Release Summary for Alere RALS System. Version 5.11

Transcription

1 2000 Holiday Drive Charlottesville, VA Release Summary for Alere RALS System Version 5.11 Contents Page New Device Supported 2 Opti Medical OPTI CCA-TS/TS2 2 The Alere RALS System Updates 3 Abbott i-stat 1 Updates 3 Alere i Updates 9 Nova Biomedical StatStrip GLU, StatStrip LAC, StatSensor CREAT 10 Quidel Sofia Strep A+ test type 12 Alere RALS equiz Updates 13 System Fixes 14 AI-DSREL0252 v1.0 Page 1 of 15 October 12, 2016

2 New Device(s) Supported Opti Medical OPTI CCA-TS/TS2 Summary: The OPTI CCA-TS/TS2 device type in the Alere RALS System covers two devices: the OPTI CCA-TS and OPTI CCA-TS2. Both devices are blood gas and electrolyte analyzers. The OPTI CCA-TS/TS2 device will support the standard features of other devices supported by the Alere RALS System. Types of Tests the Device Performs: Patient Test, QC Test, Calibration Test Supported Features: Communication: Available Reports: Uni-directional Communication Data sent to Alere RALS System Anomalous Results by Device Alere RALS equiz (if Patient test results Anomalous Results by applicable) QC test results Operator QC Management Calibration test results Institution Statistics Proficiency Management Operator ID LIS Statistics by Location Operator Management Date/Time LIS Statistics by Operator Certification Management Comments Operator ID Compliance by Results Sent to Materials Location EMR / EHR / LIS Specimen Types Supported Operator Pending Reports (Arterial, Venous, Mixed Recertification Date Edit Logs Venous, Capillary, Cord, Operator Statistics Test Material Management CPB) Operator Proficiency Evaluation Criteria Settings Patient ID Compliance by How the Device Connects Operator Direct Network (OPTI CCA-TS2 Patient ID Compliance by only) Location Serial Patient Results by Location Patient Results by Operator Patient Results by Patient QC Test Results Device Statistics Summary Test Materials Workload Summary AI-DSREL0252 v1.0 Page 2 of 15 October 12, 2016

3 Alere RALS System Updates Abbott i-stat 1 o i-stat Device Type labeled i-stat 1 Change will be visible in Device Type drop downs and Reports Note: The newly labeled i-stat 1 device module will still support customers using the i-stat PCA device o The i-stat 1 Results Review Page now support range filtering. Figure 1 Results Revew Filter Criteria Pre 5.11 Figure 2 Results Revew Filter Criteria Version 5.11 o i-stat 1 Consumables Page Updates: The Alere RALS System will now allow users to enter QC and Cal/Ver ranges Therefore, customers that do not load the evas file with the device will have access to ranges for plotting QCs on Levey-Jennings charts and Cal/Ver on Linearity charts. To support QC lots with range definitions that differ based on cartridge type, The Alere RALS System will now allow QC lots to be associated with a test type and ranges. AI-DSREL0252 v1.0 Page 3 of 15 October 12, 2016

4 Figure 3 Test Material Examples Showing Support for Test Type & Ranges o NOTE: After upgrading to 5.11, pre-existing QC and Cal/Ver lots will have been defined in the system with no test type or ranges associated. Customers can: Manually add the same lot# again and associate it with a test type and range information Or they can download results from a device after the Alere RALS System Upgrade Downloaded Lots will be displayed as new un-reviewed lots and will be associated with the cartridge type used. The original lots with no test type may either co-exist with the newly added ones or can be removed if desired. Figure 4 Consumables Page Displaying Same Lot With/Without Test Type If a user attempts to edit existing Lots, the Test Type control will display blank, be a required filed, and will not be editable. This will preserve existing Levey-Jennings Chart associations with Lot# that are not associated to a particular Test Type. AI-DSREL0252 v1.0 Page 4 of 15 October 12, 2016

5 Figure 5 Example: Existing Lot Edit Test Material Dialog Box o The Alere RALS system now support Linearity charts for Cal/Ver results: Figure 6 i-stat 1 Linearity Chart Example AI-DSREL0252 v1.0 Page 5 of 15 October 12, 2016

6 Linearity Chart List Linearity Charts are created with Cal/Ver results run within a specified date range, on a specific device for the same cartridge type and analyte. Linearity Chart Details User-defined Cal/Ver lot Mfg Ranges are used to define Cal/Ver results as in or out of range. When listing the results for a specific chart: The Result s Cartridge Lot will be displayed in the "Reagent Lot" column. The Result s Cal/Ver Lot will be displayed in the Linearity Lot column. Chart details will display a comma delimited list of cartridge lots and Cal/Ver lots used with the results associated with the chart. Linearity Reporting Linearity Report Report's Reagent Lot# will display a comma delimited list of cartridge lots used with associated results. Report s Linearity Lot# will display a comma delimited list of Cal/Ver lots used with the associated results. Cal/Vers Added evaluation criteria for Evaluate Cal/Ver Out of Range Added respective flag Evaluate Cal/Ver Out of Range. Multiple levels with Cal/Ver Lot #. This is to support entering the kit lot# on the Cal/Ver rather than the lot# for individual Cal/Ver levels. Ranges can be entered for each level. Cal/Ver now associated by test type. This change supports the associated ranges that vary by cartridge type. Figure 7 Cal/Ver Test Material pre/post 5.11 AI-DSREL0252 v1.0 Page 6 of 15 October 12, 2016

7 Liquid Controls Evaluating Evaluate QC Out of Range was updated to use user entered Ranges when QC results are not associated with EVAS ranges. Update to associated QC lots by test type. This is to support the associated ranges that vary by cartridge type. Figure 8 Liquid QC Test Material Pre/Post 5.11 i-stat 1 Sample Type Updates When a QC result is not associated with a level, the Alere RALS system will display "Control - Unknown". QC - Unknown" will be displayed as the sample type when no level was chosen at the time of test. Previously, the Alere RALS System would display Level 0. AI-DSREL0252 v1.0 Page 7 of 15 October 12, 2016

8 o i-stat 1 Levey-Jennings Charts Updates Figure 9 Levey-Jennings Chart Examplet Levey-Jennings Chart List Levey-Jennings Charts are created from QC results run in a specified date range, from the same device, same control lot, same level, same test type, and same analyte. Levey-Jennings Chart Details Range information for the result sets/charts/reports will be determined as follows: if the most recent Result Value has evas ranges included, the system uses those ranges. if the most recent Result Value does not have evas ranges included, and QC lot ranges exist, the system uses the QC lot range for defining chart ranges if the most recent Result Value does not have ranges included and there are no ranges entered for that QC lot the system displays error on chart "No target values exist for this chart." Chart parameters will include a comma delimited list of cartridge lots used for the QC results associated with the chart. When listing the associated results, each result will display the cartridge lot# used. AI-DSREL0252 v1.0 Page 8 of 15 October 12, 2016

9 Step-by-Step recommendation after upgrade to the Alere RALS System version 5.11: 1) Update QC and Cal/Ver lots by either: a. Manually entering test type and any desired ranges b. Automatically - by downloading results. This inserts Lots used with new downloaded results and will associate them with test types. Range edits and marking lots as reviewed will still need to be done manually 2) Remove Lots with no test type associated 3) Levey-Jennings Chart Page. - View Levey-Jennings charts from before the upgrade date separately than charts from after upgrade date. Alere i Results Evaluation Process Updated: o Patient result values which are positive from the device will be flagged "Abnormal". o Any result with a value of Invalid will be flagged as No Value o QC result values received with an "A" flag from the device will be flagged "Abnormal". o In addition, patient results can be flagged No Profile, No Value, Questionable Profile, Repeated Test, Uncertified Operator, Unknown Patient, Unknown Cartridge, and Expired Cartridge. o In addition, QC results can be flagged No Value, Uncertified Operator, Uncertified Patient, Unknown Control Lot, Expired Control Lot, Unknown Cartridge, and Expired Cartridge. Figure 10 Alere i Evaluation Criteria Page AI-DSREL0252 v1.0 Page 9 of 15 October 12, 2016

10 Nova Biomedical StatStrip GLU New Wireless Configuration Settings o Beginning with firmware version and the Alere RALS System version 5.11 the following additional wireless configuration setting are now available: Roam Trigger Roam Delta Max RSSI CCX Features DFS Channels Figure 11 Nova Biomedical StatStrip GLU Wireless Configuration Settings AI-DSREL0252 v1.0 Page 10 of 15 October 12, 2016

11 Nova Biomedical StatStrip GLU / Nova Biomedical StatSensor CREAT / Nova Biomedical StatStrip LAC Updates o Added specimen type and patient type selection (pre-analytical comments) Figure 12 Device Configuration Displaying New Specimen Type Selection Figure 13 Device Configuration Displaying New Patient Type Selection AI-DSREL0252 v1.0 Page 11 of 15 October 12, 2016

12 o The Alere RALS System will now allow the system administrator to determine the behavior in the Alere RALS System when a device s assigned location is changed at the meter. If the Nova Biomedical Enable Location Assignment setting is disabled in the System Configuration settings (the default state), and a Nova device's location is changed on the device, the next time the device communicates with the Alere RALS System, The Alere RALS System will only update the device's download location to match the location that was selected on the device. The assigned location in the Alere RALS System will not change automatically to match the device. In this case, to keep the device and the Alere RALS System consistent for assigned location, the assigned location will need to be manually changed in the Alere RALS System. This is the current behavior in the Alere RALS System which will not change if the Nova Biomedical Enable Location Assignment setting is disabled. If the Nova Biomedical Enable Location Assignment setting is enabled in the Alere RALS System Configuration settings, and a Nova device's location is changed on the device, the next time the device communicates with The Alere RALS System, The Alere RALS System will update the device's assigned and download locations in the Alere RALS System to match the location that was selected on the device. The Alere RALS System added support for the Quidel Sofia Strep A+ test type. Figure 14 Results Revew Displaying New Strep A+ Support AI-DSREL0252 v1.0 Page 12 of 15 October 12, 2016

13 The Alere RALS equiz Reports Page o If Display Removed Items as Filter Options is enabled in Preferences, the operator filter will display all operators indicating the removed ones in red font. o If Display Removed Items as Filter Options is disabled in Preferences, the operator filter will only display active operators. Figure 15 Preferences Settings Dialog Box Displaying Display Removed Items as Filter Options o o Only records for active operators with a Take Test permission will be displayed. To view quizzes assigned to removed operators, the operator record must first be restored on the Operators page. Figure 16 the Alere RALS equiz Reports Page Displaying Example of Removed Operator AI-DSREL0252 v1.0 Page 13 of 15 October 12, 2016

14 The Alere RALS System Fixes Results Page Improved performance on the Results Review page. Previously, when the page size was set to a very large number and the results were filtered by a specific institution, the result values were not being displayed in the grid. Nova control material upload rejected The Alere RALS System will no longer allow a user to enter a Nova Biomedical material with ranges where the Lo equals the High value. This change applies to the Nova Biomedical StatStrip GLU, Nova Biomedical StatStrip LAC, and Nova Biomedical StatSensor CREAT. NOVA Invalid Gender Codes When an ADT system sends a gender class other than F, M or U for unknown to the Alere RALS System and subsequently the Alere RALS System transmits an invalidate gender class to the device it prohibits the device from downloading. The Alere RALS System now evaluates the first character of sex and will convert it to uppercase and send to the device as is, if it matches one of the following (F, M, O, U, A N), otherwise U will be sent. Allen's Test - Sorting Problem Previously, when sorting on a column in the results review grid, where the column name contained an apostrophe (Allen s Test), a SQL error was thrown. Now, the Alere RALS System hands the apostrophe and no longer generate a SQL error. epoc Blood Analysis System - Analyte A(T) Dependency Previously, the analyte A(T) could be enabled in the Alere RALS System without also having enabled pco2(t). Now, A(T) does not become available for selection, until a checkmark is placed in the pco2(t) Enabled checkbox. Evaluator Service Failures Previously, in customer sites where vulnerability detection software is running that performs port scanning (e.g., Nessus Tenable), the Alere RALS Evaluator and IstatInterface fail with an unhandled exception. Now, port scans (similar to the Nessus Tenable) will not cause the Evaluator and IStatInterface services to fail. Institution Statistics Report End Date Previously, the Institutions Statistics report was not including last date in the range when returning results. For example, if you want data to be returned for 03/01/16-03/15/16 then you need to make the end date 03/16/16. Now, the Institutions Statistics report is including last date in the range when returning results. Piccolo xpress Comprehensive Metabolic Panel Previously, Results with Test Type (and Profile name) Comprehensive Metabolic Panel" were flagging for Unknown Product. In all flagged cases the test type the Alere RALS System received was Comprehensive Metabolic instead of expected Comprehensive Metabolic Panel Now, the Alere RALS System is no longer flagged for Unknown Product AI-DSREL0252 v1.0 Page 14 of 15 October 12, 2016

15 The Alere RALS equiz - Operator Unable to Submit Quiz Previously, when the Alere RALS System attempted to update the exam date of an operator with a missing record in certification extension table, there was an error. This problem was most commonly created when a customer moved from the Alere RALS Plus System to a newer version of the Alere RALS System and had not edited via the newer Alere RALS System. Now, operators who have not been edited in the newer Alere RALS System will have an entry in the user certifications extension table allowing them to successfully submit an equiz exam. Levey-Jennings Outliers Previously, the POCC was unable to see only the outliers in the Levey-Jennings grid when Outliers Only is selected. Normally, selecting outliers only immediately filters the grid down to just outliers. If you viewed multiple charts and arrow back or forward, outliers only was then applied to the grids. Now, the Alere RALS System appropriately applies the filter when selecting "Outliers Only" for a Levey-Jennings chart, and the grid is updated to identify only the outliers. Nova Material Expiration Date Nova Biomedical made a change based on the date coding link to display the actual expiration date on reagents instead of just the Month/Year. The Alere RALS System had been programmed to round up the expiration date to the last day of the month the reagent would expire even if the actual expiration date would occur in the beginning or middle of the month. Now, the expiration date computed by the Alere RALS System is the same as the actual expiration date specified by the lot number (i.e., manufacture date plus shelf life in months). In cases where this would yield an invalid date (e.g., months = ) the last date of the resulting month will be used (e.g., would be ). Leap years are also accounted for (e.g., would be ) Alere. All rights reserved. The Alere Logo, Alere, epoc, and RALS are trademarks of the Alere group of companies. All trademarks referenced are trademarks of their respective owners. AI-DSREL0252 v1.0 Page 15 of 15 October 12, 2016