Database image files field is the path of the default restore directory where you copied the database backup files. 11222683 Rev. A page 311 System Management 6. Select Start to start rebuilding the database. The restore operation is done in several steps. The current step is marked by the yellow arrow. Steps that are completed are marked with a green check mark. A restore is successful when all checkboxes are marked with a green check mark. Steps that failed are marked with a red cross. 7. If a step fails, examine the log at the bottom of the Restore window. After a successful restore operation, it may take several minutes before the newly restored databases are fully started. Wait at least 3 minutes before restarting the CentraLink software. You did not wait long enough if the following error message displays: There is no server for database. Restoring the Databases from a Disk Backup You can easily restore a previous database from a disk backup using the CentraLink system database restore utility. Before restoring the database, you must have a working CentraLink system installation. If a CentraLink system installation was not successful, you must reinstall the CentraLink software from the CentraLink CD-ROM before restoring the database from disk. Note Restore works only with a backup from the same CentraLink system version. The backup version must have the first digit in the three-digit version identification. Ensure that no CentraLink system client, even the one on the server, is running when the restore operation is underway. It is not necessary to manually shut down the databases; the restore program shuts down the databases automatically. Selecting and Adding Languages The CentraLink system supports multiple languages: • You can define a language for the user interface. • You can define additional languages and translations for menu options and reports. Understanding User Interface Languages The user interface languages, also called system languages, and their translations include English, French, German, Spanish, and Italian. page 312 11222683 Rev. A System Management You can use different user interface languages concurrently. One user might use an English client session while another user uses a French client session. Changing User-Defined Languages The CentraLink system database contains a table for user-defined languages. User-defined languages are used to qualify translations for multilingual fields in various tables. Multilingual fields include menu option labels and test descriptions. You provide translations for multilingual fields. Providing translations for menu options or toolbar button help text in any of the system languages is not required. These are automatically translated from the built-in glossaries when you activate a menu after database initialization. To change a language, on the menu bar, select Start > System Management > Languages. The Languages window displays the following fields: Field Description Name Unique name for the language, such as French. Code Unique identifier for the language. System language Associated user interface language, which can be used for retrieving translations of nonmultilingual strings. Defining Languages for Users When defining a new user, set the user’s language by referencing the Language table. The default language is defined in the Language field of the General tab on the system Options window. A user can override an assigned language on the Logon window. 11222683 Rev. A page 313 System Management Setting the Language for Add-on Programs Some add-on CentraLink system components, such as backup, restore, and Watchdog, run outside of the CentraLink system database. Since most of these are Windows services, they use the user language specified in Windows. The CentraLink system add-ons can also run in a language different from Windows. Error messages originating from Windows, however, are in the Windows system language. In certain cases, the language on the buttons does not match the user language. Define the Windows user language: 1. On the menu bar, select Start > Control Panel > Regional Settings or Regional and Language Options. 2. On the Regional Settings Properties window, select the appropriate language from the drop-down menu. 3. Select OK. Printing The table of printers is a table of operating system commands that is launched when non-graphical print jobs are run; for example, text-format sample and QC reports and generic browser printouts. 1. On the menu bar, select Start > System management > Printers. The Printers browser window displays. 2. To limit the display of printers to those assigned to your user name, select Show my printers only. For information on assigning printers to a user, see Assigning Printers to a User on page 275. 3. To define a new printer, select the New icon on the toolbar. page 314 11222683 Rev. A System Management The Printer editor window displays the following fields: Field Description Name A unique name for the printer. Windows path Identifies a printer installed on your network; for example:\\Centralinksvr\hplaserj. Document types that are supported are defined by a list of file extensions set in the MA Section of the <CentraLink root>/bin/Progress.ini file. Insert a line like this (the default value is “doc”): WindowsPrintingSupportedExtensions=“txt,doc” Top limit and Left limit Print command These fields are not used in the CentraLink system. Use this field whenever a document of an unsupported type is printed. It is an operating system command with a placeholder ('&1') for the name of the file to be printed: copy &1 \\<server-name>\<printer-share-name> Substitute <server-name> and <printer-sharename> as appropriate. Preamble and Postamble These fields optionally reference files to send to the printer using the Print command, before and after the actual file is printed. These files may contain printer-specific directives, for example to ensure page breaks between consecutive files. Like the Print command field, these fields are used only for printing non-supported file types. Report Builder The Printer sides (single-sided or duplex), Media tray, Sheet Collate (collated or uncollated), Report builder service, Job sheets, Print quality (high or normal) and Chromaticity (color or monochrome) fields determine the way that Jasper reports are printed. Customizing the Toolbars The CentraLink system is installed with a default set of toolbar buttons. You can add, edit, and delete toolbar buttons. Tools can be associated with, and then accessed from, the start/context menus or the toolbar. For more information, see The Review and Edit Window Workspace on page 69. 11222683 Rev. A page 315 System Management To add a toolbar button: 1. On the menu bar, select Start > System management > Menu > Toolbar buttons. The Toolbar buttons browser window displays. 2. Double-select an existing entry or select the New icon on the toolbar. The Toolbar button editor window displays. 3. Select OK after entering the relevant information. You must log out and log back in to the CentraLink system to view the toolbar button modifications. Field Description Row Determines the relative vertical position of the button. Sequence Determines the relative horizontal position of the button. Tool table and Tool mnemonic Together these field values reference the function activated by the button. Label Text that displays on the button. Help text Text that displays on the button's tool tip. The help text is visible when the mouse is positioned over the button. Image up, Image down, and Image disabled File names of the image the button displays when it is active but not selected, selected, and disabled. Image up is the only mandatory file name. These image file names are located in the <root>/img directory. Note Images and text are mutually exclusive. Insert ruler If selected, the toolbar icon is separated from other toolbar icons by a vertical line. If not selected, the toolbar icon is not separated from other icons by a vertical line. page 316 11222683 Rev. A 6 Troubleshooting The following information may be helpful in troubleshooting system problems and in everyday operation of the CentraLink system. For assistance with troubleshooting, you may consult a Siemens representative online and in real time via Siemens Remote Service (SRS). Error Messages Find Failed The following message may display: Find FIRST/LAST failed for table b_instrument If this message displays, contact your local technical support provider. CentraLink Client/Workstations Sessions The CentraLink system supports up to 15 open sessions at one time. If you attempt to open more than 15 sessions, an error message displays. The content of this message differs depending on whether the session is opened on the CentraLink system server or on a client/workstation. To close the error message, press CTRL+BREAK. Deleting Items from Tables The following message may display if you delete an item from a table while the browser for that table is open: b_Base record not on file (138) If this message displays, select OK to close the message. The system deletes the item and no further action is necessary. Manually Creating Workorders or Validating Results The following message may display when you manually create workorders or validate results: b_SpecificSelf in use by mipssys on CON:. Wait or choose cancel to stop If this message displays, wait a moment and it automatically closes. Do not select Cancel, which closes the entire CentraLink system application. 11222683 Rev. A page 317 Troubleshooting b_sample record not on file This error is generated when concurrently communicating with the ADVIA 120 system and working on the CentraLink system. Upon display of this error, you can close the Review and Edit window, reopen the window, and requery the same sample. The error message no longer displays when system processing is complete. Comments Exceeding Length on Review and Edit or Diffpad Screens If the combined comments for a sample on these screens contain more than 32,000 characters and you select the Comments button, a message displays, indicating that CentraLink cannot display the information. To view these comments individually, select each request. Manually Uploading QC data to the LIS The following message may display when you manually upload QC data to the LIS: Tsl$TimeOutAppl() If this message displays, select OK to close the message. No further action is necessary. If the message continues to display, contact your local technical support provider. Transmitting Result Messages The following message error may occur if the result message is too long to be processed within the time specified in the LIS Translator. Trl$TimeOut Appl() Error on LIS Upload The suggested value for the LIS Translator Time-out is 120 seconds. If this error continuously occurs, contact your local service provider or distributor. Troubleshooting and Tips Error message received for aspiration time Problem: When attempting to display a list of samples based on a query for “Aspiration time,” you may receive the error message, “Invalid range for aspiration time.” Solution: When filling in the Sample Query window, be sure to type in the aspiration time in 24-hour format (for example, 20:00). page 318 11222683 Rev. A Troubleshooting Blank Window when Uploading Sample Results Problem: The system may displays a blank window for a few seconds while uploading sample results. Solution: This does not affect system operation and requires no intervention. No QC Graph data displays for a test in the Across Controls window Problem: When viewing the QC results on the Across Controls window, the system does not display any information for a test in the graph columns. Solution: If a target value is specified for a test, it is used as the center point for the QC graph calculations. However, if no target value is specified, the reference value must be set to Current Statistics for the system to use the reference value as the center point on the Across Controls window. To set the reference value: 1. Open the QC Population editor for the test. For detailed information, see Specifying Parameters for a QC Lot on page 142. 2. Select the appropriate QC population. 3. Right-select the selected QC Population and then select Set Reference. 4. On the Set Reference window, set the Source to Current statistics and then select OK. Note If you choose Current Statistics, the standard deviation at the time you choose the setting is used from that point forward. Multiple Sample Types in a Single Workorder In some cases, the system discards some test requests when downloading workorders from the LIS. When the LIS downloads a workorder, the CentraLink system LIS translator assumes the sample type of the first test is the sample type for every subsequent test in the workorder. If any of the tests have a different sample type, the translator discards them. Any test received with the sample type set to the ? symbol is added to the order. 11222683 Rev. A page 319 Troubleshooting Using Symbols in Numeric Results The CentraLink system allows numeric results that include the > (greater than) and < (less than) symbols. Results that include the > or < symbols are transmitted to the CentraLink system from networked instruments or they are manually entered. You must ensure that your LIS is capable of handling any results that contain these symbols. QC Monitoring for Ratio Test Results When ratios are defined in the CentraLink system, the recalculation of a ratio is automatic when any input to the calculation changes through a rerun or a manual edit. However, when you define a test as a ratio test in the CentraLink system, the system can no longer receive or manage QC data for the test. If QC monitoring for a ratio test is essential, you must change the test type to a routine instrument-sourced test. Instrument-sourced ratio tests are not automatically recalculated when one of the inputs is rerun or manually edited. Therefore, if you disable a test as a ratio test (by removing the ratio calculation for the test), you must ensure that a warning message is added to the test definition. Images for Samples with Unknown Sample ID Numbers The CentraLink system rejects the results for sample records with unknown sample ID numbers. Any associated image files, however, remain in the FTP directory and you must manually delete them from the system. ADVIA 120/2120 Disposition Codes The CentraLink system does not display disposition codes for results from the ADVIA 120/2120 hematology system. If a result is manually edited at the ADVIA 120/2120 system and then sent to CentraLink system, there is no indication in the CentraLink system that the result is edited. You must make sure that the ADVIA 120/2120 system is set to Review None mode so that you can manually edit results only in the CentraLink system. Closing the Review and Edit Window During Calculation If you attempt to close the Review and Edit window while a calculation is running there may be a slight delay before the window closes, and the following message may display: There are asynchronous calls active on the Application Server which originated from this screen. This screen will be closed automatically upon completion of these calls. page 320 11222683 Rev. A Troubleshooting Siemens Remote Service Siemens Remote Service is a real-time remote service that connects to Siemens instruments and automation systems to allow access to global technical support from Siemens Healthcare Diagnostics. Your technical support provider will install and configure the required files to establish connectivity between the CentraLink system and Siemens Remote Service. This will allow a remote Siemens representative to perform the following: • Remote Control Session for Troubleshooting All Remote Control sessions are initiated by the Siemens representative and must be accepted by the user at the CentraLink server user interface. You may end a remote control session at any time. • Remote Training Since you can view all actions performed by the remote Siemens representative during a remote control session, this also allows for some incremental remote training. • File Transfer Siemens representatives can retrieve files from your CentraLink system to expedite troubleshooting and resolve issues remotely. Software update files can also be remotely downloaded to your CentraLink system with no on-site visit required. NOTE: All Siemens representatives are committed to maintaining patient data confidentiality and trained to comply with regional procedures for handling ePHI. CentraLink-to-SRS connectivity is established at your site by registering CentraLink as a device to the syngo Lab Connectivity Manager acting as the gateway at the site. Remote access and file transfer is not available to a CentraLink client computer. For information on other instrument connections that are supported by Siemens Remote Service, refer to the Customer Release Notes for syngo Lab Connectivity Manager. Accepting a Request for Remote Control Session When remote service is required, a Siemens representative sends a message to the CentraLink server. A window displays with this message: Accept i2iVNC Connection? To allow the remote access connection, select Accept. To reject remote access connection, select Reject. 11222683 Rev. A page 321 Troubleshooting NOTE: When a Remote Control session is active, the i2iVNC icon that is displayed in the Windows Task bar in the lower-right corner turns yellow. When the CentraLink system is using a Windows Server 2008, the Remote Control session inherits the credentials of the user who accepts the connection, and the operator will not have Administrator privileges. To allow a Siemens representative to perform administrator level activities: 1. To allow the remote access connection, select Accept. 2. Select Control + Alt + Delete keys when instructed to allow the Siemens representative to log in as Administrator. Disconnecting a Siemens Remote Service Connection Normally, the Siemens technical representative will complete the remote session and disconnect from the CentraLink server. To terminate the connection before the Siemens representative is finished: 1. If you are not logged on to the CentraLink server, log on. 2. Right-select the i2iVNC icon in the lower-right corner of the Windows Task bar and select Kill VNC Clients. page 322 11222683 Rev. A Contacts Appendix A: Contacts This section provides the Siemens Healthcare Diagnostics addresses for obtaining service and technical information and for ordering supplies. For technical assistance, customer service or additional information contact your local technical support provider. www.siemens.com/diagnostics. 11222683 Rev. A page 323 Contacts page 324 11222683 Rev. A Appendix B: Open Source Copyright Information Copyright Information This product includes open source software. Such software is provided by Siemens under the terms of the open source software licenses applicable to such software, and is distributed WITHOUT ANY WARRANTY as set forth in the corresponding licenses. Those terms require that Siemens provide the following notices and information to the purchaser of this product. Where required by the specific license terms, Siemens will make the source code for such open source software available upon request from Siemens in accordance with the terms of the relevant open source license. Versions of the GNU General Public License (GPL) and Lesser General Public License (LGPL) are available at www.gnu.org. Versions of the Apache License are available at www.apache.org/licenses. The Code Project Open License, Version 1.02, is available at http://www.codeproject.com/info/ cpol10.aspx. The Common Development and Distribution License (CDDL), Version 1.0 is available at http://opensource.org/licenses/CDDL-1.0. The Eclipse Public License, v1.0 is available at http://www.eclipse.org/org/ documents/epl-v10.php. The Common Public License, v1.0 is available at https://opensource.org/licenses/cpl1.0.php. The MIT License is reproduced below: The MIT License (MIT) Copyright (c) <year> <copyright holders> Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. 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David Eisenberg For Servlet Specification API v2.4 licensed under the CCDL, v1.0: © 2001-2007 Java Community Process For Simple Logging Façade for Java (SLF4J) v1.7.10 licensed under the MIT License: © 2004-2015 QOS.ch. For SmtpMail v5.8c licensed under the Plain-English FreeFramework License found at http://freeframework.sourceforge.net/license.shtml: © 2009 Mario Paranhos, Paul Keary and others For WinRun4J v0.4.5 licensed under the Common Public License 1.0: © 2007-2013 Peter Smith, Karl von Randow, AquaFold, Frederic Canut 11222683 Rev. A page 329 Open Source Copyright Information page 330 11222683 Rev. A Effects of Control Reported Decimals on Instrument QC Results Appendix C: Effects of Control Reported Decimals on Instrument QC Results Numeric Value The numeric value of the instrument QC result is always the value received from the instrument. You can view the numeric value on the detailed QC Result window. To open the detailed QC Result window to view the numeric value, double-select a QC result on the QC Results (Across controls view). You can also view the numeric value in the Levey-Jennings graph. Note The exception is when more than 9 decimals are received from the instrument. Under this circumstance, the numeric QC result value is rounded to 9 decimal places. String Value • Control reported decimal default value (?) For QC results, the default value is the ? symbol. If the ? symbol populates the Control reported decimals field for instrument QC results, the decimal precision of the instrument QC result displayed in the String Value column on the QC Across Controls View window is the same as that of the result value received from the instrument. Note The exception is when more than 9 decimals are received from the instrument. Under this circumstance, the numeric QC result value is rounded to 9 decimal places. • Control reported decimal value (0–1) If you enter a Control reported decimals value less than 2, a message displays warning that the result could be rounded. You must confirm that you want to enter a value less than 2. When a Control reported decimals value of 0–1 is entered, the displayed value in the String Value column is rounded to the specified number of decimals: 0 or 1. • Control reported decimal value (2–9) When a Control reported decimals value of 2–9 is entered, the displayed value in the String Value column is rounded to the specified number of decimals: 2, 3, 4, 5, 6, 7, 8, or 9. 11222683 Rev. A page 331 Effects of Control Reported Decimals on Instrument QC Results Mean and SD When the Control reported decimal value is set to 0, 1, or the ? symbol, the displayed value of the Mean and SD fields on the QC Across Controls View window is 2 decimal places. When the Control reported decimal value is between 2 and 9 inclusive, the displayed decimal precision of the Mean and SD fields is the specified number of decimal places. Target Value and Target Deviation On the QC Across Controls View window, the Target value and Target Deviation value are displayed as entered without rounding. Uploading Patient Samples to the LIS Automatically Uploading Patient Samples To automate the upload of patient samples to the LIS, define a command as follows: • Table: Sample • Description: free text (e.g. Upload validated samples) • Query: Default • Query parameter set: define a query parameter set. Do not specify the LIS channel in the sample query Typically, both “Minimal status” and “Maximal status” will be set to “Validated” as these are the only samples that can be uploaded to the LIS. • Function: UploadResults • Function parameter set: define a function parameter set. Specify the LIS channel to which the samples must be uploaded. When uploading samples to the LIS, the application will check all “Request LIS uploads” that match the specified LIS channel Specify whether uploaded results should be sent again. Link the command to a task, to execute the command on a regular basis. Manually Uploading Patient Samples to the LIS To upload patient samples manually to the LIS, right select the sample and choose either Upload result or Upload validated result. page 332 11222683 Rev. A Effects of Control Reported Decimals on Instrument QC Results Manually Uploading Validated Results to the LIS Depending on lab-specified criteria, when all tests on a sample have status Validated, the results are automatically scheduled for uploading to the LIS. With the Upload button, however, you can manually upload validated results within a sample. You can upload any result that is validated, even if all results in the sample are not yet validated. The Upload button is not activated unless at least one test has a status of Validated. To manually upload a validated result from the Review and Edit window, select Upload. The Upload validated results window displays. If you select the Include updated checkbox, matching requests are uploaded regardless of whether they already have been uploaded. LIS Channel Test upload validated results LIS to which results are uploaded. For multiple LIS systems this must be specified. only test for which requests will be uploaded. Upload result is for 1 test only. contains LIS Channel field and Include updated checkbox. Upload to LIS Upon QC Result upload, the Control reported decimal value determines the number of decimals to which the QC result is rounded. • Control reported decimal default value (?) When the ? symbol populates the Control reported decimals field for instrument QC results, the decimal precision of the instrument QC result uploaded to the LIS is the same as the decimal precision received from the instrument. No rounding occurs except when more than 9 decimals are received from the instrument. Under this circumstance, the numeric QC result value is rounded to 9 decimal places. • Control reported decimal value (0) When you enter a Control reported decimals value of 0, the decimal precision of the instrument QC result uploaded to the LIS is 0 decimal places. 11222683 Rev. A page 333 Effects of Control Reported Decimals on Instrument QC Results • Control reported decimal value (1) When you enter a Control reported decimals value of 1, the decimal precision of the instrument QC result uploaded to the LIS is 1 decimal place. • Control reported decimal value (2-9) When a Control reported decimals value of 2-9 is entered, the decimal precision of the instrument QC result uploaded to the LIS is the specified number of decimals: 2, 3, 4, 5, 6, 7, 8, or 9. Table C-1: Decimal Places for Instrument QC result Control Reported Decimal Numeric Value Across Control (String Value) Mean/ SD LeveyJennings (Y value) BioRad Data Sent to LIS ? * * 2 2 * * 0 * 0 2 2 0 0 1 * 1 2 2 1 1 2–9 * 2–9 2–9 2–9 2–9 2–9 * = whatever value comes from the Instrument Effects of Control Reported Decimals on Patient Moving Average Results Numeric Value The numeric value of the patient moving average QC result is set to the decimal precision specified by the Control reported decimals value. When the ? symbol, 0, or 1 is specified, the decimal precision is 2. When 2–9 is specified, the decimal precision is the specified value. You can view the numeric value on the detailed QC Result window. To open the detailed QC Result window to view the numeric value, double-select a QC result on the QC Results (Across controls view) window. You can also view the numeric value in the Levey-Jennings graph. String Value • Control reported decimal default value (?) For QC results, the default value is the ? symbol. If the ? symbol populates the Control reported decimals field for patient moving average QC results, the decimal precision of the patient moving average QC result displayed in the String Value column on the QC Across Controls View window is 0, 1, or 2 decimal places. page 334 11222683 Rev. A Effects of Control Reported Decimals on Instrument QC Results • Control reported decimal value (0) If you enter a Control reported decimals value of 0, a message displays warning that the result could be rounded. You must confirm that you want to enter the value 0. When a Control reported decimals value of 0 is entered, the displayed value in the String Value column is rounded to 0 decimal places. • Control reported decimal value (1) If you enter a Control reported decimals value of 1, a message displays warning that the result could be rounded. You must confirm that you want to enter the value 1. When a Control reported decimals value of 1 is entered, the displayed value in the String Value column is rounded to 1 decimal place. • Control reported decimal value (2–9) When a Control reported decimals value of 2–9 is entered, the displayed value in the String Value column is rounded to the specified number of decimals: 2, 3, 4, 5, 6, 7, 8, or 9. Mean and SD When the Control reported decimal value is set to 0, 1, or the ? symbol, the displayed value on the QC Across Controls View window of the Mean and SD fields is 2 decimal places. When the Control reported decimal value is set between 2 and 9 inclusive, the displayed decimal precision of the Mean and SD fields is the specified number of decimal places. 11222683 Rev. A page 335 Effects of Control Reported Decimals on Instrument QC Results Target Value and Target Deviation On the QC Across Controls View window, the Target value and Target Deviation value are displayed as entered without rounding. Upload to LIS Regardless of the value that populates the Control reported decimals field for patient moving average QC results, no patient moving average QC result is uploaded to the LIS. Table C-2: page 336 Decimal Places for Patient Moving Average QC result Control Reported Decimal Numeric Value Across Control (String Value) Mean/ SD LeveyJennings (Y value) BioRad Data Sent to LIS ? 2 0-2 2 2 0-2 N/A 0 2 0 2 2 0 N/A 1 2 1 2 2 1 N/A 2–9 2–9 2–9 2–9 2–9 2–9 N/A 11222683 Rev. A Using the CentraLink System with Aptio Modules Appendix D: Using the CentraLink System with Aptio Modules The CentraLink Data Management System version 15 and later supports these additional Aptio Automation modules: • Aliquot and Recapper Modules • Rack Output Module (ROM) • Slave I/O Module • Desealer Module • Bulk Input Module (BIM) • ADVIA 2120i system connectivity • Tube Inspection Module (TIM) (with limited functionality) CentraLink version 15 and later also supports connectivity to Sysmex CS-5100, CS-2000i, and CS-2100i instruments. Aliquot and Recapper Modules The Aliquot Module splits primary sample tubes into multiple secondary sample tubes for parallel processing, storage, transport to another part of the lab and send-out testing. Secondary tubes can be created as duplicates of the primary sample ID (SID), or by appending a prefix or suffix to the primary SID. Note The unique SID environment must be maintained. See Purging Patient ID and Retaining Unique Patient IDs on page 24 Secondary samples and SIDs create additional database records. Consult with your local technical support provider to configure the purge function to handle these additional records. The CentraLink system manages aliquot samples in this way: • Result reporting for all samples is based on sample ID. There is no indication on the screen, printed reports or in LIS upload messages, that a result is from a primary or secondary tube. Note The Aptio LIS configuration setting LIS Additional Field for Duplicate is not supported. Disable this field. • 11222683 Rev. A Orders for secondary samples with a different SID than the primary must be downloaded from the LIS or added manually in CentraLink if required. page 337 Using the CentraLink System with Aptio Modules • You can perform calculated tests within a single test order for a specific SID. The CentraLink software does not allow calculated tests across different test orders. • The CentraLink system does not receive information on whether an aliquot was created from a primary or secondary sample tube. • An Inlab message received for a secondary sample which matches an existing SID in the CentraLink database will be added to the existing sample, even if the existing sample has requests in status higher than Pending. Work with your LIS provider to prevent sample mismatch with secondary samples created by the aliquot module. • The CentraLink database creates records for secondary samples, even if no requests are associated with them. These sample records remain in the database until the purge command is run or they are manually deleted. • To configure the creation of aliquots before or after other tests are run on a sample, consult your local technical support provider. CentraLink Priority Bands cannot be used for this purpose. • For secondary tubes created by the Aliquot Module, the maximum supported SID length is 12 characters. If a value of greater than 12 is entered, the primary sample is routed to the Priority Output Lane of the Aptio system. • A maximum of 4 secondary samples can be created in a single aliquot session. If more than 4 secondary samples must be created, after the initial 4 samples are created, the primary sample will be routed back to the aliquot module. • A maximum of 14 duplicate (with the same SID as primary) secondary tubes can be created from a single primary sample. The Recapper Module caps the secondary sample tubes created by the aliquot module. Support for LIS Aliquot Requests The CentraLink software can receive aliquot sample requests from the LIS. Thus, LIS-defined secondary Sample IDs (SIDs) can be dynamically assigned to Aptio Automation aliquot samples. The LIS creates the new aliquot SID, and the CentraLink system sends this data to the Aptio Automation system for sample aliquot creation. You can specify a default volume, in microliters, to be used for the aliquot. page 338 11222683 Rev. A Using the CentraLink System with Aptio Modules You can view secondary samples requested from a primary sample (and vice versa) in the CentraLink Sample Query browser: 1. Select Start > Routine > Samples > Query 2. Enter the primary SID and select Aliquots from the Related Sample Requests drop-down menu to view the primary sample and all requested aliquots. 3. Enter the secondary sample SID and select Primary sample from the Related Sample Requests drop-down menu to view the requested secondary sample and the primary sample. NOTE: This functionality only applies to secondary samples created as a result of an LIS aliquot request. It does not apply to secondary samples created using the existing aliquot test functionality. LIS Aliquot Limitations • You cannot create multiple aliquots from the same primary sample, and the LIS must not request additional aliquots from the same primary sample. This is an Aptio Automation limitation which will be corrected in a future software version. • This functionality is only available on CentraLink software version 15.0.3 or higher, and Aptio software version 7.0 or higher. • This functionality is limited to the ASTM LIS, and is not supported on other LIS protocols, including Technidata LMX, Siemens Host Spec. 79, and HL7. • The CentraLink system does not generate the workorder(s) for the secondary sample. The LIS must send the tests requests for the secondary samples. Refer to your specific LIS documentation for details on the correct format of LIS aliquot request messages. • You cannot generate an aliquot request from the CentraLink application. These are triggered by the receipt of the aliquot request from the LIS. The Rack Output Module The Aptio Rack Output Module (ROM) receives sample tubes and places them in racks, in the same manner as the Aptio Input/Output Module (IOM). The ROM has no lanes. When a sample tube is received by the ROM, the ROM sends a message to CentraLink system which displays on the CentraLink Sample Log: 11222683 Rev. A • Status: Identified • LAS General Area: Node ID of the ROM on the Aptio system page 339 Using the CentraLink System with Aptio Modules • Type: LAS Location Update Note Racks on the ROM and Input/Output module are not interchangeable. Note For the CentraLink system to utilize the ROM, create a LAS General Area type of Output whose name matches the Aptio Automation ROM Node ID. The Slave Input/Output Module The slave I/O module functions in the same manner as the master I/O module, with the following limitation: You can configure more than 1 lane on the same IOM as the completion criteria for a test but only one general area (such as one IOM) can be specified. You cannot configure multiple lanes across different IOM as the completion criteria for the same test. For example, you cannot configure lane 8 of both the master IOM and slave IOM to be the sort lane for a specific test in the CentraLink system, even though Aptio Automation may support this functionality. If multiple sort lanes are required, both lanes need to be on the same IOM. Aptio Desealer Module Setting Automatic Deseal Time Use the Deseal Maximum Tube Age (Hours) field on the Aptio Automation system to set the maximum allowable time period for samples to be desealed upon CentraLink request. In this field, enter the number of hours since the collection date/time, during which the Aptio system is allowed to deseal samples. The collection date/time is downloaded in the order message from the CentraLink system, if it is available in CentraLink. For example, if you request a rerun or reflex test on a sample tube, and the Deseal Maximum Tube Age (Hours) value is 4, but the collection date/time sent by the CentraLink system to the Aptio Automation system is 5 hours ago, the sample will not be desealed. WARNING If the sample collection date/time is not sent by the CentraLink system, the Aptio Automation system automatically deseals the sample; the configuration of Deseal Maximum Tube Age (Hours) is not used. page 340 11222683 Rev. A Using the CentraLink System with Aptio Modules If a sample tube deseal request time exceeds the Deseal Maximum Tube Age (Hours) value, this message displays on the Aptio Automation system: SC020 (Sample needs manual unseal) If you attempt to rerun or reflex a test on a sample tube, and the number of deseals already performed on this sample exceeds Desealer Maximum Number of Seals, this message displays: SC021 (Sample needs manual unseal) If the system displays message SC020 or SC021, the sample is routed to the Priority Output Lane of the Aptio Input/Output Module. To run the desired tests, unlock the Priority Output rack. Manually unseal the sample tube and load it into an uncapped input lane. The Bulk Input Module The Aptio Bulk Input Module (BIM) reads sample tube barcodes and routes the sample tubes to the track in the same manner as the Aptio Input/Output Module (IOM). The BIM has no lanes; multiple tubes can be placed in the module at one time and no sorting is required. When a sample tube is picked from the BIM and placed on the Aptio Automation track, the BIM sends a message to CentraLink system which displays on the CentraLink Sample Log: 11222683 Rev. A • Status: Identified • General Area: Node ID of the BIM on the Aptio Automation system • Type: LAS Inlabbing page 341 Using the CentraLink System with Aptio Modules Aptio and ADVIA 2120i System Integration Note Ensure that your technical support provider or FSE configures the CentraLink and ADVIA 2120i system communications protocols before attempting to process samples between the 2 systems. Disabling ADVIA 2120i System Tests To disable an instrument test, you must disable the method on the CentraLink system. Rerunning certain tests on a CentraLink system may cause the creation of extra routes on the Aptio Automation system, and samples to be routed to an Incomplete Output tray. Uncheck the Allow Download checkbox on the following tests to prevent the CentraLink system from dispatching these tests to the Aptio Automation system: • Hemimage • Slide • Baso (both percentage and absolute) • NEUT (both percentage and absolute) • LYMP (both percentage and absolute) • MONO (percentage and absolute) • ESO (percentage and absolute) • LUC (percentage and absolute) Note This list is not complete. The listed tests are just suggestions. Please consult with your technical support provider for further details. Sample Tube Workflow Overview Aptio Automation systems process tubes from most supported instruments with this workflow: 1. The Aptio Automation system loads sample tubes from the Input/ Output module. 2. The Aptio Automation system centrifuges the samples based on Aptio rules. 3. The Aptio Automation system decaps the sample tubes based on Aptio rules. 4. The samples are routed to the designated instrument. page 342 11222683 Rev. A Using the CentraLink System with Aptio Modules For ADVIA 2120i whole blood samples, Aptio Automation uses a different workflow: 1. The Aptio Automation system loads the sample tubes from the Input/Output module. 2. The Aptio Automation system routes the samples directly to the ADVIA 2120i system. 3. The ADVIA 2120i system aspirates the sample 1 or 2 times, one of which can be for the ADVIA Autoslide Slidemaker Stainer. 4. The sample is returned to the Aptio Automation system and routed appropriately. 5. When results are reported and displayed at the ADVIA 2120i screen, the results (and optionally, cytogram images) are sent to the CentraLink system. Scheduling and Reagents A Reagent Empty message on the ADVIA 2120i system requires a manual restart of that system. Unreadable Barcode MISPL When the ADVIA 2120i system is processing a whole blood sample tube, it queries the CentraLink system when the sample arrives, and the tests are set to Scheduled status. If a bar-code read error occurs at the instrument, the tests remain in Pending status on the CentraLink system, but display as Processed on the Aptio Automation system and are routed to a Complete tray position. You can configure an automated command to locate these samples and resend the work orders to the Aptio Automation system. This command causes the Aptio Automation system to put the samples back on the track and attempt to query again. If 3 unsuccessful attempts occur, the sample is routed to a special sort lane to be checked for bar-code issues. If the Aptio Automation system cannot read the sample tube barcode at the gate, a Sample Code Read error is sent to the CentraLink system, and the sample is returned to the Aptio Priority Output lane for manual inspection by the operator. 11222683 Rev. A page 343 Using the CentraLink System with Aptio Modules Processing STAT Tubes on the ADVIA 2120i System Process STAT tubes on the ADVIA 2120i system in 1 of 3 ways: Put the ADVIA 2120i System Offline 1. At the Aptio Overview screen, select 2120, then select Going Offline. a. The message displays: Are you sure? b. Select Yes (checkmark icon). c. Going to Offline is displayed, and the instrument status turns pink. 2. Load STAT samples onto the ADVIA 2120i instrument. Note A maximum of 4 ADVIA 2120i racks can be loaded at one time on the Aptio Automation track. The ADVIA 2120i status indicator on the Aptio screen turns pink if 4 racks are already in place and there is no rack available for new uploads to, or downloads from, the automation track. Load the ADVIA 2120i Auto Sampler 1. Manually open the Auto Sampler Cover of the ADVIA 2120i system, and load the STAT sample into an available slot, if one exists. At the Aptio Samples screen, a Sample of Unknown Origin error message displays. Although the sample has successfully resulted, the sample is sorted to the Priority Output Lane of the Aptio Automation system. Note You may wish to create a special sorting tray for samples of this type. Pause the ADVIA 2120i Instrument and Front-Load the Sample Select the pause button on the ADVIA 2120i system. Front-load the sample within 60 seconds, using 1 of the 2 methods of manually aspirating the sample. WARNING This technique is not recommended because it may result in false clot errors. Capped and Unspun Samples on the Aptio Automation Track Sample tubes designated as capped and unspun must be loaded on the Routine Input lane of the Aptio Automation track. If you load a capped and unspun sample containing ADVIA 2120i tests into another lane type, the Aptio Automation system will route the sample to the Priority Output lane. page 344 11222683 Rev. A Using the CentraLink System with Aptio Modules Cerebral Spinal Fluid Samples and the Aptio Automation Track You cannot place Cerebral Spinal Fluid (CSF) sample tubes on the Aptio Automation track. You must stop the instrument and front-load CSF samples directly on the instrument, according to ADVIA 2120i operating instructions. Workflow for ADVIA Autoslide Slide Maker Stainer There are 2 scenarios for creating slides: • If an ADVIA Autoslide Slide Maker Stainer is connected to the ADVIA 2120i system, the ADVIA 2120i system can generate slides, and no additional workflow is necessary. • If the ADVIA Autoslide Slide Maker Stainer is not connected to the Aptio Automation system, slide tests can be downloaded to the Aptio track. You can route those samples to a special sort tray, designated for samples which need a manual slide created. Sysmex CS Instrument Connectivity CentraLink system version 14.0.4 and later supports connectivity with Sysmex CS-5100, CS-2000i, and CS-2100i instruments, with the following detail to note: CentraLink user interface fields which display a system-generated or userentered dilution coefficient for other instruments display a dilution percentage for Sysmex CS-5100, CS-2000i, and CS-2100i instruments. These fields are affected: • The autodilution coefficient field in the Result of request window • The Dilution coefficient field in the Setup auto dilution window • The Dilution type field from the Advanced Rerun window, if you select Autodilution • The Coefficient and Result Coefficient fields of the Dilution tab of the Request window Following are examples of values that you can enter in these fields: 11222683 Rev. A • 1:2 dilution: 50 • 1:3 dilution: 33 • 1:4 dilution: 25 • 1:5 dilution: 20 • 2:1 dilution: 200 • 3:1 dilution: 300 page 345 Using the CentraLink System with Aptio Modules Configuring QC Lots for Sysmex CS Instruments Contact your local technical support provider to configure new QC Lots for Sysmex CS-5100, CS-2000i, and CS-2100i instruments. Transmitting Tube Inspection Module Information to the LIS When using a Tube Inspection Module (TIM) in conjunction with the CentraLink software, the CentraLink system receives Cap Color and Container type (tube type) data from the Aptio Automation system. The CentraLink system saves this information the first time it is received, and subsequent changes are not accepted. • If you configure Container Types in the CentraLink software, the CentraLink system can send Container Type data to the LIS. Refer to Setting Up a Container Type Code in the CentraLink operator’s guide for more information. • If the LIS does not support the Container Type field, you can configure the CentraLink software to not transmit this data. • The CentraLink system cannot send Cap Color information to the LIS. Rebooting the CentraLink Server Rebooting the CentraLink server is an opportunity to identify potential hardware problems and to prevent unnecessary downtime. A schedule for recommended rebooting of the CentraLink server can be requested from your local technical support provider. It is a best practice for Aptio or ADVIA Lab Automation System customers to reboot the CentraLink system and the track system at the same time. To reboot the CentraLink server: 1. Stop processing of all samples on the instruments, and remove all samples from any Aptio or ADVIA Lab Automation System track. 2. Close the CentraLink Dashboard and all Client sessions. 3. Select Start > System Management > Services > Shutdown. 4. Close the CentraLink software on the CentraLink server and close the login window. 5. On the Microsoft Windows desktop, select Start > Shutdown> Restart. Enter a comment with name and reason for rebooting the system. page 346 11222683 Rev. A Using the CentraLink System with Aptio Modules 6. If any error messages display on the CentraLink server during system reboot, contact your Siemens technical support provider immediately. 7. Visually inspect the LEDs on the server and all hard drives. If any amber lights display, contact your Siemens technical support provider immediately. 8. If any error messages display after you log in to Windows, contact your Siemens technical support provider immediately. 9. Resume normal operation. Automatic Enabling and Disabling Methods When the CentraLink system is connected to an Aptio Automation system, you can enable/disable a method, for order download to the Instrument, based upon the reagent status received from Aptio. The Basic tab of the Method editor, Last “Enable-work orders”-change by reagent change checkbox indicates whether the method was enabled or disabled based upon the reagent status. Note This is a read only checkbox and cannot be updated by the user. It is not translated. If this checkbox is unchecked it indicates that the Enable/Disable status of the Enable Workorders field has been set by a reagent status update from the Aptio system. If this checkbox is checked it indicates that the Enable/Disable status of the Enable Workorders field has been set by a reagent status update from the Aptio system. CentraLink uses this checkbox to determine whether a method should be enabled/disabled based upon the reagent status update received from the Aptio system. If a method has been disabled manually in CentraLink or via MISPL, CentraLink will prevent a reagent status update from Aptio from reenabling that method. You must manually re-enable such methods in the CentraLink interface or via a MISPL command. This is to account for situations where Reagent is loaded on the Instrument before the user manually re-enables the test in CentraLink to allow orders to be downloaded. 11222683 Rev. A page 347 Using the CentraLink System with Aptio Modules Disabling a Method in CentraLink to Prevent Reagent Updates from Re-enabling the Method To manually disable a method in CentraLink if you want to prevent future reagent updates from changing the status of the method: 1. Right click on the Instrument and select Related > Tests to display the Methods browser 2. Double select the method to open the Method editor window. 3. a. If the Enable Workorders checkbox is selected, de-select it and select OK to disable the method and prevent future reagent updates from changing the status until the method is manually enabled. b. If the Enable Workorders checkbox is unchecked, due to Reagent Inventory depletion, then you must check the checkbox, Press OK, re-open the method, uncheck the checkbox again and press OK in order to prevent future reagent updates from changing the status until the method is manually enabled. The method will now be disabled and future Reagent status updates will not re-enable the method. Orders will not be downloaded to the instrument for that method until it is manually re-enabled. To confirm that the method is disabled, double select it and ensure that both the Enable Workorders checkbox in the Basic tab and the Last “Enable-work orders” change by to reagent change checkbox in the Basic tab are not checked. Note The manual enabling or disabling of tests must be performed on the CentraLink system if the connection between the Aptio system and CentraLink system is down. page 348 11222683 Rev. A Appendix E: ISLH Consensus Rules Introduction CentraLink system software contains an implementation of the ISLH Consensus Rules, which are based upon guidelines published by the International Society for Laboratory Hematology: http://www.islh.org/2010/index.php?page=consensus_rules This implementation is based upon a set of MISPL functions with configurable parameters to match specific customer needs. The rules are designed to operate within the functionality of the Hematology Review and Edit window, an optional feature in CentraLink version 15 and later. Three Parts of the Rules 1. Evaluation of the rules at time of result receipt from the instrument. This determines if sample results should be held in review. The rules will invalidate results based upon the sample, patient, and previous sample result details available in the CentraLink system at the time of result receipt from the instrument. Note This is optional configuration. If at least one enabled rule is triggered based on meeting the rule criteria, then all results in the sample will be held in Review status. Note This part of the rules is not reevaluated for manually entered results. 2. Evaluation of the rules at time of reviewing the sample in the Hematology Review and Edit window. This determines what rules have been triggered, and displays the appropriate information to the user via the i button. If any rules are triggered, the i button in the Hematology Review and Edit window displays to alert the user. Click the i button to display the rules which were triggered based upon the sample, patient, and previous sample result details available at the time of opening or refreshing the Hematology Review and Edit window. Note This part of the rules is reevaluated when results are manually edited and the i button will be automatically updated. 11222683 Rev. A page 349 ISLH Consensus Rules 3. Recommended actions, applicable to the information button, are displayed to the user. This can involve automatic reflex of slide tests, a display of recommended actions, and the following optional actions: • Holding future results for that sample in review. • Sorting samples to a particular area on the LAS. Note When more than one rule is triggered, you may select multiple actions. All rules can be individually enabled or disabled. The evaluation of the rules at the time of result receipt (step 1 above) can be separately enabled or disabled independent of evaluation at the time of sample review. Configurable Parameters The following parameters are available in the Consensus Rules, and can be set up by your technical support representative: • Linearity/Reference/Range Limits. Default values are as per ISLH Guidelines. • Minimum Norm severity for results in Suspect Flag rules. The default value is Norm Severity of 1. • Minimum Delta Norm severity for Delta Fail parameters. The default value is Delta Norm severity of 1. • Minimum Negative Delta Norm severity for Negative Delta parameter. The default value is Delta Norm severity of -1. • Maximum Delta Norm severity for Delta Pass parameter in Rule 38. The default value is Delta Norm severity of 0. • Neonate patient. The default value is less than 30 days. • Adult patient. The default value is 12 years old or higher. • First Time parameter. The default value is 3 days. • You can add comment text to results. • Descriptions of rules triggered and suggested actions displayed to the user. • Test names can be modified for sites that use different test names than the default configuration. Optional Configurable Parameters • page 350 You can configure a global option to prevent unsolicited samples from the Instrument being held in Review even if they trigger a consensus rule. 11222683 Rev. A ISLH Consensus Rules Note If some results of the sample are solicited and some are unsolicited, the rules will still be evaluated. If a rule is triggered, then only solicited results will be invalidated. 11222683 Rev. A • For Rules 2, 12, and 26, you can configure an option to add a Sort Test into the sample to sort the sample to a particular location when connected to Automation Systems. • For each rule you can individually configure an option to hold all future results in review for samples which trigger consensus rules and suggestion action button is clicked by the user. • For Rules 10, 11, and 12, you can configure the time limit in days for specimen age parameter. • For Rules 10, 11, and 12, you can configure an override to always assume the specimen age parameter is met. • For Rule 6, you can configure the time limit in days for previous results involved in delta checking. • For Rule 6, you can configure an option to always assume the time limit (in days for previous results involved in delta checking) is met. • For Rule 38, you can configure the time range in days for previous results involved in delta checking. • For Rule 38, you can configure an option to always assume the time range required for previous results involved in delta checking is met if a previous result is available. • For Rule 9, you can configure an override to always assume the first time parameter is met. page 351 ISLH Consensus Rules Key Implementation Details The following is important information on the CentraLink interpretation of the ISLH Rules Guidelines: page 352 • Rule 4 of the ISLH Rules Guidelines, relating to Vote Out, is not supported, because it is based upon a different technology than that used by Siemens instruments. • First sample parameter is evaluated as true if there are no previous sample results for the patient for the WBC test within a configurable period of time. • First Time parameter is evaluated as true if there are no previous sample results for the patient with the particular test involved in the ISLH Rule within a configurable period of time. • First Time parameter is not evaluated for rules involving suspect flags, rules 24, 25, 28, 32, 35, and 36. • First Time parameter is evaluated for previous sample local results in the CentraLink database, not previous results received from the LIS. • Previous confirmed result parameter is not evaluated for rules involving suspect flags, rules 33, 36, 38, and 39. • Parameters involving delta checking can be configured to use Local or LIS Previous sample results. • If LIS Previous Results are received by the CentraLink system with an associated date value but without a time, they will be stored in the CentraLink database with a time of midnight. • Comments are added to the result associated with the rule. If multiple tests or suspect flags are associated with the rule, then comments are added to WBC test result. • For Rule 41, if WBC test is not available on the sample then the comment will be added to RETICp result. • Age and Sex are not considered for upper reference range in Rule 9. A single configurable upper reference range is used and by default configured for an adult male. • A slide test is not reflexed, when the suggested action button is pressed, if it is not part of the first suggested action in the ISLH Consensus Rules Guidelines; for example, in Rule 26 where a number of initial suggested actions are to be performed before slide review is required. • Species is not taken into account in the implementation of the rules. 11222683 Rev. A ISLH Consensus Rules • 11222683 Rev. A In some circumstances, the result comment added by pressing the suggested action button will not be displayed until the Hematology Review and Edit window is refreshed. This can occur in cases where a slide test is not also reflexed. page 353 ISLH Consensus Rules page 354 11222683 Rev. A Appendix F: UIW Driver for ADVIA XPT Systems This driver supports the following functionality, and has these limitations. • Network and serial connectivity between the CentraLink system and the ADVIA Centaur XPT system, • Network connectivity between the CentraLink system and the ADVIA Chemistry XPT system. • Serial connections are not supported by the ADVIA Chemistry XPT system. • Instrument query, patient workorder download, patient result upload, and QC result upload is supported. Dilution Download for Centaur XPT Dilution download with orders is supported. Note Different tests support different dilution ranges. Downloading a dilution factor to the instrument with an incorrect dilution factor will cause the order not to be run. Dilution Download for Chemistry XPT Dilution download with orders is supported, using the dilution protocols D1 and D2 defined on the ADVIA Chemistry XPT system tests. The dilution can be downloaded with orders to the ADVIA Chemistry XPT system in the following scenarios: • If the dilution is ordered by the LIS using the dilution protocols D1 and D2, the CentraLink system will transmit the dilution with the order to the ADVIA Chemistry XPT system on query from the instrument. • The dilution can be ordered by the user as a manual action via the CentraLink user interface, using the steps described below. • Your technical support provider can create a CentraLink rule, based on your criteria, to automatically download a dilution with the order, as a new order or a rerun, to the ADVIA Chemistry XPT system upon query from the instrument. The ADVIA Chemistry XPT system will run the test at the dilution corresponding to these settings and report the results with the dilution protocol and the corresponding dilution factor. Ordering Dilutions in the CentraLink User Interface 1. Open the sample in the Review and Edit window. 11222683 Rev. A page 355 UIW Driver for ADVIA XPT Systems 2. Right-click on the request to be diluted, and select Set Auto dilution. 3. a. Double-click the Dilution condition field and select D1 or D2 as required.(Chemistry) b. Set the Dilution coefficient field to the required dilution factor. (Centaur) 4. Set the Dilution condition field to dilute only, or leave it as ? (Centaur) Rerunning a Test with a Dilution 1. Open the sample in the Review and Edit window. 2. Right-click the request that will be diluted, select Advanced rerun, and complete these fields: • Instrument: If an automation system is being used and you want to route the sample to a specific instrument, enter that instrument name. Otherwise leave as ? • Dilution type: Auto • Dilution coefficient: set to the dilution factor required. • Dilution condition (Centaur): set to dilute only or leave as ? • Dilution condition (Chemistry): Double-click the Dilution condition field and select D1 or D2 as required. • Comment: Enter a comment (optional) Manual Dilutions You can specify a manual dilution factor when creating orders on the ADVIA Centaur XPT system, which calculates the result based on the manual dilution, and uploads the adjusted result to the CentraLink system. No additional adjustment of the result for manual dilution is required in the CentraLink system. The Manually diluted flag is uploaded from the instrument, and stored with the result in CentraLink. A manual dilution factor is not downloaded with an order to the ADVIA Centaur XPT system, Chemistry XPT system, or to any other instrument. page 356 11222683 Rev. A UIW Driver for ADVIA XPT Systems If a tube containing a manually-diluted sample is placed on an instrument and the instrument queries the CentraLink system, no manual dilution factor will be downloaded with any open orders for that sample. WARNING In the CentraLink Advanced Rerun window, when the Dilution type dropdown menu is set to Manual, and the dilution co-efficient is not ?, manual dilution coefficients are applied as multipliers to results received from the instrument. If the Dilution type dropdown menu is set to Manual and a manual dilution factor has also been specified for the order on the instrument, do not enter a manual dilution coefficient in this window. ADVIA Centaur By default, a manual dilution factor is not transmitted with the result from the ADVIA Centaur XPT system. If transmitted, it will not be is not extracted by the CentraLink system. ADVIA Chemistry A manual dilution factor is transmitted with the result, and you can configure the CentraLink system to store the manual dilution factor as a result comment (for example, Manual Dilution: 50). Contact your local technical support provider to enable this option. Note Results with no manual dilution have a factor of 1. If you enable this option, a result comment indicating a manual dilution of 1 is added to undiluted test results. Preliminary Results Limitations and the ADVIA Centaur XPT System • On the instrument, the setting Automatically Send All Patient Results and Additional Data Except Results on Hold must not be selected. • On the instrument, the setting Automatically Send All Patient Results Except Results on Hold must be selected. Note For tests that are configured to auto-repeat on the instrument (for example, an auto repeat with dilution), only the repeat result will be uploaded. The initial (preliminary) result will not be uploaded. However, this does not apply to repeats of ID assay tests. If the Final Result Rule for an ID assay test is not enabled, initial and repeat results are uploaded as final results to the CentraLink database. 11222683 Rev. A page 357 UIW Driver for ADVIA XPT Systems Preliminary Results and the ADVIA Chemistry XPT System Note The transmission of preliminary results is supported only with the CentraLink UIW driver version 1.2. Previous versions of the driver do not support this feature. To support preliminary result transmission from ADVIA Chemistry XPT instruments, you must configure the CentraLink system to never autovalidate preliminary results. For more information on this setting, contact your local technical support provider. If preliminary results are not required, you must select Automatically Send All Patient Results Except Results on Hold on the instrument. Note For tests that are configured to auto-repeat on the instrument (for example, an auto-repeat with dilution), only the repeat result will be uploaded. The initial (preliminary) result will not be uploaded. If preliminary results are required, you must select Automatically Send All Patient Results and Additional Data Except Results on Hold on the instrument. When you select this option, note the following items: • When tests are auto-repeated on the instrument, the initial result is not sent until the repeat result is available. • If the results are not on hold on the instrument, the results will be sent to the Centralink system in a single message containing: First Result - The initial result of an autorepeat test is sent with a preliminary status. On the CentraLink system, this result is assigned an R9P flag. Second Result- The auto-repeated result with the Autorepeat flag and a status of Final. • When a repeat is ordered from the CentraLink system or on the instrument, the result message from the instrument will include: ○ The retransmission of all previous results, which are marked as Preliminary. These results will be assigned the R9P flag and the R9R flag on the Centralink system. ○ The repeat result, which is marked as Final with a Repeat flag. Note For tests that are configured to generate patient moving averages, the re-sending of previous results with repeat orders will contribute to the moving average. page 358 11222683 Rev. A UIW Driver for ADVIA XPT Systems If repeated results are on hold on the instrument, and a result other than the last result is designated as the active result, then the instrument will upload the following results: • Non-active results are marked as Preliminary and as manually validated (P and V status) • The active result is marked as Final and manually validated (F and V status) When you select Automatically Send All Patient Results and Additional Data Except Results on Hold, the instrument transmits repeat test results in the same result message; the final result always follows the preliminary result(s) in the message. Preliminary Results and the CentraLink System On the CentraLink system, results are stored in the order that they are received: the final result is displayed in the Current Result column, and the previous result is displayed in the Previous Run column. However, in the CentraLink Results of Request window (to choose, right-select the result and Related > Results), results received in the same message, and within the same second, may not be displayed in the order in which they were received. In the Results of Request window, to identify results marked as preliminary, right click on a result and select Related > Flags. The following status flags may display: • R9P Preliminary result. • R9R Resent result. This may be applied to a preliminary or final result. Resent preliminary results have both the R9P and R9R flags. • R9C The result has been corrected on the instrument and resent. • R9V The result has been manually validated or released on the instrument. Preliminary results that have been manually released have both the R9P and R9V flags. Note There is no flag associated with the Final result status. Retransmission of Results (Centaur XPT) Manually retransmitted results from the instrument will be accepted by the CentraLink system if the existing result status is Rerun, Scheduled or Review. Take caution when manually retransmitting results from the instrument: tests that are awaiting repeats will show multiple results in the Review and Edit window, when the same result has been received multiple times. 11222683 Rev. A page 359 UIW Driver for ADVIA XPT Systems Unresulted Test Notification If Send Unresulted Test Status to LIS is enabled on the instrument, tests that cannot be processed will appear with the result value X-NORESULT in the CentraLink database. A comment describing the problem is transmitted by the instrument, stored as a sample comment in the CentraLink database, and may be uploaded with validated results to the host. Note The comment will be stored only if the sample comment field is not already populated. Subsequent sample comments from the instrument will not be stored for that sample in the CentraLink database. Patient Demographics The ADVIA Centaur XPT system stores patient details downloaded from the LIS with the sample. The demographics are also stored as patient records on the instrument for reporting and delta checking. The reuse of Patient Identifiers, either on the instrument or on the CentraLink system, can cause a mix of demographics and affect manual order entry, consolidated reporting, and delta checking on the instrument. WARNING Do not reuse patient IDs. If you reuse a patient ID that is already referencing another physical patient, patient demographic updates downloaded from the LIS would overwrite the original patient details associated with this patient ID. Under this circumstance, an erroneous mix of new patient details that pertain to another physical patient would coexist in the same record of the CentraLink database, with unrelated patient details that pertain to the original physical patient. This also applies to the ADVIA Centaur XPT system; patient identifiers are not purged so reuse of patient IDs can lead to a mix of demographics on the patient record stored on the instrument. The ADVIA Centaur XPT system does not upload Patient IDs or Patient Demographics to the CentraLink system when the orders are manually entered on the instrument. This can affect delta checking and norm range evaluation on the CentraLink system. page 360 11222683 Rev. A UIW Driver for ADVIA XPT Systems Note The ADVIA Centaur XPT system supports Patient Identifiers of 20 characters. The CentraLink system will not download any demographics (including Physician ID and Patient Location) to the instrument if the Patient Identifier exceeds 20 characters. Additionally, if the following fields exceed the maximum values supported by the instrument software, they will not be downloaded with the order by the CentraLink system: Field Maximum Length Last Name 20 characters First Name 16 characters Middle Name 16 characters Physician ID 10 characters Patient Location 20 characters Species 12 characters If the combined length of the Last Name, First Name, and Middle Name fields exceeds 30 characters, the name is not downloaded with the order by the CentraLink system. If any of the Last Name, First Name or Middle Name fields exceeds the maximum length supported by the instrument, the patient name will not be stored with the order by the instrument. Instrument Flags The CentraLink system will be configured with all known ADVIA Centaur and ADVIA Chemistry XPT instrument flags at the time of the driver installation. If an updated version of the instrument software is installed on the ADVIA Centaur or ADVIA Chemistry XPT system, check the release notes associated with the update for the addition of new instrument flags, and if necessary, ensure that the new flags have been added to the CentraLink database as part of the update process. System Features Not Supported The following ADVIA Centaur and ADVIA Chemistry XPT LIS interface features are not supported in CentraLink software 14.0.8 and later: 11222683 Rev. A • Transmission of result queries from the CentraLink system to the ADVIA Centaur XPT System. • Instrument query for Quality Control orders. • Instrument query by Rack ID, or using a Sample ID range. • Reception of preliminary results from the instrument. page 361 UIW Driver for ADVIA XPT Systems • Blanking of existing Patient Demographic field on the instrument by downloading "" (double quotation marks). • Download of cancellation orders to the instrument. • Extraction of the manual dilution factor from uploaded results (the Manually Diluted flag is extracted and applied to the results).(Centaur only) • Download of a manual dilution factor with an order. • Extraction of reference ranges associated with a result. The reference ranges can be defined in the CentraLink software. • Extraction of the Reagent Lot Number from the result message. • Status messages indicating the reagent level. Note For more information regarding these features, see the system documentation. Support for Infectious Disease Testing Infectious disease testing that requires repeat testing as part of the Instructions For Use, and also requires all results to be sent to the LIS, is the same as described for Centaur XP instruments in the following bulletins: 084D0025-05 Infectious Disease Testing with ADVIA Centaur® and ADVIA Centaur XP Systems CentraLink® Systems (In the United States Only) 084D0026-03 Infectious Disease Testing with ADVIA Centaur® and ADVIA Centaur XP Systems ADVIA CentraLink® Systems (Outside the United States Only) 084D0034-06 Rev. B, EHIV Testing on the ADVIA Centaur® and the ADVIA Centaur XP Systems 084D0069-02 Rev. A, CHIV Testing on the ADVIA Centaur® and the ADVIA Centaur XP Systems Note To perform Infectious Disease testing on the CentraLink system, when the Final Result Rule is disabled on the ADVIA Centaur XPT instrument, leave the Transmit Results by Sample checkbox on the LIS Configuration window unselected. If this setting is selected, results are transmitted from the instrument only when all tests ordered for the sample have resulted. For ID assay tests that have been repeated in duplicate, all results will be transmitted in a single message to the CentraLink database, which will accept only one test result and reject the others. page 362 11222683 Rev. A UIW Driver for ADVIA XPT Systems This result rejection may also occur if a communication break occurs between the CentraLink system and the ADVIA Centaur XPT instrument during the processing of repeats in duplicate for Infectious Disease tests. When communication is restored, repeat results are transmitted in the same message, and the CentraLink software rejects the second result. In the CentraLink Review and Edit window, the test is held in the state Review with a comment “Waiting for Result 3.” When this occurs, compare the current result in the CentraLink database with the instrument-generated results: • If all three results are valid, and if the current result is consistent with the final result according to the IFU, it should be considered for validation. • If all three results are valid, and if the current result is not consistent with the final result according to the IFU, but the first result is consistent, revert to the first result. • If any of the results are not valid, edit the result in the CentraLink system to a value of “INVALID” to prevent auto-validation. Follow the instructions for invalid results in the relevant documentation. Note If communication is down or disabled between the CentraLink system and the ADVIA Centaur XPT instrument, stop processing Infectious Disease tests (new or pending repeat orders) if the Final Result Rule is not enabled for those tests on the instrument. On automation systems, take the instrument offline until the connection to the CentraLink system is restored. If initial and repeat results are generated and cannot be sent to the LIS, the initial result may not be the first result in the message sent to the CentraLink software when communication is restored. If one of the repeat results is transmitted first in the message and is not in the repeat range, the CentraLink system might auto-validate the result, even if it is not consistent with the final result rule. Before restoring communication with the CentraLink system: 11222683 Rev. A • At the instrument, review any samples with ID Assay test that have initial and repeat results that have not been uploaded to the CentraLink database. • If neither the initial nor repeat results are consistent with the final result rule, delete the results, and reorder and repeat the test on the instrument. page 363 UIW Driver for ADVIA XPT Systems ELF Results On the ADVIA Centaur XPT instrument, the Enhanced Liver Fibrosis Test (ELF) score is reported without a result aspect, and the interpretive result is reported with an INTR aspect. In the CentraLink software, the ELF score and interpretive values are treated as separate results, rather than as separate aspects of the same result. In the Review and Edit window, the interpretive result appears in the Current column, and the ELF score appears in the Prev Run column. The CentraLink system will upload only the interpretive result to the LIS. Your Siemens technical support provider can configure the CentraLink system to also upload the ELF score to the LIS, as a comment of the interpretive result. page 364 11222683 Rev. A Symbols ? placeholder, using 19 A Add-on programs setting the language for 312 Advanced privilege 280 ADVIA 120 QC data, importing 177 ADVIA CentraLink system logging on and off 13 Allow on type error 78 Ambiguous result patient 75 ambiguous result patient 76 Aspect, defining 195 Audit tab of Request window 114 Autovalidation, Configuring 247 B Backing up ADVIA CentraLink 308 Binocular icon, using 21 Browser windows 17 C CentraLink system introduction 10 operator functions 12 system management functions 12 tips 21 toolbar 16 using the workspace 14 Closing Out QC 176 Coding systems container type 258 sample type 257 setting up 255 species 258 test codes 256 using 256 Comment tab of Request window 113 Comments appending to a request 102 11222683 Rev. A coded comments 102 viewing 79 Component test 135 Concentrator overriding values 226 workorder processing 226 contacts 321 Container type code setting up 258 Context menus 18 customer service 321 D Dashboard using 291 Databases checking storage 303 purging data 305 restoring 310 Default privilege 280 Default report model changing 268 Delta norms 192 Diff Pad 117 using 115 Dilution tab of Request window 112 Dimension editor, using 190 Dimension, setting 190 Double-select menus 18 E Editor windows 17 Enter results manually 92 Error Messages 315 F Feature Auto-skip sample 95 Field access controlling 281 Field data protecting 280 Find function, using 21 page 365 Flags viewing 76 Functions adding to privileges 276 H Hematology Review and Edit Window (Patient and Sample Toolbars) 125 I Ignored deviation count 146 Images viewing 87 Importing ADVIA 120 QC data 177 Instrument flags setting 235, 236 Instrument Groups Creating and Modifying 267 Instrument tests (methods) 237 Instrument tests (methods) and flags 235 Instruments viewing information 216 Invalidating results 101 K Keyboard shortcuts 20 L Languages changing 311 defining 311 selecting and adding 310 setting for add-on programs 312 Levey-Jennings graph about 149 the button bar 150 viewing 148 LIS Previous Result tab of Request window 114 Log file checking 286 Logging on and off 13 page 366 M Menus context 18 double-select 18 using 17 Method, setting 237 Morphology flags 191 moving average viewing 156 N New users adding 271 Norms 191 O Omit a test 100 Omitted results viewing 101 Omitted status, defined 81 open channels 210 open system 210 Operator functions about 12 Order entry 132 P Panels 195 deleting 197 Patient and Sample Toolbar Icons 125 Patient locations, configuring 259 Patients accessing records of 136 Pending status, defined 81 Physician adding a report model 137 Physicians browsing 136 Print Commands 137 Printers adding 312 Printing (configuring printers) 312 Privileges 11222683 Rev. A adding 275 adding functions 276 adding users to a 276 advanced 280 assigning 274 protecting tables and fields 280 Q QC Browser color display 163 QC Close Out 176 QC Data Point auditing 174 comment 174 omitting 173 reinstating 173 QC Data, viewing 155 QC lot adding 141 viewing 140, 261 QC population query 143 QC population report generating QC population reports. 260 QC Results QC result flags 171 QC results viewing 148 viewing Levey-Jennings graph 148 QC Results (Across Controls View) window 156 QC severity, resetting 166 question mark (?), using 19 R Ratio test 68, 135 calculation for 186 Report formats selecting 137 Report model 137 changing the default 268 Reports 267 Request appending comments to 102 11222683 Rev. A Request window 111 Audit tab 114 Comment tab 113 Dilution tab 112 LIS Previous Result tab 114 Result Detail tab 111 Severity tab 113 Requestables adding tests to 197 creating panels for 195 Rerun advanced reruns 106 manual dilution 106 Rerun status, defined 81 Rerunning a test 91 Restoring the database 308 Restoring the database from disk 310 Result choice editor, using 190 Result choices, setting 190 Result Detail tab of Request window 111 Results entering manually 92 invalidating 101 omitting 100 rerunning 91 selecting by status 83 uploading 331 Viewing associated QC results 101 viewing images 87 viewing omitted 101 Results of request window 97 Review and Edit Access using Preconfigured Toolbar Icon 198 Review and Edit Window 67 Review status definition of 81 Right-select menus 18 S Sample browsing all 27 page 367 details 43 finding a single sample 43 navigating through list of 28 query 29, 30 selecting alternate data 30 status overview 43 using the context menu 37 viewing 23 viewing standard data 29, 30 Sample query window 29 Sample reuse period 99 Sample type code setting up 257 Samples Dispatch to LAS 38 Rerun 38 Scheduling tasks 306 Security setting up 271 Server manually starting 289 manually stopping 288 stopping and starting 286 service 321 Severity tab of Request window 113 Severity, resetting 166 Species Code setting up 258 Specific 29 Starting the server 286, 289 Status sample status 27 Stopping the server 286, 288 system open channels 210 open system 210 System management functions about 12 T Table access controlling 280 page 368 Table data protecting 280 Tasks scheduling 306 Test configuring 179 viewing test list and test details 179 Test aspects, defining 195 Test code setting up 256 Test request information viewing 110 Test, configuring adding test to list 179 creating panels 195 deleting test from list 188 editing a test definition 188 setting delta norms 192 setting morphology flags 191 setting norms 191 setting result choices 190 setting units 189 using the test editor 180 Tips for using the CentraLink system 21 Toolbar adding buttons 314 using the function toolbar 16 ToolTips, using 17 Troubleshooting 315 Type error 74 U Unit dimensions for 190 setting 189 Unit editor, using 189 units of measure identical definition 182 Upload results 331 Uploaded status, defined 81 User interface languages 310 User-defined languages 311 11222683 Rev. A Users adding to a privilege 276 setting up 271 V Validated results uploading 331 Validated status changing 101 definition 81 W Watchdog alerts 291 registering 297 starting and stopping 298 Westgard Rules configuring for instrument 251 configuring for method 253 configuring for test 253 Windows browsers and editors 17 Workorder manually entering 132 11222683 Rev. A page 369 page 370 11222683 Rev. A