Release Summary for RALS System Version 5.6. AI-DSREL0174 v1.0 Page 1 of 12 February 17, 2015
Contents RALS New Devices Supported Page Quidel Sofia Analyzer.. 3 Roche Urisys 1100.. 4 RALS New System Features Password Security.. 5 Login Locked.. 7 WLAN Configuration Changes.. 8 Roche Accu-Chek Inform II Firmware Update.. 9 RALS-eQuiz User Updates.. 10 RALS System Updates Nova Manual Test Updates.. 11 RALS System Fixes Miscellaneous System Fixes.. 12 2015 Alere. All rights reserved. The Alere Logo, Alere, and RALS are trademarks of the Alere group of companies. All other trademarks referenced are trademarks of their respective owners. AI-DSREL0174 v1.0 Page 2 of 12 February 17, 2015
New Devices Supported Quidel Sofia Analyzer Summary: The Quidel Sofia device is a uni-directional device that connects to the RALS System through direct network connection. The device is a small bench top Fluorescent Immunoassay Analyzer for diagnostic testing of hcg, FluA+B, Legionella, RSV and Strep A. The device measures and stores patient, QC, calibration and proficiency data and uses advanced immunofluorescence-based lateral-flow technology as well as barcode technology. It also has WALK AWAY and READ NOW result modes. The RALS system supports automatic and manual addition of test materials for the device. Types of Tests the Device Performs: Patient Test, QC Test, Calibration, Proficiency Supported Features: Communication: Available Reports: Uni-directional Communication RALS-eQuiz (if applicable) Patient, Management QC Management Proficiency Management Operator Management Certification Management Device Management Results Sent to EMR / EHR / LIS Reports Edit Logs Test Material Management Evaluation Criteria Settings Data sent to RALS Patient test results QC test results Calibration test results Proficiency test results Operator ID Date/Time Location How the Device Connects Direct network connection Anomalous Results by Operator Institution Statistics LIS Statistics by Location LIS Statistics by Operator Location Statistics Operator ID Compliance by Location Operator Pending Recertification Date Operator Pending Recertification Range Operator Statistics Operators With No Certifications Patient ID Compliance by Operator Patient ID Compliance by Location Patient Results by Operator Patient Results by Patient QC Test Results RALS Devices Log RALS Setup Test Materials Workload Summary by Location Comment Code Utilization Comment Code Results AI-DSREL0174 v1.0 Page 3 of 12 February 17, 2015
New Devices Supported Roche Urisys 1100 Analyzer Summary: The Urisys 1100 device is a bi-directional (RALS sends operator list to the device) device that connects to the RALS System through RRC and Digi connections. The device measures Specific Gravity, ph, Leukocytes, Nitrate, Protein, Glucose, Ketone, Urobilinogen, Bilirubin and Erythrocytes in urine using a urine sample. It is a portable tabletop device that measures and stores patient and QC data. The device uses Chemstrip 10, Chemstrip 7 and Chemstrip 5 OB as test strips. The device eliminates visual inspection and waiting for results. It has automatic result printout capability as well as operational operator lockout capability. The RALS System supports automatic and manual addition of test materials. Types of Tests the Device Performs: Urinalysis Supported Features: Communication: Available Reports: Bi-directional Communication Data sent from Urisys 1100 Anomalous Results by Device RALS-eQuiz (if applicable) Patient test results Anomalous Results by Operator Patient Management QC test results Institution Statistics QC Management Operator ID LIS Statistics by Location Operator Management Date/Time LIS Statistics by Operator Certification Management Location Location Statistics Device Management Operator ID Compliance by Results Sent to How the Device Connects Location EMR / EHR / LIS RALS Remote Connect (RRC) Operator Pending Recertification Date and Range Reports RALS Dataport Edit Logs Operator Statistics Results Management Operators With No Certifications Test Material Management Evaluation Criteria Settings Patient ID Compliance by Operator Patient ID Compliance by Location Patient Results by Operator Patient Results by Patient QC Test Results RALS Devices Log RALS Setup Test Materials Workload Summary AI-DSREL0174 v1.0 Page 4 of 12 February 17, 2015
RALS New System Feature(s) Password Security: For systems that get upgraded to 5.6, the password requirements will change in the following ways. Can no longer include password Can no longer be same as operator ID Cannot contain first or last name The new settings apply to new users that need passwords and when changing an existing password. Existing passwords will not be affected, unless they choose to change the password. If a POCC changes a password for another user, that user will be forced to reset their password upon next login. 5.6 introduces new security options for users that want to take advantage of additional password requirements. The POCC s as a group can decide if they want them changed or disabled. Changes can only be made by the Alere Informatics support line. AI-DSREL0174 v1.0 Page 5 of 12 February 17, 2015
Password Security (continued) Character requirements (Uppercase, Lowercase, Numbers, Others) o Default: 3 o Range 1-4 Minimum length o Default: 10 o Range: 1-120 Max # of consecutive repeated characters o Default: 2 o Range: 2-99 Number of days until password expires o Default: 90 days o Range: 1-366 days Number of days password can be changed after last change o Default: 1 day o o Range: 7 days If value is 0, user can change their password at any time Number of consecutive failed attempts account will be locked o Default: 5 o Range: 3-20 Number of minutes account will remain locked o o o Default: 60 minutes Range: 0-1440 minutes If value is 0, user will be locked out indefinitely If a user s password expires, upon next login, the user will be forced to reset their password. If a POCC is locked out of RALS, they have 3 options: 1. Wait it out (if applicable) 2. Contact another POCC to unlock their account in the RALS operator profile page 3. Have an administrator email RALSSupport@alere.com permitting us to unlock the POCC account. For security integrity, RALS Customer Support cannot add/edit RALS users (including password resets) without emailed permission from an administrator. AI-DSREL0174 v1.0 Page 6 of 12 February 17, 2015
Login Locked: A POCC may lock or unlock another RALS user by checking or unchecking this box Login Locked will be automatically checked if Login Blocking is enabled and the user failed to login to RALS within the configured requirements (e.g. 5 failed consecutive attempts) Login Locked applies to logging in to the RALS application, and does not apply to device login attempts. AI-DSREL0174 v1.0 Page 7 of 12 February 17, 2015
WLAN Configuration User Changes Prior to version 5.6, Inform II wireless settings were configured by a separate user WLAN_Institution. This account was limited to the access of wireless configuration settings only. New in 5.6, all WLAN_Institution accounts will be removed from the system. This change will not affect the existing wireless configurations. Former WLAN administrators will need to be added to RALS as an operator, with a System Role as the new default WLAN Configuration role. POCC s will need to add the new user. For security integrity, RALS Customer Support cannot add/edit RALS users without emailed permission from an administrator. o As a reminder edits made to the WLAN Configuration role, like any role, will affect all operators from all institutions who are assigned to that role. o The Authority Level for the WLAN operator should be Devices Operator as shown below. AI-DSREL0174 v1.0 Page 8 of 12 February 17, 2015
Roche Accu-Chek Inform II Firmware Update New in 5.6, Inform II firmware upgrades will be handled in the same way as other device firmware updates that are supported in RALS RALS users with the ability to Manage Firmware in Roles will have access to the Devices > Firmware Updates page in RALS (enabled for POCC s by default). AI-DSREL0174 v1.0 Page 9 of 12 February 17, 2015
RALS -equiz User Update Taking an Quiz Prior to Version 5.6, when an RALS-eQuiz user logged into RALS, they were taken directly to the RALS-eQuiz Summary page. New in Version 5.6, the user will be taken to the Status > Summary page. They will need to click on the equiz tab in order to view the equiz Summary and take the equiz. equiz Test Taking now managed with Role Management New in 5.6, access for taking an equiz is enabled in Operator Roles, called Take Test. By default, all standard Roles except the new WLAN Configuration role will have this access enabled. A POCC may choose to disable this access for a role, keeping in mind that edits made to Roles affect ALL operators from ALL institutions who are assigned to a particular role. AI-DSREL0174 v1.0 Page 10 of 12 February 17, 2015
RALS Updates: Nova MTE Added support for the following Nova Biomedical Manual Test QC tests: Fecal Occult: QC Negative QC Positive Gastric Occult: QC Negative QC Positive Added new Nova HIV manual test value types: HIV HIV2 Ag Ab Negative Control Line Added new Nova tbili manual test value types: Infant Age Calibration Nomogram Intervention AI-DSREL0174 v1.0 Page 11 of 12 February 17, 2015
RALS Fixes Ping Status process improved to reduce status errors Issue while adding Serial Download Points has now been resolved Nova MTE buttons no longer initiate a required-entry on disabled text boxes. The issue with the button name value being lost when clicking off the button name-change box has also been resolved. Previously when a linearity chart with two results and no target values, the system counted no target VALUES as a targets of zero for linearity. However, when you view the report, the report appears to show the target values as 1 and 2 instead of 0 and 0. Results with no target values now appear on the linearity graph in the linearity report correctly. Issue with equiz filters has been corrected making default filters available regardless of what institution is selected and when a new equiz report filter is added (or copied); the new report filter is assigned to the current institution for the system Roche Accu-Chek Inform II operator upload has been improved. Previously following a session error, the Inform II meters would be sent a complete operator list which could result in some operators not having access to the meter if the list send is interrupted. RALS will now query the device for its set of items, and then either send the changes or the full operator list. This avoids always sending a full list following a session error and risking the interruption and consequent lockout. Sig+ EQC results now available on the Results Management page. AI-DSREL0174 v1.0 Page 12 of 12 February 17, 2015