cobas IT 1000 application, version 2.01 Point of Care CoordinatorTraining Guide

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1 cobas IT 1000 application, version 2.01 Point of Care CoordinatorTraining Guide

2 Roche Diagnostics Commercial Education

3 Intent and Reference Information This Training Guide is to be used for a progressive learning experience during this training session. The information and instructional procedures contained in this training guide are for training purposes only and do not supersede the information and instructional procedures contained in the cobas IT 1000 application operator documentation or Customer Bulletins. The contents of this manual, including all graphics and photographs, are the property of Roche Diagnostics. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development. Disclaimer: This Training Guide and the cobas IT 1000 application may contain information and references to products that may not be available in your country or sold by Roche Diagnostics. This manual makes no claims regarding the use or performance of those products. The complete list of Roche Diagnostics and 3rd party products available for use with the cobas IT 1000 application in the US can be found at Other Roche Diagnostics or 3rd party products listed within the software or manuals which are not listed at are not available for use with the cobas IT 1000 application in the US. This training guide was created by Roche Diagnostics Commercial Education department. Direct questions or concerns regarding the contents of this document to: Roche Diagnostics Commercial Education Department 9115 Hague Road P.O. Box Indianapolis, IN USA COBAS, ACCUCHEK and LIFE NEEDS ANSWERS are trademarks of Roche. All other trademarks are property of their respective owners Roche Diagnostics. All rights reserved Distribution in USA by: Roche Diagnostics, Indianapolis, IN This training guide is printed in the US and available on Additional copies of this document can be obtained by sending a message to or by leaving a message at the Technical Publication Hotline at , mailbox cobas IT 1000 v2.01 Point of Care Coordinator Training Guide Version 1 i

4 Revision Information Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document may be reproduced in any form or by any means without prior written consent. Publication Reference Number Date Revision Purpose August 2013 New Document for software version November 2013 Update for flow and new technical support number. ii cobas IT 1000 v2.01 Point of Care Coordinator Training Guide Version 1

5 Technical Support Roche Diagnostics provides 24 hour-a-day, 365 day-a-year telephone assistance. For any questions or concerns that occur outside of your webinar training session please call: Roche Health Care Professional Customer Care: cobas IT 1000 v2.01 Point of Care Coordinator Training Guide Version 1 iii

6 Table of Contents Topic Page # Section 1: Application Overview Log on 2 Change Password 2 Global Area Buttons 3 Module Descriptions 4 Multi-Site 7 Section 2: User Management Add a new operator 10 Certify an operator using User Management 14 Deactivate a user from User Management 15 Workgroup Definition 16 Section 3: Certifications Phases of Certifications 18 Add a Certification for an Operator 19 Privileges Tab 20 Pending Tab 21 Interim Tab 23 Certified Tab 24 Reminder Tab 25 User Certification 26 Add a Certification for an Observer 28 Steps for OTS on an ACCU-CHEK Inform II 28 How to Group Certify Operators 31 How to Decertify an Operator 33 How to Deactivate a Certification 33 Certification Tasks 34 Section 4: Competencies Add a Competency 37 Section 5: Notification Templates How to set up Operator Certifications Notifications 40 How to setup Supervisor Notifications 43 Section 6: Instruments Tips and Tidbits 46 Status 47 Send a message to an instrument 48 Add a new Instrument Configuration 48 Add/Assign Comments 59 iv cobas IT 1000 v2.01 Point of Care Coordinator Training Guide Version 1

7 Table of Contents Topic Page # Section 7: Materials Add a new lot of test strips and mark as reviewed 64 How to assign new materials to locations 67 Add new Linearity and QC lots 68 Section 8: Quality Control Quality Control 70 Result Management 71 Review Invalid Results 72 How to review Details for a specific QC result 72 How to display and review Levey Jennings charts by month 73 How to review Levey Jennings charts by specific Lot 74 How to display linearity charts 76 Section 9: Results and Patients How to review a flagged result and mark with Accept, Reject or Hold 78 Repeated patient tests (Error Code = TRR) 80 Result Validation Buttons 81 Validation Alarm Symbols 82 Patient Cleaner Process 82 Result Query 83 Patient Query 84 Patient Troubleshooting Tips 86 Section 10: Reports How to generate a report 88 Report Examples 89 How to generate a report to View and Save Log 95 Section 11: Daily Tasks Tasks 98 cobas IT 1000 v2.01 Point of Care Coordinator Training Guide Version 1 v

8 Notes Notes vi cobas IT 1000 v2.01 Point of Care Coordinator Training Guide Version 1

9 Application Overview Section 1: Application Overview Training Objectives: At the end of this session the trainee will be able to: Log into the cobas IT 1000 application Describe Global Area buttons Describe Modules Identify module changes that impact single versus multi-site configurations 1 Point of Care Coordinator Training Guide

10 Application Overview Log on 1. Launch the cobas IT 1000 application. 2. The cobas IT 1000 application Login screen is displayed. 3. Enter your user ID and password, click Login. 4. If your institution has multiple sites, the site list will appear. Select the site needed and click OK. Password The password may only consist of the letters (A-Z) or numbers (0-9). No special characters will be supported. Be aware of the password requirement settings under System > General Settings. Default = up to 6 characters; 1 capital letter; 1 number Point of Care Coordinator Training Guide

11 Application Overview Global Area Buttons: In this area you can view functions that are permanently accessible. Close Button: Log out and closes the application window. Print Button: Shows and hides the specific data export buttons. You can export data as PDF, Excel, Text, and Preview & Log (PDF). For ease of use, load Excel on the server and client where cobas IT 1000 is installed. Help Button: Opens the Help menu containing links to: System help Help Version number About Pressing F1 also takes you to Help Log Out Button: Logs you out of the application, but keeps the login screen up. Pressing F5 also logs you out. 3 Point of Care Coordinator Training Guide

12 Application Overview Module Descriptions The cobas IT 1000 application is divided into the following modules. Some pages may display differently dependent upon the user profile. The POCT Admin login has the highest permission level within the cobas IT My Settings: Provides a single access point to configure settings specific to the current POCT. System: Allows you to configure all settings of the application which affect the behavior of the other modules Point of Care Coordinator Training Guide

13 Application Overview Module Descriptions (cont.) Organization: Where the cobas IT 1000 hierarchy is created and configured. Materials: Lot Management stores information for test strips, QC and linearity materials used with the meter. Instruments: Can verify meter communication, configure meter, assign meter to a location, and create comments for the meter. 5 Point of Care Coordinator Training Guide

14 Application Overview Module Descriptions (cont.) Quality Control: Used to review and validate QC and Linearity results received from an instrument. Results & Patients: Review and validate patient results received from the meter. If using TELCOR, this module will be used very minimally. Reports: Generate canned reports such as patient results, QC Lot statistics, L-J (Levey-Jennings) graph, QC summary, and Linearity Point of Care Coordinator Training Guide

15 Application Overview Single site vs. Multi-site Module Functionality Important: Changes to modules may impact all sites within a multi-site. Red outlines indicate modules where changes made would impact all sites. Green outlines indicate modules where changes made would impact only the single site. 7 Point of Care Coordinator Training Guide

16 Application Overview Single site vs. Multi-site Module Functionality (cont.) Multi-site Limitations Each site must have its own patient ID range that will not be used in any other site. Otherwise follow the Consillia Workflow. Each Site must have its own user ID range which will not be used in any other site. All Sites will have the same general settings (some of them are instrument specific). All sites will work with the same predefined comments. All sites will have the same severities of the alarm flags. Each site must have its own certificates in order to avoid issues when assigning certifications to a large group of individuals Point of Care Coordinator Training Guide

17 User Management Section 2: User Management Training Objectives: At the end of this session the trainee will be able to: Add a new operator and assign users to locations Deactivate/Activate an Operator Certify a single operator using User Management Manage operators within a Workgroup 9 Point of Care Coordinator Training Guide

18 User Management How to add a new operator Navigate to Organization>User Management>Add. Functionality of the Action Buttons Reset Password: Configured in System>General Settings; can be set up as a Default Password or Empty password. Warnings: Duplicate function - set per POCC under My Settings. Certifications: Use to certify an individual user. Competencies: Do not manage here, use the Competencies module. Filter: Click to refresh the page or when you see this icon. Add: Click to add a new user. Deactivate: Select a user to remove them from the Active list Point of Care Coordinator Training Guide

19 User Management How to add a new operator (cont.) Click Add to open Details section of the screen. Fields marked with a blue dot ( ) are mandatory and must be filled in. Items on left side of screen: Enter User/Operator ID (20 character maximum). Enter Last Name. Add a Description if warranted. Password is a mandatory field; currently the ACCU-CHEK Inform II meter doesn t require a password but cobas Academy will require a password. Once you add the Password an error will be displayed until you add the password again under Confirm Password. Password Change Date will display the date the password was entered originally or last changed. Select one of the six canned User Profiles from the dropdown. Enter the address if you are using this feature within IT 1000 Enter a Mobile Phone number if desired. Select a Workgroup if using workgroups within your facility. 11 Point of Care Coordinator Training Guide

20 User Management How to add a new operator (cont.) Items on right side of screen: Enter First Name. Enter 2 nd Last Name. Enter Role. Password Confirmation: Enter password to confirm Creation Date- NA. LDAP field is automatically checked, leave as is. Enter Phone number. Enter Comment. Assign User to Locations Click the Assign button Point of Care Coordinator Training Guide

21 User Management How to add a new operator (cont.) The Location Selection page will open. Select the locations from the left screen and move them to the right Assigned Locations area using the middle arrow buttons. If you would like to organize your users by location, you may select a Home Location for each of them. 13 Point of Care Coordinator Training Guide

22 User Management How to certify an operator under User Management 1. Select the user you would like to certify. 2. Click Certification. 3. Click Add Certification. 4. All available certifications will be displayed. 5. Using the Selected column, choose the desired certification for the user. A check will appear in the Accepted column once you click Save. 6. By default the New Stage is set to Pending, however, you can choose another stage using the drop down menu. 7. Enter the Certification Start Date (Back date by one day). 8. Click Save. 9. Click the back arrows twice to get back to the User Management module Point of Care Coordinator Training Guide

23 User Management How to deactivate a user from User Management 1. Select the user who no longer needs access within the facility. 2. Click Deactivate. 3. Click OK Hint: Forget who is inactive? Status column defaults to Active. Simply use the drop down and select Inactive or All. Click Filter. 15 Point of Care Coordinator Training Guide

24 User Management Workgroup Definition If a Workgroup is defined and assigned to the users, the POCC would be able to sort by the workgroup under User Management Point of Care Coordinator Training Guide

25 Certifications Section 3: Certifications Training Objectives: At the end of this session the trainee will be able to: Discuss different phases of Certification Add a Certification for an Operator Discuss User Certification Add a Certification for an Observer to be used with OTS Group Certify Operators Decertify an operator Deactivate a Certification Export a list of Certification Tasks to view status 17 Point of Care Coordinator Training Guide

26 Certifications Phases of Certifications Navigate to Organization>Certification to set up, manage and maintain operator certification for ACCU-CHEK Inform II meter. The Certification screen opens to display available operator certification(s). Select a certification from the list and click Certifications to display a list of operators certified for this certificate. There are 3 possible phases of Certification: Pending Phase: Optional Applies to a new user with pending certification in order to meet certification criteria Time window to meet criteria can be defined Able to run QC and OTS only Must be filled in when using Automatic recertification but an operator may then be moved to Certified phase without completing pending requirements Interim Phase: Optional Applies to certified user with limits on certification expiration timeline (e.g. 6 months length for new user) Treated as a full certified user during this period This phase can be bypassed and an operator can be assigned directly to the Certified phase Certified Phase: Full term certification expiration Note: All phases use Automatic recertification criteria no POCC intervention is required to move through phases Pending and Interim phases include Observation Time Interval (OTS) Point of Care Coordinator Training Guide

27 Certifications Add a Certification for an Operator General Tab From the Organization > Certification page, click Add to open the following screen and fill in the fields as applicable. Note: ACI2 GLU for ACCU-CHEK Inform II meter. Place a check in Auto Recertifying if you want the cobas IT 1000 to automatically recertify operators who have completed the required tasks. Field Instrument Type Non-Expiring Valid (Months) Auto- Recertifying Is Observer Certificate Type Comment Description Instrument Type and test parameter. Defines whether the certification will be non-expiring or expire after x month(s). Validity for certified stage. Activate/deactivates tabs Pending, Interim and Certified. Defines whether the holder of a valid certification can act as an observer for OTS and free text criteria tasks for (Certification) instrument types. Name of Certification. Recommendation: Prefix with site ID in multisite installations. Comments regarding this certification. Start date of automatic recertification period: Refers to the expiration date of the certification minus the number of days defined in the field Time Frame (Days) End date of automatic recertification period: Refers to the same day as the expiration date of the certification 19 Point of Care Coordinator Training Guide

28 Certifications Add a Certification for an Operator (cont.) Privileges Tab During the definition of the certification and depending on the instrument type, a set of user privileges can be defined. Privileges determine which functions the user can access on instruments of this type. If a user holds different certifications the effective privileges are derived from the combination of privileges. The Privileges Tab groups a defined set of privileges (instrument access level). Privileges can only be set for instrument types supporting this depth of access control. If the selected instrument type does not support privileges, the Privileges Tab is disabled. WARNING: Make sure to only check Glucose related privileges and uncheck all others. Failure to do so could result in an incomplete certificate Point of Care Coordinator Training Guide

29 Certifications Add a Certification for an Operator (cont.) Pending Tab Pending Phase is intended for new operators. No patient testing allowed in this phase. Suggestion: Select Competency Required with short observation time frame. Then attach the ACCU-CHEK Inform II training sign-in sheet for competency. The Pending phase always needs to be defined, but you could manually certify somebody for the Interim phase directly. The history report will show that the users were certified manually, not automatically. The Pending phase can be used for new operators, even if there was no cobas IT 1000 in place when the users were initially trained on the meter. During the original go-live training, you could define the Pending phase to only need a competency, scan the documents produced when training the operators (attendance sheets, checklists and the like) and attach them to the respective competencies. This way you would have one system holding all of the information on which the certification is based. Therefore in the case of an audit, you would only need to look into this one system. 21 Point of Care Coordinator Training Guide

30 Certifications Add a Certification for an Operator (cont.) Pending Tab (cont.) Field Observation Time (Days) QC Level OTS Freetext Criteria Freetext Criterion Competency Required Exam Required Description Observation time in which all tasks have to be fulfilled. Starts with the first activity. Number of QC samples with no errors. Observed test sequence: Defines whether a patient measurement must be performed under supervision. Number of free text criteria to be fulfilled. Activities are to be reported via cobas Academy. Criterion are to be fulfilled and reported via cobas Academy. Defines whether competency is required. Defines whether cobas Academy exam is required. Will be set by cobas Academy once a training course is linked to the certification. The following Error is displayed if an Observation Date and at least 1 QC is not selected: Point of Care Coordinator Training Guide

31 Certifications Add a Certification for an Operator (cont.) Interim Tab This phase will only be activated if selected in the General Screen. If the certification is valid for 12 months then the Interim phase duration could be set to 6 months. Interim may only be used once for a specific certificate. Field Observation Time (Days) QC Level Patient Samples OTS Duration (Months) Freetext Criteria Freetext Criterion Competency required Exam required Description Observation time in which all tasks have to be fulfilled. Before the end of 6 months. Number of QC samples with no errors. Number of patient samples with no errors. Defines whether a patient measurement must be performed under supervision (OTS = Observed Test Sequence) Duration for the Interim phase. Number of free text criteria to be fulfilled. Activities are to be reported via cobas Academy. Criterion are to be fulfilled and reported via cobas Academy. Defines whether competency is required. Defines whether cobas academy exam is required. Will be set by cobas Academy once a training course is linked to the certification. 23 Point of Care Coordinator Training Guide

32 Certifications Add a Certification for an Operator (cont.) Certified Tab Field Observation Time (Days) QC Level Patient Samples OTS QC every Duration (Months) Freetext Criteria Freetext Criterion Competency required Exam required Description Observation time in which all tasks have to be fulfilled. Before certification expires. Number of QC samples with no errors. Number of patient samples with no errors. Defines whether a patient measurement must be performed under supervision (OTS = Observed Test Sequence) Allows you to request interim checks at which the defined number of QC results have to be performed within the observation timeframe. Duration for the Interim phase. Number of free text criteria to be fulfilled. Activities are to be reported via cobas Academy. Criterion are to be fulfilled and reported via cobas Academy. Defines whether competency is required. Defines whether cobas Academy exam is required. Will be set by cobas Academy once a training course is linked to the certification. It is possible to add a new competency for each phase within the Certification, for a total of three. The competency is attached to the user via the certification Point of Care Coordinator Training Guide

33 Certifications Add a Certification for an Operator (cont.) Reminder Tab Field Remind user by Cc Supervisor Remind user by Letter Remind user on Instrument Remind Supervisor Supervisor is Exam required Description Allows notifying the user about pending tasks by . Select the notification template to be used. Defines whether the supervisor will receive the notification as well. Allows notifying the user about pending tasks by printing a letter. Select the notification template to be used. Allows notifying the user about pending tasks on the instrument. Select the notification template to be used. Allows notifying the supervisor about pending tasks by . Select the notification template to be used. Defines who the supervisor for the user is: Supervisors of the user s home location. Supervisor s ID must be selected under each location (Location Manager) in order to use. Supervisor of all locations the user is assigned to. Administrator of user s workgroup. Defines whether cobas Academy exam is required. Will be set by cobas Academy once a training course is linked to the certification. 25 Point of Care Coordinator Training Guide

34 Certifications User Certification Observation timeframe Observation timeframe (OTF): period of time during which the tasks have to be performed to get an automatic recertification (before the current certification expires). Phase Observation timeframe (Days) The following general settings configure the internal periods of time in the observation time frames: Observation timeframe medium warning timeframe Observation timeframe narrow warning timeframe Recently expired certification timeframe. Set from System Module >General Settings page: Example: Certification of 12 months from 1/1/2013 to 12/31/2013 Observation timeframe is 31 days Medium timeframe: 50% (in this case 16 days before certification expires) Narrow timeframe: 20% (in this case 7 days before certification expires) Recently expired certification timeframe: 15 days 12/1/13 12/15/13 12/25/1 1/1/14 1/15/14 16 days to expiration 7 days to expiration Point of Care Coordinator Training Guide

35 Certifications User Certification (cont.) Warnings are generated when certifications are close to expiration date and displayed to POCC in the Warnings area. Upcoming certifications: for certifications that enter Observation Timeframe Pending certifications: for certifications that enter Medium Observation Timeframe Urgent certifications: for certifications that enter Narrow Observation Timeframe Expired certifications: for certifications that enter Expired Observation Timeframe - When date reaches Long Time expired, it is no longer visible in cobas IT You would need to filter to locate it 27 Point of Care Coordinator Training Guide

36 Certifications Add a Certification for an Observer Select Organization > Certifications for a person responsible for watching an operator perform testing (Observed Testing Sequence-OTS). This certification will apply to those persons who will be observing operators performing testing. Steps for OTS on an ACCU-CHEK Inform II Observed Test Sequence (OTS) function allows an observer (supervisor) to assess and record an operator s performance (e.g. for recertification purposes). The observer monitors an operator during a test to check that the test is being performed according to the recommended procedures. He/she then evaluates the performance and passes or fails the operator. This assessment is saved together with the glucose test result and any desired comments. When a certification needs to be renewed, the operator will receive a message when they log into the meter informing them that they need to renew their certification. A request for an Observed Test Sequence comes from the cobas IT 1000 and cobas Academy Point of Care Coordinator Training Guide

37 Certifications Steps for OTS on an ACCU-CHEK Inform II (cont.) Observer: 1. Touch Patent Test. (In the Patient Test Menu, the Glucose Test button is disabled (see above) until the observer has logged in). 2. Touch Observer Login. 3. Wait until the Observer ID screen is displayed. Enter your Operator ID or scan your Operator ID barcode. 4. Enter the (optional) password in the Observer Password screen, and touch to log in. The Patient Test Menu is displayed again. The Glucose Test button is now available. 5. Hand the meter to the operator who can now perform the patient test under supervision. 29 Point of Care Coordinator Training Guide

38 Certifications Steps for OTS on an ACCU-CHEK Inform II (cont.) Operator: 1. Touch Glucose Test. Perform the patient test as usual. Once the test is completed, the observer has to complete the next steps. 2. Hand the meter back to the observer. Observer: 3. Touch to log in again. 4. After you enter your password, touch to proceed with the assessment. 5. Assess the test result validity but touching Yes or No. 6. Assess the operator s performance by touching Pass or Fail. 7. Touch, it you want to add a comment. 8. Touch to return to the Main Menu screen. The OTS information is saved together with the test result Point of Care Coordinator Training Guide

39 Certifications How to Group Certify Operators Access Organization>Certification 1. From the list of possible certificates, select the Certificate Type to certify a group of operators. 2. Click the Certification button to open a listing of currently certified operators. 3. Click the Add button. See next page. 31 Point of Care Coordinator Training Guide

40 Certifications How to Group Certify Operators (cont.) 4. A list of current operators is displayed. If this is a new certification and all operators need to be certified with this certificate, click the Select All Users button or select specific operators that need certification. 5. In the Detail area fill in the Certification Start date and choose the Stage. (Defaults to Pending) 6. Click the Save button. The updated information is displayed in the Certification List area. 7. When using Automatic recertification criteria, operators will be automatically recertified at the end of their certification expiration date if they have fulfilled the criteria and any certification tasks Point of Care Coordinator Training Guide

41 Certifications How to Decertify an Operator 1. Open the User Certification page, to display list of certificates. 2. Select certificate, click Certifications. 3. Click the Add/Remove button to display list of operators. 4. Select operator(s) to be decertified then Click the Decertify button. How to Deactivate a Certification 1. Open the User Certification page. 2. Select the Certificate Type to be deactivated. 3. Click the Deactivate button, bottom right-hand side of page. 33 Point of Care Coordinator Training Guide

42 Certifications Certification Tasks Use the Certification Tasks page to view the status of the certification tasks for operators who need to maintain their certifications. For each of the tasks, the completion status is displayed in the column labeled Completion (e.g. number of patient samples done against number of patient samples needed). Export the list of certification tasks that is displayed on the screen to a Microsoft Excel file. This file is enhanced with additional information not shown in the Certification Tasks List area. To export list of certification tasks 1. Select Organization>Certification tasks 2. Apply the filters so that the screen displays the list of certification tasks to be exported. 3. Click the Export List button. The system automatically launches Microsoft Excel, displaying the list of certification tasks in a spreadsheet. Cerification Tasks Status Symbols: Certification is valid Certification is expired or long-time expired Certification is non-expiring Certification is upcoming, urgent or pending Point of Care Coordinator Training Guide

43 Competencies Section 4: Competencies Training Objectives: At the end of this session the trainee will be able to: Add a Competency 35 Point of Care Coordinator Training Guide

44 Competencies Add a Competency The definition of competency is the following: The quality of being competent or capable of performing an allotted function. When using the cobas IT 1000 you would define a competency in the software. Assign the competency to the people who need it. Complete the training and then attach the proof of training such as a sign in sheet or roster. (This document should include the date and time of the course, the title, signature of attendees and trainer.) You must add a Competency before it is made available to assign to an operator. 1. Open Competencies page, click Add to open Details section of the page. 2. Select the Certificate Type which automatically fills in Instrument Type. 3. Fill in Date which automatically fills in the Competency name. 4. Select the Stage. 5. Click Browse to locate Training Sign-in sheets or any document to be used to deem operators competent. (Perhaps a Read and Understand for a new process.) 6. Click the Users button on bottom of screen to assign this competency Point of Care Coordinator Training Guide

45 Competencies Add a Competency (cont.) 7. Open Certification Tasks to see listing of operators with assigned tasks: 8. Once the Competency document is attached, the task will be complete and be removed from this list. The maximum size of the attachable file is defined in General Settings: under Size Warning Limit for Competency Files (MB and Default = 10MB). Once a competency has been used to certify an operator, move to the next stage or to renew the certified stage, it is read-only. 37 Point of Care Coordinator Training Guide

46 Competencies Notes Point of Care Coordinator Training Guide

47 Notification Templates Section 5: Notification Templates Training Objectives: At the end of this session the trainee will be able to: Set up Operator Certification notifications 39 Point of Care Coordinator Training Guide

48 Notification Templates The cobas IT 1000 application comes with the following predefined notification templates: Template - User notification by Template - User notification by letter (print out) Template - Supervisor notification by Template - Instrument (ACI2) notifications can only be selected once the connection is switched on (System > General Settings). How to set up Operator Certification Notifications For a new Notification Template, it is required to create a copy of an existing predefined template. 1. Select the template to be copied. (Example: Template-Instrument ACI2) 2. Click Copy to open Details section of the page. 3. Rename the Template. (Ignore Copied From) 4. Click OK and this new Template will be displayed in the list above. 5. Highlight the newly named template and click Edit to modify the content. Here the contents of the template can be customized. Remove and data that doesn t apply. (See screen shot below) There are predefined Place Holders (Insert Merge Field) that may be used in order to populate the template with the needed information Point of Care Coordinator Training Guide

49 Notification Templates How to set up Operator Certification Notifications (cont.) 6. To access the Placeholders select the Field tab and click the Insert Merge Field button and select the required Place Holder from list. Theoretically you can put in as many fields and as much text as you want, however the message sent to the instrument needs to be a maximum of 120 characters (this is the maximum number of characters that the instrument supports). 41 Point of Care Coordinator Training Guide

50 Notification Templates How to set up Operator Certification Notifications (cont.) 7. Once the required fields have been selected it is possible to preview the newly created template. 8. Click the Preview button and the template will be displayed. Example Notification: 2121 Your certification (ACI2 GLU will expire on 01/08/2014. Please do: Patient Samples, QC Level 1, QC Level Point of Care Coordinator Training Guide

51 Notification Templates How to Setup Supervisor Notifications 1. Select the template to be copied (Example: Template - Supervisor ). 2. Click Copy to open Details section of the page. 3. Rename the Template (Ignore Copied From ). 4. Notice Attach List is checked- list of operators. 5. Click on Table Layout (Select appropriate fields to be displayed to supervisor). 6. Select Send Notification time: Do you want to notify this supervisor? (Daily, Weekly, Bi-Weekly) 7. Click OK. 8. New Supervisor is displayed in list, Highlight and click Edit to open. 9. Make sure you approve of the wording in the template, change as needed. 43 Point of Care Coordinator Training Guide

52 Notification Templates How to Setup Supervisor Notifications (cont.) 10. Click the Fields button then click on Insert Customer Table (Make sure mouse is in an empty space). Notice that the Table Full wording allows you to know the table has been attached. 11. Click the Preview button on top of page to display actual Point of Care Coordinator Training Guide

53 Instruments Section 6: Instruments Training Objectives: At the end of this session the trainee will be able to: Monitor the Instrument status Configure the application for the Instrument Add a new device to the cobas IT 1000 system and assign a location 45 Point of Care Coordinator Training Guide

54 Instruments Tips and Tidbits You must place a new ACCU-CHEK Inform II meter in the base-unit to initially download the meter. Once downloaded it will populate the following in the cobas IT 1000 application: - Instrument type - Instrument name - Instrument number serial number (SN) - Default configuration - DO Not Add a Device Manually! Once the ACCU-CHEK Inform II downloads in cobas IT 1000, the meter must be assigned to a Location. (Select location from the drop-down list). Criteria that must be met to send an operator list to the ACCU-CHEK Inform II meter: - User needs to be assigned to the same location as the instrument. - User needs to be certified for the required instrument type. - User list needs to be activated in the configuration. Criteria that must be met to send a patient list to the ACCU-CHEK Inform II meter: - Patient visit needs to be admitted to an HIS location which belongs to the same location as the instrument. - Patient list needs to be activated in the configuration. - ADT feed must be available and current. If an instrument is used without assigned locations, the meter will be available in all locations and results will download with a blank Location column and not be associated with any location (audit trail) The ACCU-CHEK Inform II downloads with the Default Configuration settings. Confirm this configuration is applicable for this location and re-assign a new configuration if necessary Point of Care Coordinator Training Guide

55 Instruments Status The Status page supports 2 main functions: 1. Review events/errors that download from the device. Status page opens to display meters with errors and the Event column defaults to display meters with errors only. Any meter event, such as warnings, exceptions, errors or required actions will be displayed in detail on the bottom section of the page. 2. Last Communication column displays last meter download date/time. Change Event column header from Yes to All which then displays all downloaded meters. Select On-line. A green dot means the meter is on-line and has synchronized within the last 15 minutes. Instruments Grid Column Symbol Meaning Event The instrument has some event which has not yet been acknowledged. Lockout Status Instrument locked by the system. Instrument locked manually by user. Instrument locked by maintenance task being performed. Instrument auto-lockout. Online/Offline Instrument is online. This means that the instrument has been synchronizing at some point within the past 15 minutes. Instrument is offline. If the instrument has not been synchronizing within the past 15 minutes, the status is set to Offline. Check the column: Last Communicated to confirm last time the meter downloaded successfully. 47 Point of Care Coordinator Training Guide

56 Instruments To send a message to an instrument 1. Select Instruments>Status. 2. Click the Filter button and enter the search criteria to retrieve instrument records. 3. Select the active instrument to which a message is to be sent and click Send Message. A new record appears in the Detail area. 4. Double-click this record under the Comment column. The comment text box becomes editable. 5. Write the message and click OK. The message is automatically sent to the instrument. If the instrument is not online, the message will be sent when the instrument is connected. Add a new Instrument Configuration 1. Open Instrument Module > Configuration page. 2. Click Add to open a list of all devices with a corresponding configuration. 3. Select Instrument Type and Configuration ID from the list. (Use this Default configuration and settings, rename it and then make changes to the configuration as needed). Instrument Configuration 1. Open Instrument> Configuration >Device Conf. 2. From the drop down at Instrument Type select ACI II (ACCU-CHEK Inform II). 3. Click Filter to display a list of all configurations within the System. 4. Click Add. 5. Select (highlight) the configuration from the list of displayed configurations. 6. Click the Device Conf button to open the Configuration Selection page Point of Care Coordinator Training Guide

57 Instruments Instrument Configuration (cont.) Date/Time Format: MM/DD/YY-Standard for US 12 hr or 24 hr clock Beep Tone: Certain events on the device cause a beep, select volume. On-Meter Editing: Allows glucose materials to be entered on meter or set to require a password for scanning. Recommend selecting Password Needed so that only the POCC can scan new lot of strips. Result Memory: Represents length of time results stay in meter before cleared. Result Upload Required: Yes Download results to cobas IT 1000 before clearing meter. 49 Point of Care Coordinator Training Guide

58 Instruments Instrument Configuration (cont.) Main Menu Format: Use to make buttons display on ACCU-CHEK Inform II device. Setup- allows manual configuration on the device (password required). Other Test Entry Menu: Select when using other test entry on device and mark appropriate boxes. Shutdown Timeout: When meter is not in use, displays how long the meter will remain on before it shuts down to save battery. Power Save: The length of idle time before the device will enter power save mode. (Screen darkens). Download Warning: Length of time before the operator will be warned to dock the meter else they will be locked out. Download Lockout: Time during which the device must be re-docked before testing can resume. This does not apply when using Wireless communication. WLAN Communication: Select this option when using wireless communication Point of Care Coordinator Training Guide

59 Instruments Instrument Configuration (cont.) Other Test Entry If using Other Test Entry (OTE) on ACCU-CHEK Inform II, first place a! in Other Test. Entry Menu and then select which tests will be used. ACCU-CHEK Inform II firmware version 3.04 required for OTE. 51 Point of Care Coordinator Training Guide

60 Instruments Instrument Configuration (cont.) User User ID Entry Mode: Mode the operator is required to use to enter their ID in the meter. ID Validation Mode: Mode used for validation. None means the device would not ask for an ID. Total Length: requires an operator to enter ID of a specified length. Issue: They could enter any numbers or letters within that length. List: cobas IT 1000 will send a list of certified operators to the meters where they are assigned to work. User ID Timeout: Once the meter turns off, how long should the operator s ID remain in the meter? Suggest 0. Clear the Operator ID once the meter shuts off. Setup Password: Default=Setup. This is the password to be entered into the device to enter test materials and adjust the time. Password can be changed but be sure to alter person who needs to add the Test Strip. User ID Applicability: All tasks allow the operator to perform patient and QC testing on the meter. User ID Barcode Mask: Applies to operator IDs scanned into the meter. Enter specific characteristics to mask numbers to require a specific entry when scanning. Not usually needed for operator barcodes Point of Care Coordinator Training Guide

61 Instruments Instrument Configuration (cont.) Patient Patient ID Entry: How will the Patient ID be entered into device? Patient Confirmation: once entered, how shall the ID be confirmed? Patient ID Mapping: Entering Account#, MR# =Patient ID 1 or if entering Visit#- select Visit #. ID Validation Mode: If receiving ADT feed, suggest using List-allowed to add new. Patient List: will be checked if ID Validation is set to List Incoming Patient List:! Instrument Use Only to send the patient list to instruments in one location where the patient is admitted or send All patients to All Locations? Don t recommend sending All Patients to multi-sites sharing one server. 53 Point of Care Coordinator Training Guide

62 Instruments Instrument Configuration (cont.) Patient (cont.) Patient ID Barcode Mask: Example- Barcode is reading AC but the operator is scanning a barcode without the letters: AC. Set Mask: ^A^C. (10 periods). Patient ID Barcode Mask This mask is applied to patient IDs that are scanned in via the barcode reader. The characters in the mask have the following effect: * The character read from this position will be discarded. ~ The character read from this position must be numeric (0-9) and will be discarded. + The character read from this position must be a letter (A-Z) and will be discarded. $ The character read from this position will be saved. ^ The character following the carat in the mask must occur in that position in the barcode and will be saved. : The character read from this position must be numeric (0-9) and will be discarded. Any other character: The barcode must contain that character at this position, but will not be saved. The barcode mask can be up to 40 characters long Point of Care Coordinator Training Guide

63 Instruments Instrument Configuration (cont.) Glucose (Patient) Comments: Required: Select one of the four settings. Range: If Out of range only is selected then choose which ranges. Normal Range Critical Range Reportable Range Measuring Range Custom Comment: may be enabled to enter customized comments at meter. 55 Point of Care Coordinator Training Guide

64 Instruments Instrument Configuration (cont.) Glucose (Patient cont.) Display Strip Limitations Warning: Remove check as there are currently no limitations for ACCU- CHEK Inform II. Critical Result Display: Want to display the critical value? Glucose Result Ranges: Enter Normal, Critical and Reportable ranges. Result Range Messages: 100 character limit to display your institution s policy on managing critical or out of range patient results. STAT Test Configuration: Will you allow the operator to perform a STAT if QC is due? Strip Lot Verification: How will the operator confirm the test strip lot? Point of Care Coordinator Training Guide

65 Instruments Instrument Configuration (cont.) Glucose (Control) QC Result Display: How will the QC result value be displayed on the meter? Actual Value or Pass/Fail? QC Lockout: Most sites use Time in Between Hours and set to 24 hours which requires QC to be run once every 24 hours. Lot Verification: How will the test materials be verified on the device when ready to test? Device displays the lot #. Operator must select! if lot# is correct or Press X to enter different lot# w/ Yes/No. Lot Number Entry: Requires the operator to enter the lot# each time they ran a test. Barcode Scanner Only: Operator would scan the strip vial or the control bottle into the device before testing. Linearity does not have a barcode. 57 Point of Care Coordinator Training Guide

66 Instruments Instrument Configuration (cont.) Glucose (Control cont.) WLAN Settings: WLAN: Enabled under Instrument in this same screen. Information here will be entered with your IT Department s guidance Point of Care Coordinator Training Guide

67 Instruments Instruments (Adding/Assigning Comments) Comments are defined in cobas IT 1000 and assigned to locations and displayed on the ACCU-CHEK Inform II meter. On this page, it is possible to add a new comment as well as assign pre-defined comments that came with the system. Click Instruments > Comment Assignment to add a new comment to the system. 1. Click Add to open the Detail section of the page. 2. Select the Instrument Type from the drop down box. 59 Point of Care Coordinator Training Guide

68 Instruments Instruments (Adding/Assigning Comments cont.) 3. Select the comment from the Comment drop down box : (Notice <Add New> choice) 4. Select the Order of Display. a. Will determine how the comments are displayed on the meter. Do you want the comments used most often to be first or do you want comments of most importance to be first? b. Comments can only have one order of display. Meaning no two comments can be assigned the same order number. This is especially important for institutions sharing a common server as this is a shared page. Institutions would need to agree on one order of display or create a unique comment with an institution s Initials in the name. This way they could create their own comments with their own order. You may change the order of the comments at a later date if needed. 5. Mark as Erroneous: indicates if this comment should be marked as an Error. Remember that marking a comment as an Error would stop the result with this comment on the Result Validation page. This may be a useful tool to stop a result that has a comment: Do Not Chart or Procedure Error Point of Care Coordinator Training Guide

69 Instruments Instruments (Adding/Assigning Comments cont.) 6. Fill in the Result Type. When should a comment display on the meter? (Patient testing, Control testing, etc.) Highlight from the Available selections and click the arrow(s) to move the result type to Assigned. 7. Click the Assign button to open the following page: 8. Assign the comment to the locations where it will be used. Highlight locations from Available, use arrow(s) to move to Assigned. Download the meters and the comments will be available. 61 Point of Care Coordinator Training Guide

70 Instruments Notes Point of Care Coordinator Training Guide

71 Materials Section 7: Materials Training Objectives: At the end of this session the trainee will be able to: Add a new lot of test strips via the ACCU-CHEK Inform II meter and mark as reviewed Assign new materials to locations Add Linearity and QC Lots 63 Point of Care Coordinator Training Guide

72 Materials How to add new lot of test strips and mark as reviewed 1. Log into the ACCU-CHEK Inform II. 2. Touch the right arrow button to open Main Menu Touch the Strip Lots button. 4. Touch the Add button. 5. Insert the strip lot code key in the code key reader. The LED light starts flashing green and signals that the reader is ready to transfer data. 6. Immediately hold the ACCU-CHEK Inform II above the Code Key Reader then touch the rightarrow button to start the transfer. As a rule of thumb, the Infrared eye of the code key reader must be placed below the cobas symbol in the ACCU-CHEK Inform II meter, which will match the location of the Infrared Eye in the instrument Point of Care Coordinator Training Guide

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