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

Transcription

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 [email protected] 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

73 Materials How to add new lot of test strips and mark as reviewed (cont.) 7. After successful strip lot addition, the meter will display a confirmation message similar to the one displayed below. Touch the without changes. button to store the data for this test strip lot in the meter (You may also touch number before storing it in the meter.) to modify the data for this test strip lot Warning: If custom ranges are used, there is a potential for the cobas IT 1000 system to round up results and send a different value than what is displayed on the meter. 8. The instrument will display a Make Current screen. Press the button to confirm that you want this lot number to be the current lot in use. (Alternately you can touch to store the strip lot for later use.) 9. Dock the meter and allow time for synchronization to be completed. 10. In cobas IT 1000, click Materials > Lot Management to display list of materials. 65 Point of Care Coordinator Training Guide

74 Materials How to add new lot of test strips and mark as reviewed (cont.) 11. Double click the newly added strip lot Glu2-T to open details. 12. Check the box Reviewed. 13. Select the Locations tab to assign the new test strip to the locations where it will be used. 14. Assign the locations using the Arrow buttons and click the OK button. 15. Undock and dock meter(s) allowing time for synchronization to be completed Point of Care Coordinator Training Guide

75 Materials How to assign new materials to locations 1. Open Materials > Lot Management to display the list of Control Lots or Linearity lots in use for ACCU-CHEK Inform II. 2. Double click the newly added material lot to open details. 3. Determine if the lot is marked as Reviewed. 4. Select the Locations tab and then click the Assign button to assign the new material to the locations where it will be used. 5. Click either the single arrow to assign material to one location or double arrows to assign the material to all locations. 6. Click the OK button when finished. 7. Undock and re-dock the meter (s), allowing time for synchronization to be completed. Note: If a material lot is not assigned to a specific location, the material lot is used for all locations. 67 Point of Care Coordinator Training Guide

76 Materials Add new Linearity and QC lots Control ranges will be downloaded with the test strip Linearity ranges must be entered in the cobas IT 1000 application with each lot of test strips. Double click the test strip lot; click the Ranges tab to enter the linearity range. Linearity Range is not lot specific; the range is consistent no matter what linearity lot or test strip lot in use. (The ranges are located on the linearity package insert and the % deviation depends on your institution s policy). Control lots and linearity lots can be either scanned into the meter or entered manually into cobas IT Point of Care Coordinator Training Guide

77 Quality Control Section 8: Quality Control Training Objectives: At the end of this session the trainee will be able to: Review QC and linearity ranges 69 Point of Care Coordinator Training Guide

78 Quality Control Quality Control Comments may be added to a QC result before rejecting it. (Select result and click Comments) An alarm (MTE) is displayed if the material lot of the result received is unknown to the system. Remember to mark the new lot as Reviewed in Materials > Lot Management screen so the alarm is not seen when running future tests. Accepted control results are included in statistics while Rejected results are not. When a QC result downloads from an ACCU-CHEK Inform II meter, it is automatically checked against: o QC range as defined in Test Materials o Operator- is this a certified operator? o Material- is this a known lot in cobas IT 1000? o Instrument- is there an instrument flag? Point of Care Coordinator Training Guide

79 Quality Control Result Management Use Result Management to review QC results that have been transmitted from the ACCU-CHEK Inform II meter. Each result is automatically verified against the QC range and entered into Lot Management. A QC result is automatically accepted if no Alarm associated with this result has a severity of Error. Result with a green check mark is a valid result. 71 Point of Care Coordinator Training Guide

80 Quality Control Review Invalid Results 1. Select Date & Time and choose From..To 2. Change column to Pending; click Filter to see a list of only invalid QC results. 3. Review the graph, values will be displayed in red, check out the values compared to the level. Was the QC level switched? 4. Add a Comment before rejecting the result? Select result, click Comment. The page opens to display an operator entered comment. If you receive a blank page, no comment was entered at the time of the test. 5. From Type, click the dropdown arrow and select: QC Result. 6. Add a free-text comment in the Text field or click Add Coded to add a pre-defined comment. When selecting a coded comment, double-click on the comment you want and it will populate in the Text field. Click OK when finished. How to review Details for a specific QC result: Highlight the result and double-click on Instrument Name to open the following Details screen: Point of Care Coordinator Training Guide

81 Quality Control Levey Jennings Review Use this component to review all QC test combinations in a systematic approach, based on a monthly review schedule. How to display and review LJ charts for one month 1. From the Navigation Tree select Quality Control > Levey-Jennings Review. 2. In the list, double-click on the line for the month to be displayed. 3. The chart for the selected month appears at the bottom of the screen. 4. Accept a chart by clicking on the Accept button and/or add a comment to the chart. Click the button to open a comment screen then click the Add button to add a freetext comment or click the Add Coded Comment the list. button to select a comment from 5. Once accepted, the icon in the list turns green. Any updates are automatically stored in the database and the LJ Review grid will display the following 73 Point of Care Coordinator Training Guide

82 Quality Control Levey Jennings Review (cont.) How to display and review LJ charts for one month (cont.) 6. Click the button at the bottom of page to print the displayed chart. Notice the Statistical data that is provided: L= QC Level SD =Std. Deviation M = Mean CV =Coefficient of Variation Bias 1.48% (Relative deviation of the calculated Mean from the expected Mean.) Point of Care Coordinator Training Guide

83 Quality Control Levey Jennings Review (cont.) How to Review LJ Charts by specific Lot Select the lot number and the specific month of the LJ chart to be displayed. When reviewing by lot the graph only displays dots without connectivity lines to increase readability. 75 Point of Care Coordinator Training Guide

84 Quality Control How to display linearity charts: 1. Select Quality Control > Linearity Review. 2. List of available linearity charts will be displayed in the list, double-click one line in the display to open the associated linearity chart. 3. Select Comment if you want to add a comment or select Accept to mark the chart as reviewed. Status Icons in the list are color-coded: Red: Yellow: Green: the specific daily chart is not yet accepted, or that changes were made after acceptance. indicates that the chart cannot yet be generated. Possibly because the calendar day on which the results were received is not over; some results are not available; or the graph is not complete. indicates that the chart is already accepted. Accepted charts in the list show the user who accepted them and when they were accepted. Graph Description x-axis y-axis Grey dashed line Blue dots Blue dashed line/graph Light blue shaded area Target values. Measurement unit is defined under System>Test Definition. Measured values. Measurement unit as defined under System>Test Definition. Ideal values (as defined in target values). Effectively measured values. Connection of the measured values to indicate the tendency. QC range for the corresponding QC level. Note: Use Ctrl + P to print Point of Care Coordinator Training Guide

85 Results and Patients Section 9: Results and Patients Training Objectives: At the end of this session the trainee will be able to: Validate results Query for results Query for patients 77 Point of Care Coordinator Training Guide

86 Results and Patients Results & Patients Result Validation: Only patient tests with error alarms/flagged appear in the Results & Patients > Result Validation screen so they can be reviewed by the POCC. All other results, even if they have warning or information alarms are automatically validated by cobas IT 1000 application and will be displayed in Results & Patients > Result Query screen only. When a result is displayed on this screen, POCC must Accept, Reject or place On Hold while investigating the value. Results displayed here will not be available in the patient s electronic record. The cobas IT 1000 application supports a generic patient ID: and must not be edited. Results are associated with the generic patient if they cannot be associated with a specific patient ID. This happens if: Patient samples are tested or entered without a patient ID or Visit ID. Patient ID 2, Patient ID 3 or Visit ID was used as Patient ID and no patient with the respective ID is known to the cobas IT 1000 application. (e.g. because the ID was misspelled or the ADT information was not yet updated by the HIS) How to review a flagged result and mark with: Accept, Reject or Hold 1. From the Result Validation Screen, filter on the Date and Time column to select appropriate timeframe, then click the Filter button to activate. 2. Review the result. What is the value? What is the Alarm? Are there any columns colored in Red? Is there an operator comment? Point of Care Coordinator Training Guide

87 Results and Patients How to review a flagged result and mark with: Accept, Reject or Hold (cont.) 3. What about the Alarms associated with the result? Click on alarms to view the details and description of each: Note : For TELCOR Users, patient results alarms will all be set to Information/Warning which means patient results will all cross to TELCOR where they can be reviewed. Notice there are 3 different Actions associated with the Alarms. Only the Error Alarms stopped this patient result on the Result Validation page 4. Once the result has been reviewed and the Alarms addressed, it is up to the POCC to mark the result with Accept or Reject or Hold. ACCEPT- Highlight the result and click the Accept button to send the result to the patient s chart. Result is removed from this page but will still be displayed on Results Query page. REJECT- Highlight the result and click the Reject button. The result will be marked with a red X and will remain on this page while simultaneously be available in Result Query. HOLD - Highlight the result and click the Hold button while investigating but ultimately mark the result with Accept or Reject. A result placed in Hold will be marked with a Yellow H and will remain on this page while simultaneously be available in Result Query. The POCC would need to address each result on the Result Validation page. The goal is to keep this page clean and upload patient results if possible. 79 Point of Care Coordinator Training Guide

88 Results and Patients Repeated patient tests (Error Code = TRR) The cobas IT 1000 application will hold every patient result for the time set in the Repeat Time Interval screen to see if a repeated test downloads. Once the time frame is over the patient result will be processed. If a repeated test downloads, both results will be flagged as repeated tests and POCC must upload one or the other to the LIS. 1. Navigate to System > General Settings and change the Current Value from No to Yes (doubleclick to open Details) 2. Double-click on your configuration to open Details and set Repeat Time Interval. Result Query- It is possible to filter on repeated patient tests: Point of Care Coordinator Training Guide

89 Results and Patients Result Validation Buttons The following is a list of Result Validation buttons. The POCC would need to select one specific patient result from the list and Click the following button to take the action: Review/Edit comments (There are 2 types of comments: one entered on the device at the time of test and one entered by the POCC after the test downloads into the cobas IT 1000). Query/Modify patient s personal/demographic data. Click this button to open Single Patient Edit screen. All demographic data can be edited except Patient ID. Change patient demographic data. Click this button to open Patient Query screen. Put test results on hold to investigate. Reject result(s) Result will never cross to patient s chart. Accept result(s). Display detail result information. Display all results for selected sample. Display all results of patient (Probably won t use). Add new sample manual result screen (Probably won t use). Add test to sample manual test result (Probably won t use). Resend test results to LIS (Can only re-send results that crossed and failed). 81 Point of Care Coordinator Training Guide

90 Results and Patients Validation Alarm Symbols System or user validation (depending on the column) No Alarms With Alarms Manually rejected result. Results may only be rejected if the measurement is considered to have not been performed correctly. Rejected results are considered to contain no information on patients or instrument. Result that has been put on Hold Patient Cleaner Process For Information only: your Roche Representative will manage the settings. The automatic patient cleaner process changes the status of the visit and its associated patient from admitted to discharged, for visits which reached the defined timeframe in the General Settings for: Patient Class Groups starting with the admission date and time. Idle patient starting with the last received result date and time or, if no result is received, with the admission date and time. If the visit has no associated result(s), then the application checks in the general settings if deletion of this visit is allowed. If set to yes and the selected visit is not the only visit from the patient, the application deletes the visit. If set to yes and the selected visit is the only visit from the patient, the application deletes the visit and its associated patient. If set to no, the application sets the visit from admitted to discharged Point of Care Coordinator Training Guide

91 Results and Patients Result Query The Result Query page will hold and display every patient test result. If a patient result has an Error Alarm/Flag, the result will be displayed on this page while simultaneously being displayed in Result Validation. The following functions are available but to view patient information ONLY. Edits are not possible as edits will be done in Patient Validation or Patient Query: Screen columns supported in Result Query: Most of the column headers are self-explanatory except for: OTS (Observed Test Sequence) For OTS results, a graphic indicator (red/green) indicates if the result was approved by the supervisor. Drag the mouse over the indicator to get additional information: User ID of the observer User ID of the user Any comments provided by the observer during the validation of the result OTS-Observed Test Sequence cobas Academy is required to populate OTS. 83 Point of Care Coordinator Training Guide

92 Results and Patients Patient Query The Patient Query page is populated from the institution s ADT feed and is a very useful page. A patient id may be manually entered in the open box above Patient ID 1 or click Filter to display all patients: Notice, the display provides admission and discharge dates as well as HIS location. If the HIS location is blank the patient result will not cross to the patient s chart. The HIS location is a required field. Review the following three examples: 1. In the example below, check the status of a patient s result(s). Did the result(s) cross to their chart? Query for the status of individual tests to see whether the results of specific tests have been validated, sent to the HIS/LIS or locked. To query for status of tests a. Choose Results and Patients > Patient Query. b. If necessary, set a filter to display specific patients. c. Double-click the patient s record. The samples for the selected patient appear in the Detail area. d. Select the sample whose test status is to be queried, and under the list in the Detail area. Click the Status button. The Patient Sample Status window is displayed Point of Care Coordinator Training Guide

93 Results and Patients Patient Query (cont.) 2. In the example below, the patient ID is correct however; perhaps something in the demographics must be reviewed or edited. To Edit the patient s demographic and visit information data: a. Choose Results & Patients>Patient Query. b. Set a filter to display specific records. c. Select the patient record to be edited and click Edit. The Single Patient Edit screen appears. d. Modify the fields for patient and visit information and click OK. 3. In this example, the Patient ID is incorrect and needs to be changed: Editing a Patient ID a. Choose Results & Patients>Patient Query. b. Enter Patient ID number of the record to be edited and click Filter. c. Click Edit. d. Click Edit Patient ID. e. Edit the necessary fields and then click OK. The modified Patient ID is saved. View all results for one patient and then further check to view its results. Note: It is possible to add a patient to the system, however: Do not add patient records manually when the application is configured to receive patient information from several host systems in parallel. 85 Point of Care Coordinator Training Guide

94 Results and Patients Patient Troubleshooting Tips What if? The patient ID does not exist and you are prompted to add it. The patient s last name is introduced in the Patient ID 1 field (or no numbers are introduced). o The Patient query screen appears. An automatic search of the patient s last name is performed. o Highlight the patient s record and click Select. Sample ID already exists. o The order data is retrieved and appears on the screen. A patient ID is entered. If the patient exists and has only one visit, the visit information is displayed. If the patient has more than one visit, the Patient Query screen appears. Select the desired visit and click Select. If the patient does not exist, the Single Patient Edit screen appears to add a new patient. A visit ID is required. If the visit is admitted, patients and visit information is displayed. If the visit is discharged, the information is displayed that manual result cannot be created for this visit. If the visit does not exist, the Single Patient Edit screen appears to add a new visit Point of Care Coordinator Training Guide

95 Reports Section 10: Reports Training Objectives: At the end of this session the trainee will be able to: Generate a report Identify various report examples 87 Point of Care Coordinator Training Guide

96 Reports Report Generation Use the Report Generation page to extract information from cobas IT 1000 by means of standardized reports, which can be used for documentation or information exchange purposes. Based on predefined reports, the application will provide individual query criteria to narrow down the information that will be presented in the report. The report is then generated as a PDF file and can be processed depending on the intended purpose of the report. Each generated report may be stored in the application by clicking Store and View on the Report page. Note: Before generating a report ask: What is the purpose of this report and who is the intended audience? Do you need a formal report of can you retrieve the information directly from the working page? How to Generate a Report: 1. On the Navigation Tree, select Reports > Report Generation. 2. Double-click the report type to be generated to open the Detail section of the page. 3. Enter the criteria. Depending on the report, may not need to fill in every field. 4. Click the View button. The system automatically generates a report according to the set parameters and launches Acrobat Reader to visualize the report in PDF format Point of Care Coordinator Training Guide

97 Reports Levey-Jennings report Recommendation: Accept or Reject QC results from Quality Control Module > Result Management page before proceeding to a report. 1. Double-click the LJ Graph Report from the list to open Details. Fill in the fields as needed. Notice the blank fields above; you don t want to limit the report. 2. Click on the View button. A Documents Setting box will open, simply click OK to move on. 3. Report is displayed and the following functions are available: Statistical information for each accepted QC result by QC level and location is displayed. Limitation: Report provides QC values on a separate page from LJ graph which results in many pages of documentation. 89 Point of Care Coordinator Training Guide

98 Reports User Certification History Report (sorted by Home location) This report is used to document the history of users and their certifications, requested tasks and their completion status Point of Care Coordinator Training Guide

99 Reports All Results by Date report This report provides a listing of all results (Test, QC, Linearity, and Proficiency) run over the defined period of time, including instrument maintenance and instrument exceptions. This report contains a full log of all results received from an instrument in combination with instruments and user comments related to these results. This type of report presents all the results that match the filter criteria ordered by date. First page of Report provides totals for patient, QC, Linearity and Proficiency testing by Site. 91 Point of Care Coordinator Training Guide

100 Reports QC Summary (By Location and Instrument) This report shows the QC results based on a statistical evaluation sorted by location, instrument type and individual instrument. With this report you can compare the QC results between different individual instruments. This report provides QC statistics for each device in individual locations: N Mean SD CV% Target Min. Max. #Inside Range # Outside Range # Rejected Good to check how the device is behaving but the report doesn t sort by date. (All conclusive) QC Summary (By Instrument Type and Location) This report shows QC results based on a statistical evaluation sorted by instrument type and location. With this report you can compare the QC results between different locations. Report provided statistic totals per test strip and control lot. Not device specific Point of Care Coordinator Training Guide

101 Reports Monthly QC Summary (Location) This report contains a QC summary by Sending Location and given month for each instrument type. This report also provides a comparable statistic for entire site. The report consists of two parts which are a combination of the comparable statistic and summary for all locations. The first part contains a summary for the entire site and for each given month without Sending Location aggregation. The second part contains a summary for the given months grouped by the Sending Location. The report does not show rows with null values in the summary (no results for given instrument type and lot combination). Corrective Action Report The Corrective Action report lists all QC or Test results that have comments attached to the result. For example, for an analyzer like ACCU-CHEK Inform II, the comment is that which the POCC enters (predefined or custom) after the test is performed. Hence, report to demonstrate: Cleaned Meter comment entered by operators at time of test. POCT Monthly Feedback Report This report provides information sorted by location, instrument, test and calendar month. This report shows an analysis of all results received from each Sending Location, instrument, test and calendar month (for which there is applicable information returned by the filtering) belonging to the same site the requesting user is currently logged in, for one page of report. Sample Count (by Instrument and Location, with Date Range) This report provides information about the amount of tests performed on individual instruments, sorted by location and instrument type. In combination with the Validation Flags filter you can get efficiency statistics based on certain exception criteria (flagged results), such as patient or user information, test/qc out of range, etc. 93 Point of Care Coordinator Training Guide

102 Reports Test/Sample Count (by Location and Instrument type) This report shows Statistics on the numbers of performed tests and samples for a specific time frame and location. You can select a single location, all locations or no location. The location is unknown in the following cases: For QC results: During upgrade the Sending Location could not clearly be identified because there was no patient results for that period. For both, QC and patient results: The measurement has been taken, while the instrument assignment to a location was not done (yet). Filter Criteria Date Range From Date Range To Location Alarm Group The starting date (inclusive) of the results to be included in the report. The ending date (inclusive) of the results to be included in the report. Name of the organizational location which reported the test results. Groups of alarms triggered by the result Point of Care Coordinator Training Guide

103 Reports How to generate a report to View and Save Log: 1. On the Navigation Tree, select Reports > Report Generation. 2. Double-click the report type to be generated to open the Detail section of the page. 3. Fill in all criteria spaces in the Detail Area. 4. Click Store & View. 5. This report will be saved and available under Reports > Report Log. Benefit of Report Log: Use the Report Log to review reports that were stored using View and Store. Report is available and can be recalled when needed. No need to print. Provides a Created Date to show Inspector when a specific report was reviewed. How to set a report as favorite: 1. On the Navigation Tree, click Reports > Report Generation. 2. Set a filter to view non-favorite reports. a. Under Favorite colum, use drop down to select No favorite, Click Filter to set filter. b. Highlight the report and Click the button to mark it as a favorite. c. Don t forget to change the Favorite column back to Favorite to display the report in the list. 95 Point of Care Coordinator Training Guide

104 Reports Notes Point of Care Coordinator Training Guide

105 Daily Tasks Section 11: Daily Tasks Training Objectives: At the end of this session the trainee will be able to: Confirm all meters have downloaded before reviewing results Clear the Patient Validation Page if not using TELCOR 97 Point of Care Coordinator Training Guide

106 Daily Tasks Daily Tasks Under Instruments > Status, confirm that all meters have downloaded before reviewing any results. (Don t forget to change Event column Header to All.) If not using TELCOR, please review and clear the Patient Validation page. (Results displayed here have not crossed to the patient s chart.) Point of Care Coordinator Training Guide