BN™ II System Software Version 2.7 Job Aid for Security Administrators

SIEMENS Healthineers ---- BN™II System Software Version 2.7 ............... Job Aid For Security Administrators Template Effective Date: 27 May 2019 | HOOD05162003010284 Job Aid Effective Date 23 Jul 2021 | HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Table of Contents Overview 3 Customizing User Account Management 6 Login as Security Administrator 6 Add a New User 7 Change a User Account 10 Lock/Unlock a User Account 11 Delete a User Account 12 Viewing and Printing Audit Log Events 13 Accessing the Audit Log and Viewing Audit Log Events 13 Viewing a Selected Date Range in the Audit Log 14 Printing Audit Log Events 15 2 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Overview The BN™ II System software package version 2.7* includes new features designed to meet customer expectations for compliance with GDPR and FDA standards. The new software features include but are not limited to: • User management-separate login accounts for all users, managed by the Security Administrator. Accounts are linked with configurable privileges. Activity and results can be traced back to individual users. Electronic Signatures from individual users can now be documented • Data privacy-in compliance with data privacy regulations, (for example GDPR), patient and user data related to the system is protected. User viewing privileges of personal and patient data are adjusted based on institutional policy • Audit trail-user activity is tracked and logged in the system and comments can be added. User activity logs can be generated and viewed by the Security Administrator • Traceability-sample result traceability of all available data that contributes to a released result can be viewed in the user interface. Traceability reporting is archived to view this inactive data in the system • Sample search function-to quickly locate samples still stored in the system, search by the sample ID in the user interface. You can also search for samples in the archive using the sample ID *BN II software version 2.7 will only be provided with new BN II analyzers and as an optional update for existing systems (Continued on the next page) 3 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Overview How does software version 2.7 protect personal data? How do I prevent loss of privacy protection? Data Encryption Ask “Is it mandatory to enter personal • Protects against unauthorized persons reading patient data directly from files data?” Limit entering personal data to what is necessary for • System owner designates a trusted person (Security Administrator) to issue, store and protect an encryption the intended purpose key (password). Siemens Healthineers service will not have knowledge of the password Only enter personal data in fields • Provide the encryption key to Siemens Healthineers provided explicitly for the type of input service if files need to be transferred to another computer Do not enter personal data in fields that are not meant for that data or that allow free input. Personal User traceability via separate login accounts data entered in the correct fields is protected avoids unauthorized logins to view patient data according to GDPR conformity • Security Administrator-limited to sample ID, sample results and audit log, configures user access, keeps encryption key Lock the operating terminal of the system (password) when unattended • Lab Supervisor and Routine User-allowed full access to Prevent unauthorized persons from accessing patient data but no access to user ID personal data or other sensitive data or information • Siemens Healthineers service-limited to sample ID, sample result, sex, age and user display name for troubleshooting purposes 4 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Overview The Security Administrator Role The system owner designates a trusted person at the facility as the Security Administrator. Besides managing the user accounts for the BN II software, the Security Administrator will issue, store and protect the system encryption key (password). The Security Administrator has the following two rights within the BN II System: 1. Configure and manage individual user accounts for Routine and Lab Supervisor • Add a new user • Change a user account • Enable/disable a user account • Delete a user account 2. Access the audit log and view audit log entries Note: The Security Administrator is the only user who can manage user accounts. If the Security Administrator forgets their password, they are locked out of the system and Siemens Healthineers service would need to reset the password. Siemens Healthineers highly recommends creating a second Security Administrator account 5 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Customizing User Account Management Log in as Security Administrator Login/Logout Full version: V2.7a3 Release version: V2 1. Select System > Login/Logout from the menu Current user: Lxxxxxxn 2. Enter user name and password 3. Select OK A. Security Administrator functions are now enabled in User admin 2 the menu Password: ......... Cancel Change password OK 3 Logout BNII File Edit Routine Results QC Calibration Definition System 1 BNII File Edit Routine Results QC Calibration Definition System Rack status Rack status 96 S User service User service Loading Rack status Lab Journal Patient Journal Control Journal Precision test Loading Rack status Lab Journal Patient Journal Control Journal Precision test Configuration Configuration Data exchange Data exchange Shift change Shift change A Change to night mode Change to night mode Show journal legend ... Show journal legend ... Audit log Audit log Audit log comment Audit log comment Reset nassword Reset password Login/Logout Login/Logout 6 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Customizing the User Account Management Add a New User BNII File Edit Routine Results QC Calibration Definition System 3 Rack status User service Loading Rack status Lab Journal Patient Journal Control Journal Precision test 1. Select System > Configuration > Users & Access in 1 Configuration Measurement the menu Data exchange Users & Access 2. Enter your user-name and password in the Shift change Host Change to night mode Journal Login/Logout dialog Show journal legend ... Audit log 3. Select the icon to add a new user in the Manage user Audit log comment accounts dialog Reset password Login/Logout (Continued on the next page) Manage user accounts OK 3 Routine_1 Routine 2 User ID: LabSupervisor Routine_3 Security Administrator Display name: SuperLab SuperLab Password: ..... User access role Laboratory Supervisor Password validity 90 days Password expiration 16. Dec 2020 User account disabled Save 7 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Customizing the User Account Manager Add a New User (continued) Manage user accounts OK ? 5 0 4. Enter the User ID in the User ID field Routine_1 • User ID is alphanumeric, case-sensitive and cannot contain Routine 2 User ID: 4 LabSupervisor Routine 3 blanks Security Administrator Display name: SuperLab 5 SuperLab • The minimum number of characters is 5 and maximum is 20. Password: Each entry must be unique ..... 6 5. Enter the Display name in the Display name field User access role 7 Laboratory Supervisor • The display name defines the user name displayed in the list Password validity 90 days on the left, appears in the Login/Logout dialog, audit log and other dialogs as the current user Password expiration 16. Dec 2020 • Display name is alphanumeric, case-sensitive and cannot User account disabled contain blanks. The minimum number of characters is 5 and maximum is 20. Each entry must be unique Save 6. Enter the Password in the Password field • The Security Administrator must inform the new user about the initial password defined here. Users can then change the password • The password is alphanumeric and case-sensitive. The minimum number of characters is 5 and the maximum is 20 7. Select the User access role from the drop down menu The menu selections include Routine, Laboratory 8 • Supervisor and Security Administrator (Continued on the next page) Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Customizing the User Account Management Add a New User (continued) Manage user accounts OK 8. Select the length of time the password is valid in the Routine_1 Routine 2 User ID: LabSupervisor Password validity field Routine_3 Security Administrator The menu selections are 7, 30, or 90 days or Display name: SuperLab SuperLab • Unlimited (does not expire) Password: .... • The password expiration date is automatically User access role Laboratory Supervisor calculated and displayed based on password validity Password validity 90 days 9. Select Save 8 Password expiration 16. Dec 2020 User account disabled Save 9 9 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Customizing the User Account Management Change a User Account O Manage user accounts 1. Navigate to the dialog Manage user accounts Routine_1 2. Select the user whose account needs to be changed from Routine 2 User ID: LabSupervisor Routine_3 the list on the left Security Administrator Display name: SuperLab SuperLab 3. Change the settings as required: To change a user’s password, edit the Password field Password: .... 3 • To change a user’s access rights, edit the User access 2 Laboratory Supervisor • User access role role field To change the validity of a user’s password, edit the Password validity 90 days • Password validity field Password expiration 16. Dec 2020 4. Select Save User account disabled Save 4 10 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Customizing the User Account Management Lock/Unlock a User Account O Manage user accounts 1. Navigate to the dialog Manage user accounts Routine_1 2. Select the user whose account is to be locked or unlocked Routine 2 User ID: LabSupervisor Routine_3 from the list on the left Security Administrator Display name: SuperLab SuperLab 3. Select or deselect the check box User account disabled Password: .... • Select the check box to lock or disable the user account 2 User access role Laboratory Supervisor • Deselect the check box to unlock or enable the Password validity 90 days user account 4. Select Save Password expiration 16. Dec 2020 User account disabled 3 Save 4 11 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Customizing the User Account Management Delete a User Account Manage user accounts OK 3 4 1. Navigate to the dialog Manage user accounts Routine_1 2. Select the user whose account is to be deleted from the Routine 2 User ID: LabSupervisor Routine_3 list on the left Security Administrator Display name: SuperLab SuperLab 3. Select the icon in the toolbar Password: .... • A confirmation dialog is displayed 4. Select the icon in the toolbar 2 User access role Laboratory Supervisor • The user is deleted from the list on the left Password validity 90 days Password expiration 16. Dec 2020 User account disabled Save 12 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Viewing & Printing Audit Log Events Accessing the Audit Log and Viewing Audit BNII File Edit Routine Results QC Calibration Definition System 1 Rack status Log Events User service Loading Rack status Lab Journa Patient Journal Control Journal Precision test Configuration The audit log generates logfiles in compliance with the Data exchange requirements of 21 CFR Part 11 issued by the United States Shift change FDA. Each audit log entry consists of at least the following Change to night mode Show journal legend ... information: Audit log • When the audit log entry was generated Audit log comment Who initiated the creation of the audit log entry Reset password • Login/Logout • What activity triggered the entry or what type of data it affects .. Audit log View Last 24 hours Number of entries: 347 Audit log entries cannot be changed or deleted by the user Date and time Display name Event 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720085620208 , assay: Cysc 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91720075720101 , assay; CRP1 and can only be viewed by the Security Administrator 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720075720101 , assay: ALB 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91720075720101 , assay: PRE 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91719041700101 , assay; PRE 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91719041700101 , assay: CRP2 To view the audit log: 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91720085340107 , assay: lgG 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720085340107 , assay; lgA 1. Select System > Audit log from the menu mod 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720085340107 , assay: lgM mod Labadmin Sample result deleted; sample: 91720085340107 , assay: HPT • The audit log dialog displays showing the entries from 3/11/21 14:29 3/11/21 14:29 Labadmin Sample result deleted; sample: 91719095410201 , assay: HPT 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91719095410201 , assay: PRE the last 24 hours. This is the default setting 3/11/21 14:29 Labadmin Sample resul deleted; sample: 91719095410201 , assay; a2M 3/11/21 14:29 Labadmin Sample result deleted; sample: 91719095410201 , assay: CRP2 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91720054929806 , assay: ALB 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720077460302 , assay; PRE 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720077460302 , assay: CysC 3/11/21 14:29 Labadmin Sample resut deleted; sample: 91720087510102 , assay: lgG 13 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720087510102 , assay: ligA Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Viewing & Printing Audit Log Events Viewing a Selected Date Range in the Audit Log Audit log 1. Select View and select Selected time frame from the OK View toolbar to view the entries for a specified time frame V Last 24 hours 2. Enter the desired time frame in the dialog Selected time frame Number of antros: 347 1 3. Select OK: Date and time Display name Event • The events in the timeframe selected are displayed. 1/1121 14:47 Labadmin Rosull released; sample: Serum-2 . asuay: AAG Use the scroll bar at the right to display all events Time frame for display in audit log • If the message Number of entries inside selected date range too big for display in list. Reduce the date range appears, there are more than 10,000 entries in the 3/11/21 selected time frame. You will need to reduce the 2 from timeframe 3/11/21 until Cancel OK 3 14 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Viewing & Printing Audit Log Events Printing Audit Log Events BNI File Edit Routine Results QC Calibration Definition System Tue 16:54 Close 1 Page setup. Print one Print ... 1. Select File > Print in the menu and make the required Audit log settings OK View 6/1/20 - 6/1/22 Number of entries: 495 • The events of the defined timeframe are printed Date and time Display name Event 3/11/21 13:16 Security_Admin User account changed; display name: Security_Admin 3/11/21 13:16 Security_Admin User logged on; application: BNII Reagents 3/11/21 13:17 Security_Admin User account added; display name: Labadmin Reagents 3/11/21 13:18 Security_Admin User account added; display name: Z00345 3/11/21 13:18 Labadmin User logged on; application: BNII missing 3/11/21 13:22 Labadmin User logged on; application: BNII not sufficient 3/11/21 13:26 Labadmin User logged on; application: BNII not required 3/11/21 13:27 BNII Result released; sample: 320385259705 , assay: FLC-r STDS/CTRLS 3/11/21 13:31 Labadmin User logged on; application: BNII missing (Continued on the next page) 3/11/21 13:40 Result released; sample: 061088255602 , assay: FLC-r 3/11/21 13:51 Result released; sample: 061088255602 , assay: FLC-r not sufficient 3/11/21 13:53 User logged on; application: BNII not required 3/11/21 14:15 Labadmin Sample result deleted; sample: 061088292102 , assay: FLC_L 3/11/21 14:28 User logged on; application: BNII Information 3/11/21 14:29 Labadmin Sample result deleted; sample: 91719088540202 , assay: lgG Logbook 3/11/21 14:29 Labadmin Sample result deleted; sample: 91719088540202 , assay: lgA mod Measurement 3/11/21 14:29 Labadmin Sample result deleted; sample: 91719088540202 , assay: lgM finished mod Sample result deleted; sample: 91719088540202 , assay: HPT System status 3/11/21 14:29 Labadmin 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720034260201 , assay: CysC 3/11/21 14:29 Labadmin Sample result deleted; sample: 91720082460202 , assay: CRP2 Send behind : last sample measured: V2.783 15 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 Security Administrator – SIEMENS Healthineers Viewing & Printing Audit Log Events Printing Audit Log Events (continued) BNII File Edit Routine Results QC Calibration Definition System 2. Select the PDF drop down to export and save the Audit Log events OOO Audit log Print View 6/1/20 - 6/1/22 Printer: A No Printer Selected Date and time Display name Event Copies: 3/11/21 13:16 Security_Admin User account change 3/11/21 13:16 Security_Admin User logged on; appl Pages: All 3/11/21 13:17 Security_Admin User account added; 3/11/21 13:18 Security_Admin User account added: 3/11/21 13:18 Labadmin User logged on; appl - 3/11/21 13:22 Labadmin User logged on; appl - 3/11/21 13:26 Labadmin User logged on; appl 3/11/21 13:27 BNII Result released; sam 3/11/21 13:31 Labadmin User logged on; appl 3/11/21 13:40 BNII Result released; sam 3/11/21 13:51 BNII Result released; sam 3/11/21 13:53 Labadmin User logged on; appl 3/11/21 14:15 Labadmin Sample result delete 3/11/21 14:28 Labadmin User logged on; appl 3/11/21 14:29 Labadmin Sample result delete 3/11/21 14:29 Labadmin Sample result delete 3/11/21 14:29 Labadmir Sample result delete mod 3/11/21 14:29 Labadmin Sample result delete 3/11/21 14:29 Labadmin Sample result delete 3/11/21 14:29 Labadmin Sample result delete 1 of 15 2 ? PDF Show Details Cancel Print 16 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022 SIEMENS Healthineers Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. © Siemens Healthcare GmbH 2022 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens-healthineers.com 17 Effective Date: 23 Jul 2021|HOOD05162003208523 Unrestricted © Siemens Healthineers, 2022