CentraLink® Data Management System Operator Training Workbook Siemens Healthineers CentraLink Data Management System Operator Training Workbook CentraLink Data Management System T08001.017 Effective Date: 03/11/22 ©2022 Siemens Healthineers. All rights reserved. ii CentraLink Data Management System Table of Contents 1: Welcome 2: System Overview 3: Sample Management 4: Result Management 5: Quality Control 6: Maintenance and Troubleshooting CentraLink Data Management System iii iv CentraLink Data Management System Welcome 1 Welcome Siemens Healthineers Training would like to welcome you to operator training on the CentraLink® Data Management System. This course is designed to teach you the basic skills needed to operate, maintain, and troubleshoot the CentraLink Data Management System. Our staff welcomes the opportunity to present this training program to you. CentraLink Data Management System 1-1 Welcome Training Course Objectives After participating in this training, you will be able to: 1-2 • Identify system components and their function. • Navigate the CentraLink application. • Manage samples. • Manage results. • Manage Quality Control. • Perform maintenance and troubleshooting. CentraLink Data Management System Welcome CentraLink Data Management System Course Validation Checklist The participant places a checkmark beside the competency when it is completed. When all competencies are checked, the instructor and participant sign and date below as record of completion. Topics Competencies System Overview Describe the communication flow Completed Describe the purpose of CentraLink Software Log in/out of the CentraLink application Identify commonly used icons and toolbars Sample Management Introduce Daily Operations Identify colors on sample screens Quality Control Define QC lot numbers Reset QC severities Generate QC reports, LJ graphs and export Configure patient moving averages Maintenance Perform Daily Operations Troubleshooting Describe the Watchdog Dashboard Shutdown/Startup CentraLink and the server Start/Stop the translators and services Investigate common issues Instructor: __________________________________________________ Participant: __________________________________________________ Date: __________________________________________________ CentraLink Data Management System 1-3 Welcome What was most helpful to you during this program? How can we improve this program to make it more meaningful to you? 1-4 CentraLink Data Management System System Overview 2 System Overview CentraLink Data Management System 2-1 System Overview System Overview Resources • CentraLink Data Management System Operator’s Guide Objectives After completing this module, you will be able to: 2-2 • Describe the features and benefits of CentraLink. • Identify system components. • Describe the communication flow. • Log into the CentraLink application. • Identify commonly used icons and toolbars. • Navigate the CentraLink application. • Log out of the CentraLink application. CentraLink Data Management System System Overview Hardware Overview Label Component Description A 8 Port Lantronix Terminal Server Connects serial instruments to TCP/IP connection B 8 Port HP Switch Connect TCP/IP devices (instruments /printers) C Printer Prints hardcopy reports D UPS Uninterruptable Power Supply – battery backup E CentraLink High Capacity Server Connects up to 39 instruments (version 16 – up to 75 instruments) Not Shown CentraLink Standard Capacity Server Connects up to 6 instruments Communication Flow 1. Orders download from LIS to CentraLink. 2. Sample is introduced to instrument. 3. Instrument reads barcode and queries CentraLink for test orders. 4. CentraLink sends test orders to instrument. 5. Instrument processes tests and sends results to CentraLink. 6. CentraLink transmits final results to LIS. 7. CentraLink requests reruns and reflex tests as needed. CentraLink Data Management System 2-3 System Overview Describe the Features and Benefits of CentraLink Exercise CentraLink Data Management System communicates with connected instruments and automation to manage sample, result, and quality control data. 1. What features of CentraLink will be used in your laboratory? 2. What improvements do you expect to see by using the CentraLink features? Identify System Components Exercise Match the letters from the picture to the descriptions below. _____ Uninterruptable Power Supply (UPS) _____ Printer _____ CentraLink Server with Windows Server Operating System _____ Switch _____ Terminal Server 2-4 CentraLink Data Management System System Overview Describe the Communication Flow Exercise Place these data flow steps in the order in which they occur. ___ Sample is introduced to the instrument ___ Instrument produces the results and transmits to CentraLink ___ Instrument reads the barcode & queries CentraLink for the orders ___ CentraLink transmits the results to the LIS ___ Orders download from the LIS to CentraLink ___ CentraLink sends the orders to the instrument ___ CentraLink requests reruns and reflex tests as needed CentraLink Data Management System 2-5 System Overview Software Overview CentraLink Login Screen Option Description Name User login name – Customer account managed Password Configured account password – CaSe SeNsItiVE Language Not used in the USA CentraLink Workspace Screen 2-6 CentraLink Data Management System System Overview Item # Name CentraLink Description 1 Title Bar Displays database name 2 Menu Bar Menu dropdown buttons 3 Editing Toolbar Icons for common tasks and navigation 4 Function Toolbar Icons for commonly used functions 5 Workspace Displays application browser and windows 6 Status Bar Displays messages, workstation name, and level of logged in user Editing Toolbar Buttons 1 2 3 4 5 New Select All Go to First Record Cut Active window on foreground Copy Deselect All Previous Screen Copy Active window to background Open Lookup Next Screen Paste Resize active window Save Zoom Go to Last Record View Find Delete Find Next Calculator Filter Site Attributes Statistics Print CentraLink Data Management System 2-7 System Overview Functions Toolbar Buttons 1 2 Instruments Browser Services Tests Browser Translators Order Entry Window Patients Browser Physicians Browser Sample Query Window Review and Edit Window Result Entry Window QC Results Window Log off CentraLink To exit or log off the CentraLink application, simply select Start and then Exit. This will require any other users to login to access the CentraLink application. 2-8 CentraLink Data Management System System Overview Log into CentraLink Exercise You are ready to begin using the CentraLink application. At the desktop, select the CentraLink icon. Log in with the user name and password that was created for you. Where is the user name displayed on the workspace? _____________________________________________________________ Identify Commonly Used Icons and Toolbars Exercise Match the icons with their function. Patients QC Results Sample query Physicians Result entry Order Entry Tests Instruments Services Review and edit CentraLink Data Management System 2-9 System Overview Navigate the CentraLink Application Exercise 1. Select the Order Entry icon. Under what circumstance would you need to create a manual work order in CentraLink? Select Cancel when complete. 2. Select the Review and Edit icon. Which window appears? 3. Select OK. a. Which window appears? b. Why would you access this window? 4. Select the QC icon and then select Apply. What happened when you selected apply? 5. Access the Help menu and select About. Review the Application tab to answer the following questions: What version of CentraLink is running? 6. Access the Help menu and select Help. Enter ‘result status’ in the Find field. What is the result status for a test request when it is first created? 7. Select the Sample query icon and click OK. a. What window displays if the user double clicks on a sample? b. What displays if the user right-clicks on a sample? 2-10 CentraLink Data Management System System Overview 8. Select the Review and Edit icon. The Sample query window opens. a. What displays when the user double-clicks on the ? in the Collected from field? b. What displays when the user double-clicks on the ? in the Test field? c. What displays when the user double-clicks on the ? in the Sample ID field? 9. Log out of the CentraLink application. CentraLink Data Management System 2-11 System Overview 2-12 CentraLink Data Management System Sample Management 3 Sample Management CentraLink Data Management System 3-1 Sample Management Sample Management Resources • CentraLink Data Management System Operator’s Guide Objectives After completing this module, you will be able to: 3-2 • Define result and sample statuses. • Search for samples. • Describe Samples browser colors. • Take action using right click menu options. o Report o Review and Edit o Un-schedule requests o Upload validated results • Use Sample Status Overview features. • Create manual work orders. • Print reports. CentraLink Data Management System Sample Management Result Status • Pending (PND): Request is created and downloaded from the LIS • Rerun (RRN): Request with results has been marked for rerun • Scheduled (SCH): Request has been downloaded to the instrument • Review (REV): Test result needs to be manually reviewed • Validated (VAL): Result has been validated by the operator or automatically • Uploaded (UPL): Result has been uploaded to the LIS • Omitted (OMT): Request has been omitted and will not be uploaded to the LIS CentraLink Data Management System 3-3 Sample Management Define Result and Sample Statuses Exercise 1. Match the following result status to its definition: Enter letter from Column B that matches the item in Column A Column A Column B OMT a. Test is first created SCH b. Request for test to be repeated PND c. Instrument has queried for a work order d. Result value that requires attention has been assigned e. Result has been automatically or manually released UPL f. Test order has been removed RRN g. Result has been transmitted to the LIS VAL REV 2. The status of a sample reflects the lowest (earliest) status of a test request within the sample. Review the sample test panels below and fill in the overall sample status. Test Status Test Status CK SCH BUN REV MMB SCH CREAT REV TROPI RRN LYTES REV AST REV GLU SCH ALT REV MG REV GLU REV CA REV SAMPLE STATUS SAMPLE STATUS PLEASE STOP HERE 3-4 CentraLink Data Management System Sample Management Sample Search Using Sample Query 1. Select the Sample query icon . 2. Enter parameters to narrow the search (? represents a wildcard – no exclusions). 3. More advanced searches can be performed by selecting a filter from the advanced tab. Basic Query Options Advanced Query Options Note: if no parameters are entered, all samples in the database are displayed by default. This is NOT recommended as it will affect performance. CentraLink Data Management System 3-5 Sample Management 4. Select OK to apply the query and display samples in the Samples browser. 5. Use the spacebar to individually select or the Select All selections in browsers. button for mass Use the spacebar to individually deselect or the Deselect All mass (de)selections in browsers. 3-6 Right Select option Right Select Action Report Allows the generation of a sample report Review and Edit Opens a Review and Edit window for the selected samples Un-schedule requests Allows the un-scheduling of requests for selected samples button for CentraLink Data Management System Sample Management Search for Samples and Take Actions Exercise 1. Select the Sample query icon. Perform a query to return any sample that has at least one test in Review status. a. How would you ensure to include all samples with at least one test in Review status? b. How do you select and deselect individual samples in the Samples browser? c. What do you select so that the total number of samples is displayed in the status bar at the bottom? d. Why are there samples listed that have a status other than REV? e. What is the significance of the different colors? 2. Scenario: The IMMULITE 2000 1 is taken offline for maintenance. You removed sample tubes off the instrument during this time. The removed samples will have the tests in what status in CentraLink? a. Can you run these samples on another instrument with no further action? b. To query for these specific samples, what options would you select in the Sample query window? c. From the Samples browser, what “right click” menu action would you need to perform? d. What does the status of the samples change to? CentraLink Data Management System 3-7 Sample Management 3. Scenario: You are trying to find the ER sample that you ran a STAT CTNI on within the last hour. What information would you use to query for samples that would fit this criteria? 4. Scenario: A nurse calls to inquire about results for sample ID DD002936.You want to go to the instrument to investigate the delayed labs. From the Samples browser what “right click” menu option opens a window that displays the instrument in question? 5. Scenario: Daisy Johnson’s sample DD000121 was deleted from the LIS by mistake and it needs to be re-transmitted. Use the Sample query to locate and re-transmit the results. a. How do you know that this sample has been transmitted before? b. What two right-click options are there for transmitting results? c. Will you also need to do this for all samples that are run during an LIS downtime? PLEASE STOP HERE 3-8 CentraLink Data Management System Sample Management Sample Status Overview 1. From the menu bar, select Start > Routine > Samples > Status Overview. 2. Select the checkbox and enter number of minutes for data counters to autorefresh. CAUTION Do not select the Purge button as this will use all system resources to purge qualifying data. Sample Status Overview Version 16 CentraLink Data Management System 3-9 Sample Management Creating My Counters User-defined counters can be created in the My counters section of the Sample status overview window. 1. Select the Ellipsis button (at the right of a counter). 2. Using the Sample query window define the counter and select OK. Basic Query Options Advanced Query Options 3. Using the text box label the counter based on the query parameters set above. (CTNI>30 is the free text example) 4. Select the checkbox next to the new counter and select the Refresh button to update the counter. 3-10 CentraLink Data Management System Sample Management Use Sample Status Overview Features Exercise 1. Select the Sample Status Overview toolbar button. What is the total number of samples in Review status? 2. Select the button indicating the total number of samples in Review. a. What type of window opens? b. Without leaving this window, how can you change the list to all samples with at least one request in Review? c. How many samples are in the list now? 3. Set up a counter for Vista Troponins (CTNI) that has been pending for more than 30 minutes. a. What button do you use to start the configuration? b. Which fields do you complete to create the counter? c. Will every logged in user see this counter? PLEASE STOP HERE CentraLink Data Management System 3-11 Sample Management Create a Work Order 1. Select the Order entry icon Order Main tab . Order More tab 2. Type the Sample ID (Required field). 3. Enter the tests in the Requests field (Required field) – (double select to select from Requestables list). 4. Enter the Collection Date and time in the Collection D/T field – (double select for date picker). 5. Double select Sample types and choose the sample type. 6. Double select Container type and choose the container type. 7. Double select Patient ID to display a list of patients, chose the patient or create a new record. 8. Double select Patient location and choose a patient location. 9. Select the More tab to add a comment to the order. 10. Select OK. 3-12 CentraLink Data Management System Sample Management Work Orders Exercise 1. Create a manual work order with the following information: • Sample ID: 112233 • Panel: !Chem4 • Priority: STAT 2. When would the ordering of panels from the CentraLink most likely be used? 3. What advantage is there to entering manual work orders in CentraLink during downtime? Print Sample Reports 1. Select the Sample query icon . 2. Enter parameters to narrow the search (? represents a wildcard – no exclusions). 3. Select OK. 4. Select one or more samples. 5. Right select in the sample browser > Report. 6. Select the printer. 7. Select OK. Print Reports Exercise A doctor’s office is requesting faxed reports on 4 consecutive samples with IDs (DD001638 through DD001641) that were run on Vista1500 1 and uploaded to the LIS. The lab printer is temporarily out of order so you decide to use the CentraLink printer. Does the CentraLink Report feature generate all 4 reports at once or one at a time? PLEASE STOP HERE CentraLink Data Management System 3-13 Result Management 4 Result Management CentraLink Data Management System 4-1 Result Management Result Management Resources • CentraLink Data Management System Operator’s Guide Objectives After completing this module, you will be able to: 4-2 • Search for samples using Review and Edit icon. • Describe Review and Edit features. • Use Review and Edit features. o Function buttons o Right click menu options o Audit validation or omission user • Review results for status, severity, and color. • Use advanced features of Review and Edit. o Right click > Related > Results o Windows preferences o Coded comments and free text CentraLink Data Management System Result Management Sample Search using Review and Edit 1. Select the Review and Edit icon . 2. Enter parameters to narrow the search. Basic Query Options Advanced Query Options Note: Status is preselected as Review. 3. Select OK to apply the query and display the Review and Edit window. 4. Use the navigation buttons on the main system toolbar to navigate between samples. Go to first, Previous, Next, or last record. CentraLink Data Management System 4-3 Result Management Sample Search Using Review and Edit Exercise Perform a Review and Edit sample query for all samples that have at least one result in Review status. 1. Where is the number of samples returned from the query displayed in Review and Edit? 2. How do you navigate to the next sample? 4-4 CentraLink Data Management System Result Management Review and Edit Screen Overview Description 1 Sample information area: Basic tab - displays sample and patient demographics Advanced tab – displays additional demographics LAS tab – displays information specific to lab automation 2 Tests and results area – see table below for details 3 Function (disposition) area – see next page for details CentraLink Data Management System 4-5 Result Management 4-6 Column Description 1st column Indicates selected items (>) Test Requested test Sts Status of requested test (see Status definitions) Current Current result value F Asterisk (*) indicates a flag is present; flag description displays in Flags field below P Asterisk (*) indicates a previous result could not be translated into a value Prev Run Result from the previous run for this test Prev Sample Most recent result value from a previous sample on the same patient Date/Time Date and time that the previous sample value was recorded Norm Normal range of acceptable values NS Value that indicates the degree to which a result is out of the normal range DS Delta norm severity – Value that indicates the failure of a delta check QS Quality control severity – Value that indicates a violation of Westgard rules IS Instrument flag severity – Value that indicates the presence of an instrument flag(s) C Asterisk (*) indicates a comment is present which is described in the Comments field T Asterisk (*) indicates an instrument has been targeted to perform the test Instrument Instrument that produced the result or has been targeted to perform the test CentraLink Data Management System Result Management Result Actions in Review and Edit 1. Select the test(s) requiring action. a. Select a test by highlighting it and pressing the spacebar OR use the Select dropdown option in the function area to select or deselect multiple tests. b. Select Apply. 2. In the function area of the Review and Edit window select the appropriate button. Function Button Button Action Validate Validates selected results Rerun Reruns selected tests Rerun All Reruns all tests on sample Revert Reverts selected test to previous results Upload Uploads selected tests to LIS Flags Opens window to review all flags for the sample Comments Opens window to review all comments for the sample Options Sets flags, Image and comments windows to remain open (user specific) CentraLink Data Management System 4-7 Result Management 3. Select the appropriate action from the Right select menu in Review and Edit. 4-8 Right Select option Right Select Action Edit result comment Allows free text comment or enter /, then mnemonic for a coded comment Related> Results View all results, Date, Time and Instrument for selected test Revert Enables selecting a final result from a list of results for the selected test Un-schedule Changes the selected order status to pending making it available to be run on another instrument View QC Enables viewing of quality control of the selected test CentraLink Data Management System Result Management Review and Edit Screen Overview version 16 Column Description Prev Run D/T Date and time of the previous run for this request Unit Unit of the current result #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 TAT Turn Around Time calculation for the request. The calculation is based on the start event and end event defined on the Review and Edit tab of the system Options window CentraLink Data Management System 4-9 Result Management Customize Review and Edit Screen version 16 Navigate to the Review and Edit window by selecting the Review and Edit icon. Then select OK. 1. Select the Visibility button in the top right corner. 2. The columns with a checkmark are displayed in the Tests and results area. 3. To remove a column from displaying in the standard Review and Edit window, select the column name in the list so that the checkmark is removed. Note: The column visibility setting is user specific and the following columns cannot be hidden. 4-10 • Test • Current CentraLink Data Management System Result Management Use Review and Edit Features Exercise 1. Select the Coag toolbar button. a. How many samples are displayed in the counter? b. Navigate to sample 230001. What is the result, date and time of the patient’s previous APTT? c. Is the instrument shown for the current result or previous result? 2. Validate this result. The system automatically displays the next sample. What comment is associated with APTT result? 3. Deselect the PT and rerun the APTT. What happens to the initial result? 4. In this case, the selection of Rerun was in error. List the steps to release the original APTT result to the LIS. 5. Validate the result and proceed to the next sample. What option in the Select: drop down menu will rapidly deselect all tests? 6. Right click on the D-Di test and select View QC. a. What is the name of the browser that opens? b. What test automatically populates the test field? Note: there are no QC points for this test in this database CentraLink Data Management System 4-11 Result Management 7. Close the QC window and verify that only D-Di is selected. Right click and omit the test, indicating that the doctor cancelled the test. a. What happens to the omitted test on the Review and Edit screen? b. List the steps to see the omitted test on the Review and Edit screen. 8. Double-click the omitted test and select the Audit tab. Who is the Omission User? 9. Un-schedule the APTT. a. What does the status change to? b. Why would a user need to un-schedule a test? PLEASE STOP HERE 4-12 CentraLink Data Management System Result Management Review Results for Status, Severity, and Color The Review and Edit screen displays severities in four columns. Select the Vista toolbar button. Advance through each of the samples and document the test and severities you observe. Sample ID Test and Severities Observed 120020 220001 220002 220006 DD002953 DD003044 DD005011 1. What components and colors are pre-defined in Review and Edit? 2. What colors have been added and what do they signify? 3. If a test shows an NS 1 in green and a DS 3 colored in red what color will the Current value be? 4. What does an NS -1 mean? PLEASE STOP HERE CentraLink Data Management System 4-13 Result Management Use Advanced Features of Review and Edit Exercise 1. You want to review all of the samples that have panic or critical values to see if the result comments are being automatically applied. Set up a Review and Edit query using the filter (Advanced tab) called FL_Find samples with Panic (Critical) values. With Review and Edit displayed, open the Comments window so it is easy to view all comments. What occurs as you advance through the samples using the navigation buttons? 2. You would like for the Comments window and Flags window to open automatically when you review samples. Set up the Windows preferences from the Review and Edit screen. a. What happens when you close and re-open Review and Edit? b. Are these settings user-specific or server-specific? 3. You queried for sample 220006 to review the delta severity. You notice that there were no comments associated with the calcium results. Add the coded comment “Review for clinical validity” using the mnemonic /REVIEW. a. What path would you take to add a comment to the result? b. What should you enter in the pop up window? c. What does it change to when you select Update? d. What appeared in the Comment field in the Review and Edit window? 4. Now add the free text comment “Test has been rerun”. Describe 2 ways that you can read all of the comments that you entered above. 4-14 CentraLink Data Management System Result Management CentraLink Data Management System 4-15 Quality Control 5 Quality Control Levey Jennings CentraLink Data Management System 5-1 Quality Control Quality Control Resources • CentraLink Data Management System Operator’s Guide Objectives After completing this module, you will be able to: • View QC results. • Take action on QC results and document. o Omit and reinstate data points o Enter QC comments • Define QC lot numbers, reference and target ranges. • Reset QC severities. • o For single test using QC icon o For all tests using Instruments icon Generate QC reports, LJ graphs and export data. o • 5-2 Viewing versus printing Configure patient QC moving averages. CentraLink Data Management System Quality Control View QC Results Option 1: 1. Access the Review and Edit window. 2. Right click on a test > View QC. Option 2: 1. Select the QC Results icon . 2. Enter parameters to narrow the search. 3. Select Apply. QC Results Screen Overview 1 1 2 2 3 Description 1 Query parameters area 2 QC results area – see table for details 3 Statistics area – see table for details CentraLink Data Management System 5-3 Quality Control 5-4 Column QC Results Area Description Test Test Instrument Instrument that ran the QC Lot/Species Lot number of the QC material; ‘Human’ indicates patient QC Assessed Date and time the QC was run GH Indicates that a QC severity has caused other methods to have their severity set, placing a Group Hold on the results. C Asterisk (*) indicates a comment which is displayed in the Comment field below String Value QC result F Asterisk (*) indicates an instrument flag which is displayed in the Flags field below MS Method Severity -3 -3 to -4 SD; result beyond -4 SD is indicated by a left arrow -2 -2 to -3 SD -1, 0, +1 -2 SD to +2 SD +2 2 to 3 SD +3 3 to 4 SD Right Select Option Right Select Action Edit comment Allows free text comment or enter /mnemonic for a pre-defined comment Omit Allows removal of QC result from statistics; requires comment Reinstate Allows restoring omitted QC result; requires comment Upload Uploads selected QC results to LIS Related Allows access to the Actions menu and QC Populations CentraLink Data Management System Quality Control Levey Jennings Chart Legend Green ±2 SD Yellow ±2-3 SD Red±3-4 SD Statistics Area Description Comment Displays description of comments; corresponds to asterisk in the C column Flags Displays description of instrument flags; corresponds to asterisk in the F column Target value Manually entered value that the QC of the method is aiming for Target deviation Value that represents 1 standard deviation from the target value Current QC results that are active and can be edited or commented Cumulative QC results that have been closed out and cannot be edited or commented Date range QC results that were assessed between the dates and times entered in the query parameters area N Number of QC results Mean Average of QC results SD Standard deviation of QC results CV% Percent coefficient of variation of QC results Reset severity Function button that sets the method severity and QC severity back to zero CentraLink Data Management System 5-5 Quality Control View QC Results Exercise Review the Potassium (K+) QC results on the Vista instruments. 1. What steps are necessary to view lot 45631 only? 2. What statistics are available to the operator from the QC Results screen? 3. What additional statistics are available when you enter January 1, 2012 to January 27, 2012? Take Action on QC Results and Document Exercise Now review the statistics for Vista1500_2 only. 1. What steps would you take to omit the QC points from January 5th & 6th that are due to an “instrument problem” using IP as the mnemonic for the comment? 2. What changes are observed after the points are omitted? 3. How can you undo the omission of the data point on January 5th using the free-text comment – omitted by mistake? PLEASE STOP HERE 5-6 CentraLink Data Management System Quality Control Enter QC Lot Information 1. Start > Routine > Quality Control > QC lots > by lot number. 2. Double select Autocreated QC lot (For New Lot, Select the New icon ). 3. Enter Name, Level and Expiration date. 4. Select OK. 2 Set Target and Deviation 1. Start > Routine > Quality Control > QC Populations. 2. Select lot number (double click to browse) > OK. 3. Right select on test > Set target. 4. Enter Target value and enter 1SD for the Target deviation. 5. Select OK. CentraLink Data Management System 5-7 Quality Control Define QC Lot Numbers, Targets, and Reference Ranges 1. New lots of QC were just assayed on an instrument. How are QC lots created in the CentraLink Data Management System? 2. Select the QC Results icon on the toolbar. Set the query parameters for Lot 78231 and select Apply. What is missing from the LJ Chart and why? 3. Access the QC lots browser by the following path: Start> Routine > Quality Control> QC Lots> By Lot Number. a. What is the first clue that the new lots crossed over to CentraLink? b. What should you do to finish the QC Lot’s creation? 4. The package insert indicates the following information: Lot 78231 78232 78233 Mean 14.0 sec 30.2 sec 48.8 sec 2SD range 11.4 – 16.6 24.2 – 36.3 39.0 – 58.5 From the QC Lots table, select the Lot, right-click, Related, select QC Populations, and select OK. Right-click and select Set Target to enter the given target and deviation. a. What values did you enter for the deviations of 1SD? b. In this window what other values are set by default? 5-8 CentraLink Data Management System Quality Control Reset Method Severity Individual Test 1. Select the QC Results icon . 2. Enter Query parameters > select Apply > Reset severity > enter a comment. CentraLink Data Management System 5-9 Quality Control Reset Method Severity Multiple Tests on an Instrument 1. Select Instrument icon . 2. Right select on Instrument > Related > Tests. 3. Select applicable tests (use spacebar to select). 4. Right select > Reset QC severity. 5. Enter comment. 6. Select OK. 5-10 CentraLink Data Management System Quality Control Reset Method (QC) Severities Exercise 1. Select Review and Edit. Query all samples with at least one result in Review for IMMULITE 2000_2. a. What severities were triggered to put these samples in Review? b. To investigate this severity, what action can you take from the Review and Edit Screen? CentraLink Data Management System 5-11 Quality Control 2. Review the KT4 QC results on the QC Results (Across controls view) window. a. What is the color and severity in the MS column of the QC result of 4? Note: In a live environment the Test, Instrument, and Value columns would be the same color as the MS b. What is the color and severity in the MS column of the good QC result of 3 that was processed at 12:58 and why? c. What stops occurring when a Method Severity is set? 3. Navigate to IMMULITE2000_2 > Related > Tests. What severity is shown for KT4? 4. Return to KT4 QC results on the QC Results (Across controls view) window. What action must be taken to recover from a QC violation? Perform that action now. Note: In a live environment the Test and Instrument, columns will turn back to white. 5. Repeat the Review & Edit query from Step 1. a. What is the status of the held results from before? b. What action must the operator perform to release these results to the LIS? c. Some of the held patient results were processed after the quality control was reprocessed and filed as acceptable. Why were these results still held in Review? PLEASE STOP HERE 5-12 CentraLink Data Management System Quality Control Generate Reports, LJ Graphs, and Export Data By QC Population 1. Select Instrument icon . 2. Right select Instrument > Related > Tests. 3. Right select test > Related > QC populations. • Select one or multiple lots. • Right select on a highlighted lot > Report. o Report • • CentraLink Data Management System Format: • HTML – displays/prints statistics, Levey-Jennings graph, and values for one QC population per page. • Text – displays/prints statistics and values for one QC population per page. Select date range. (1/1/12-1/27/12) 5-13 Quality Control Levey-Jennings • Select date range. (1/1/12-1/27/12) Export 5-14 • Enter first and last day of the month. • Select Bio-Rad Summary Data format. • Locate file on D:\CentraLink. CentraLink Data Management System Quality Control Export Lot Data 1. Start > Routine > Quality Control > QC Populations. 2. Select a QC lot (double click to browse) > OK > OK. 3. Select all . 4. Right select > Export >. d. Enter first and last day of the month. e. Select Bio-Rad Summary Data format. f. Locate file on D:\CentraLink. CentraLink Data Management System 5-15 Quality Control By QC Lot 1. Start > Routine > Quality control > QC Lots > by lot number. 2. Select one or more lot numbers. 3. Right select > Report. • 5-16 Format: o HTML – displays/prints one continuous report per lot which includes statistics and Levey-Jennings graph for each QC population in that lot. o Text – displays/prints one continuous report per lot which includes statistics for each QC population in that lot. • Enter date range. (1/1/12-1/27/12) • Select Sort by: Instrument or Test; if sorted by Test enables side by side comparison of values from like instruments. • Select OK. CentraLink Data Management System Quality Control Generate QC Reports and Export Data Exercise 1. Create a QC Population report for creatinine on Vista 1500_1 for Lots 45631 and 45632 for preview in HTML for January 1, 2012 to January 27, 2012. Did it generate a report of statistics, Levey-Jennings graph, and values for one QC population per page? 2. Create a QC Population report for creatinine on Vista 1500_1 for Lots 45631 and 45632 for preview in Text for January 1, 2012 to January 27, 2012. Did it generate a report of statistics and values for one QC population per page? 3. Create a QC Lot report for Lots 45631 and 45632 for preview in HTML for January 1, 2012 to January 27, 2012. Did it generate one continuous report per lot which includes statistics and Levey-Jennings graph for each QC population in that lot? 4. Create a QC Lot report for Lots 45631 and 45632 for preview in Text for January 1, 2012 to January 27, 2012 sorted by Test. a. Did it generate one continuous report per lot which includes statistics for each QC population in that lot? b. What does sorting the report by test enable you to do? 5. You would like to export the QC populations for this lot in Bio-Rad Summary Data format. What must be specified on the QC Lots editor window for a successful Bio-Rad export? PLEASE STOP HERE CentraLink Data Management System 5-17 Quality Control Configure Patient Moving Averages Set the batch size and enable the method all at the Method level 1. Select the Instruments icon . 2. Right select the Instrument> Related> Tests. 3. Double select the test. 4. Select the checkmark in the Moving Average area of the Method window to enable the moving average.. 5. Enter a value for the Batch size directly beneath the enabled radio box. 6. Select OK. 5-18 CentraLink Data Management System Quality Control Configure Patient QC Moving Averages Exercise 1. Configure Patient QC for K+ with a batch size of 1 on Vista 1500_2. Which two fields must be completed to set up this configuration? 2. Select the QC Results icon. Set query parameters to APTT and Patient and select Apply. What is missing from the chart for the patient QC values displayed? 3. Enter a target mean of 30 and 1SD value of 2.5 for the patient QC for APTT. 4. Access the Review and Edit screen for samples provided. a. What severities, if any, were applied to this sample and why? 5. Select the QC Results icon on the toolbar. Set the query parameters to APTT and Patient. Select Apply. a. What does CentraLink use for the lot number of Patient QC? b. What is the Method Severity and Comment for the patient QC value of 50? PLEASE STOP HERE CentraLink Data Management System 5-19 Maintenance and Troubleshooting 6 Maintenance and Troubleshooting CentraLink Data Management System 6-1 Maintenance and Troubleshooting Maintenance and Troubleshooting Resources • CentraLink Data Management System Operator’s Guide Objectives After completing this module, you will be able to: 6-2 • Navigate the LIS Downtime procedure. • Stop and start translators using Watchdog. • Perform proper shutdown and startup of the server. • Monitor server and investigate common issues. • Perform Daily Operations. CentraLink Data Management System Maintenance and Troubleshooting LIS Downtime Procedure Services and Translators 1. Select the Translators icon . 2. Highlight the LIS Translator. 3. Right select and choose Stop. 4. Go to Start >System Management >Commands >Tasks>By Next Run. 5. Double select Report Validated Samples. CentraLink Data Management System 6-3 Maintenance and Troubleshooting 6. Modify From and Next Run boxes to Current Date and/or Time. 7. Select the Services Icon . 8. Highlight Downtime Reports. 9. Right select > Start. 6-4 CentraLink Data Management System Maintenance and Troubleshooting Manually Ordering Samples 1. Select on Order Entry icon . 2. Scan the Downtime Label or manually type the SID into the Sample ID field, enter the collection date and time if needed. 3. Double select in the Requests box. 4. Start typing the name of the test or panel to be ordered. Highlight the name and press the space bar to place a “>” next to it. Type the name of the next test if you need to select more than one. Press the space bar again to select. Repeat this until all tests are selected. 5. Select on the OK button at the bottom of Requestables window. CentraLink Data Management System 6-5 Maintenance and Troubleshooting 6. Fill in demographics if you want the patient name attached. If CentraLink has seen this patient before, you can double click in the Patient Last Name or Patient ID boxes to find him. Select the patient from the list and the information will populate the fields. Be careful to choose the right one as the Patient ID is different than the Sample ID. You may need to enter demographics to ensure correct reference ranges (male/female or age specific ranges) are reported on printout. 7. Select OK at the bottom of Order Entry window. 8. If the patient is not in the list, type directly into the boxes on the Order Entry screen. You must fill in Patient ID, Last Name, First Name, Birth Date and Sex. See Example Below. 9. Select OK on Specified patient not found; create? 10. Repeat steps for all patients to be ordered. 6-6 CentraLink Data Management System Maintenance and Troubleshooting After the LIS Downtime 1. Restart the LIS translator. 2. Stop the Downtime Reports service. CentraLink Data Management System 6-7 Maintenance and Troubleshooting Troubleshooting Communication Status Dashboard (Watchdog) If you are experiencing any communication issues with results or orders not uploading or downloading to the LIS, Watchdog can be used to identify color coded issues. RED LIS or Instrument communication has been inactive for more than 1 minute GREY Communications are inactive – connections may have been manually stopped GREEN Communication is Active and CentraLink reports no errors with sending or receiving To access the Watchdog Dashboard, select the If a connection shows as red and is having communication issues, it can be restarted by Right clicking the device button and first selecting Stop, then Start to restart the service or translator. 6-8 CentraLink Data Management System Maintenance and Troubleshooting Utilize Watchdog Communication Dashboard Exercise 1. Launch the Watchdog Communication Dashboard. a. What is the name of the shortcut used to launch Watchdog? b. What colors would you expect to see in the dashboard when all devices and connected? 2. Stop the LIS translator a. What is color of the translator and what does it mean? b. When would you want to stop the LIS translator? PLEASE STOP HERE CentraLink Data Management System 6-9 Maintenance and Troubleshooting Server Shutdown and Startup 1. Log off or close the CentraLink application on all Clients (if applicable). 2. Start > System Management > Services > Shutdown. 3. Wait for the services to stop. 4. Close CentraLink by going to Start in the Application and Exit. 5. Select the Windows Start button 6. Select the Shut Down button . . 7. Select Restart in the top field. 8. Enter the reason for shutting down in the Comment field > OK. 9. After restarting log into Windows with: User names: LabManager, LabTech, RemoteLabTech Password: Siemens1 (default for all users) 10. Select the CentraLink desktop icon . 11. Log in with a valid CentraLink user account. 12. Start > System Management > Services > Startup. 13. Select OK. 6-10 CentraLink Data Management System Maintenance and Troubleshooting Shutdown and Startup of the Server Exercise The CentraLink is having some communication issues and you have been advised to properly shutdown and restart the server. 1. When is it necessary to shut down and restart the CentraLink application and server? 2. Is the Watchdog Dashboard available after you shut down the services? 3. After the final step in the startup process is the Watchdog Dashboard available? 4. Are the translators running? 5. When were they restarted? PLEASE STOP HERE CentraLink Data Management System 6-11 Maintenance and Troubleshooting Investigate Common Issues Start-up Database Error Problem: After rebooting the server, the following error appears when trying to launch the CentraLink application Solution The database had not completed its startup before CentraLink was launched; Wait a few minutes and try again. Monitor External Devices Problem: CentraLink is not communicating with an instrument, LAS or LIS. Solutions 1. What should you check to rule out hardware failure? • Loose or broken cables and adapters. 2. What connectivity indicators should be checked? • NIC link lights are blinking on the server. • Switch power light is on. • Switch port lights are blinking. • Terminal Server power light is on. 3. What should you check within the CentraLink application? • Check activity of services and translators. 4. Where are the serial number and contact information located? 6-12 • Serial number is located on the server label • Contact information will be posted on the workstation CentraLink Data Management System Maintenance and Troubleshooting Monitor Server and Investigate Common Issues Exercise 1. Due to a communications issue you shut down and restarted the CentraLink. When you tried to launch the CentraLink application the following error was displayed “There is no server for database dbf/genro error.” a. What is the most likely cause of the error? b. What would you do to remedy the problem? 2. The Centaur is not producing any results and at first glance it appears that Centaur is not getting the orders from CentraLink. a. How would you verify that CentraLink received the orders from the LIS? b. On CentraLink where would you look to verify that the Centaur connection is okay? c. If the Centaur connection is not okay what would you do? PLEASE STOP HERE CentraLink Data Management System 6-13 Maintenance and Troubleshooting Maintenance Daily Operations QC Review Verify QC Results after Running on Analyzers 3. Select the QC icon . 4. Leave Test box as ? unless you want to only look at one test at a time then choose the test. 5. Select the instrument you wish to view by double-clicking in the instrument box. 6. Choose From box and select date. Enter time if you need specific time of day. 7. Click Apply. If you would like to view closed out QC, place a check mark in that box then click apply. 8. Review the dots. Asterisks will be in the comment box to notify you if QC fails a Westgard Rule. Green ±2 SD Yellow ±2-3 SD Red ±3-4 SD 9. Right select on the result and select Edit comment to document QC actions. Refer to Coded Comment list for available comments. If using a coded comment enter /, then the mnemonic. For example, enter /RCAL. The comment will expand in the comment box and on the QC reports. You can also add free text. 10. If QC is out of range or fails some of the Westgard Rules, it will apply a severity to all patient results for that test. This severity will need to be reset to 0 so that any new controls or patient results will not have this severity applied. 11. To view the Levey Jennings graph for the last 7 days, select QC Population on toolbar. Then select L-J Graph. It defaults to a 7 day look back. You can modify the date as needed and select Draw to update. 6-14 CentraLink Data Management System Maintenance and Troubleshooting Resetting QC Severities Do both RESET 1 and RESET 2 Daily **Only reset severity once you know QC has been rerun and is within range** Reset 1 1. As you are viewing the control data points, you can select Reset severity at the bottom of the screen. The test and instrument will automatically populate the appropriate fields. Enter a comment or action taken to resolve, if necessary using pre-defined Comments or free text. Select OK 2. Each test, not each level, with a severity will need to be done individually. It is not necessary to reset each level only the test. A severity will carry over to the next level on that test even if the next level is within range. This is how it stops autovalidation. Reset 2 (used to reset tests not seen in QC review. (i.e. GLU1, GLU2) 1. Select the Instruments icon . 2. Highlight the instrument to be reset. 3. Right select, select Related and then Tests from the list. 4. Highlight any test on the Tests on Instrument list. (use the spacebar to multiselect). 5. Right select on the test and select Reset QC severity. 6. Enter a comment or action taken to resolve, if necessary. Select OK. 7. Select the next instrument in the Instruments table and the test list will change to the new instrument’s tests. Repeat steps 4-7 to reset the second instrument’s QC severity. Continue as needed for each instrument. CentraLink Data Management System 6-15 Maintenance and Troubleshooting Results Review All patient results in Review and Edit will need to be manually validated and/or rerun. 1. Select the Sample query icon . 2. Leave SID as a ? and set Minimum status as Rerun and Maximum Status as Review. 3. Place in At least one request in status. 4. Select OK. 5. Right select the first sample and select Review and Edit. 6. Use the navigation toolbar buttons to navigate up and down. 7. Select F5 on the keyboard to refresh the list, and look for status of REV to review results. 8. Before validating any results, look at the Severity columns to review why that test is being held for your review. A Severity of 2 or greater will not autovalidate. No severity = Normal Result. 6-16 Norm Severity Result Classification Action NS ± 1 Abnormal result; not critical Result autovalidated by CentraLink NS ± 2 Review range; outside of lab’s autovalidation range Review result, comments, and instrument flags; validate or rerun NS ± 3 Critical result Review result, comments, and instrument flags; validate or rerun NS ± 7 Result above linearity (AMR) Wait for second result before validating NS ± 9 Result > AMR x dilution factor Make a manual dilution. Review comments and instrument flags; validate or rerun. Delta Severity Result Classification Action DS ± 2 Failed delta check Review current and previous results. Review comments and instrument flags; validate or rerun. QC Severity Result Classification Action QS 2 Failed Westgard rule___________________ Troubleshoot, rerun QC; reset Method severity if QC is in range QS 3 Failed Westgard rule___________________ Troubleshoot, rerun QC; reset Method severity if QC is in range Instrument Severity Result Classification Action IS 2 Flag indicates problem with result Review instrument flags and troubleshoot CentraLink Data Management System Maintenance and Troubleshooting If you validate all results, the screen will advance to the next patient. If you rerun any of the assays, then select . This will advance you to the next patient for you to review. If you have a full page of assays to review, the label on the Validate button will change to Scroll. It will automatically scroll to the bottom of the page for you to look at all results and the button will revert to Validate. You can also use the scroll bar to view all results. Once you validate in Review and Edit, results will automatically upload to LIS every minute. Selecting Upload on the Review and Edit window will upload VAL results to LIS immediately. CentraLink Data Management System 6-17 Maintenance and Troubleshooting Daily Operations Exercise Perform a sample query for all samples with at least one result in Review. Navigate to Review and Edit. Fill in the table below with your findings for each sample and how you would proceed. Sample ID Issue(s) Found Actions 120020 124403 220002 220006 6-18 CentraLink Data Management System Maintenance and Troubleshooting Note: Instructor will provide samples for additional practice. Sample ID Issue(s) Found CentraLink Data Management System Actions 6-19 Maintenance and Troubleshooting Sample ID 6-20 Issue(s) Found Actions CentraLink Data Management System