Roche cobas IT 1000 Operators Manual
Roche cobas IT 1000 is a data management software system for managing professional Point of Care testing. It collects test results and associated data and evaluates the data based on user-configurable criteria. The system automatically receives data from POC devices and delivers this data to a server application that can be accessed via a thin client via the hospital’s network for review by professional personnel.
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cobas IT 1000 application
User Manual
Version 4.7
Software version 2.07.00
cobas IT 1000 application
Revision history
Roche Diagnostics
2
3.7
3.8
3.9
4.0
3.3
3.4
3.5
3.6
2.9
3.0
3.1
3.2
2.2
2.3
2.4
2.5
2.6
2.7
2.8
4.1
4.2
4.3
Table 1
1.10
1.11
1.12
1.13
1.14
1.14.00.02
2.0
2.00.01
1.08
1.09
1.09.01
1.09.02
1.07
1.07.01
1.07.02
1.07.03
1.07.03_01
1.07.04
1.07.05
2.01.00
2.02.00
2.03.00
Revision history
Manual version
1.0
2.0
2.1
Software version
1.0
1.05
1.06
Revision dates
June 2004
June 2005
November 2005
March 2009
June 2009
November 2009
February 2010
June 2010
October 2010
June 2011
April 2012
February 2006
August 2006
October 2006
April 2007
June 2007
August 2007
November 2007
February 2008
May 2008
October 2008
December 2008
March 2013
November 2013
June 2014
Main change
Software update
Software update
Software update.
Alarm definitions added.
Software update
Software update, corrections
Software update, corrections
Software update, corrections
Corrections
Software update
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
User Manual · Version 4.7
cobas IT 1000 application
Manual version
4.4
4.5
4.6
4.7
Software version
2.04.00
2.05.00
2.06.00
2.07.00
Revision dates
December 2014
June 2015
November 2015
June 2016
Main change
Software and manual updates
Software and manual updates
Software and manual updates
Software and manual updates
Table 1
Revision history
Editor’s note
This manual is for users of the
cobas IT
1000 application.
Every effort has been made to ensure that all the information contained in this publication is correct at the time of publishing. However, the manufacturer of this product may need to update the publication information as output of product surveillance activities, leading to a new version of this publication.
Software updates are done by Roche Service representatives.
Intended use
The
cobas IT
1000 application is a data management software system for managing professional Point of Care testing. It collects test results and associated data and evaluates the data based on user-configurable criteria. The system automatically receives data from POC devices and delivers this data to a server application that can be accessed via a thin client via the hospital’s network for review by professional personnel.
The professional personnel can review data coming from multiple devices, auditing that appropriate quality controls have been run, detect duplicate analyses and perform other data management functions.
Not in scope of intended use
This product is not intended for the diagnosis, screening, monitoring or treatment of patients.
Features and Functionalities
The main functions are: o
Receiving electronically: patient test results, quality control results, instrument messages and instrument maintenance events o
Receiving manually: quality control results and comments o
Storing patient test results, quality control results, instrument messages and instrument maintenance events o
Managing users & certifications o
Sending patient test results and quality control results to customer IT systems
(HIS&LIS) o
Assessment of patient and quality control results to support compliance with the customer’s quality environment o
Configuring the workflow of connected instruments o
Reporting o
Support for
cobas® infinity
POC mobile, access granted through connection to
cobas® infinity
POC mobile adapter.
cobas® infinity
POC Mobile is an App that uses already existing
cobas IT
1000 application data and displays it on a mobile device, information displayed covers: POC devices, operators and certifications.
Before using the system, it is important to read this manual thoroughly.
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Intended users
User group Description of use
(1)
Nurses/Nurse Educator Manual entry of quality control results
POC Coordinator
Entry of test material data (lot no., expiry date)
Retrospective assessment of results to support compliance with thecustomer’s quality environment
View information generated by
cobas IT
1000 application on cobas infinity POC mobile
Retrospective assessment of results to support compliance with thecustomer’s quality environment
Entry of test material data (lot no., expiry date)
IT Manager
Adaptation of the configuration of
cobas IT
1000 application
Configuration of connected instruments
View information generated by
cobas IT
1000 application on c
cobas® infinity
POC mobile
WLAN device configuration security type EAP
EAP Settings management (EAP settings and EAP settingsassignment).
WLAN device configuration security type EAP
Table 2
Users
(1) include potential system interfaces
User roles, profiles and access rights
User access rights to the application are governed by means of user profiles.
User access rights to instrument types are governed by means of certification.
User role Description of use
User
Table 3
Person who physically interacts with the software and/or the instrument.
A user is assigned to one or several locations.
User profile: Operator The user profile “Operator” is used for individuals who do not have access to the application but who physically interact with the instrument.
An operator is assigned to one or several locations.
An operator is required to be certified for each of the instrument types used.
User roles
CAUTION
General attention
To avoid incorrect results, ensure that you are familiar with the instructions and safety information.
r
Pay particular attention to all safety notices.
r
Always follow the instructions in this publication.
r
Do not use the software in a way that is not described in this publication.
r
Store all publications in a safe and easily retrievable place.
Training
Do not carry out operation tasks or maintenance actions unless you have received training from Roche Diagnostics. Leave tasks that are not described in the user documentation to trained Roche Service representatives.
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Screenshots
The screenshots in this publication have been added exclusively for the purpose of illustration. Configurable and variable data such as patient demographics, parameters, results, path names etc. visible therein is fictitious and must not be used for laboratory purposes.
Warranty
Any customer modification to the system renders the warranty or service agreement null and void.
For conditions of warranty, contact your local sales representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service representative, or perform such updates with their assistance.
Copyright
© 2007-2016 F. Hoffmann-La Roche Ltd. All rights reserved.
License information
The
cobas IT
1000 application software is protected by contract law, copyright law, and international treaties. The
cobas IT
1000 application contains a user license between F. Hoffmann-La Roche Ltd. and a license holder, and only authorized users may access the software and use it. Unauthorized use and distribution may result in civil and criminal penalties.
Open Source and Commercial
Software
The
cobas IT
1000 application may include components or modules of commercial or open-source software. For further information on the intellectual property and other warnings, as well as licenses pertaining to the software programs included in the
cobas IT
1000 application, refer to the electronic distribution included with this product.
This open source and commercial software and the
cobas IT
1000 application as a whole can constitute a device regulated in accordance with applicable law. For more detailed information, refer to the user manual and labeling.
Please note that the respective authorization is no longer valid according to the corresponding legislation should any unauthorized changes be made to the
cobas IT
1000 application.
Trademarks
Recognized trademarks: o
ROCHE, ROCHE OMNI, ACCU-CHEK, ACCU-CHEK INFORM, ROCHE
CARDIAC, COBAS B, COBAS, COAGUCHEK and LIFE NEEDS ANSWERS are trademarks of Roche.
o
Roche and the Roche symbol are registered trademarks of the Roche group.
o
All other trademarks are trademarks of their owners.
Feedback
Every effort has been made to ensure that this guide fulfills its intended use. All feedback on any aspect of this guide is welcome and will be considered during updates. Please contact your Roche representative, should you have any such feedback.
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Disclaimer
This manual 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. Selected 3 rd
party products are available for use with the
cobas IT
1000 application.
The complete list of Roche Diagnostics and 3 rd
party products available for use with the
cobas IT
1000 application in the US can be found at http://usdiagnostics.roche.com/cobasITdevices.
Other Roche Diagnostics or 3 rd
party products listed within the software or manuals which are not listed at http://usdiagnostics.roche.com/cobasITdevices are not available for use with the
cobas IT
1000 application in the US.
Contact addresses
Manufacturer
US Distribution
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250-0457
USA
What is new in publication version 4.4
Safety information
Safety information regarding WLAN communication were added.
u
For details, see
Predefined user profiles
New predefined user profiles were added to
cobas IT
1000 application.
u
For details, see
EAP security
It is possible to configure EAP security for WLAN communication between instruments and
cobas IT
1000 application.
u
For details, see
q
WLAN communication using EAP security is not available for all instruments.
Manual result entry
The manual entry of patient test results has been deleted.
u
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Content of reports
For the
2008 Monthly Report
and the
User Statistics
report, additional information were added about the content of the reports. u
For details, see
The description of the report fields of the
User Certification History
report was added.
u
For details, see
What is new in publication version 4.5
Versions of Silverlight and
Internet Explorer on client
Higher version of Silverlight is needed, either in 32 bit or 64 bit version. Required version of Internet Explorer added.
u
Warnings applicable to user access rights
Only warnings applicable to the corresponding user profile and privileges can be assigned to a user.
u
u
Defining warnings for other users
Recently expired certification timeframe (Days)
The default value of the
Recently expired certification timeframe (Days)
parameter was changed to 60.
u
Recently expired certification timeframe (Days)
New patient alarms
Two new patient alarms were added: o
PD
:
Patient discharged
o
PN
:
Patient not admitted
u
Patient alarms (system alarms)
Operator lists for instruments
Operators with certifications in status (long-time) expired are not downloaded to the respective connected instruments requiring operator lists.
u
u
u
q
Operator lists are not available for all instruments.
Certification Tasks screen
Information about required exams was added to the Certification Tasks screen. The
Reset academy counter
button was renamed to
Reset Exam Attempts
button and is now always enabled for exam tasks, even if
cobas
academy is not installed.
u
Import of exam results to
cobas IT
1000 application
Training courses in a 3 rd
party learning management system (LMS) can be set as certification tasks in
cobas IT
1000 application. Exam results of such training courses can be imported to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
u
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Manual entry of test lots
The manual entry of test lots for instruments using code key information has been removed.
u
Data display on Instruments
> Status screen
o
The default filtering of the
Event
column on the
Status
screen was changed and depends on the way the screen is accessed.
o
The user name in the format “Last Name, First Name” is displayed as tooltip for entries in the
User Name
column.
u
Field definitions for Result
Management screen (QC RiliBÄK)
The field definitions of the Detail area of the
Result Management
screen (QC
RiliBÄK) were added. u
POCT Monthly Feedback report
This report includes statistical information about QC results only if the control material and lot remained unchanged during the reported calendar month.
u
What is new in publication version 4.6
Intended use
The intended use section has been updated.
u
u
u
Login after Silverlight installation
The Manual describes how to start
cobas IT
1000 application after installing
Silverlight.
u
Filtering criteria
The Manual describes the filtering function in the
List area
. u
LMS exam results imports
The manual explains how to avoid failed LMS exam results imports.
u
Correcting failed imports of exam results
Printing Levey-Jennings charts
The description of how to print Levey-Jennings charts has been extended.
u
Printing Levey-Jennings charts
Result validation
The manual describes the multi-select functionality in the
Result validation
screen.
u
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What is new in publication version 4.7
Update front matter
The front matter has been updated. u
u
u
u
Open Source and Commercial Software
Online help
The section on now to access the Online help has been revised.
u
Safety information
The system safety information has been revised and updated.
u
Login in with Network ID
The manual describes how to log in with the Network ID.
u
To login to the cobas IT 1000 application
https
The manual explains how to log in when https is enabled.
u
To login to the cobas IT 1000 application
Supported characters
The supported characters for patient ID and visit ID have been extended.
u
Instrument alarms
The user is instructed not to edit alarm texts.
u
New alarms
A new user alarm (OII), and a new patient alarm (PII) have been added. u
u
Patient alarms (system alarms)
HIS Locations
The manual describes when a manually entered description of a HIS Location is overwritten.
u
LDAP and Network ID
New information about the use of LDAP and the Network ID has been added.
u
u
Patient ID mapping
A new safety message about changing patient ID mapping has been added.
u
Levey-Jennings Review by Lot
The manual explains how assigning an instrument affects the counting of results in the
Result management
screen, but not in the
Levey-Jennings Review by Lot
screen.
u
Levey-Jennings Review by Lot screen
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Effective QC range
The manual explains how the lower and upper range limits of the QC range are calculated.
u
Calculation of lower and upper range limits
Results with invalid characters
The manual notifies the user about the potential consequences of accepting results containing invalid characters in the user ID and/or patient ID.
u
Invalid patient ID/visit ID
A new safety message about the manual entry of Patient ID/Visit ID has been added.
u
LmsId Reference Field
If the LmsId Reference Field is enabled,
cobas IT
1000 application now identifies the user solely by the Comment, Email, or User ID.
u
Formatting for the LMS input file
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Table of contents
What is new in publication version 4.4
What is new in publication version 4.5
What is new in publication version 4.6
What is new in publication version 4.7
Conventions used in this manual
Understanding
cobas IT 1000 application
Using cobas IT 1000 application
Patient Demographic Assignment
Organization module components 131
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Quality Control (RiliBÄK) module
Appendix
12 Formats for exam results input files
Index
cobas IT 1000 application
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Conventions used in this manual
Within step by step procedures, we have included screen captures from the application to provide you with graphical representations of where and how to perform tasks.
The following symbols and conventions are used in this manual.
Symbols
The following symbols may be used to draw your attention to important information: u
Symbol
p s o q
Meaning
Cross-reference
Procedure start
Procedure end
List item
Tip
Safety alert
Table 4
Information symbols q o
Keep this manual in a place where it will not be damaged.
o
Ensure that this document is available at all times.
This document
This document serves three purposes: o
It provides descriptions of the
cobas IT
1000 application user interface elements.
o
It provides step by step procedures to perform routine tasks.
o
It provides information regarding various aspects of the
cobas IT
1000 application.
The document consists of two main parts and an appendix.
o
Understanding cobas IT 1000 application
An overview of the
cobas IT
1000 application, a description of the user interface and a description of the warnings and error messages.
o
Using cobas IT 1000 application
Instructions on using the various software modules.
o
The list of used terms and their definitions
To help you find the information you are looking for, there is a table of contents at the beginning of each chapter, as well as at the beginning of the manual.
This same document is used to produce the help, in addition to the printable User
Manual.
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cobas IT 1000 application
RiliBÄK Installation of
cobas IT
1000 application for
Germany only
In Germany only, the RiliBÄK quality rules apply. To reflect this, a special RiliBÄK installation of
cobas IT
1000 application is available for Germany only. Therefore, all
RiliBÄK related content in this User Manual is taken from this RiliBÄK installation, is applicable for Germany only and does not show in the standard installation.
Online help
The Online help provides quick access to help information on screen.
Context-sensitive help
You can find specific information relevant to the currently active window by pressing
<F1> on the keyboard.
System help
You can open the Online help on the first page and search for information about
cobas IT
1000 application.
A
B
A
Navigation area
Figure 1
Online help window
B
Main area
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Navigation area
At the top, the Navigation area contains 3 buttons supporting different search strategies as explained in the table below.
Button
Contents
Index
Search
Table 5
Search options
Description
Table of content of the Online help opens
Search for topics based on a list of keywords
Full-text search within the Online help
Main area
The content of the Online help is shown on the right. Links to related topics are highlighted by underlined blue text.
q
Only the English language pack is installed by default. To use context-sensitive help with a different language, install the respective language pack. For more information on language packs, contact Roche Service.
Accessing Online help
Online help provides context-sensitive help and system help to search for information about
cobas IT
1000 application.
p
To access system help
1
Click the button in the Global area.
2
From the drop-down list, choose the
System Help
option.
The first page of the Online help opens.
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Figure 2
s
Online help title page p
To acces context-sensitive help
1
Open the window in
cobas IT
1000 application for which you desire more information.
2
Press <F1> on the keyboard to open the context-sensitive help.
Alternatively, click the button in the Global area and choose the
Help
option in the drop-down list.
s
15
cobas IT 1000 application
Safety classifications
WARNING
CAUTION
NOTICE
The following safety information applies to the system and is listed in accordance with ANSI Z535.6. The Danger safety classification to indicate a situation that will result in injury or death is not applicable to this system and is therefore not listed.
Safety alert symbol
r
The safety alert symbol alone promotes awareness to hazards that are generic or direct the reader to safety information provided elsewhere in the document.
These symbols and signal words are used for specific hazards:
Warning
r
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
Caution
r
Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
Notice
r
Indicates a hazardous situation which, if not avoided, may result in damage to the system.
Important information that is not safety relevant is indicated with the following icon: q
Tip
Indicates additional information on correct use or useful tips.
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System safety information
CAUTION
CAUTION
CAUTION
Failure to observe the following safety information may result in incorrect results, data corruption, and data losses.
Malicious software or unauthorized access can result in data loss or solution unavailability.
To avoid infection by malicious software or the unauthorized access and misuse of the solution, the following recommendations are essential: r
Do not install and/or execute unapproved software on the
cobas IT
1000 server.
r
It is the customer’s responsibility to ensure that other computers and services on the network (for example, the LIS, archiving share, backup share, or service) are properly secured and protected against malicious software and unauthorized access.
r
Customers are responsible for the security of their local area network, especially in protecting it against malicious software and attacks. This protection might include measures, such as a firewall, to separate the server from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code.
r
Make sure that access and queries to the database are properly secured and protected against unauthorized access. r
Make sure that system backup and archive files are protected from any unauthorized access and disaster, this includes: remote storage location; disaster recovery sites; secure transfer of backup files.
r
Prevent credential theft.
o
Use strong passwords.
o
Do not share passwords.
o
Do not write passwords down.
o
Do not use the same credentials on multiple instruments.
Unauthorized access to the system
Unauthorized physical access to the system and attached IT infrastructure can compromise the integrity and confidentiality of private data stored on the
cobas IT
1000 server or on related removable media.
r
Restrict physical access to the system to authorized persons.
r
Physically protect the server running the application.
r
Store related removable media in a safe place.
r
Make sure that all device components maintaining private data are physically secure
(i.e. require a physical key to be accessed or removed).
r
Implement security and authentication measures for removable media (i.e. USB drives,
CD-Rom/DVD, tapes, etc.).
Unauthorized access to the system configuration
Unauthorized access to the system configuration (administration interface, configuration store, query packages) can lead to system failure, corrupted data, and unauthorized disclosure of protected health information.
r
Make sure that the system configuration in properly secured and protected against unauthorized access.
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CAUTION
CAUTION
NOTICE
NOTICE
cobas IT 1000 application
Sensitive data - data tampering in transmission
Unprotected Wi-Fi connections between instruments and the
cobas IT
1000 application can lead to unauthorized data access and tampering.
r
Make sure that your Wi-Fi connections are properly secured.
o
If supported, use EAP security for Wi-Fi connections.
Data loss and disaster recovery
Unexpected disasters, such as hard disk failures, system software failures or natural disasters such as fires or floods can occur.
r
The Customers IT department must assemble a disaster recovery kit to protect the entire system.
r
Ensure that backups are made regularly (ideally ever day) and stored securely.
Data transmission is not secured
Unsecured communication can compromise the integrity and confidentiality of the transmitted data. It is the customer's responsibility to ensure that the network infrastructure provides appropriate protection for the transmitted data.
r
Such protection can be achieved by system level tunneling protocols or other means of network encryption.
Data is not encrypted
Data in the database is not encrypted. It is the customer's responsibility to ensure that access to the data storage and backup files is permitted only to authorized entities.
Maintenance
Failure to observe the following safety information may result in incorrect results, data corruption, and data losses.
Data loss or damage to the system due to power failure
r
Ensure regular maintenance of the uninterruptible power supply.
CAUTION
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Laboratory workflows
WARNING
WARNING
CAUTION
CAUTION
Failure to observe the following safety information may result in incorrect results, data corruption, and data losses.
Incorrect results due to expired calibration and quality controls
r
Perform regular quality controls and calibrations.
Incorrect results due to incorrect entry
r
Ensure that manually entered data is correct.
Incorrect results due to incomplete patient data
Patient results can only be correctly validated if all of the required patient data is stored in the system.
r
In case of incomplete transmission of patient data through the Hospital Information
System, tests may have to be repeated.
Unreliable validation due to unauthorized changes to the validation settings
r
The manufacturer is not liable for any consequences whatsoever resulting from subsequent, unauthorized modifications to accepted validation settings included in the system upon customer request.
Third-party software
CAUTION
Failure to observe the following safety information may result in incorrect results, data corruption, and data losses.
Malfunctions and incorrect results due to third-party software
The installation of any third-party software that has not been approved by Roche
Diagnostics International Ltd may lead to malfunctions.
r
Do not install any unapproved software.
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cobas IT 1000 application
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Understanding cobas IT 1000 application
cobas IT 1000 application
Table of contents
Software Overview
1 Software Overview
1
This chapter is an overview of the entire
cobas IT
1000 application. It contains a short description of the purpose and main functions of each of the modules in this application, and the main workflow principles that are applicable through all the modules.
In this chapter
Chapter
1
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Table of contents
cobas IT 1000 application
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System requirements
System requirements
Below is a list of system requirements for the
cobas IT
1000 application.
Requirements may vary depending on what the computer is used for. The listed requirements are a strict minimum for the correct operation of the application.
However, it is recommended to consider a configuration that provides sufficient performance depending on the work load and number of users.
Client
These are the minimum system requirements for clients of the
cobas IT
1000 application.
Processor
RAM
Hard disk drive
Network
Optical drive
Monitor
Mouse/keyboard
Barcode reader
Software
Font
Pentium® III 1.6 GHz
512 MB
20 GB
Recommended NTFS file system
Dual speed ethernet adapter (10/100)
Optional
1152x864 pixels with 65.536 colors
Both o o
Optional: Keyboard looped models and/or barcode scanner
Microsoft Silverlight 5.1.30514.0 (32 bit or 64 bit version, depending on browser version installed)
(1)(2)
Microsoft Internet Explorer 8 or higher, supporting
Silverlight 5.1.30514.0
If outputs in pdf or Excel are required on client: o o
Adobe Acrobat reader 8.0 or higher
MS Excel 2003 with MS Office 2007 compatibility patch, or higher
The font Arial Unicode must be installed on clients using non-
Western language settings (e.g. Thai or Chinese).
(1) Depending on the installed version of Internet Explorer, 32 bit or 64 bit version of Silverlight is needed; please contact the system administrator of the local intranet if
cobas IT
1000 application offers choice of upgrade after start.
(2) After the latest Silverlight version is installed, close the browser window and re-start
cobas IT
1000 application.
Server
Server requirements depend on the number and types of connected instruments, and the installed cobas POC IT solution components. Please contact Roche Service for server requirements matching your institution’s needs.
q
UPS (Uninterruptible Power Supply)
When the UPS is activated a safe shut down procedure is started before power supply is interrupted.
It is strongly recommended that UPS software is always updated and UPS functioning is regularly checked up.
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1 Software Overview
System requirements
WARNING cobas IT 1000 application
Warning
r
The
cobas IT
1000 application has been proven to work under the specified operating systems. If you want to update your operating system, please contact your Roche
Service representative.
r
You must perform regular maintenance tasks on the server PC, such as hard disk defragmentations, virus checking and checking of system logs in order to prevent the system from becoming unstable or losing performance.
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Browser settings
Browser settings
In the Internet Explorer browser, a setting must be applied for the
cobas IT
1000 application to work as intended.
You must enable pop-ups for the
cobas IT
1000 application to function properly.
It is not necessary to disable Google or MSN toolbars whenever the
cobas IT
1000 application is used, but perhaps the pop-up blocker of these toolbars must be disabled.
Enabling application pop-ups
If necessary, use this procedure for any third party popup blocker, or disable it altogether.
p
To enable application pop-ups
1
Access Internet Explorer.
2
In the
Tools
menu, select
Pop-up Blocker > Pop-up Blocker Settings
.
The
Pop-up Blocker Settings
dialog is displayed.
3
In the
Address of website to allow
field, enter the
cobas IT
1000 application
URL, and click
Add
.
4
Close this dialog.
s
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1 Software Overview
Security concept
Security concept
cobas IT 1000 application
A security system is implemented in the
cobas IT
1000 application to make sure that only authorized users can access the application.
Login name and password
Only users who are granted a user name and password by the administrator can login to the application.
u
User Profiles
In addition, user profiles are assigned that restrict their access to specific areas in the application.
u
Access only from intranet
The system administrator of the local intranet may also need to grant permission to
Windows users to give them access to the
cobas IT
1000 application. Users cannot access the application from outside their intranet unless they hold special permissions for that. Special Permission must be granted by customer's network administrators.
Special permissions are also provided to change users, tests, system and instrument configurations.
Adequate training
Provide
cobas IT
1000 application users with adequate training on the application to avoid misuse of the software (data misinterpretation or data loss, wrong configuration of system and analyzers, and so on).
Standard procedures to deal with instrument breakdown
We also encourage laboratory management personnel to develop standard procedures that describe how to proceed in the event of instrument breakdown while tests are running or data is being transmitted, or if problems arise during the validation process.
Activation of alarms
We also encourage the person in charge of setting up the application configuration to activate and map all the necessary alarms to ensure the awareness of any possible errors in communication or configuration.
u
For more information about how alarms are configured, see:
Remote access
The
cobas IT
1000 application allows remote access by Roche Service to solve possible problems. Roche Service guarantees security and confidentiality in all remote access connections.
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cobas IT 1000 application
Initial steps
1 Software Overview
Initial steps
Before using the
cobas IT
1000 application, the administrator of the local intranet needs to give permission to the PC user to access the application.
The application needs careful setup of parameters, instrument configurations, test details, and many functions and options necessary for its correct and intended functioning.
The application administrator has to create a different user name and password for each user, as well as assign them to a location and profile.
q
Please contact the system administrator of the local intranet, if
cobas IT
1000 application offers choice of Silverlight upgrade (32 bit or 64 bit version) after start.
q
Installing Silverlight
If Silverlight is not installed when you open
cobas IT
1000 application, a window appears asking you to install either the 32-bit or 64-bit version of Silverlight. If this window still appears after installing Silverlight, do the following: o
Close and re-open Internet Explorer.
o
Enter
http://servername/cobasit1000
cobas IT
1000 application.
Logging in
o
Login paths should be
http://servername/cobasit1000
. The server name is provided by the administrator of your intranet.
If https is enabled, you must log with
https
://<machine name or ip>.
o
Users must have an assigned profile.
o
Each user must have his/her own user name and password.
o
The password must comply with the minimum length and character types defined in
System > General Settings
.
o
If multiple sites are connected, you have to select your site to be logged on.
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Figure 1-1 Login
screen
29
1 Software Overview
Initial steps
cobas IT 1000 application
q
Depending on the installation of
cobas IT
1000 application, the build number in the
Login
screen may differ from the one shown in figure
Use the
Login
button to authenticate to the system and enter the application.
q
What if...?
Password validity is due for renewal after a certain period of time.
o
The application displays a message with the password validity period.
o
Either click
Change Password
and enter the new password, or click
OK
and login without changing the password.
Password has not been changed for a certain period of time.
o
The application displays a message requiring to enter a new password.
You have access to more than one site.
o
Choose the site from the drop-down list.
p
To login to the cobas IT 1000 application
1
In the web browser, enter or select the login address.
The
cobas IT
1000 application
Login
screen is displayed.
2
Enter your
User ID
and
Password
, then click
Login
.
q o
If LDAP is enabled, you must log in with the Network ID and the password stored in the network authentication system. o
If LDAP is disabled, you must log in with the User ID and Password stored in
cobas
IT
1000 application.
u
If https is enabled, you must log with
https
://<machine name or ip>.
The site list appears at the bottom of the dialog.
3
Select the site needed and click
Login
.
The computer loads the application and creates a new session.
s
Changing the user password
The new password can only consist of letters (A to Z) and numbers (0 to 9). No special characters or country specific letters are recommended. Password length and complexity required depend on the selected application settings.
u
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cobas IT 1000 application 1 Software Overview
Initial steps
Figure 1-2 Password Change
dialog p
To change your password
1
In the web browser, enter or select the
cobas IT
1000 application address.
The application
Login
screen is displayed.
2
Enter the
User ID
and click
Change Password
.
3
Enter the current password, the new password, the confirmation of the new password, and then click
OK
.
The new password is saved.
s
Predefined Configurations
WARNING
The
cobas IT
1000 application comes with predefined configurations that are intended to facilitate the configuration tasks of Roche Service during the installation and configuration of this software.
Predefined user configurations for Roche Service
r
Take the predefined configurations for Roche Service as a reference only. Do not use them as default without further configuration process.
Warning messages
Warning
messages alert you about wrong procedures, actions that could not be performed, problems or important system information that you must be aware of.
Action required
Click
OK
to confirm that the warning message has been read. If further actions are necessary, proceed accordingly.
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Figure 1-3 Warning
message
31
1 Software Overview
Initial steps
Error messages
cobas IT 1000 application
Error
messages are those messages that appear on the screen to inform you about an error that has occurred.
Action required
Click
OK
to confirm that the error message has been read and take corrective actions.
Figure 1-4 Error
message
Information messages
They provide additional information about application actions or conditions.
Action required
Click
OK
to confirm that the message has been read. No further action is necessary.
Figure 1-5
Information message
Confirmation messages
They ask you to accept or cancel an action before it is taken.
Action required
Click
OK
to accept and give permission for the action to be performed. Click
Cancel
to stop the procedure that was about to start.
Figure 1-6 Confirmation
message
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cobas IT 1000 application
Module descriptions
1 Software Overview
Initial steps
The
cobas IT
1000 application is divided into the following modules: o
My Settings
o
System
o
Organization
o
Materials
o
Instruments
o
Quality Control
o
Results & Patients
o
Reports
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Initial steps
Business rules
cobas IT 1000 application
These are the basic business rules of the
cobas IT
1000 application.
General
Each user has a user ID and a password assigned to be able to access the application.
u
o
Users can only perform those actions they have permission for.
o
Changes on the records are traced in a log (e.g. changes of status).
o
Configuration of users, instruments, materials and tests is required before the application can be used.
o
When you see
Server Error
in the
cobas IT
1000 application, the database was stopped while you were working or the connection to the server dropped. Log out and login again.
Instruments
o
Each instrument type needs its own driver installed to be able to interact with the application.
o
Different configurations are possible for the same instrument type.
o
Users need to be certified to use a specific instrument type.
Data
o
Tests with blocking alarms can only be manually validated.
o
The
Comment
button enables you to add comments to test results or patients in the validation screen, or to QC results and graphs in the QC module.
o
Some fields cannot be duplicated. When trying to save duplicated data which must be unique, an error message appears on the screen.
o
If any field content is not compliant with the previously defined setup (e.g. wrong type or wrong format of data entered), the system displays a warning message.
o
Generated data can be backed up.
o
By default, only Western European character sets are supported in instrument communication. However, support for Unicode character sets can be activated if necessary beyond the areas supporting Unicode data per default.
q
Note o
The patient ID and visit ID can contain uppercase letters (A to Z), numbers (0 to 9), and the additional characters +,/,_,-,$,\,@.
o
Ensure that the supported character sets of instruments connected to
cobas IT
1000 application are also supported by
cobas IT
1000 application.
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cobas IT 1000 application
Table of contents
User Interface
2 User Interface
2
This chapter describes the
cobas IT
1000 application user interface and a detailed description of the most commonly used procedures.
In this chapter
Chapter
2
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Table of contents
cobas IT 1000 application
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cobas IT 1000 application
A
B
C
Application screen overview
The
cobas IT
1000 application screen is divided into five areas.
2 User Interface
Application screen overview
D
E
A
Global area. For more information see
B
Multi-site area
C
Navigation area
D
Work area
E
Warning area. For more information see
Figure 2-1
Application screen overview
Multi-site area
One tab per site
If the application is managing more than one site, an additional tab will appear for each site. If more than two sites are connected, the additional tab is replaced by a drop-down menu.
Navigation tree is site-specific
The Navigation tree is site-specific. Click the respective tab to access the Navigation tree of the site you wish to work on.
u
For more information on the multi-site concept, see
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D
E
A
B
2 User Interface
Application screen overview
cobas IT 1000 application
Using cobas IT 1000 application
The figure below describes the different functions of the application screen in more detail. Note that the Work area is divided into two parts: the List area and the Detail area.
C
F
A Show/Hide
button. Used to either display or hide the Navigation and the Warning area.
B
Module. Click the triangle to open or close its list of screens.
C
List area. Displays a list of available data.
D
Sort by
Severity
, Sort by
Date
and
Refresh
buttons to organize warnings in the Warning area.
E
Detail area. Mainly used to enter data in order to add an additional list entry
F
Total number of listed records on all pages
G Restore the original configuration
button. Restores the layout changes in the List area.
H Grid settings
button. Hide and show columns in the list.
I Filter dynamically
button. For more information see
J Group by...
button
Figure 2-2
Understanding the application screen
G H I J
Navigation area
Structure of Navigation tree
There are two different structures of the Navigation tree, depending on the settings defined in the user profiles. The Navigation tree is structured either by
Module
(default) or by
Type
. The structure by
Type
is mainly used by administrators during set up procedure.
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Application screen overview
Calling sequences in this manual
In some chapters, there are two calling sequences (paths) provided at once. In this case, the first calling sequence refers to the structure by
Module
. The second calling sequence (provided in bold, below the first calling sequence), refers to the structure by
Type
.
Switching between navigation structures
p
To switch between navigation structures (by Module/by Type)
1
Choose
Organization > User Profiles
.
2
In the List area, choose the user profile for which you wish to alter the structure of the Navigation tree.
3
Choose the
Menus
button.
The menu settings for the selected user profile are displayed.
4
Under
Presentation by:
, choose between
Module
or
Type
.
5
Do one of the following: o
To confirm, click the
OK
button.
or, o
To activate the settings, log out and log in again.
s
List area
Adjusting the List area
o
To sort a list by content, click the column header.
o
To move a column in a table, click the column header, keep it clicked, drag and drop.
o
To change the width of a column, click the column border and adjust it to the required width.
o
To change the column display in a list to hide or show columns, click the
Grid settings
button, and select or clear the columns as required. The column display settings are stored for each user individually. By default all columns are visible.
o
To group data according to selected columns, click the
Group by...
button, select the columns to group by, and click the
OK
button.
o
To activate or deactivate dynamic filtering click the
Filter dynamically
symbol.
o
To select multiple records in the List area, use the [Ctrl] key. To select a range of records use the [Shift] key.
Restoring default layout
o
To reset all layout changes in the List area to default layout, click the
Restore the original configuration
button.
Page navigation in the List area
o
To navigate by a single page, click the left or right arrow.
o
To go to the first or last page, click the left-most or the right-most arrow.
o
To go to a specific page, enter its number directly in the
Page
field.
Figure 2-3
Page Navigation Bar
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Application screen overview
cobas IT 1000 application
Filtering
o
Define your filter criteria to narrow down your search.
o
Use an asterisk (*) as placeholder as illustrated in the example below:
Search term
(1)
Search result
(e.g. patient name)
st*
*st
*st*
Table 2-1
All patient names starting with the character string "st".
e.g. Stanley, Stephens, or Steen
All patient names ending with the character string "st".
e.g. Guest, Herbst, or Provost
All patient names containing the character string "st".
e.g. Acosta, Stout, or Proust
Searching with filters
(1) Search is not case sensitive.
Detail area
In the application screens, the Work area is divided into two areas: o
List area o
Detail area
Double clicking a line in the List area opens the Detail area in most screens. Selecting another line in the List area closes the Detail area.
Using dynamic filtering
The dynamic filter enables you to filter retrieved data. This function is useful when you prefer to restrict your search to the retrieved data rather than searching the entire database.
The color of the dynamic filtering icon indicates its status.
Activated (Blue). If you click
Filter
, while the filter icon is blue, the query is set only against the data that is shown in the List area.
Deactivated (Red). Default. If you click
Filter
, while the filter icon is red, the entire database is queried.
Disabled from use (Grey). If the filter icon is gray, the dynamic filter function is not available.
p
To use dynamic filtering
1
In the text field above the respective column, enter or select the criterion for which you want to search the entire database.
2
Click
Filter
.
The retrieved data is displayed in the List area.
3
To activate dynamic filtering, click the red filter icon.
The color of the filter icon changes to blue.
4
In the text field, enter or select the filter criterion you wish to apply on the retrieved data.
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Application screen overview
5
Click
Filter
.
The data displayed in the List area is queried.
s
Global area
In the Global area you can see functions that are permanently accessible.
Close
button. Logs you out and closes the application window.
button. Shows and hides the specific data export buttons.
The following formats are available for export:
PDF, Excel, Text, and Preview & Log (PDF).
Help
button. Opens the help menu which contains links to general system help, context specific help, information about the version number and the
About
dialog.
Logout
button. Logs you out and re-opens the
Login
screen.
Alternately, <F5> can be used to log out.
q o
When exporting to text, some language specific characters may not be displayed correctly. Right-click on the text window and select the
Encoding > Auto-Select
command from the shortcut menu. If the
Auto-Select
command is already selected, clear it and select it again.
o
You cannot export as xls (Excel) file via the
button, when the application page of the
cobas IT
1000 application is not in the trusted sites list of the browser.
Exporting lists to Excel
Use the
button to export lists in the List area to Excel. The export includes the displayed data only. Data that is hidden by a filter or hidden columns are not included in the export to Excel.
Three options are available: o
Export all displayed records on all pages.
o
Export the current page only.
o
Export selected records.
p
To export lists to Excel
1
In the Global area, choose the
button and then the
Excel
button.
2
Do one of the following: o
Choose
All records from the grid
to export all records on all pages.
or, o
Choose
Current page
to export the current page only.
or, o
Choose
Selected records
to export the selected records from the list.
Microsoft Excel is opened showing the exported data.
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2 User Interface
Application screen overview
cobas IT 1000 application
3
Navigate to the directory where you want to save the exported Excel file. Enter a file name and choose the
Save
button. s
Warning area
NOTICE
In the Warning area (C), automatically generated messages are displayed and can be viewed while carrying out your routine work. The warnings are grouped by site. Site independent warnings are grouped in a
General
site.
The alarm and information messages are color-coded in order of importance. The sites are also color-coded with the color of the highest severity warning.
The Warning area refreshes every minute.
These messages and their severity are configured in the
My Settings > Warnings
Configuration
screen.
The icons indicating the severity of the warning are color-coded.
Flashing icon. Critical severity alarm indicates that the warning is critical and requires your immediate attention.
High-severity alarm indicates that the warning requires your urgent attention.
Medium-severity alarm that requires your attention soon.
Low-severity alarm that also requires your attention.
An arrow indicates that the number of underlying events is increasing or decreasing.
An equal sign indicates that the number of underlying events has not changed.
Clicking a warning opens the tab of the related site and navigates to the related screen. If a filter is required, it is preset so that the correct data is displayed that corresponds to the warning.
No site-specific warning messages for users not assigned to corresponding location
If you add a new user and do not assign him to any locations,
cobas IT
1000 application raises a confirmation message. You are asked to confirm for this user to have access to all sites. But even after clicking
OK
, such a user does not receive site-specific warnings, but can only see general warnings. r
For a user to see site-specific warnings, assign him to at least one location of the site.
u
See
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cobas IT 1000 application 2 User Interface
Software basics
Function key assignment
The following list describes the functions assigned to the function keys. The function assignment differs in parts from the typical assignment as known from Windows applications. If a key is not listed, it means that it is not active in the application.
F1
F5
F11
Opens the online help site related to the currently opened page of the application.
Note:
F1 only opens context-sensitive online help, if the respective language pack has been installed.
For information on language packs contact your system administrator or
Roche Service.
Logs you out and re-opens the
Login
screen.
Full-screen mode.
Software basics
Configuration
Screens are interdependent, therefore it must be ensured that the required information or parameters have been previously set up.
Entering and working with data
By default, text input fields present a lighter background when they are editable and a darker background when they are read-only.
Fields with a red dot to the left are mandatory.
Before information is saved, its consistency and correctness is checked. If the information is not correct a pop-up message is displayed.
Log information
All changes are traced in a log file that can be exported.
Progress indicator
When the
cobas IT
1000 application is processing or retrieving data, a Progress indicator appears. When this is active, you can still click in the Navigation area to open another screen, but the current operation will be aborted upon confirmation.
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Software basics
cobas IT 1000 application
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Using cobas IT 1000 application
cobas IT 1000 application
Table of contents
My Settings
3 My Settings
3
This module enables you to configure the following settings: the language, the date & time format, the number format, the warning configuration. Most of the components in this module are used during initial configuration of
cobas IT
1000 application and are rarely used thereafter.
In this chapter
Chapter
3
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3 My Settings
Table of contents
cobas IT 1000 application
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Language
3 My Settings
Language
q
Any other language other than English needs to be installed by Roche Service.
Use this component to set your language, number, time and date format. The selected settings are stored with your profile and will be recovered when you re-log in.
Different users being simultaneously logged in at different workstations may have different settings at the same time.
q
The formats selected (especially time and date format) in this screen have to be used consistently throughout the whole application when entering data.
My Settings > Language
Figure 3-1 My Settings > Language
screen
Changing the regional settings
Language
Select the desired language from the list. The version number shown with a language entry is the application version for the respective language pack. As a result some screen labels may appear in English if translations of these labels were not included in the indicated version number.
q
When the installed language pack does not match the installed
cobas IT
1000 application version, the default language for the Online Help is set to English.
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3 My Settings
Language
cobas IT 1000 application
Number Format
Select the desired number format:
-X,XXX.XX
-X.XXX,XX
-X XXX,XX
Thousands and millions are separated by a comma; decimals are indicated with a period.
Thousands and millions are separated by a period; decimals are represented by a comma.
Thousands and millions are separated by a space; decimals are indicated with a comma.
Time Format
Select the desired time format:
HH:mm hh:mm tt
24-hour format
12-hour format (AM/PM)
Date Format
Select the desired date format:
dd
MM yyyy yy
Day (2 digits)
Month (2 digits)
Year (4 digits)
Year (2 digits) p
To change regional settings
1
In the Navigation tree, click
My Settings > Language
.
The regional settings setup screen is displayed.
2
Select the language, the numbers, the date and time format, and then click the
OK
button.
Changes are saved and applied.
s
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Warnings Configuration
Warnings Configuration
Use this component to activate warnings and assign their degrees of severity shown, restrict the events that trigger warnings and configure the sending of e-mails for each warning.
o
There are 4 degrees of severity:
Critical
,
High
,
Medium
and
Low
.
u
For more information on the color-coding and display of warnings see
q
Warning on expired material lot
Warnings on expired QC and linearity material lots must be activated if instruments which cannot detect a lot expiration are connected.
q
Sending e-mails for warnings
The parameter
Enable sending of e-mails
must be activated in
System > General
Settings
, if you want the application to e-mail warnings.
u
My Settings > Warnings Configuration
(
Import > Warnings Configuration
)
Figure 3-2 My Settings > Warnings Configuration
screen
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3 My Settings
Warnings Configuration
cobas IT 1000 application
From this screen, you can perform the following tasks: o
Assign a degree of severity to each type of warning for the current user.
o
Access the
Personalizations
screen to personalize the events that can trigger warnings for the current user.
o
Configure sending e-mails for each warning.
O
Activate/deactivate the sending of e-mails.
O
Under
Initial Threshold
define the number of occurrences before sending an e-mail.
O
Under
Additional Threshold
define the further interval for sending e-mails.
Example:
Initial Threshold = 10, Additional Threshold = 20
E-mails will be send after 10, 30, 50, 70, 90, ... occurrences of the warning.
Settings only apply to current user
The settings and personalizations defined in this screen only apply to the user that is currently logged on. Only warnings applicable to the current user’s profile and privileges are displayed and can be configured.
Warning configurations for other users are defined under
Organization > User
Management
.
u
For information on how to define warnings and warning personalizations for other users,
Defining warnings for other users
Activating/deactivating a warning
p
To activate a warning
1
Choose
My Settings > Warnings Configuration
.
2
Select the warning to be activated.
3
Click
Activate
.
4
Double-click the warning to change its severity. The details for the selected warning are displayed in the Detail area.
5
Select the degree of severity to be applied to the warning and click
OK
.
s p
To deactivate a warning
1
Choose
My Settings > Warnings Configuration
.
2
Select the warning to be deactivated.
3
Click
Deactivate
.
The warning is deactivated.
s
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cobas IT 1000 application 3 My Settings
Warnings Configuration
List of Warnings
Warning message Related module Description/Action required
Backup error
BGE instrument critical error
BGE instrument error
Check disk space
Expired Certifications
Pending Certifications
Upcoming Certifications
Automatic database backup creation failed. Contact Roche Service.
A Roche blood gas instrument connected to
cobas bge link
is in status Critical Error. Check status and initiate corrective actions in
cobas bge link
urgently.
cobas bge link
version 4.0 or higher required.
A Roche blood gas instrument connected to
cobas bge link
is in status Error. Check status and initiate corrective actions in
cobas bge link
.
cobas bge link
version 4.0 or higher required.
Database has exceeded expected size. Check disk space, if necessary contact Roche Service.
Organization > Certification
Certification has expired. This warning message is for certifications that enter the expired observation timeframe.
Check the corresponding certification.
Organization > Certification
Certification will expire soon and will be pending. This warning message is for certifications that enter the medium observation timeframe.
Check the corresponding user certification.
Organization > Certification
Certification will expire and will be upcoming. This warning message is for certifications that enter the observation timeframe.
Check the corresponding user certification.
Instrument Events
(unacknowledged)
Internal Communication error
Maintenance Task Due
Material Expired (Lin)
New LOTs (Test)
Instruments > Status
Check status information, address reported issue.
Unable to communicate with all application modules. Ensure that all application servers are running. If problem persists, contact Roche
Service.
Instruments > Maintenance
Definition
Maintenance required for one or more instruments according to schedule.
Materials > Lot Management
Linearity lot expiration date exceeded. Deactivate affected linearity lot(s).
Materials > Lot Management
QC lot expiration date exceeded. Deactivate affected QC lot(s).
Material Expired (QC)
Material Expired (Test) Materials > Lot Management
Test lot expiration date exceeded. Deactivate affected test lot(s).
New Instruments Pending
New LOTs (Lin)
Instruments > Instrument
Assignment
A new instrument has been connected to the application. Assign the desired configuration and organizational location and enter the desired name.
Materials > Lot Management
Un-reviewed linearity lot in use on instruments. Check expiration date, targets and allowed deviation (material dependent) and review to authorize general usage.
New LOTs (QC) Materials > Lot Management
Un-reviewed QC lot in use on instruments. Check expiration date, ranges (material dependent) and review to authorize general usage.
Materials > Lot Management
Un-reviewed test lot in use on instruments. Check expiration date, ranges (material dependent) and review to authorize general usage.
Pending LED (mandatory) Materials > Lot Management
> LED
One or more LED proposal(s) based on a complete control cycle were created. The warning is raised for acceptable LEDs only. In the definition of the warning, it is possible to filter the warning by
Instrument type
and
Instrument location
. This is done in the
My settings > Warnings configuration > Personalizations
screen.
Table 3-1
List of warning messages (Sheet 3 of 3)
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3 My Settings
Warnings Configuration
cobas IT 1000 application
Warning message Related module Description/Action required
Pending LED (voluntary)
QC Lock
QC Warning
QC results violating RB rules
QC Lock
QC Warning
Materials > Lot Management
> LED
Quality Control > Result
Management
Quality Control > Result
Management
Quality Control (RiliBÄK
2008) > Alarms Monitor
Quality Control (RiliBÄK
2008) > Result Management
Quality Control (RiliBÄK
2008) > Result Management
One or more LED (lab-established deviation) proposal(s) based on a current control cycle or on results not belonging to a control cycle were created. The warning is raised for acceptable LEDs only. In the definition of the warning, it is possible to filter the warning by instrument type and instrument location. This is done in the
My settings > Warnings configuration > Personalizations
screen.
Instrument test locked as QC result was out of range and/or violated multirule(s) and/or flagged with system alarm(s) with severity
Error
. Address underlying technical or process issue and rerun control.
Instrument test in warning state as QC result violated multirule(s) and/or flagged with system alarm(s) with severity
Warning
. Address underlying technical or process issue and rerun control.
Instrument test locked as accepted QC result was outside allowed deviation. Address underlying technical or process issue, document corrective action and acknowledge alarm.
Instrument test locked as QC result was outside allowed deviation and/or violated system alarm(s) with severity
Error
. Address underlying technical or process issue and rerun control.
Instrument test in warning state as QC result violated system alarm(s) with severity
Warning
. Address underlying technical or process issue and rerun control.
RiliBÄK Error
RiliBÄK Warning
RMSE Error
RMSE Warning
Quality Control (RiliBÄK
2008) > Alarms Monitor
Quality Control (RiliBÄK
2008) > Alarms Monitor
Quality Control (RiliBÄK
2008) > RMSE Alarms
Monitor
Quality Control (RiliBÄK
2008) > RMSE Alarms
Monitor
One or more unacknowledged RiliBÄK alarms with the severity level
Error
(e.g. QC result outside of allowed deviation) are pending review and corrective action.
One or more unacknowledged RiliBÄK alarms with the severity level
Warning
are pending review and corrective action.
One or more unacknowledged RiliBÄK RMSE alarms with the severity level
Error
(e.g. RMSE for a control cycle outside of allowed deviation) are pending review and corrective action.
One or more unacknowledged RiliBÄK RMSE alarms with the severity level
Warning
(e.g. running RMSE for the current month outside of allowed deviation) are pending review and corrective action.
Scheduled QC not done
Severe RiliBÄK QC Error
Quality Control (RiliBÄK
2008) > Result Management
Quality Control (RiliBÄK
2008) > Alarms Monitor
Quality control not done within defined time frame. Instrument requires immediate QC.
One or more unacknowledged RiliBÄK alarms with the severity level
Severe Error
are pending review and corrective action.
Severe RMSE Error
Urgent Certifications
Unreviewed Linearity
Graphs
Unreviewed LJ Graphs
Unreviewed LJ Graphs
Table 3-1
Quality Control (RiliBÄK
2008) > RMSE Alarms
Monitor
One or more unacknowledged RiliBÄK RMSE alarms with the severity level
Severe Error
(e.g. RMSE for two consecutive control cycles outside of allowed deviation) are pending review and corrective action.
Organization > Certification
Certification will expire shortly and will be urgent. This warning message is for certifications that enter the narrow observation timeframe.
Check the corresponding user certification.
Linearity runs of previous day(s) are awaiting review by a user.
Quality Control > Linearity
Review
Quality Control > Levey-
Jennings Review
Quality Control (RiliBÄK
2008) > Result Management
List of warning messages (Sheet 3 of 3)
Levey-Jennings graphs of previous month(s) are awaiting review by a user.
Levey-Jennings graphs of previous months are awaiting review by a user.
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Warnings Configuration
Warning message
Unreviewed L-J (by LOT)
Graphs
Unreviewed effective QC ranges
Unreviewed QC results
Unreviewed QC results
Unreviewed test results
Table 3-1
Related module
Quality Control > Levey
Jennings Review by Lot
Quality Control (RiliBÄK)
> Effective QC Range Review
Quality Control > Result
Management
Quality Control (RiliBÄK
2008) > Result Management
Results & Patients > Sample
Validation
Description/Action required
Levey-Jennings graphs by Lot of previous months are awaiting review by a user.
An effective QC range has not yet been marked as reviewed. In the definition of the warning, it is possible to filter the warning by
Instrument type
and
Instrument location
.
Some QC results were not automatically validated by the application as they were flagged with alarms with severity
Error
. Review these results and accept or reject them according to institutional SOPs.
Some QC results were not automatically validated by the application as they were flagged with alarms with severity
Error
. Review these results and accept or reject them according to institutional SOPs.
Some patient results were not automatically validated by the application as they were flagged with alarms with severity
Error
.
Review these results and accept or reject them according to institutional SOPs.
List of warning messages (Sheet 3 of 3)
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Personalizations
Personalizations
cobas IT 1000 application
Use this screen to define personalizations to the events that may generate a warning for the current user.
This functionality may be interesting if you are sharing tasks with other users. To give an example: You could define, that the warning
Unreviewed results
is triggered only for certain tests or for instruments with a certain user.
o
An unlimited number of personalizations can be defined.
o
When a personalization is defined for a specific warning, only events matching the defined criteria will appear in the Warning area.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
My Settings > Warnings Configuration > Personalizations
Figure 3-3
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Personalizations
screen q
Values button inactive
If the
Values
button is not active, then no personalizations are available for the selected warning. Personalization options are predefined and cannot be added manually via the user interface.
User Manual · Version 4.7
cobas IT 1000 application 3 My Settings
Personalizations
Defining personalizations
p
To define personalizations
1
Choose
My Settings > Warnings Configuration
.
2
Click the
Personalize
button.
3
In the Detail area, select the
Warning
and the
Filter
criterion.
4
Click
Values
.
A pop-up is displayed containing the values related to the selected filter criterion.
5
Select the values that should trigger events and click
OK
.
The updated information is displayed in the List area. Changes are automatically stored into the database.
s
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Table of contents
System
4 System
4
This module enables you to configure all settings of the application which affect the behavior of the other modules, for examples the test definitions used throughout the entire application. This includes the following settings: various system settings, patient demographics, instrument flag assignment, predefined comments, sample types, tubes, test parameters, and test groups. Most of the components in this module are used during initial configuration of the
cobas IT
1000 application and are rarely used thereafter.
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In this chapter
Chapter
4
Automatically (re-)send samples with unclear sending status to host..............64
Delete visit records without result(s) upon discharge.........................................64
Delay to retry the resend to the Host (Minutes)..................................................65
Refresh Time (seconds) for Instrument Status Page ...........................................67
Number of characters to read from Hemochron patient ID..............................67
Number of characters to read from Hemochron operator ID ...........................68
Password change required - warning period (Days)...........................................69
Size warning limit for Competency files (MB) ....................................................69
Enable authentication via LDAP-based directory service ..................................69
Certification Expiration Warning Time (Days)...................................................70
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60 cobas IT 1000 application
LDAP server is a Windows Active Directory server ...........................................70
LDAP server name or IP address and port...........................................................71
Recently expired certification timeframe (Days).................................................72
Observation timeframe - medium warning timeframe (%)...............................72
Observation timeframe - narrow warning timeframe (%).................................72
Password - minimum number of capital letters...................................................73
Password - minimum number of digits or symbols ............................................73
Weekday for sending of supervisor notifications ................................................73
Automatic QC validation for normal values ........................................................74
Extension (in percent) of the allowed deviation/range for running RMSE .....74
Minimum number of QCs required for calculation of running RMSE............75
Time-triggered routine period check on QC for non-POCT instruments......75
QC result set used for automatic LED proposal calculation ..............................75
QC result (per calendar day) for LED proposal calculation ..............................75
Numeric value of n (for LED proposal calculation)............................................76
Sample unvalidation - additional information entry - name of first parameter..
Sample unvalidation - additional information entry - status of first parameter .
Sample unvalidation - additional information - text pattern.............................77
Discharge all visits belonging to idle patient record ...........................................78
Number of days after which a patient record is considered idle .......................79
Maximum Operators to be sent to Accu-Chek Inform ......................................79
Maximum Patients to be Sent to Accu-Chek Inform..........................................79
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Table of contents
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User Manual · Version 4.7
4 System
Patient Class Group III - Timeframe (Days)........................................................81
Save Audit Log for Review of Patient Demographics .........................................81
Delimiter to concatenate result and sample comments ......................................81
Sample unvalidation - additional information - enable entry ...........................81
Guide user to next component on sample unvalidation.....................................82
Generate new Sample ID for unvalidated sample................................................82
Timeframe for sample unvalidation (Hours) .......................................................82
Number of days after which to purge Audit Log data.........................................84
Supported character set for instrument communication ...................................84
Enable Unicode for all fields (not recommended) ..............................................85
Supported character set for host communication ...............................................86
Number of days after which to purge other log data...........................................86
Maximum Length for Comments Shown as Tool Tip ........................................87
Delay of user e-mail notifications on certificate type update (Minutes) ..........88
Warning e-mails - include link to component .....................................................88
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General Settings
General Settings
This component enables you to configure general settings which will influence the behavior of other modules and components within the application.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
q
The structure of the Navigation tree depends on the settings defined in the
User Profiles
.
The Navigation tree can be set to be presented by
Module
(default) or by
Type
(second calling sequence provided above, in bold).
System > General Settings
(Navigation tree structured by
Module
)
(
Configuration > General Settings
) (Navigation tree structured by
Type
)
Figure 4-1 General Settings
screen o
System configuration options cannot be added, deactivated or deleted.
o
The values defined in this screen affect the behavior of the entire application, therefore careful setting of the parameters is essential.
From this screen, you can modify general setup values to adapt them to the desired point-of-care workflow.
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General Settings
NOTICE
cobas IT 1000 application
Default setting instead of empty value
If an empty value is specified for this general setting (if accepted),
cobas IT
1000 application takes the default value instead.
Exceptions:
The general setting
Default password for password reset
takes the empty value.
The general settings
Predefined value for empty QC results
and
Predefined value for empty patient results
do not accept an empty value.
q
Click the
Default
button to reset the parameter to its default value.
HCA
This section describes the different settings that may affect the behavior of the application and the settings’ interaction. They are grouped according to the processes that they influence.
Patient data feed (ADT) active
This parameter activates the ADT data processing, which enables the reception of patient information from the hosts and send it to the instruments. When this parameter is set to
Yes
, ADT messages received from one or more hosts are processed and the
cobas IT
1000 application’s patient database is updated accordingly.
Default value
Yes
Possible values
o
Yes
o
No
Automatically (re-)send samples with unclear sending status to host
If set to
Yes
, the application will (re-)send samples where all results have been accepted, but one or more results have an unclear sending status, to the host, if the sending of results to a host has been configured.
Default value
No
Possible values
o
Yes
o
No
Delete visit records without result(s) upon discharge
This parameter allows to set if a visit record without result(s) will be automatically deleted instead of discharged after a discharge event for this visit is received.
If the setting is switched to
Yes
, then the application automatically deletes this visit record.
If the setting is switched to
No
, then the visit record will be treated as if a patient result would be associated.
Default value
No
Possible values
o
Yes
o
No
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General Settings
Update of non-existing patient creates record
If the host sends an event to update a patient record that did not exist or has been discharged with no test results, the
cobas IT
1000 application creates a new patient record with the received information.
If a patient record having test results had been discharged (and hence the discharged patient record still exists), the
cobas IT
1000 application still applies demographic field updates to the patient record. If this setting is set to
No
, such an update will not set a discharged patient record to status
Admitted
.
Default value
Yes
Possible values
o
Yes
o
No
NOTICE
Data overload
If this parameter is set to
Yes
, the number of entries in the application database and in the instrument lists can become dangerously large.
Delay to retry the resend to the Host (Minutes)
This parameter defines the maximum waiting time for the
cobas IT
1000 application to receive a confirmation from the host, after test results were sent from the application to the host. After this time, if no acknowledgement is received, the application sends the test results to the host again.
This parameter is only applicable if the host is configured to send an acknowledge message.
Default value
90
minutes
Send alarms as comments
This parameter allows to enable/disable the possibility to send result alarms to the connected host in form of result comments. If enabled, the application sends instrument and system alarms that had been activated to this purpose as result comments to the host interface. If disabled, the application does not send any system alarms or instrument alarms.
Default value
Yes
Possible values
o
Yes
o
No
q
There are two levels for enabling/disabling the sending of these comments: o
Application wide (under
System > General settings > Send alarms as comments
) o
Instrument specific (under
System Alarm Assignment > Operator comment
and under
Instrument Alarm Assignment
, check box
Send as comment
)
Instruments
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General Settings
cobas IT 1000 application
Always send Operator List to instruments
This parameter is used to define whether the operator list is always to be sent to the instruments. It is only applicable to instruments such as the
Accu-Chek Inform
instrument family, the
CoaguChek XS Plus
, the
CoaguChek XS Pro
or the
cobas h
232.
q
Also refer to the documentation of the individual instrument drivers.
When this parameter is enabled, the list of operator IDs is sent to the instruments regardless of the instrument configuration. When this parameter is disabled, the list of operator IDs is only sent to the instruments if their individual configuration requires an operator list.
For the
Accu-Chek Inform
instruments, this is defined in the
User
tab on the
Instruments > Configuration > Device Configuration
screen, in the field
ID
Validation Mode
.
u
For the
CoaguChek XS Plus
, the
CoaguChek XS Pro
and the
cobas h
232, this is defined on the
Instruments > Configuration > Device Configuration
screen, in the
ID Setup
section.
u
When the operator list is sent to an
Accu-Chek Inform
instrument, the instrument is able to display the operator name after the corresponding ID has been entered.
Default value
No
Possible values
o
Yes
o
No
Always send Patient List to instruments
This parameter is used to define whether the patient list is always to be sent to the instruments. It is only applicable to instruments such as the
Accu-Chek Inform
instrument family, the
CoaguChek XS Plus
, the
CoaguChek XS Pro
and the
cobas h
232.
When this parameter is enabled, the list of patients is sent to the instruments regardless of the instrument configuration. When this parameter is disabled, the list of patients is only sent to the instruments if their individual configuration requires a patient list.
For the
Accu-Chek Inform
instruments, this is defined in the
Patient
tab on the
Instruments > Configuration > Device Configuration
screen, in the fields
Patient
ID Entry Mode
and
ID Validation Mode
. u
For the
CoaguChek XS Plus
, the
CoaguChek XS Pro
and the
cobas h
232, this is defined on the
Instruments > Configuration > Device Configuration
screen, in the
ID Setup
section. u
On the
Single Patient Edit
screen under
Results & Patients > Patient Query > Edit
, select the
Admitted
check box if the current patient is to be sent along with the list.
Default value
No
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General Settings
Possible values
o
Yes
o
No
Patient Upload: Force daily synchronization
Currently applicable for
Accu-Chek Inform II
. If this parameter is set to
Yes
, patient lists are synchronized every day.
Default value
Yes
Possible values
o
Yes
o
No
Operator Upload: Always force full upload
If this parameter is set to
Yes
, then whenever a user record is updated, the entire list is uploaded rather than just the changed records.
Default value
No
Possible values
o
Yes
o
No
NOTICE
Data management
Setting this parameter to
Yes
may cause extended communication and incomplete lists.
Patient Upload: Always force full upload
Currently applicable for
Accu-Chek Inform II
. If this parameter is set to
Yes
, then whenever a patient record is updated, the entire list is uploaded rather than just the changed records.
Default value
No
Possible values
o
Yes
o
No
Refresh Time (seconds) for Instrument Status Page
This parameter sets how often the information about instrument connections and warnings on the
Instruments > Status
screen is updated.
Default value
90
seconds
Number of characters to read from Hemochron patient ID
This number represents the patient ID length. This determines how the application extracts the patient ID (right to left) from the number that
ITC Hemochron Jr. Signature
instruments send. This setting applies to
ITC Hemochron Jr. Signature
instruments only, not to other
ITC Hemochron
instruments.
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Explanation
ITC Hemochron Jr. Signature
instruments add leading zeros to the Patient ID to fill in the maximum length the instrument supports. The parameter set in this field is intended to cut-off these extra leading zeros.
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WARNING
Example
Patient ID received from the Hemochron instrument
Number of ending characters to get from Hemochron’s patient identifier
Resulting Patient ID stored in the cobas IT 1000 application
000000034533
5
34533
Use this parameter with care!
r
If your institution supports patient IDs of different lengths, this setting can lead to confusion. e.g.: if there are two patient numbers 01234 and 1234, then setting this length to 5 will result in the second patient ID stored as 01234 instead of 1234, while setting it to 4 will result in the first patient number stored as 1234 instead of 01234.
The maximum number of characters currently supported by the instrument is 12.
Setting this parameter to zero prevents the
cobas IT
1000 application from storing the
Patient ID.
Default value
30
characters. This represents the maximum number of characters supported by the
cobas IT
1000 application.
Number of characters to read from Hemochron operator ID
This number represents the operator ID length. This determines how the application extracts the operator ID (right to left) from the number that
ITC Hemochron Jr.
Signature
instruments send. This setting applies to
ITC Hemochron Jr. Signature
instruments only, not to other
ITC Hemochron
instruments.
Explanation
ITC Hemochron Jr. Signature
instruments add leading zeros to the operator ID to fill in the maximum length the instrument supports. The parameter set in this field is intended to cut-off these extra leading zeros.
WARNING
Example
User ID received from the Hemochron instrument
Number of ending characters to get from Hemochron’s user identifier
Resulting User ID stored in the cobas IT 1000 application
000000034533
5
34533
Use this parameter with care!
r
If your institution supports user IDs of different lengths, this setting can lead to confusion. e.g.: if there are two user IDs 01234 and 1234, then setting this length to 5 will result in the second user ID stored as 01234 instead of 1234, while setting it to 4 will result in the first user ID stored as 1234 instead of 01234.
The maximum number of characters currently supported by the instrument is 12.
Setting this parameter to zero prevents the
cobas IT
1000 application from storing the user ID.
Default value
12
characters.
The
cobas IT
1000 application supports operator IDs with up to 20 characters.
Organization
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General Settings
Show driver users in Certification Tasks
This parameter defines if generic instrument users shall be shown in the
Certification Tasks
status component.
Default value
No
Possible values
o
Yes
o
No
Password change period (Days)
This parameter sets how often users must change their password.
Default value
90
days
Password change required - warning period (Days)
This parameter defines how many days before a password change is due you get a warning to change the password when logging in to the application.
Default value
5
days
Size warning limit for Competency files (MB)
This setting is used to display a warning if the user is trying to upload a file with more than the defined megabytes as a competency file.
The file upload is not affected.
Default value
10
Possible values
“0” to “999” (integer)
Enable authentication via LDAP-based directory service
About LDAP
This setting defines whether user authentication via an LDAP based directory service is active or not for the application.
If the general setting is not active, then the user setting is ignored and the user authentication is done against the user password stored in the application.
If the general setting is active, then the user setting defines whether a user shall be authenticated against LDAP or the user password stored in the application.
q
To enable LDAP
To enable this functionality the following general settings in
System > General Settings
must also be configured: o
LDAP server is a Windows Active Directory server
o
LDAP domain name
o
LDAP server name or IP address and port
o
LDAP search user: Password
o
LDAP search user: User name
o
LDAP Base DN to use for searches
o
LDAP unique search attribute
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Default value
No
Possible values
o
Yes
o
No
Certification Expiration Warning Time (Days)
This parameter sets how many days before the certification expiration date the system displays a warning in the Warning area.
The application setting applies to expiring certifications.
The application setting does not apply to auto-recertifying certifications or to non-expiring certifications.
Default value
90
Possible values
“0” to “99” (integer)
Default password for password reset
This parameter defines the default password of the instrument user when the POCC resets the user's password for the instrument.
The parameter only has an effect when the application setting
Reset password to ...
is set to
Default Password
.
u
Default value
<empty>
Possible values
free text q
The password must comply with the settings that define the minimum length and the type of characters to be used as passwords.
u
Password - minimum number of capital letters
Password - minimum number of digits or symbols
Reset password to...
This parameter defines the options for resetting a user's password for an instrument.
Default value
Empty Password
Possible values
o
Empty Password
o
Default Password
LDAP server is a Windows Active Directory server
This parameter is used to define whether the connected LDAP server is a “Windows
Active Directory” or not.
Default value
Yes
Possible values
o
Yes
o
No
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LDAP search user: Password
This parameter defines the password of the user that will be used to search the LDAP tree.
Default value
<empty>
Possible values
free text
LDAP search user: User name
This parameter defines the user name that will be used to search the LDAP tree.
Default value
<empty>
Possible values
free text
LDAP Base DN to use for searches
This parameter is used to define the LDAP base DN for searches.
Example
DC=emea, DC=example, DC=com
Default value
<empty>
Possible values
free text
LDAP domain name
This parameter is used to define the LDAP domain name.
Default value
<empty>
Possible values
free text
LDAP server name or IP address and port
This parameter is used to define the server name (or the IP address) and the port of the LDAP server.
Example
dc01.emea.example.com:389
Format
DNS name:port or IP:port
Default value
<empty>
Possible values
free text
LDAP unique search attribute
This parameter is used to define the LDAP unique search attribute depending on the used LDAP server.
The application verifies the inserted user name on logon against the value in the
LDAP database for the LDAP unique search attribute.
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General Settings
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q
The “unique search attribute” specifies a unique identifier of each user record, which therefore makes it appropriate for look-ups. As default value for this general setting
“sAMAccountName” is used. Unique Search Attribute will be filled with the user name of the LDAP user which is to be queried.
Default value
sAMAccountName
Possible values
free text
Printer for auto-print of notification letters
This parameter defines the name of the printer used for automatic printing of notification letters.
Default value
<empty>
Possible values
free text
Recently expired certification timeframe (Days)
This parameter defines how many days after the expiration of a certification a warning (reminder) is displayed in the Warning area.
Default value
60
q
Change of default value with upgrade
The default value of this parameter is changed. When upgrading a previous version of
cobas IT
1000 application to version 2.05, the application shows the following behavior: o
An active default value will be changed to the new default value of 60 with the update.
o
An active, differently set value will be kept with the update.
Possible values
“0” to “999” (integer)
Observation timeframe - medium warning timeframe (%)
This parameter defines the “medium warning timeframe” reminder as a percentage of the “observation timeframe”.
The entered value must be greater than or equal the value for the application setting
Observation timeframe - narrow warning timeframe (%)
.
Default value
35
Possible values
“0” to “99” (integer)
Observation timeframe - narrow warning timeframe (%)
This parameter defines the “narrow warning timeframe” reminder timeframe as a percentage of the “observation timeframe”.
The entered value must be smaller than or equal than the value for the application setting
Observation timeframe - medium warning timeframe (%)
.
Default value
15
Possible values
“0” to “99” (integer)
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Password - minimum number of capital letters
This parameter sets the minimum number of uppercase letters that user passwords must contain.
Default value
1
character
Possible values
“0” to “99” (integer)
Password - minimum number of digits or symbols
This parameter sets the minimum number of digits or symbols (not letters) that user passwords must contain.
Default value
1
character
Possible values
“0” to “99” (integer)
Password - minimum length
This parameter sets the minimum total number of characters that user passwords must have.
Default value
8
characters
Possible values
“0” to “99” (integer)
Weekday for sending of supervisor notifications
This parameter is used to define the day of the week when e-mail notifications shall be sent to the supervisor.
Default value
Sunday
Possible values
o
Sunday
o
Monday
o
Tuesday
o
Wednesday
o
Thursday
o
Friday
o
Saturday
Base day for certification date calculation
This parameter is used to define how certification dates from user data import files are calculated.
Default value
Received date
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Possible values
o
Received date
. The system takes the date as it is defined in the import file.
o
First day of the week
. The system replaces the date in the import file with the first day of that week.
o
First day of the month
. The system replaces the date in the import file with the first day of that month.
u
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First day of the week
When the value in
Base day for certification date calculation
is set to
First day of the week
, this setting defines whether the first day of the week is Sunday or Monday.
u
Base day for certification date calculation
Default value
Monday
Possible values
o
Sunday
o
Monday
Quality Control RiliBÄK 2008
Automatic QC validation for normal values
This parameter defines whether the system should perform QC validation automatically. A QC result is accepted automatically if no alarm associated with this
QC result has a severity of
Error
.
If QC management is done on a connected information system, such as an LIS, set this parameter to
Yes
.
If you want to manually validate each QC result, set this parameter to
No
.
Default value
Yes
Possible values
o
Yes
o
No
Apply proposed LED automatically
This parameter is used to define whether or not LEDs proposal which can be accepted are automatically accepted and applied. Acceptable proposals have a numeric proposal which leads to an effective QC range wider than the target value and not exceeding the defined QC range.
If
Yes
is set, proposed LEDs are automatically accepted and applied.
Default value
No
Possible values
o
Yes
o
No
Extension (in percent) of the allowed deviation/range for running RMSE
This setting enables you to extend or reduce the allowed deviation/range that the running RMSE is evaluated against. If it is set, for example, to
-10
, an RMSE warning is raised if the running RMSE for a test is higher than 90% of the allowed deviation
(in column 3), i.e. entering -10 in effect gives an advance warning on a potential
RMSE violation.
Default value
0
(The default value assumes the defined deviation/range)
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Possible values
Numeric value to indicate the adjustment in percent to the allowed deviation/range.
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Minimum number of QCs required for calculation of running RMSE
RMSE stands for Root Mean Square of the Error of measurement. The mean square is calculated per control cycle. This setting enables you to enter the minimum number of QC tests that are required before a running RMSE is calculated. Only if the number of non-rejected QC results for a specific instrument, lot (combination) and level not yet included in a previous control cycle exceeds this value, the running RMSE will be calculated.
Default value
7
Possible values
Numeric value to indicate the number of QC results.
Time-triggered routine period check on QC for non-POCT instruments
This setting activates a time-triggered check on whether a second QC test was done
16 hours or less after the first QC of this routine period.
Default value
Undefined
Possible values
o
Yes
o
No
o
Undefined
QC result set used for automatic LED proposal calculation
Defines which QC results are used in automatic calculation of LED proposals. If
Most recent completed control cycle results only
is set, an LED proposal is calculated if the latest completed control cycle contains at least 15 days with accepted
QC results.
If
Current control cycle results/non-control cycle results also
is set: o
The LED is calculated after having 15 days with accepted QC results, even if the current control cycle is not yet complete.
o
If there is a completed control cycle, and the current cycle has less than 15 days with accepted QC results, then the QC results from the most recent completed control cycle are used for LED proposal calculation.
o
If for the instrument no RMSE calculation is done (and hence control cycles do not apply), QC results not associated with a control cycle are used. All accepted
QC results are used for LED proposal calculation.
Default value
Most recent completed control cycle results only
Possible values
o
Most recent completed control cycle results only
o
Current control cycle results/non-control cycle results also
QC result (per calendar day) for LED proposal calculation
To calculate an LED proposal, one QC result per calendar day (not necessarily consecutive) is used. This parameter is used to define which of the QC results per day is to be used for the LED proposal calculation.
Default value
1st Result
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Possible values
o
1st Result
o
N-th Result
o
Last Result
o
Random Result
Numeric value of n (for LED proposal calculation)
This parameter is used to define the numeric value of
N
used in the setting
QC result
(per calendar day) for LED proposal calculation
. The value must be an integer greater than 0.
Default value
1
Possible values
Any integer > 0
Results & Patients
Sample unvalidation - additional information entry - name of first parameter
This parameter is used to define the displayed name of the “first parameter” that can be added as additional information to an unvalidated sample.
Default value
Incident Number
Possible values
free text
Sample unvalidation - additional information entry - status of first parameter
This parameter is used to set the status of the “first parameter”. What this basically does is to enable the display of the first parameter with the name configured in the setting
Sample unvalidation - additional information entry - name of first parameter
.
u
Sample unvalidation - additional information entry - name of first parameter
Default value
Optional
Possible values
o
Mandatory
o
Optional
o
Not used
Sample unvalidation - additional information entry - name of second parameter
This parameter is used to define the displayed name of the “second parameter” that can be added as additional information to an unvalidated sample.
Default value
Reason
Possible values
free text
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Sample unvalidation - additional information entry - status of second parameter
This parameter is used to set the status of the “second parameter”. What this basically does is to enable the display of the first parameter with the name configured in the setting
Sample unvalidation - additional information entry - name of second parameter
.
u
Sample unvalidation - additional information entry - name of second parameter
Default value
Optional
Possible values
o
Mandatory
o
Optional
o
Not used
Sample unvalidation - additional information - text pattern
This setting is used to define a text pattern for “additional information” with up to two variables. These variables (“%Parameter1” and “%Parameter2”) are the ones defined as first and second parameter in the settings
Sample unvalidation - additional information entry - name of first parameter
and
Sample unvalidation - additional information entry - name of second parameter
.
Default value
Sample cancelled (incident no. %Parameter1) because of %Parameter2.
Possible values
free text with up to two variables (“%Parameter1” and “%Parameter2”)
Predefined value for empty QC results
A character the system uses to indicate that an instrument has sent an empty result for a QC test.
Default value
-
(A dash, or minus sign) q
Empty result values of instruments connected by means of an ICA driver will not be reported in the application. For information on whether a specific instrument type is connected via an ICA driver please check
Instruments > Instrument Assignment
or contact Roche Service.
q
For RMSE calculation
When the predefined value for empty QC results is set to the default “-” or another qualitative value and the QC result is accepted and released, QC results with an empty result value (e.g. “-”) are included in the RMSE calculation as if they would have a value of
0.
Predefined value for empty patient results
A character the system uses to indicate that an instrument has sent an empty result for a patient test.
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Default value
-
(A dash, or minus sign).
q
Empty result values of instruments connected by means of an ICA driver will not be reported in the
cobas IT
1000 application. For information on whether a specific instrument type is connected via an ICA driver please check
Instruments > Instrument
Assignment
or contact Roche service.
Discharge all visits belonging to idle patient record
This parameter is used to define whether visits of an idle patient (no results done for this patient) will be discharged after a preset time as set by the parameter
Number of days after which a patient record is considered idle
.
When set to
Yes
, the status of patient visits are automatically changed to discharged when there are no results during the defined time interval.
When set to
No
, the status of patient visits is not changed.
Default value
No
Possible value
o
No
o
Yes
Enable sample unvalidation
This parameter is used to activate/deactivate the sample unvalidation.
Default value
No
Possible values
o
Yes
o
No
Generic Patient
WARNING
This parameter is used to set the ID for one or more generic patients.
Generic patient
r
Do not admit or discharge a generic patient.
r
Do not merge a generic patient into or from another patient ID through an ADT message.
r
Any ADT message (admit, merge, discharge, pending admit, pending discharge) involving a generic patient will be reported as an error in
cobas IT
1000 application.
r
A merge message having the same source and target will be ignored by
cobas IT
1000 application.
r
If your current patient ID scheme allows for patient ID 999999, contact Roche Service for assistance with setting a default, generic ID that will not overlap with patient IDs.
Format
comma separated list of IDs
Default value
999999
Possible values
free text
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Number of days after which a patient record is considered idle
This parameter sets after how many days a patient record that is not receiving any test results is considered idle. Visits of an idle patient record will be automatically set to discharged if the value of the setting
Discharge all visits belonging to idle patient record
is
Yes
.
Default value
30
Possible values
“1” to “9,999,999,999” (integer)
Instrument Patient ID
This parameter sets which of the 3 possible Patient IDs or Visit ID defined in the database is used as
Instrument Patient ID
, when communicating with an instrument.
Default value
Patient ID 1
Possible values
o
Patient ID 1
o
Patient ID 2
o
Patient ID 3
o
Visit ID
q
This setting is used for instruments connected via an ICA driver.
This setting is used for instruments not connected via an ICA driver, when the
Instrument
Patient ID
is not set specifically within the instrument's configuration.
For information on whether a specific instrument type is connected via an ICA driver please check
Instruments > Instrument Assignment
or contact Roche service.
Maximum Operators to be sent to Accu-Chek Inform
This parameter sets the maximum number of operators that can be sent to an
Accu-
Chek Inform
or
Accu-Chek Inform II
. For other values the instrument limits must be taken into account.
Default value
2000
users
Maximum Patients to be Sent to Accu-Chek Inform
This parameter sets the maximum number of patients that can be sent to an
Accu-
Chek Inform
or
Accu-Chek Inform II
. For other values the instrument limits must be taken into account.
Default value
2000
patients
Patient Class Group I
NOTICE
This parameter is used to set which of the patient classes shall be grouped together.
This group has as default value the patient class “outpatient”.
Default setting instead of empty value
If an empty value is specified for this general setting,
cobas IT
1000 application takes the default value instead.
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Default value
O
Possible values
List of letters, separated by commas
Patient Class Group I - Timeframe (Days)
This parameter is used to define how many days the patients of the patient class(es)
(grouped in
Patient Class Group I
) shall be admitted in the application before the background process “Patient Cleaner” is executed.
Default value
2
Possible values
“1” to “999” (integer)
Patient Class Group II
NOTICE
This parameter is used to set which of the patient classes shall be grouped together.
This group has as default value the patient class “inpatient”.
Default setting instead of empty value
If an empty value is specified for this general setting,
cobas IT
1000 application takes the default value instead.
Default value
I
Possible values
List of letters, separated by commas
Patient Class Group II - Timeframe (Days)
This parameter is used to define how many days the patients of the patient class(es)
(grouped in
Patient Class Group II
) shall be admitted in the application before the background process “Patient Cleaner” is executed.
Default value
365
Possible values
“1” to “999” (integer)
Patient Class Group III
NOTICE
This parameter is used to set which of the patient classes shall be grouped together.
This group has as default value the patient classes “obstetrics”, “emergency”,
“preadmit” and “recurring patient”.
Default setting instead of empty value
If an empty value is specified for this general setting,
cobas IT
1000 application takes the default value instead.
Default value
B,E,P,R
Possible values
List of letters, separated by commas
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Patient Class Group III - Timeframe (Days)
This parameter is used to define how many days the patients of the patient class(es)
(grouped in
Patient Class Group III
) shall be admitted in the application before the background process “Patient Cleaner” is executed.
Default value
365
Possible values
“1” to “999” (integer)
Save Audit Log for Review of Patient Demographics
This parameter allows to save an audit log of all users that have accessed the
Results
& Patients > Single Patient Edit
screen.
Default value
Yes
Possible values
o
Yes
o
No
q
By default, audit logs are saved on the application server in the folder
...\cobasIT1000\Services\Audit\
This folder cannot be accessed directly from the client.
The default path can be changed in the general setting
Path for log data export
.
u
Detect repeat results
This parameter allows to set if repeated results shall be automatically detected or not.
u
Default value
No
Possible values
o
Yes
o
No
Delimiter to concatenate result and sample comments
This parameter allows to set character(s) as delimiter between comments in a comment list. Used for delimiter separated lists in the
Result Validation
and the
Result Query
screen (Order: result comments and then sample comments).
Default value
,
(comma)
Possible values
free text (maximum number of characters: 255)
Sample unvalidation - additional information - enable entry
This parameter defines if additional information will be added to an unvalidated sample (first parameter and second parameter).
Default value
No
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o
Yes
o
No
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Guide user to next component on sample unvalidation
This parameter sets whether a user will be guided automatically to the patient selection component (
Results & Patients > Sample Validation > Result Validation
> Select Patient/Visit
) after a sample unvalidation was done.
Default value
No
Possible values
o
Yes
o
No
Generate new Sample ID for unvalidated sample
This parameter allows to define if an unvalidated sample shall get a new generated sample ID.
If the general setting is set to
No
, then the application retains its “original auto-generated sample ID”.
Default value
No
Possible values
o
Yes
o
No
Timeframe for sample unvalidation (Hours)
This parameter defines the maximum timeframe (in hours) starting after sample validation, during which a user shall be able to unvalidate a sample.
Default value
24
Possible values
“0” to “999” (integer) q
If this parameter is set to “0” (zero), then the timeframe is unlimited.
Automatic Validation with Tolerance
This parameter allows automatic validation of test results, if they fall within ranges for automatic acceptance. These ranges for automatic acceptance are defined as
Auto
Accept Low
and
Auto Accept High
values in the
System > Test Definition
> Reference Range
screen.
u
Default value
Yes
Possible values
o
Yes
o
No
System
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Automatically discharge idle patients
This parameter defines whether the admission status of a patient will be automatically changed from admitted to discharged.
If set to
Yes
, the admission status is automatically changed to discharged.
If set to
No
, the admission status remains unchanged.
Default value
No
Possible values
o
No
o
Yes
Allow Multiple Login
This parameter sets whether more than one user with the same user ID and password can log into the application simultaneously.
q
Restrictions/Examples for multiple login: o
If the user opens two different instances of Microsoft Internet Explorer and tries to open the
cobas IT
1000 application by accessing to the URL on both instances, only one window instance will remain.
o
If the user had created a session in one instance of the Microsoft Internet Explorer and tries to open
cobas IT
1000 application by using another instance, the original instance will be reset and the login screen will appear again.
Default value
Yes
Possible values
o
No
o
Yes
Export log data before purging
This setting defines whether log data shall be exported before it is automatically purged. If enabled, only log data that could be successfully exported from the database will be purged. The automatic purging (and if enabled export) of log data is done automatically (per default) every 24 hours, its configuration also includes the following 3 settings.
q
Exported audit log information can be re-imported if needed. For a re-import of exported log information please contact Roche Service.
Default value
Yes
Possible values
o
Yes
o
No
Path for log data export
A valid path for the folder where log data to be purged is exported to. This setting is effective only if
Export log data before purging
is set to
Yes
.
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q
It is strongly recommended to export log data to a hard disk other than those used for database or journal data storage. A mechanism should be put in place to ensure that exported log data is transferred to a permanent medium in regular intervals to prevent the respective hard disk from running out of space.
Default value \cobasIT1000\Services\Audit\
Possible values C:\logbck
Number of days after which to purge Audit Log data
This is the number of days for which audit log data are kept in the database. Audit log data older than the number of days set will be automatically purged from the database. Even if set to something less than 61 days the system will always keep a minimum of 61 days of audit log data in the database.
q
The automatic purging of log data can be deactivated entirely by Roche Service. When log data is not automatically purged, an increased growth in database size and decreased log specific performance is expected.
Default value
61
Possible values
One to three digit numeric (“0” to “999”)
Supported character set for instrument communication
This parameter defines what type of character set is used for communicating patient and user demographic data to instruments during a query or when uploading lists.
During the communication, the system replaces any characters that are outside the range defined by this parameter.
This parameter does not affect the following features: o
ID fields o
Result upload o
Configuration values
Default value
8-Bit ASCII, replace other
Possible values
1.
No limitations
. All characters are kept unchanged.
2.
7-Bit ASCII, replace other
. Characters outside the 7-Bit ASCII range are replaced.
3.
8-Bit ASCII, replace other
. Characters outside the 8-Bit ASCII range are replaced.
4.
None, send substitute only
. All communicated characters are replaced by a specified character. This character is determined by service settings.
Enable automatic printing
This parameter defines if automatic printing is enabled.
Default value
No
Possible values
o
Yes
o
No
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Enable sending of e-mails
This parameter defines if sending of e-mails is enabled for the application.
Default value
No
Possible values
o
Yes
o
No
Enable Unicode for all fields (not recommended)
This parameter allows you to enable unicode entry for all input fields. This is useful for languages that include characters not covered by the 8-Bit ASCII set, such as Thai.
q
Before enabling unicode, check whether all instruments support unicode
Not all currently connectable instruments support the reception of unicode information.
Before enabling unicode for all fields, make sure that all of the actually connected instrument types support the reception of unicode information.
If unicode is enabled, the application will send unicode content irrespective of whether or not this can be successfully processed by a connected instrument.
q
Unicode not applicable for all fields
Besides Dates, hours and numeric fields, there are restricted fields where unicode is never accepted, even if the above option is activated: o
Unique identifiers (e.g.
User ID
,
Patient ID 1
,
Patient ID 2
,
Patient ID 3
,
Sample ID
,
Test ID
).
o
Password.
o
Instrument Configuration Values.
o
Test, QC and/or Linearity Material Names.
o
Test, QC and/or Linearity Lot Numbers.
o
Messages sent to instruments.
o
Certification names (reserved for future usage) sent to instruments.
HIS/LIS communication: o
Unique identifiers (e.g.
User ID
,
Facility ID
,
Location ID
,
Patient ID 1
,
Patient ID 2
,
Patient ID 3
,
Sample ID
,
Test ID
,
Test Abbreviation
).
o
Password.
o
Location name.
o
Instrument serial number o
Test, QC and/or Linearity Material Names.
o
Test, QC and/or Linearity Lot Numbers.
Default value
No
Possible values
No
: Unicode inactive
Yes
: Unicode active, except for the above mentioned fields.
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Session Expiration Time (Minutes)
This parameter sets the period of time the user can be inactive before the session expires and login is required again. It also defines the maximum time allowed between a user logging in to
cobas
academy and completing the examination. If the time taken to complete the examination exceeds this, it is shown with the results.
Default value
90
minutes
Supported character set for host communication
This parameter defines what type of character set is used for host communication.
The system replaces any characters during the communication that are outside the range defined by this parameter.
Default value
No limitations
Possible values
o
No limitations
. All characters are kept unchanged.
o
7-Bit ASCII, replace others
. Characters outside the 7-Bit ASCII range are replaced.
o
8-Bit ASCII, replace others
. Characters outside the 8-Bit ASCII range are replaced.
ID field character limitation
This parameter allows to restrict ID fields when unicode is active.
Default value
No limitation for ID fields
Possible values
o
No limitation for ID fields
o
7-Bit ASCII
o
8-Bit ASCII
o
Only numeric entry values are valid
Number of days after which to purge other log data
This is the number of days for which other log data (per default instrument warnings) are kept in the database. Other log data older than the number of days set will be automatically purged from the database. Even if set to something less than 61 days the system will always keep a minimum of 61 days of other log data in the database.
Default value
61
Possible values
One to three digit numeric (“0” to “999”)
SMTP password
This parameter defines the password of the user which has to be used for sending e-mails. This parameter is needed when the SMTP server requires an authentication of a user in order to allow the sending of e-mails.
Default value
<empty>
Possible values
free text
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SMTP username
This parameter defines the user name which has to be used for sending e-mails.
This parameter is needed when the SMTP server requires an authentication of a user in order to allow the sending of e-mails.
Default value
<empty>
Possible values
free text
SMTP server name/IP address and port
This parameter defines the name or the IP address and the port of the SMTP server which has to be used for sending e-mails.
It is possible to enter a DNS name and the used port or to enter an IP address and the used port.
Format
DNS name:port or IP address:port
Default value
<empty>
Possible values
free text
Use Secure SMTP
This parameter defines whether communication with the SMTP server shall be secured (using SSL/TLS) or not. Currently only Explicit SSL (STARTTLS) is supported.
Default value
Yes
Possible values
o
Yes
o
No
Sender address for notification e-mails
This parameter defines the e-mail address of the sender of notification e-mails.
Format
Example
Default value
<empty>
Possible values
free text
Maximum Length for Comments Shown as Tool Tip
This parameter sets the number of characters of comments that are displayed as Tool
Tip in the
Results & Patients > Result Validation
and the
Quality Control > Result
Management
screens.
Default value
120
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Delay of user e-mail notifications on certificate type update (Minutes)
This setting allows to delay the creation of e-mails for user notifications for the defined number of minutes.
Default value
15
Possible values
“0” to “99” (integer) q
The delay does not apply to warnings for a POCC or notifications for a supervisor.
Warning e-mails - include link to component
This parameter defines whether a link to the component, i.e. the screen in
cobas IT
1000 application the warning refers to, is included in the e-mail warning.
Default value
Yes
Possible values
o
Yes
o
No
Warnings
Maximum Size of Database (Mb)
This parameter sets the maximum size that the database is expected to have. When free space is expected to be not enough to continue working, a warning message is displayed.
Default value
3600
MB
Warning Page Refresh (Minutes)
This parameter sets how often the information in the Warning area on the screen is updated.
Default value
1
minute
Warning Size of Database (%)
This parameter sets the percentage of the maximum expected database size that displays a warning to the user when reached. By default, the system automatically displays a warning message when the free space is less than 20%.
Default value
80
%
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Demographic Definition
Demographic Definition
This component enables you to set up the patient and sample demographics within the application. In this screen, you can deactivate/activate demographic fields, edit the name as it appears in the application and add new sample or patient demographic fields.
System > Demographic Definition
(
Configuration > Demographic Definition
)
Figure 4-2 Demographic Definition
screen
Term definition
In the
cobas IT
1000 application there are two groups of demographic information: o demographic information related to patients (such as patient ID, name, sex, and date of birth).
o demographic information related to samples (such as sample ID; registration year, date, and time).
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Demographic Definition
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Configuration
Depending on the hospital requirements, administrators can define new, customized demographic fields.
Roche predefined fields cannot be edited, but can be renamed.
When a demographic field is first created in the
System > Demographic Definition
screen, it appears as inactive in the
System > Demographic Assignment
screen. It has to be activated to become visible.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
q
There are two calling sequences provided above, because the structure of the Navigation tree can be altered in the
Menus
settings of the
User Profile
. The first calling sequence refers to the presentation by
Module
. The second calling sequence refers to the presentation by
Type
.
u
For more information on how to change the navigation structure, see
Switching between navigation structures
Field definitions
Current Name
System Name
Used With...
Data Type
Table Name
Status
Name of the demographic field as it is displayed in other screens of the application. The Current Name can be changed.
Name of the demographic field as it is recorded in the system. The
System Name is predefined and cannot be changed.
It indicates whether the field is used as a patient or sample demographic.
Type of data or information that can be introduced in this specific demographic field. The different types include
Free Text
,
Predefined
,
Free Text / Predefined
,
Image
,
URL
,
Table
,
Date
,
Time
,
General Text
.
Only active if data type is set as
Table
. Specific system table from which the respective information is retrieved. Enter the name as it is defined in the database.
It indicates whether the demographic field is activated or deactivated.
Tasks
From this screen, you can perform the following tasks: o
Create a new demographic field to be used later in sample or patient assignment and data entry.
o
Query for demographic fields to see the details assigned to a specific demographic field.
o
Activate/deactivate a demographic field so that it is visible/not visible in other screens where patient or sample demographic fields are used.
o
Modify an existing demographic field.
o
Access the
Values
screen to manage fields of the data type
Predefined
values.
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Demographic Assignment
Demographic Assignment
Use this component to define display order and default values of the fields which have been previously defined in the
System > Demographic Definition
component.
Only fields that have been activated under
Demographic Definition
can be edited.
Several fields are mandatory and cannot be disabled. Some fields cannot be edited.
Prerequisites
o
Demographic records must have been previously added to the system through the
System > Demographic Definition
screen.
o
Predefined values must have been previously added to the system through the
System > Demographic Definition > Values
screen.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
System > Demographic Assignment
(
Configuration > Demographic Assignment
)
Figure 4-3 Demographic Assignment
screen
When a demographic field is created in the
System > Demographic Definition
screen, it is shown as inactive in the
System > Demographic Assignment
screen.
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Field definitions
System Name
Current Name
Display Order
Mandatory
Default Value
Status
Internal name for Roche predefined demographic fields.
Information can only be read in the List area. It is not editable.
Name of the demographic field as it is displayed in other screens of the application.
The
Current Name
field is editable and usually translated.
It indicates the order of appearance for sample and patient demographic fields in other screens of the application.
The
Display Order
field is editable. Use this field to define the desired order of appearance for sample and patient demographic fields by entering a number.
It indicates whether it is compulsory to enter a value.
Value that appears by default when a new record is added.
It indicates whether the demographic field is activated or deactivated.
Tasks
o
Managing sample demographic assignments.
o
Managing patient demographic assignments.
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Patient Demographic Assignment
Patient Demographic Assignment
Use this screen to assign patient demographic data fields to be shown in the
Results
& Patients > Single Patient Edit
and
Results & Patients > Patient Query
screens and define their desired order of appearance (
Display order
).
To be able to store data received via ADT, the respective patient demographic has to be set active in this component.
Prerequisites
o
To access the
Patient Demographic Assignment
screen (rather than
Sample
Demographic Assignment
), select
Patient
from the
Used with:
drop-down list.
o
Patient demographics must have been previously defined (such as patient name, patient ID, date of birth, sex).
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Tasks
o
Querying for patient demographic assignment information to see the details assigned to a specific demographic field record.
o
Deactivating a patient demographic assignment record so that it is not available or visible in the
Results & Patients > Single Patient Edit
screen.
o
Modifying existing patient demographic assignment information.
Activating patient demographic records
Set patient demographics as active.
p
To activate patient demographic records
1
Choose
System > Demographic Assignment
.
2
From the
Used with:
drop-down list, choose
Patient
.
3
Set the filter of the
Status
column to
All
to view inactive records.
4
If the desired demographic record is active, double-click the entry.
5
If the desired demographic record is inactive, select the record and click
Activate
.
6
In the Detail area, assign a sorting order by entering a number into the
Display
Order
field.
This is the order in which the active demographic fields will be shown in the
Results & Patients > Single Patient Edit
screen.
7
Click
OK
.
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Sample Demographic Assignment
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Use this screen to assign data fields for sample demographics and to apply a numbered sorting order. In this screen the demographic fields to be used in
Results
& Patients > Patient Query
are defined.
Prerequisites
o
To access the Sample Demographic Assignment screen (rather than
Patient
Demographic Assignment
), select
Sample
from the
Used with:
drop-down list.
o
Sample demographics must have been previously defined (such as sample ID; registration year, date, and time).
Particularities
Both sample and patient demographic lists are shown on the screen. However, this patient demographic list has no functionality in the current version of the application. Some of the data for the selected fields cannot be entered manually. As instruments may send this bit of information to the system, it can therefore be queried in
Results & Patients > Patient Query
.
u
Other screens involved
The selected fields will be displayed in the sample detail list in the
Results & Patients
> Patient Query
screen.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Tasks
o
Querying for sample demographic assignments, especially details assigned to a specific demographic field.
o
Deactivating a sample demographic assignment so that it is not visible or available in other screens.
o
Modifying existing sample demographic assignment information.
Activating a sample demographic item
p
To activate a sample demographic item
1
Choose
System > Demographic Assignment
.
2
From the
Used with:
drop-down list, choose
Sample
.
3
Set the filter of the
Status
column to
All
to view inactive records.
4
In the
Sample Demographics
list, select the sample demographic item to be activated, and click
Activate
.
5
In the Detail area assign a sorting order by entering a number to the
Display
Order
field, and click
OK
.
The updated application demographic records information is displayed in the List area. All data modifications are stored in the database.
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Instrument Alarm Definition
Instrument Alarm Definition
There are two categories of alarms in the
cobas IT
1000 application: o
Instrument alarm
Instrument alarms are triggered by an instrument flag (e.g. “result below instrument measurement range”, “Instrument maintenance due”).
o
System alarm
System alarms are flags triggered by the application (e.g. “un-reviewed test results”) u
For information on system alarms, see
q
In the column
Editable
two types of alarms are defined: o
Alarms that have the check box checked (editable):
Only the
Alarm Text
can be changed.
Note:
Do not edit alarm texts. The new text is only stored in the database. In
cobas IT
1000 application, the original text is displayed after choosing the
Filter
button, or starting a new session.
o
Alarms that have the check box unchecked (not editable):
Only the
Default Severity
can be changed.
Predefined alarms
There are predefined alarms available for use, but you can also create new ones.
Alarm types
Alarm types are used to standardize individual flags sent by different instrument types within the application.
Mapping flags to alarms
The mapping of the defined flags with the instrument alarms is done in the
System
> Instrument Alarm Assignment
component.
System > Instrument Alarm Definition
(
Configuration > Instrument Alarm Definition
)
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Instrument Alarm Definition
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Figure 4-4 Instrument Alarm Definition
screen
Default alarms are not editable. Only those alarms defined by a user can be edited.
Tasks
o
Creating new alarms to be matched with flags sent by the instrument.
o
Querying for user-defined alarms for displaying their details.
o
Activating an alarm to make it available for other screens.
o
Deactivating an alarm to make it unavailable for other screens.
o
Modifying user-defined alarm types that are already stored in the database.
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List of predefined alarms used as system alarms
Following is a description of all predefined alarms with details of what causes them.
Alarm ID
IAR
IAU
IB
IMI
IMTW
IMT
IMW
IMQ
INA
Alarm flag received from instrument
Unknown alarm flag received from instrument
Result received from locked instrument
Test related instrument maintenance due
(information)
Test related instrument maintenance due
(warning).
Test related instrument maintenance due (error)
QC related instrument maintenance due
(warning)
QC related instrument maintenance due (error)
Result received from inactive instrument
Triggering event Comment Result type
The related test result received from the instrument was flagged by the instrument.
The related test result received from the instrument was flagged by the instrument using a flag not set up in the application.
Patient, QC
This specific alarm is triggered, when an instrument sends an alarm flag with the result not mapped in
System
> Instrument Alarm
Definition
. This alarm will be shown as: IAU_< Alarm code sent by the Instrument>, e.g.
IAU_2 (2 is the alarm flag sent by the instrument).
Patient, QC
Patient, QC When a result is received from an instrument set to status
Locked
in
Instruments > Status
.
A maintenance set up in
Instruments
> Maintenance
is due.
This specific alarm is triggered, when a patient result is received and a maintenance with type
Information
(selected in the
Validation
Alarm
field of the
Pending
tab) is due.
A maintenance set up in
Instruments
> Maintenance
is due.
This specific alarm is triggered, when a patient result is received and a maintenance with type
Warning
(selected in the
Validation Alarm
field of the
Pending
tab) is due.
A maintenance set up in
Instruments
> Maintenance
is due.
This specific alarm is triggered, when a patient result is received and a maintenance with type
Error
(selected in the
Validation Alarm
field of the
Pending
tab) is due.
A maintenance set up in
Instruments
> Maintenance
is due.
This specific alarm is triggered, when a QC result is received and a maintenance with type
Warning
(selected in the
QC
Alarm
field of the
Pending
tab) is due.
A maintenance set up in
Instruments
> Maintenance
is due.
This specific alarm is triggered, when a QC result is received and a maintenance with type
Error
(selected in the
QC
Alarm
field of the
Pending
tab) is due.
When a result is received from an instrument deactivated in
Instruments > Configuration
.
Patient
Patient
Patient
QC
QC
Patient, QC
Instrument Alarms
Table 4-1
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Alarm ID
IRH
IRL
IUE
IUU
Table 4-1
Alarm text Triggering event
Result above instrument measurement range
Result below instrument measurement range
Instrument not docked at home location
Result unit not defined for this test.
The result is above the reportable range of the instrument.
The result is below the reportable range of the instrument.
The result was downloaded from an
IP address (station) not assigned to the location the instrument is assigned to.
The unit(s) set up for this test in
System > Test Definition
do not match the unit sent by the instrument.
Instrument Alarms
Comment
For configuration settings, contact the Roche Service.
For configuration settings, contact the Roche Service
Requires the use of a docking station. Applies only to
Accu-
Chek Inform
instruments.
Result type
Patient
Patient
Patient, QC
Patient, QC
QC alarms (system alarm)
Alarm ID
MQC
MRE
MRW
MTE
QCW
QCE
QCNR
QCOR
Table 4-2
Alarm text Triggering event Comment
QC material LOT not valid
QC lock (Multirule violation)
This control material lot does not exist in the application or has no ranges.
A multirule with severity error
(red icon) has been violated.
QC warning (Multirule violation)
A multirule with severity warning (yellow icon) has been violated.
Test material LOT not valid
Result received during
QC warning
Result received during
QC lock
No range defined (QC result)
Value out of range (QC result)
This test material lot does not exist in the application, or has expired, is deactivated or has not been reviewed by the user.
The patient result was received while the related test on this instrument was in QC warning status (multirule violation).
The patient result was received while the related test on this instrument was in QC lock QC
(non-RiliBÄK) - multirule violation.
No ranges are defined for this material in
Materials > Material
Definition
.
When a numeric QC result is out of range and when an alphanumeric QC result does not match the target value defined in
Materials > Material
Definition
.
QC alarms
This alarm will be shown as
MRE_< violated multirule code>, e.g. MRE_1x2s
This alarm will be shown as
MRW_< violated multirule code>, e.g. MRW_1x2s
Result type
QC
QC
(non-RiliBÄK)
QC
(non-RiliBÄK)
Patient, QC
Patient
Patient
QC
QC
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Alarm ID
QCQN
QLR
RBM
RBS
RBE
RBE_QUAL
RBE_COL3A
RBE_LED
RBE_RNG
RBN1
RBN2
RBNL
RBP1
Alarm text
Qualitative result, but defined range is numeric
Result received after completion of control cycle
No QC done within required time
No QC schedule defined
QC lock (RiliBÄK)
QC lock (RiliBÄK)
QC lock (RiliBÄK)
QC lock (RiliBÄK)
QC lock (RiliBÄK)
No QC done since routine started
No second QC done since routine started
No second QC level done since routine started
No QC done in defined interval
Triggering event Comment Result type
The test result is alphanumeric, but the applicable ranges defined for this test in
Materials
> Material Definition
are all numeric
The alarm is triggered when a
QC result is received after completion of a control cycle.
This QC result is not part of the evaluation of the control cycle.
Also, the result is not included in the RiliBÄK report.
RiliBÄK mode only The QC requirements (on number and levels of QC) have not been met within the specified time frame.
There is no QC schedule defined for this configuration (
Accu-
Chek Inform
instruments) or instrument (all other).
The alarm is triggered when the
RiliBÄK ranges are violated or none are defined.
RiliBÄK mode only
RiliBÄK mode only. This alarm will be shown as RBE if the ranges are not defined or as e.g. RBE_SP3+ /
RBE_SP3- (RiliBÄK 2008) if ranges are violated
QC
QC (RiliBÄK mode only)
Patient
(RiliBÄK mode only)
Patient
(RiliBÄK mode only)
QC (RiliBÄK mode only)
RiliBÄK mode only QC (RiliBÄK mode only)
The alarm is triggered when the
QC result does not match the target value.
The alarm is triggered when the
QC result is outside the allowed deviation (col. 3a).
The alarm is triggered when the
QC result is outside of the LED.
The alarm is triggered when the
QC result is outside of range.
RiliBÄK mode only
RiliBÄK mode only
RiliBÄK mode only
QC (RiliBÄK mode only)
QC (RiliBÄK mode only)
QC (RiliBÄK mode only)
The alarm is triggered when the
RiliBÄK timing rules are violated by patient results for which no QC has been done since routine started.
The alarm is triggered when the
RiliBÄK timing rules are violated by patient results for which no second QC has been done since routine started.
The alarm is triggered when the
RiliBÄK timing rules are violated by patient results for which no second QC level has been done since routine started.
The alarm is triggered when the
RiliBÄK timing rules are violated by patient results for which no QC has been done in the defined interval.
Non-POCT instruments only. Used to define more specifically, which
RiliBÄK violations will stop the automatic validation of patient results.
Patient
(RiliBÄK mode only)
Non-POCT instruments only. Used to define more specifically, which
RiliBÄK violations will stop the automatic validation of patient results.
Patient
(RiliBÄK mode only)
Non-POCT instruments only. Used to define more specifically, which
RiliBÄK violations will stop the automatic validation of patient results.
Patient
(RiliBÄK mode only)
Non-POCT instruments only. Used to define more specifically, which
RiliBÄK violations will stop the automatic validation of patient results.
Patient
(RiliBÄK mode only)
Table 4-2
QC alarms
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Alarm ID
RBP2
RBPL
RBY3
Alarm text Triggering event Comment Result type
No QC done in defined pre-interval
No second QC level done
No QC done in previous routine period
The alarm is triggered when the
RiliBÄK timing rules are violated by patient results for which no QC has been done in the defined pre-interval.
The alarm is triggered when the
RiliBÄK timing rules are violated by patient results for which no second QC level has been done.
The alarm is triggered if over the course of a completed routine period no QC has been done and no active RBN1 alarm mapping exists for patient results of the respective instrument type.
Non-POCT instruments only. Used to define more specifically, which
RiliBÄK violations will stop the automatic validation of patient results.
Patient
(RiliBÄK mode only)
Non-POCT instruments only. Used to define more specifically, which
RiliBÄK violations will stop the automatic validation of patient results.
Patient
(RiliBÄK mode only)
Non-POCT instruments only.
Patient
(RiliBÄK mode only)
QC alarms
Table 4-2
User alarms (system alarms)
Alarm ID
OC
OCE
OII
OM
ONC
OOU
OP
OU
Table 4-3
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Alarm text
User comment
Marked as erroneous by user (comment)
Triggering event
The user performing the measurement has entered/selected a comment during the measurement.
The user performing the measurement has selected an
“error comment”.
Comment
An “error comment” is a comment defined in
System
> Comment Definition
and has
Mark as Erroneous
assigned in
Instruments > Comment
Assignment
.
u
For supported characters,
Operator ID contains an invalid character
Operator ID missing
Operator not certified for this instrument type
Operator testing outside assigned location(s)
The operator ID entered during measurement contains an invalid character.
No operator ID has been entered on the instrument when the measurement was performed
The operator having performed the measurement has no valid certification for this instrument type.
The user is not assigned to the location the instrument is assigned to.
Operator profile does not support task
This user profile has no privileges for task 1 (send results from the instrument).
This alarm is currently not fully implemented in the application, as the tasks component is disabled.
Unknown operator
The operator ID entered during measurement is not known to the application.
User alarms
Result type
Patient, QC
Patient, QC
Patient, OC
Patient, QC
Patient, QC
Patient, QC
Patient
Patient, QC
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Instrument Alarm Definition
Patient alarms (system alarms)
Alarm ID
PA
PD
PII
PN
PU
TG
Table 4-4
Alarm text
Unknown patient
Patient discharged
Patient ID contains an invalid character
Patient not admitted
Patient not located in instrument location
Patient ID missing
Patient alarms
Triggering event Comment
The patient ID entered during measurement is not known to the application.
The patient is already discharged.
The patient ID entered during measurement contains an invalid character.
The patient is not admitted, i.e. the
Admitted Status
check box on the
Single Patient Edit
screen is not selected.
The patient is either not assigned to a location or the patient location is not assigned to the location the instrument is assigned to.
No patient ID has been entered during measurement.
u
For supported characters,
Result type
Patient
Patient
Patient
Patient
Patient
Patient
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Validation alarms (system alarms)
Alarm ID
TANR
TD
TNR
TH
TL
TPH
Table 4-5 cobas IT 1000 application
Alarm text
Qualitative result with numeric range - no autovalidation possible
Delta check violation
No reference range defined
Result above upper reference range
Result below lower reference range
Result above upper critical range
Triggering event
The test result is alphanumeric, but the applicable ranges defined for this test in
System > Test
Definition
are all numeric.
The difference with the last result of this test for this patient was too large.
Comment
No ranges are defined for this test in
System > Test
Definition > Reference
Range
.
The result was above the normal range for this test.
The result was below the normal range for this test.
The result was above the critical range for this test.
Delta checks can be set up in
System > Test Definition
> Delta Check
. The check is always done against the oldest result in the specified time frame.
Ranges can be set up in
System
> Test Definition > Reference
Range
. They are based upon demographic criteria and their use is therefore only recommended when the application is receiving patient information from the hospital information system.
Ranges can be set up in
System
> Test Definition > Reference
Range
. They are based upon demographic criteria and their use is therefore only recommended when the application is receiving patient information from the hospital information system.
Ranges can be set up in
System
> Test Definition > Reference
Range
. They are based upon demographic criteria and their use is therefore only recommended when the application is receiving patient information from the hospital information system.
Ranges can be set up in
System
> Test Definition > Reference
Range
. They are based upon demographic criteria and their use is therefore only recommended when the
cobas
IT
1000 application is receiving patient information from the hospital information system.
Result type
Patient
Patient
Patient
Patient
Patient
Patient
Validation alarms
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Alarm ID
TPL
TTH
TTL
TRH
TRL
TRR
Table 4-5
4 System
Instrument Alarm Definition
Alarm text Triggering event Comment Result type
Result below lower critical range
Result above upper tolerance range
Result below lower tolerance range
Result above upper rerun range
Result below lower rerun range
Repeat result detected
The result was below the critical range for this test.
The result was above the tolerance range for this test.
Ranges can be set up in
System
> Test Definition > Reference
Range
. They are based upon demographic criteria and their use is therefore only recommended when the application is receiving patient information from the hospital information system.
Tolerance ranges allow the automatic validation of a specific result range independent of whether the result is marked as out of normal/critical range.
Patient
Patient
Patient The result was below the tolerance range for this test.
The result was above the rerun range for this test.
The result was below the rerun range for this test.
Tolerance ranges allow the automatic validation of a specific result range independent of whether the result is marked as out of normal/critical range.
Rerun is currently not fully implemented in the application.
Once completed, it will facilitate the identification of tests which are a re-run of a previous test for the same patient.
Rerun is currently not fully implemented in the application.
Once completed, it will facilitate the identification of tests which are a re-run of a previous test for the same patient.
The result is a repeated result. The result is a repeated result. It is flagged with system alarm
TRR
and set to status
Pending
.
The general setting
Detect repeat results
must be enabled to activate the repeated results detection process.
If enabled, for each instrument type configuration it is possible to define in the field
Repeat
Time Interval
the amount of minutes when, if a repeated result is sent, it will be marked as repeated (flagged with system alarm
TRR
).
u see
Patient
Patient
Patient
Validation alarms
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Other alarms (system alarms)
cobas IT 1000 application
Alarm ID
MR
TM
ERV
Table 4-6
Alarm text
Manual Result
Triggering event
The result has been entered manually.
Result modified by user
The result has been modified by a user of the application.
Empty Result Value
The related test result has no value.
Other alarms
Comment
Recommended to be used with connectable instruments.
Manual result entry is only possible for QC test results.
Result type
QC
Patient
Patient
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Instrument Alarm Assignment
Instrument Alarm Assignment
q
Refer to the instrument specific manuals for the definition of the alarms sent by the instruments.
This screen is used to map flags sent by the instruments with the alarms previously defined in the
Instrument Alarm Definition
screen. Here, you also assign an alarm severity to this mapping and, if applicable, their corresponding codes in the host protocol definition.
q
Any instrument or system alarm with alarm severity of error will cause a result to be held in result validation.
Prerequisites
Alarms must have been previously defined.
System > Instrument Alarm Assignment
(
Configuration > Instrument Alarm Assignment
)
Figure 4-5 Instrument Alarm Assignment
screen
Tasks
o
Creating a new alarm mapping to create a correlation between a flag sent by an instrument with the alarm code set up in the
System > Instrument Alarm
Definition
screen.
o
Querying for alarm mapping definitions to see the details of a specific alarm correlation.
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Instrument Alarm Assignment
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o
For each instrument alarm: Enabling/disabling the sending of an alarm as a result comment to the host. By default, the value is set to
Disabled
(do not send).
o
Filtering for alarms to display only alarms which are (or are not) sent as comments to the host (column
Send as comment
).
o
Activating an alarm mapping so that the alarm is displayed when this specific flag is received from an instrument.
o
Deactivating an alarm mapping so that the alarm is not displayed any more when this specific flag is received from an instrument.
o
Modifying an alarm mapping to change the correlation between the flag received from the instrument and the alarm displayed in the
Results & Patients > Result
Validation
screen.
o
Defining a host code for the instrument alarm, in order to send, for instance, abnormal flags in the result message to the LIS.
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System Alarm Assignment
This screen is used to map the system-predefined alarms with each instrument type and assign them not only an alarm severity, but also a result type (patient or QC).
You must first review the alarms in the
Instrument Alarm Definition
screen, and then map them in the
Instrument Alarm Assignment
or
System Alarm
Assignment
screens. Only mapped alarms can block or flag tests and QC results.
Alarms mapped as errors block results. Alarms mapped as warnings or information flag results, but do not block them. q
Any instrument or system alarm with alarm severity of error will cause a result to be held in result validation.
Use this component to correlate system alarms with the alarm codes and descriptions displayed in the validation screen, and, if applicable, their corresponding codes in the host protocol definition.
Prerequisites
Instrument types must be previously defined.
System > System Alarm Assignment
(
Data > System Alarms Mapping
)
Figure 4-6 System Alarm Assignment
screen
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System Alarm Assignment
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Tasks
o
Creating a new assignment to establish a correlation between system alarms and the respective instrument types.
o
Querying for the details of existing assignments.
o
Filtering for alarms to display only alarms which are (or are not) sent as comments to the host (column
Send as comment
).
o
For each system alarm: Enabling/disabling the sending of an alarm as a result comment o
Activating an existing assignment so that it is in use when the application is running.
o
Deactivating an assignment so that it is not taken into account when the application is in use.
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Comment Definition
Comment Definition
Use this component to set up comments and comment codes, to both simplify and standardize commenting. Comments defined in this screen will be displayed as a selection list within the
Comments
screen of the
Results & Patients
as well as the respective
Quality Control
module and in the
Comment Assignment
screen of the
Instruments
module.
Comments defined in this screen will be available in all screens where predefined comments can be added. Each comment is assigned a short code (two to four letters) for quick comment entry in the application and for upload to instruments supporting pre-configured comments (like
Accu-Chek Inform II
and
cobas h
232 instruments).
This is done in
Instruments > Comment Assignment
. The system comes with predefined comments for the
Accu-Chek Inform
. To deactivate these comments, deactivate them in
Instruments > Comment Assignment
first.
System > Comment Definition
(
Configuration > Comment Definition
)
Figure 4-7 Comment Definition
screen
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Comment Definition
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Tasks
o
Creating a new predefined comment to optimize the institution's workflow.
o
Activating a comment so that it can be used in other screens supporting the use of predefined comments.
o
Deactivating a comment so that it cannot be used in other screens supporting the use of predefined comments.
Predefined comments
Comment Code
ACC
ASY
CLM
DON
LAD
NCL
NKL
NLN
NOA
NSL
PRE
PRT
RCT
RNN
SQV
WRT
Table 4-7
Comment Text
Acceptable Control
Asymptomatic
Cleaned Meter
Doctor Notified
Lab Draw
New Control Lot
New Strip/Kit Lot
New Lot Number
No Action
New Strip Lot
Procedure Error
Proficiency Test
Repeat Control Test
RN Notified
Switched QC Vial
Will Repeat Test
Abbreviations of the predefined comments
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Sample Type Definition
Sample Type Definition
Use this component to define and manage the various types of samples to be tested.
Used for manual entry of QC results for off-line instruments
The functionality of the
Sample Type Definition
component in the current version of the application is mainly intended for use with off-line instruments, where QC results are entered manually rather than being sent by an instrument.
Sample type added with instrument driver
No additional definitions are necessary for instruments that can be connected to the application. Most sample type definitions are added during installation of the respective instrument driver.
Default sample types
The application comes with a set of default sample types to be used with connectable instrument types.
Test definition
For the definition of a test, both sample types and tubes need to be defined.
u
For more information on defining tube types, see
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
System > Sample Type Definition
(
Configuration > Sample Type Definition
)
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Sample Type Definition
cobas IT 1000 application
Figure 4-8 Sample Type Definition
screen
Tasks
o
Creating a new sample type definition to determine the physiological samples on which tests can be conducted.
o
Querying for sample type definitions to see the details assigned to a specific sample type.
o
Activating a sample type definition so that it is available in other screens supporting sample type data.
o
Deactivating a sample type definition so that it is not available in other screens supporting sample type data.
o
Modifying an existing sample type definition. All fields are editable except for the
Sample Type ID
.
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Tube Definition
Tube Definition
This component is mainly intended for off-line instruments, where results are entered manually rather than being sent by an instrument.
Prerequisites
Sample types must have been previously defined.
Interdependency with Sample
Type Definition
If you add a sample type, you are required to create the corresponding tube.
Currently supported instruments do not physically use tubes for sample analysis.
Tubes have no direct functionality in the current version of the application. However, the concept of tubes has been implemented in anticipation of future versions where more instruments will be managed by the application.
Default tubes
The application comes with a set of default tubes for use with connectable instrument types.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
System > Tube Definition
(
Configuration > Tube Definition
)
Figure 4-9 Tube Definition
screen
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Tube Definition
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Tasks
o
Defining a new tube to specify the tube used for analysis.
o
Querying for tube definitions to see the details assigned to a specific tube identifier.
o
Activating a tube definition so that it is available in other screens supporting tube information.
o
Deactivating a tube definition so that it is not available in other screens supporting tube information.
o
Modifying an existing tube definition. All fields are editable except for the tube identifier.
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Test Definition
Test Definition
Use this component to either add a new test definition or to edit parameters such as the
Full Test Name
or the measurement unit that is used with a test. This is necessary in order to align the settings with the ones used in your organization.
Manually adding new test definitions is only required for off-line instruments. All connectable instrument types come with a predefined set of test definitions.
Prerequisites
Tubes must have been previously defined.
Related screens
The test definitions must be defined before you can use them in the following screens: o
Instruments > Configuration
o
Instruments > Instrument Assignment
o
Materials > Material Definition
o
Materials > Lot Management
. When changing the units of measurement for a system test, the ranges defined for material lots must be changed accordingly q
Application administrator rights required
You must have administrator rights to make changes in this screen.
WARNING
CAUTION
Test Configuration
r
Ensure that test properties are configured correctly, as a wrong configuration may have a serious impact on results interpretation.
Manually entered Test IDs
r
To ensure that manually entered Test IDs and Test Abbreviations do not conflict with those that will be included in future software or driver releases, the following rules must be respected: o
Test ID
: Use only Test IDs in the range of 1000–1999 (should this range be inadequate, contact Roche Service).
o
Test Abbreviation
: End each test abbreviation with an underscore ‘_’ character, e.g.‘Glu_’
System > Test Definition
(
Configuration > Test Definition
)
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Test Definition
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Figure 4-10 Test Definition
screen
Field definitions
Test ID
Version Date
Test Abbreviation
Full Test Name
Tube Name
Tube Volume
Primary Unit
Identification code corresponding to one specific test.
(Max. 6 alphanumeric characters.)
Date of the version when the test was created or last modified. Version date must be the current date or later.
Abbreviated name of the test. (Max. 8 alphanumeric characters.)
Full name of the test. Test names are unique. (Max. 30 alphanumeric characters.)
Name of the tube used to carry out this specific test.
Sample Type volume required to carry out the test. (Max.
4 numeric characters.)
Units in which the results of this test are expressed: %, °C,
μ mol/L, inch, mL, etc.
Note:
When the primary unit for a result from an
Accu-
Chek Inform II
is mg/dL, the secondary unit defaults to mmol/L.
If the instrument measurement unit is mmol/L and both the primary as well as the secondary unit configured in
System > Test Definition
are mmol/L, QC results are flagged with
IUU
. The
IUU
alarm does not appear when the secondary unit is set to mg/dL.
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Test Definition
Number of Decimals
Secondary Unit
Conversion Factor
Formula
Max. Linearity
Min. Linearity
Delay
Catalogue ID
Analytical Method
The number of decimal places to be used in the rounding of test results supplied by the instruments.
Note:
When operating with RiliBÄK 2008, result ranges, target values and actual results are calculated and reported to the precision specified in this setting.
Note:
When calculating the target value for a QC lot,
cobas IT
1000 application uses 1 decimal digit more than defined for the test.
Secondary units in which the results are expressed.
When the primary unit for a Glu2 test result from an
Accu-Chek Inform II
is mg/dl, the secondary unit defaults to mmol/L.
Note:
If the primary unit is s, the secondary unit needs to be set to sec to allow correct processing for RiliBÄK 2008
QC results.
Factor used to determine a secondary unit result from a primary unit result. (Max. 6 characters total — 5 numeric characters +1 decimal separator.) Currently applicable only for
Accu-Chek Inform
instruments.
For other instrument types no unit conversion is done for other than RiliBÄK 2008 QC results.
Note:
If the primary unit is s, the conversion factor needs to be set to 1 to allow correct processing for RiliBÄK 2008
QC results.
Formula applied to calculate a result from the result of other tests, reserved for future functionality.
Maximum linearity value for the obtained results. The system accepts lower values without alarms (Max. 10 numeric characters.), reserved for future functionality.
Minimum linearity value for the obtained results. The system accepts higher values without alarms (Max. 10 numeric characters.), reserved for future functionality
(in days) Time lapse before the results are available (Max.
3 numeric characters.), reserved for future functionality.
External test identification, reserved for future functionality.
Measuring method used to carry out the test. If defined, each default system test is updated with the information on the analytical method. This field is used in RiliBÄK
QC mode only.
Tasks
o
Defining a new tube to specify the tube used for analysis.
o
Creating a new test.
o
Querying for test information to see the details assigned to a specific test.
o
Activating a test so that it is available in other screens supporting test information.
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NOTICE
o
Deactivating a test so that it is not available in other screens supporting test information.
Interrupted application data flow
Automatically validated results may not be sent to the HIS/LIS, if tests are deactivated without removing the test mapping first.
r
Prior to deactivating a test, do the following:
Remove the test from materials defined in
Materials > Material Definition
.
Depending on the instrument type, deactivate the test in
Instruments
> Configuration > Driver Configuration
, and/or
Instruments > Instrument
Assignment > Driver Configuration
.
o
Modifying an existing test to change its features, such as the measurement unit.
o
Access the
Delta Check
screen to handle the Delta Check definitions of the selected test.
o
Access the
Reference Range
screen to handle various ranges of the selected test.
Delta Check
Use this option to define and manage the Delta Check parameters which are to be applied to the associated test during validation of patient test results.
Term definition
Delta Check is to the comparison of the current result with a previous result of the same test performed on the same patient and is used to check result plausibility.
A Delta Check violation is set when the difference exceeds the defined limits. The definition of Delta Check limits is optional. However, if you do define limits, they must be violated in order to trigger a Delta Check (e.g. if you define 2 limits (absolute and percentage) both must be violated to get a Delta Check). A Delta Check failure automatically blocks the result from automatic validation.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
All the actions taken in this screen affect the test selected in the previous screen,
System > Test Definition
screen.
System > Test Definition > Delta Check
(
Configuration > Test Definition > Delta Check
)
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Test Definition
Figure 4-11 Delta Check
screen
Field definitions
Result Type
Number of Days
Lower Limit
Upper Limit
Use Percentage
Allowed Delta (Absolute)
Allowed Delta (%)
Old Value
New Value
Type of result yielded in this test: Numeric and
Alphanumeric
Number of days to look back for Delta Check verification.
Lowest value for which Delta Check verification is triggered for this set of criteria. (Only with numeric type results.)
Highest value for which Delta Check verification is triggered for this set of criteria. (Only with numeric type results.)
It indicates whether the Delta Check deviation is given as a percentage. (Only with numeric type results.)
Delta Check limit expressed as absolute numbers. (Only if
Use Percentage
is not selected.)
Delta Check limit given as a percentage. (Only if
Use
Percentage
is selected.)
Previous value taken as a reference for Delta Check verification. (Only with alphanumeric type results.)
Current value to trigger Delta Check verification. (Only with alphanumeric type results.)
Table 4-8
Title
o
Creating a Delta Check definition.
o
Querying for Delta Check information to see detailed information.
o
Modifying Delta Check information of an already existing record.
o
Deleting Delta Check definitions.
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Test Definition
Reference Range
cobas IT 1000 application
Use this option to define and manage various ranges that are to be applied to the associated test parameter during validation of test results.
o
This screen is accessed by clicking the
Reference Range
button on the
System
> Test Definition
screen.
o
All the actions taken on this screen affect the test record selected in the previous screen,
System > Test Definition
screen.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
o
Only one range set for each sex can be defined.
o
When a test result is received, it is checked against the configured range set. For results belonging to a patient record that has no specific entry in the
Sex
field, the
Generic
range set is used.
System > Test definition > Reference Range
(
Configuration > Test definition > Reference Range
)
Figure 4-12
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Reference Range
screen
Tasks
o
Creating range sets to be used with a specific test.
o
Querying for range sets to see its details.
o
Modifying existing range sets.
o
Deleting range sets.
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Test Definition
q
Rerun High
and
Rerun Low
fields are not functional in the current version of the application since the application does not support automatic repetition of a test.
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Test Group Definition
Test Group Definition
cobas IT 1000 application
Use this component to manage the various tests, which have been defined in the
System > Test Definition
component, and classify tests into test groups and test group categories. There are three predefined test group categories: o
Host Communication
: test groups in this category are used to define groups of tests that need to be sent to certain hosts (e.g. all glucose results go to a diabetes information system, all blood gas results go to an ICU information system, or certain results alike Baro are not supposed to be sent to a Host system at all). The test groups defined in this category are mapped to specific hosts by Roche Service.
o
Panels
: test groups in this category are used as grouping criterion, e.g. for reports.
o
Security
: test groups in this category are used in combination with user profiles.
This is useful if certain tests need to be managed by a special group of users, e.g. if
POCC responsibilities for glucose and blood gas instruments are taken care of by different users or groups of users. The test groups defined in this category are mapped to the user profiles in the
User Profiles
screen.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
System > Test Group Definition
Figure 4-13
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Test Group Definition
screen
Color-coding
A blue-colored icon indicates an active group or category.
A grey icon indicates an inactive group or category.
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Test Group Definition
Field definitions
Category
Complementary
It groups together test groups. Non-default categories are of no significant use within the current version of the application.
If this option is selected, the same test cannot be included in more than one group of the same category.
Group
Category
Group Name
Category to which the test group belongs.
Full name of the test group.
The active test groups in the category
Panels
are the tests groups available in the
Manual Result Entry
component.
u
The active test groups in the category
Security
are the test groups available in the
Organization > User Profiles > Test Groups
screen.
u
The active test groups in the category
Host Communication
are the test groups available for organizing which results are sent to which hosts.
Panels
,
Security
and
Host Communication
categories cannot be deactivated.
Querying for group definitions
You query for group definitions to see the tests assigned to a specific group.
p
To query for group definitions
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Expand the category and select the group to be queried.
All the tests of this group are displayed in the List area on the right.
3
If necessary, set a filter on the tests list.
s
Adding a new category
You add a new category to classify tests in different groups.
p
To add a new category
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Click
Add Category
, fill in the fields in the Detail area, and then click
OK
.
The updated group information is displayed on the Group structure. All the information is automatically stored into the database.
s
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Test Group Definition
Adding a new group
cobas IT 1000 application
Add a new test group so that tests are classified and it is easier to work with them.
p
To add a new group
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Select the category to which a group is to be added, click
Add Group
, fill in the fields in the Detail area, and then click
OK
.
The updated group information is displayed in the Group structure. All the information is automatically stored into the database.
s
Adding a new test to a group
You can add a new test to an already existing group to adapt test groups definitions to the institution’s working needs.
p
To add a new test to a group
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Select the group to which a test is added, and click
Add Test
.
The
Test Selection
screen appears.
3
Select the test or tests to be added from the list by clicking the check box, and then click
OK
.
The
Test Selection
screen is closed and the added tests appear on the grid.
s
Adding a new group through a copy
You can copy an already existing group to create a new one with similar properties.
p
To add a new group through a copy
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Select the group to be copied, click
Copy Group
, fill in the fields in the Detail area, and then click
OK
.
The updated group information is displayed on the Group structure. All the information is automatically stored into the database.
s
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Test Group Definition
Editing group or category information
Use this option to modify the name of an existing group or category, or to move a group to another category.
p
To edit group or category information
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Ensure that the group or category to be edited is active.
u
See
3
Select it, and click
Edit Name
, edit the fields in the Detail area and click
OK
.
The updated group information is displayed in the List area. All the information is automatically stored into the database.
s
Deleting a test from a group
You delete a test from a group when a test is removed from a group, the test definition itself is not deleted.
p
To delete a test from a group
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Select the group from which a test is to be removed, optionally set a filter, select the test to be removed.
3
Click
Delete Test
.
The updated information is displayed in the List area. All the information is automatically stored into the database.
s
Deactivating a group
You deactivate a group so that it is not available in other screens where test groups may be required.
p
To deactivate a group
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Select the group to be deactivated, and click
Deactivate Group
.
3
In the
Confirmation
dialog, click
OK
.
The updated group information is automatically displayed on the Group structure.
s
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Test Group Definition
Activating a group
cobas IT 1000 application
You activate a group so that it is available in other screens where test groups may be required.
p
To activate a group
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Select the group to be activated, and click
Activate Group
.
The updated group information is automatically displayed on the Group structure.
s
Activating a category
You activate a category so that its test groups can be used.
p
To activate a category
1
From the Navigation tree, select
System > Test Group Definition
.
All categories are displayed in the Group structure to the left of the List area.
2
Select the group to be deactivated, and click
Activate Category
.
The updated group information is automatically displayed on the Group structure.
s
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Message Broker Monitor
Message Broker Monitor
The
Message Broker Monitor
is used as an internal system analysis tool, and can provide Roche Service with quick system information in case of problems with application data flow. The
Message Broker Monitor
is only to be used by Roche
Service or trained administrators of the application.
This screen is for consultation only. However, messages that are no longer relevant can be deleted.
Symbols used to identify the delivery status:
The message has been delivered without errors.
The message is not yet delivered.
The message is being processed.
The message has been delivered with errors and could be reopened.
System > Message Broker Monitor
Configuration > Message Broker Monitor
Figure 4-14 Message Broker Monitor
screen
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Message Broker Monitor
Reopening a message
cobas IT 1000 application
Use this function to re-process data that the receiving sub system has not processed correctly and is flagged with a red circle. Point on the red circle to get information about the processing error.
p
To reopen a message
1
Choose
System > Message Broker Monitor
, select the server to be reviewed, and select the flagged record that is to be re-opened.
2
Click
Reopen
.
The record is reprocessed and information delivery to the respective sub system is attempted.
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Table of contents
Organization
5 Organization
5
In this chapter you will find information about storing and managing users of the
cobas IT
1000 application and instruments connected to
cobas IT
1000 application.
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Chapter
5
Importing exam results from a 3rd party learning management system (LMS) 167
129
5 Organization
Table of contents
cobas IT 1000 application
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Organization module components
Organization module components
It enables you to store and manage information on instrument trainings, as well as the ability of the user to work with an instrument.
You can import information on users and HIS locations into the
Organization
module from external files which provides easy interaction with other electronic systems in the hospital.
It includes organizational information regarding sites, locations and HIS locations.
Each site consists of locations (also called wards) and HIS patient locations. To each location, instruments, instrument users, patient visits (via their HIS location assignment), and patient test results are assigned. Settings in this module affect the other modules in the application, such as users’ access permissions.
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Sites
Sites
cobas IT 1000 application
Use this component to create new sites, or to maintain administrative information for existing sites.
Within the application’s data hierarchy, a site is the highest level to reflect an institution’s organizational set-up. In this structure, each location belongs to a specific site.
Users and instruments (and therefore their QC and test results) can be assigned to locations and therefore to sites.
u
For more information about locations, see
o
Sites are unique.
o
Except for the
Site Name
and
Site ID
, the data in this screen regarding each category, site is additional information used in reports.
o
Make sure that the site name is unique.
o
You can only edit information of a particular site if you are set up as
Site Manager
of that site. Otherwise, you cannot modify site information.
o
You will be prompted to choose the site during the login process.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > Sites
(
Data > Sites
)
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Sites
Figure 5-1 Sites
screen
Field definitions
Site ID
Site Name
Medical Director
Site Manager
Role
Identifier of the site.
For usability reasons, restrict site ID to max. 5 characters.
In case of Consilia workflow, all site IDs have to have the same length.
Name of the site.
Name of the medical director of the site (Max. 30 alphanumeric characters).
User ID of the administrator who is responsible for this particular site.
Administrator’s profession (e.g. nurse, POCC, etc.).
Tasks
o
Creating a site to start a new hierarchical organization in which the site is the highest level (e.g. if the application is used by two different hospitals).
o
Querying for site information to see the details assigned to a specific site.
o
Modifying site information of an already existing site.
o
Activating a site so that it is visible and/or available in other screens within the application where it may be required.
o
Deactivating a site so that it is not visible or available in other screens within the application.
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Sites
Multi-Site concept
cobas IT 1000 application
The multi-site configuration enables you to manage more than one site (e.g. hospitals, laboratories) from one single installation of the
cobas IT
1000 application.
Settings applied to all sites
If the application is managing multiple sites, some information/settings are sitespecific whereas other apply to all sites.
Site-specific vs. global components
The images below show the various application components.
o
Blue highlighting indicates that the information/settings in this component affect all sites (global settings).
o
Orange highlighting indicates that the information/settings in this component are site-specific.
q
Note that the main
Certification
screen applies to all sites. But all screens reachable from the
Certification
screen are site-specific.
Figure 5-2
Blue highlighting: Affects all sites. Orange highlighting: Site-specific
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Sites
Figure 5-3
Blue highlighting: Affects all sites. Orange highlighting: Site-specific
Figure 5-4
Blue highlighting: Affects all sites. Orange highlighting: Site-specific
Implications
o
Each site must have its own user ID range which cannot be used in any other site.
o
Each site must have its own patient ID range which cannot be used in any other site.
o
All sites will have the same general settings.
o
All sites must work with the same materials.
o
All sites will have the same severities assigned to the alarms.
o
It is recommended for each site to maintain its own certifications, e.g. by using the site ID as prefix for the certificate type, in order to avoid issues when assigning certifications to a large group of users.
Shared responsibility of involved
POCCs
A point of care coordinator of a particular site is solely responsible for the following components: o
User Management
o
Certification o
Result Management
o
Levey-Jennings Chart
o
Cumulative Chart
o
Levey-Jennings Review
o
Levey-Jennings Review by Lot o
Linearity Review
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Sites
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o
Manual Result Entry
(of QC test results) o
Sample Validation
o
Result Validation
o
Result Query
o
Report Generation
o
Report Log
For all other components, the point of care coordinators of the involved sites share responsibility.
Overlapping patient IDs on multiple sites / Consilia workflow
If two or more hospital information systems using the same patient ID ranges are to be connected, the
cobas IT
1000 application will add the site ID as a prefix to the received patient ID. In this way, patient IDs are unique in the application, if all site
IDs are equally long.
This scenario is referred to as the Consilia workflow.
The setup is done by Roche Service. If the Consilia workflow is implemented, the site
ID is displayed as a prefix to the patient ID and visit ID in the application. The site ID is not displayed on the instruments. LIS and instruments will only display the patient
ID or visit ID, without prefix.
q
Note
If your site requires Consilia workflow, please contact Roche Service.
p
To move an instrument from one site to another in Consilia workflow
q
Follow this procedure to make sure that measurements are assigned to the correct patient.
1
Dock the instrument to synchronize it with
cobas IT
1000 application. Make sure that all measurements have been successfully transferred to
cobas IT
1000 application. Undock the instrument.
2
In the
Instruments > Instrument Assignment
screen in
cobas IT
1000 application, assign the new configuration and location to the instrument.
3
Dock the instrument again to synchronize it with
cobas IT
1000 application.
Undock the instrument.
4
Login to the instrument and verify that it is assigned to the correct site and runs with the desired configuration.
5
Move the instrument to the new site.
6
Run a dummy measurement. Dock the instrument to synchronize it with
cobas
IT
1000 application.
7
In the
Results & Patients > Result Query
screen in
cobas IT
1000 application, verify that the result was assigned to the correct patient.
s
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Locations
5 Organization
Locations
Use this component to create new locations, or to maintain administrative information for existing locations, such as a unique name, description, nurse, manager and phone number. Furthermore, existing locations can be copied and edited.
Locations are the fundamental link between user, instrument, patient and result data.
Due to the important role as a unique identifier, location names are provided as query criteria in most areas of the application.
o
Users are assigned to a location using the
Assign Users
function.
u
To assign multiple users to a single location
o
HIS locations can be assigned to locations either in the
Organization > Locations
screen or in the
Organization > HIS Locations
screen.
o
A location can be deactivated even though an instrument is assigned to it. In this case, assign the instrument to a different location in the
Instruments
> Instrument Assignment
screen.
o
A location can be deactivated even though an HIS location is assigned to it.
However, in this case, you cannot assign the same HIS location to a different location in this screen directly. Reassign the HIS location in the
Organization
> HIS Locations
screen.
u
Prerequisites
Sites must have been previously defined.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > Locations
(
Definition > Locations
)
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Figure 5-5
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Locations
screen
Field definitions
Location ID
Initial Sample ID
Final Sample ID
Specific Auto Sample ID
Identifier of the location.
For usability reasons, restrict location ID to max. 5 characters.
Initial number of the sample ID range for the location. If an initial sample ID is entered, a final sample ID must also be entered. (Max. 5 numeric characters.)
Final number of the sample ID range for the location. It is mandatory if initial sample ID has been introduced. Max.
5 numeric characters.)
If activated, samples from instruments assigned to this location receive an auto generated sample ID, whose incremental part is between the initial and final sample
ID of this location.
Tasks
o
Creating a location to be able to relate it to the users of this application, the instruments used and the patients.
o
Copy a location to reuse it and edit the information of the designated new location in the Detail area.
The location will be copied with all assigned instrument users, all assigned instrument comments, all assigned material lots and all active and inactive records including their status.
o
Querying for location information to see the details assigned to a specific location.
o
Editing the information of an existing location.
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Locations
o
Activating a location so that it is visible and/or available in other screens within the application where it may be required.
o
Deactivating a location so that it is not visible or available in other screens within the application. Deactivated locations are not listed in the filter options of other grids.
q
Patient locations can also be assigned to a location in the
Organization > HIS Locations
screen.
Copying a location
p
To copy a location
q
Only locations of the active site can be copied.
1
Click
Copy
.
2
Select the designated location in the displayed pop-up.
Only locations of the active site are listed.
3
Click
OK
.
4
Fill in the fields in the Detail area.
5
Click
OK
in the Detail area to save the new location.
s
Assigning multiple users to a single location
Use the
Assign Users
button to allocate multiple users to a single location.
The
Home Location
function allows you to set the home location for the assigned users in one step to the current location.
Prerequisites
Locations and users must have been previously defined.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > Locations > Assign Users
(
Definitions > Locations > Assign Users
)
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Figure 5-6 Users Assignment
screen p
To assign multiple users to a single location
1
Choose
Organization > Locations
.
2
In the List area, select the location to which you want to assign users.
3
Choose the
Assign Users
button.
The
User Assignment
window is displayed.
4
If required, choose a filter from the drop-down list to limit the number of listed users.
The following filters are available: o
All
o
Unassigned
o
Workgroups
o
Locations
o
Home Location
5
In the list of available users, select the users that you want to assign to the location and choose the button.
Use the button to assign all listed users at once.
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Locations
6
If required, select one or more assigned users and choose the
Home Location
button to set the current location as home location for the selected users.
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HIS Locations
HIS Locations
cobas IT 1000 application
This component enables you to create new HIS locations, or to maintain information for existing HIS locations, such as the room name and assigned bed(s). The HIS location is used as the link between patient visits and locations, based on the ADT information, received from the administrative system connected to the application.
Assignment of the HIS location to the proper location is essential to distribute patient visits correctly, thus providing appropriate patient information to individual instruments used in different locations.
q
Note: if you enter a description for the HIS Location manually, the text will be overwritten by the value received in the patient message from the host.
Prerequisites
Sites and locations must have been previously defined.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > HIS Locations
(
Definition > HIS Locations
)
Figure 5-7 HIS Locations
screen
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HIS Locations
Tasks
o
Creating a new HIS location to be able to maintain accurate information about where patients are located.
o
Querying for HIS location information to see the details assigned to a specific location.
o
Editing HIS location information of an already existing one.
o
Activating an HIS location so that it can be visible and/or available in other screens within the application where it may be required.
o
Deactivating an HIS location so that it is not visible or available in other screens within the application
Description of HIS Location
If you enter a description for the HIS Location manually,
cobas IT
1000 application overwrites the entered text when it receives an ADT message from the HIS/LIS.
Figure 5-8 HIS Locations
detail screen
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Workgroup Definition
Workgroup Definition
cobas IT 1000 application
Use this component to define new workgroups, or to maintain information for existing workgroups, such as workgroup name, manager and description of the workgroup.
With the workgroup attribute, used in the
Organization > User Management
component, you can group individuals by a common criterion (e.g. profession or roles).
This criterion is independent of the location they are assigned to. Users are assigned to workgroups in the Detail area of the
Organization > User Management
screen.
Prerequisites
Users must have been previously setup so that a user can be defined as a manager of the workgroup. The selection of a manager is mandatory.
q
When updating from an earlier version of the application
If no manager is assigned to a workgroup, the application automatically assigns the user
ROCHE
as the manager of this workgroup.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > Workgroup Definition
Figure 5-9
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Workgroup Definition
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Workgroup Definition
Tasks
o
Adding a workgroup to group together users of this application.
o
Querying for workgroup information to see the details assigned to a specific workgroup.
o
Editing workgroup information to change any of the features of a specific workgroup o
Activating a workgroup so that it can be used in other screens within the application.
o
Deactivating a workgroup so that it cannot be used from other screens.
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User Profiles
User Profiles
cobas IT 1000 application
Use this component to create new user profiles, or to maintain information for existing user profiles.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Main function
Defining to which modules and components a user is granted access. A user can only see the modules that are assigned to his user profile.
Profile definition
Typical user profiles are defined based on job functions, such as point-of-care coordinator, nurse or physician.
Assigning profiles to users
Profiles are assigned to users in the
Organization > User Management
component.
Default setting
By default, new user profiles do not have access to any menu options. Access rights must be granted.
u
For more information on how to assign menus to users, see
Predefined profiles
The following profiles are predefined in the
cobas IT
1000 application:
Predefined profile Description
Device Mgmt.
IT Manager
Manual Entry
Nurse Educator
Operator
POCC
POCT Admin
Service
Table 5-1
For internal use only
For managing EAP Settings
For manual entry of quality control results
For end users with training responsibilities
For users of instruments without access to the application
For the POCC
For the system administrator
For Roche service
Predefined profiles in
cobas IT
1000 application yes yes yes
Administrator rights
no yes yes no no
Administrators, Nonadministrators
Users with administrator rights will be able to edit and manage those pages that necessarily require administrator rights as indicated in this manual (mainly configuration screens). Non-administrator users will be able to access these screens
(unless menu access is restricted), but they will appear to them as read-only.
Deactivating a profile
If a profile is deactivated, none of the users with this profile can log in to the system.
Organization > User Profiles
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Figure 5-10 User Profiles
screen
Field definitions
Profile Name
Description
Administrator Rights
Non-expiring Password
Data Volume
Assigned Users
Full name of the profile. (Max. 15 alphanumeric characters.)
Brief description of the profile. (Max. 40 alphanumeric characters.)
It indicates whether the user has administrator rights.
Select this option when the password of the profile members should never expire.
Number of rows displayed on the grid. For performance reasons, it is recommended to set the volume to
Low
. The number of data rows assigned to a level can be adapted by
Roche Service. Default settings for
Low
and
High
are 800 and 5000 rows respectively.
The users assigned to this profile will be listed here. Users are assigned to a profile in the
User Management
module.
Tasks
o
Creating a new user profile to define a new group of permissions and settings that can be assigned to users.
o
Querying for profile information to see the details assigned to each individual profile.
o
Activating a profile so that it can be assigned to new users and be available from other application screens.
o
Deactivating a profile so that users with that profile cannot access the application and it cannot be assigned to new users or be available in other screens.
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o
Editing profile information to change any of the features of a profile.
o
Accessing the
Tests
screen to handle test access level of the selected profile. See
o
Accessing the
Menus
screen to handle menu access level of the selected profile.
Test Groups
Use this option to assign permission for the ability to work with individual test groups to the respective user profile. Permission can be assigned to each test group, ranging from no access to full read, write and validate access. Permissions are applied to all test parameters included in the selected test group.
o
To access the
Tests
screen click the
Test Groups
button in the
User Profiles
screen.
o
By default, new user profiles have full access to all tests (
R/W/V
).
Prerequisites
Test groups must have been previously assigned to the
Security
category in the
System > Test Group Definition
screen.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Test access levels
These are the different levels of access that can be granted to users. Result modification is applicable only to manually entered results.
Results received from instruments cannot be manually modified.
No Access
Add
R/V
R
R/W
R/W/V
User has no access to the results of the selected group of tests.
User has permission to add new results of tests belonging to the selected group when entering a new sample.
User can only read and validate results for these tests.
User can only read test results, but cannot modify them.
User can read and modify test results.
User can read, modify and validate test results.
Organization > User Profiles > Test Groups
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Figure 5-11 Tests
screen
Setting test access level
Set tests access restrictions to user profiles to determine the type of access for users with the selected profile.
p
To set test access level
1
In the
Tests
screen, select a test group and choose the test access type to be assigned to this group.
2
Click
OK
.
The updated profile information is displayed in the List area.
s
Menus
Use this option to grant access to individual screens of the application to a user profile. Access can either be granted or denied. If access is granted, the related screen can be accessed from the Navigation area. If denied access, the related module or component will not appear within the Navigation area.
o
To access the
Menus
screen, click the
Menus
button on the
User Profiles
screen.
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q
Application administrator rights required
You must have administrator rights to make changes in this screen.
q
Default menu presentation is by
Module
. If presentation by
Type
is selected, next time the user logs into the application, the Navigation tree will have a different structure than that in this manual, ordered by the type of information, not by modules
Organization > User Profiles > Menus
Figure 5-12
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Menus
screen
My Settings
Language
Warnings Configuration
System
General Settings
Demographic Definition
Demographic Assignment
Instrument Alarm Definition
To define the language and regional settings.
To configure the warnings to be displayed in the
Warning area.
To define the basic workflow parameters of the application.
To define or customize patient and sample demographic fields.
To define the usage of the previously defined demographic fields.
To configure alarms with which test and QC results can be flagged.
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Instrument Alarm Assignment
System Alarm Assignment
Comment Definition
Sample Type Definition
Tube Definition
Test Definition
Test Group Definition
Message Broker Monitor
To map the configured alarms with flags sent by the instrument and set their severity.
To set the severity of the alarms generated by the system.
To predefine comments.
To define types of samples used in
Tube Definition
.
To define the types of tubes used in
Test Definition
(for sample collection/storage).
To define the tests that can be run with the instruments connected to this application and their settings.
To make test groups for preset test panels for manual entry / Sample Statistics or to restrict access to certain data or define rules for sending results to host systems
To check for possible errors in the communication between the application and the instruments and hosts.
Organization
Sites
Locations
HIS Locations
Workgroup Definition
User Profiles
User Management
Certification Tasks
Certification
Competencies
Notification Templates
HIS Location Import
User Import
To configure the sites where the application is used.
To configure the locations that make up each site.
To configure the HIS locations associated with each location.
To configure the workgroups that users may belong to.
To configure user profiles and grant or restrict access to certain screens or data.
To create accounts for users who have access to the application or work with the instruments.
To view a list of certification tasks.
To define and manage user certification for instrument access.
To add and edit competencies. This function is used to document classroom trainings with all users who attended the training.
To configure notification templates for e-mails and letters.
To import information about HIS locations from a text format file.
To import information about users from a text format file.
Materials
Material Definition
Lot Management
To define the various types of materials used with each instrument type.
To maintain information on specific lots of defined material types.
Instruments
Status
Maintenance
Maintenance Definition
Configuration
To get an overview of the status of the instruments connected to the application.
To control the status of the maintenance tasks and to configure maintenance tasks that must be performed on each instrument.
To manage received, desired and system comments.
To define the configurations for the instruments connected to the application.
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EAP Settings
EAP Settings Assignment
Instrument Assignment
Comment Assignment
Off-Line Instruments
To manage EAP settings definitions.
By default, only the
IT Manager
and the
Service
user profiles have access to this screen.
To manage the assignment of EAP settings to instruments with a configuration where WLAN security type is EAP.
By default, only the
IT Manager
and the
Service
user profiles have access to this screen.
To define the specific setup for each instrument connected to the application.
To define the comments that are made available for selection on connected instruments.
To configure types of instruments not connectable to the application, configurations for and individual instruments of such types.
Quality Control
Result Management
Levey-Jennings Chart
Cumulative Chart
Levey-Jennings Review
Levey-Jennings Review by Lot
Linearity Review
Multirules
Manual Result Entry
QC Test Mapping
To review the QC results received from instruments and check their status.
To view Levey Jennings charts and the corresponding QC statistics.
To view cumulative charts and the corresponding QC statistics.
To review monthly Levey Jennings charts from QC data.
To review monthly Levey Jennings charts by Lot from
QC data.
To review day-based linearity charts.
To define the multirules that are to be used with QC test results to detect instrument errors.
To enter QC results manually
To map individual tests with generic tests in instruments that run several types of tests but use one QC test only.
Results &Patients
Sample Validation
Patient Query
Result Validation
Result Query
To validate all tests in one specific sample.
To search for, to view and maintain patient information.
To validate patient test results.
To view patient test results. It is for consultation only.
Reports
Report Generation
Report Log
To generate reports by using the predefined types of reports.
To review the previously generated reports stored in the database.
Quality Control (RiliBÄK)
Result Management
Levey-Jennings Chart
Cumulative Chart
Levey-Jennings Review
Manual Results
To review the QC results received from instruments and check their status.
To view Levey Jennings charts and the corresponding QC statistics.
To view cumulative charts and the corresponding QC statistics.
To review monthly Levey Jennings charts from QC data.
To enter QC results manually.
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Test Mapping (RiliBÄK)
Result Alarm Monitor
RMSE Alarm Monitor
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User Profiles
To map QC (RiliBÄK) tests with system tests.
To see the RiliBÄK alarms and their details.
To see the RMSE RiliBÄK 2008 alarms and their details.
Granting access to menus
Set access to the application menus to determine which are the menus to which users with this profile should have access.
p
To grant access to menus
1
If necessary, sort the list of available menus on the
Menus
screen.
2
Select a menu and grant or deny access to it, and then click
OK
.
All the information is automatically stored into the database.
s
Copying settings from another profile
Use this option to set the same or similar settings to another profile.
p
To copy settings from another profile
1
On the
Menus
screen, click
Copy from Profile
.
A dialog with a list of the existing user profiles appears.
2
Select the profile of which you want to make a copy.
3
If necessary, edit the access settings.
4
Click
OK
.
The system automatically fills out the detail information for the selected profile in the Detail area of the
Menus
screen.
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User Management
cobas IT 1000 application
Use this component to add new users, to maintain information for existing users, to reset user passwords, to personalize warnings and to assign locations, user profiles, certifications, competencies, user ID, password and user demographics.
Before any person can work with the software application, the system administrator must assign a user profile. Authorization for use of POC instruments will be controlled by providing instrument certifications to each user on an instrument type basis.
o
Certifications can also be managed through the
Certification
screen.
o
Competencies can also be managed through the
Competencies
screen.
o
There is a predefined user with user name
ROCHE
and profile
Service
o
The user ID can contain uppercase letters (A to Z), numbers (0 to 9), and the additional characters +,/,_,-,$,\,@.
During input, the system automatically converts lowercase to uppercase letters.
q
Ensure that the supported character sets of instruments connected to
cobas IT
1000 application are also supported by
cobas IT
1000 application.
o
The password can only consist of letters (A to Z and a to z) and numbers (0 to 9).
No special characters or country specific letters are accepted. The complexity of the password is defined in
o
The
Reset Password
function has to be configured in
System > General Settings
.
o
If LDAP is enabled, the
Reset Password
function is not available. This function allows to authenticate users via an LDAP based active directory service instead of using the internal
cobas IT
1000 application password.
Note:
if LDAP is enabled, the Network ID is a mandatory field, and the user must log in with the Network ID and the LDAP password.
q
To enable LDAP
To enable this functionality the following general settings in
System > General
Settings
have to be configured: o
Enable authentication via LDAP-based directory service
o
LDAP server is a Windows Active Directory server
o
LDAP domain name
o
LDAP server name or IP address and port
o
LDAP search user: Password
o
LDAP search user: User name
o
LDAP Base DN to use for searches
o
LDAP unique search attribute
u see
u
o
In the
Grid settings
window, you can define the maximum number of records that is displayed per page
Prerequisites
Locations, workgroups and profiles must have been previously defined.
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q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > User Management
5 Organization
User Management
Figure 5-13 User Management
screen
Field descriptions – Table column header
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User ID
Last Name
First Name
Network ID
Password Expiry
Certification Expiry
The unique identification number assigned to the selected user.
The last name/surname of the selected user.
The first name of the selected user.
The network ID refers to the LDAP user name (domain user name).
u
Enable authentication via LDAP-based directory service
Note:
After upgrading to software version 2.07, the
Network ID may be displayed at the far right of the grid.
If you restore the default settings, the Network ID is displayed after the First Name. Alternatively, you can drag and drop the column to any position in the grid.
The date on which the password will expire.
The date on which the user’s earliest expiring certification will expire.
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User Profile
Workgroup
Status
Field descriptions – Detail area
User ID
First Name
Last Name
2nd Last Name
Description
Role
Password
Password Confirmation
Password Change Date
Creation Date
User Profile
LDAP
Network ID
Phone cobas IT 1000 application
The user profile selected for the user. The selection of a user profile is mandatory. For those using only connected instruments, we recommend the predefined user profile.
The work group with which the user is affiliated. For more information see
Work group affiliation can be used as a filtering criterion when searching within, e.g., certification screens.
The status of the user. If checked the user is active.
The unique identification number assigned to the selected user.
The first name of the selected user.
The last name/surname of the selected user.
An alternative last name/surname for the selected user.
An additional free-text description of the selected user.
This can be used if the user represents a group of users rather than a single user, e.g. Temporary employees.
The job that the user performs.
The password that the user will use to access the
cobas IT
1000 application and/or connected instruments.
A repetition of the password that you use to access the
cobas IT
1000 application and/or connected instruments.
This is to ensure that you enter the intended password correctly.
The date on which the password was last modified.
The date on which the user was newly entered in to the
cobas IT
1000 application.
The user profile selected for the user. The selection of a user profile is mandatory. For those using only connected instruments, we recommend the predefined user profile.
LDAP is a protocol of active directory synchronization of users. A central system in the Lab that allows you to log in with all the users in the network not just in the system.
The user can use the HIS or LIS password instead of using the internal
cobas IT
1000 application password -
Integrated user name and password. The LDAP setting in
General Settings enables this functionality for all users, and the LDAP setting in this screen enables LDAP for a particular user.
Note:
If LDAP is enabled, the
Reset Password
function is not available.
LDAP user name to log in to the hospital network.
Note:
if the
LDAP
check box is selected, the Network ID is a mandatory field.
Note:
if the
LDAP
check box is cleared, it is not required to delete the Network ID.
u
The e-mail address of the selected user.
The land line telephone number of the selected user.
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User Management
Mobile Phone
Comment
Workgroup
The mobile telephone number of the selected user.
A free text field for user information that is not directly covered by one of the other fields
The work group with which the user is affiliated. For more information see
Work group affiliation can be used as a filtering criterion when searching within, e.g., certification screens.
Location selection – Detail area
Click the
Assign
button in the Detail area to open the
Location Selection
pop-up window. Here, you can assign one or more locations to the user.
Available Location(s)
Assigned Location(s)
Home Location
The available location(s) are listed.
The organizational location(s) with which the user is affiliated. In the
cobas IT
1000 application a user has access to the data of a specific site if affiliated with one or more of the site’s locations. If a user is not affiliated with any specific location, s/he has access to all the application sites.
Assign the designated locations to the user.
The assignment of the instrument to a specific location affects whether the user has access to the instrument, i.e. the user must be affiliated with the location to which the instrument is assigned. Another factor which may influence whether instrument access is allowed is the user’s instrument type certification status.
Select the check box for the location where the user is based, i.e. the organizational location with which the user has the strongest affiliation.
NOTICE
No instrument access without location assignment
If you add a new user and do not assign him to any locations,
cobas IT
1000 application raises a confirmation message. You are asked to confirm for this user to have access to all sites and therefore locations. But even after clicking
OK
, such a user is not uploaded with the operator list to instruments assigned to a specific location.
r
Always assign at least one location when adding a new user. r
For users to have access to all locations, assign all locations to them.
LDAP – Detail area
Select the LDAP check box in the Detail area to allow user authentication via an
LDAP based active directory service. If LDAP is enabled, the following rules apply: o
User login: For the user to be able to login to
cobas IT
1000 application, the same user must exist in active directory.
If the LDAP check box is checked,
cobas IT
1000 application authenticates the user based on the Network ID, and logging in with the user ID is not possible.
q
The Network ID must be unique among other Network IDs and cannot be equal to the user ID of another user.
o
User addition: New users added to one of the systems (
cobas IT
1000 application or active directory) must be added to the other system as well. There is no automatic exchange of user profiles between
cobas IT
1000 application and active directory. o
User deletion: Users deleted from active directory will be unable to login to
cobas
IT
1000 application.
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o
Password update: If LDAP is enabled, password updates cannot be made via
cobas IT
1000 application. Passwords must be managed in active directory. o
Instrument access: If a user logs on to an instrument, the instrument password is always checked against the application database, not against active directory. A user deleted from active directory will still have access to instruments. Therefore, instrument passwords need to be managed in
cobas IT
1000 application, even if
LDAP is enabled. o
If you upgrade
cobas IT
1000 application, the following 2 scenarios can occur:
1) If the
LDAP
check box is checked and the general LDAP settings are active
(
System > General Settings
), the user ID is copied to the Network ID field.
2) If the
LDAP
check box is checked and the LDAP settings are inactive (
System
> General Settings
), the user ID is not copied to the Network ID field, and the
LDAP
check box is cleared. u
To enable LDAP, see
Tasks
o
Adding users.
o
Querying a user’s record to see the details assigned to it.
o
Activating a user’s record so that the user can access the application and its data is available in other screens where user data is required.
o
Deactivating a user record so that the user cannot access the application and its data is not available in other screens where user data is required.
o
Reset user passwords.
o
Accessing the
Warnings Configuration
screen to define the warnings the selected user should see in the Warning area.
o
Accessing the
Certification
screen to manage the selected user’s certifications.
o
Accessing the
Competencies
screen to manage the selected user’s competencies.
Defining warnings for other users
You can define which warnings should be visible for the selected user, assign the warning severity and define personalizations to limit the events that can trigger a warning.
The definition of the warning settings is done in the same way as under
My Settings
> Warnings Configuration
.
u
For information on how to define warnings and personalizations of warnings, see
p
To define warnings for other users
1
Choose
Organization > User Management
.
2
In the List area, select the user, for which the settings shall be valid.
3
Click
Warnings
.
The
Warnings Configuration
screen opens showing all warnings that are applicable to the user profile and privileges.
4
To activate or deactivate a warning, select the warning in the List area and click
Activate
/
Deactivate
.
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5
To restrict the events that can trigger a warning for this user, click
Personalize
.
The
Personalizations
screen opens.
s
Resetting a user‘s password
Use this option to reset a user‘s password. At the next login to the application the user will be forced to change his password.
Select the designated user in the List area and click
Reset Password
.
q
After a password reset, the password defined in the general setting
Reset password to...
is the password the user needs to insert in the
Current Password
field in the
Password
Change
dialog. Make sure to inform the user accordingly.
u
Prerequisites
The settings
Default password for password reset
and
Reset password to...
under
System > General settings
must have been previously defined. These settings determine the new password set to the user.
u
q
Application administrator rights required
You must have administrator rights to reset a user password.
q
If LDAP is enabled, the
Reset Password
function is not available.
Certifications
Use this option to review instrument type certifications, which have been assigned to the selected individual.
The status (active / inactive) of existing instrument certifications can be changed, and additional certifications can be assigned by selecting the
Add Certification
option.
All information displayed in this screen refers to the user selected on the previous screen (
Organization > User Management
), so all the possible modifications will affect that specific user.
Prerequisites
Certification types and certifications must have been previously defined.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > User management > Individual (Certifications)
(
Data > User management > Individual (Certifications
)
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Figure 5-14 Individual (Certifications)
screen
Tasks
o
Querying for user certification information.
o
Activating a certification for a user.
o
Deactivating a certification for a user.
o
Adding a certification.
Adding a certification
Use this option to assign a new certification to the selected user. Based on the concept of certifications, the assignment of a certification is tied to a certificate type and a specific certification date. To assign a certification via this option, select an existing certification from the given list.
All the information displayed in this screen refers to the user selected on the previous screen (
Organization > User Management
), so all the possible modifications will affect that specific user.
Prerequisites
Certifications and certificate types must have been previously defined in the
Organization > Certification
screen.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
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Organization > User Management > Individual (Certifications) > Add
Certifications
(
Data > User Management > Individual (Certifications) > Add Certifications
)
Figure 5-15 Add Certifications
screen
Button
Select This
Select All
Deselect All
Reset New State
Table 5-2
Function
The certification highlighted by the cursor is selected.
All certifications are selected.
All selected certifications are deselected.
Resets New State back to Current State. If the current state is
Pending, and you change the new state to Certified, clicking the
Reset New State
button changes the new state back to
Pending.
Buttons in list area p
To add a certification
1
Choose
Organization > User Management
.
2
Select the user for which you want to add a certification and click the
Certifications
button.
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3
In the
Individual (Certifications)
screen, select the instrument and click
Add
Certification
.
The
Add Certifications
screen appears, from which a query can be made to find the certification to be added.
4
Select the certification to be granted to the selected user, and then click
Save
.
All the information is automatically stored into the database.
s
Adding a competency
Use this option to assign new competencies to the selected user.
In this screen new competencies can be added to the selected user and attached files of already existing competencies of this user can be viewed.
The definition of competencies is done in the same way as under
Organization
> Competencies
.
u
For information on how to define competencies, see
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > User Management > Competencies
(
Data > User Management > Competencies
)
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Figure 5-16 Competencies
screen p
To add a competency
1
Choose
Organization > User Management
.
2
Select the user for which you want to add a competency and click the
Competencies
button.
3
In the
Competencies
screen, click
Add
.
4
To add a competency the following fields have to be defined:
Instrument Type
,
Certificate Type
,
Date
,
Competency
,
Stage
Furthermore, a file can be attached and participating users can be added to the competency. For example, the uploaded file could be a scanned attendance list in which the instrument users prove with their signature that they have attended the competency.
5
Click
OK
to add the competency.
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Certification Tasks
cobas IT 1000 application
Use this component to view the status of the certification tasks for users who need to maintain their certifications.
For each of the tasks, the completion status is displayed in the column
Completion
(e.g. number of patient samples done against number of patient samples needed).
q
You must have administrator rights to make changes in this screen.
Expiration status symbols
Certification is valid.
Certification is expired or long-time expired.
Certification is non-expiring.
Certification is upcoming, urgent or pending.
q
Observation timeframe
The observation timeframe is the period of time, before a certification will expire, when the tasks have to be performed to get an automatic recertification.
The following general settings configure the internal periods of time in the observation timeframes: o
Recently expired certification timeframe (Days)
o
Observation timeframe - medium warning timeframe (%)
o
Observation timeframe - narrow warning timeframe (%)
u
Example: Certification of 12 months from 01.01.2015 to 31.12.2015
Observation timeframe: 60 days
Medium warning timeframe:
Narrow warning timeframe:
35% (in this case 21 days)
15% (in this case 9days)
Recently expired certification timeframe:
Table 5-3
60 days
Example for observation warning timeframe
A B
C D
E F
A
Duration of validity of certification
B
Observation timeframe
C
Medium warning timeframe
Figure 5-17
D
Narrow warning timeframe
E
Recently expired certification timeframe
F
Certification in status long-time expired
Example for duration of certification and observation timeframe
A user with a (long-time) expired certification is not downloaded to the respective connected instrument requiring operator list.
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q
Expiration date of expiring certifications
The date displayed in the
Expiration Date
column may be earlier than expected, if the certification date falls on a day that does not exist in the month of the expiration date. E.g., if the certification date is the 31st of January and the certification is valid for 1 month, the expiration date is the 27th of February instead of the 28th of February.
Organization > Certification Tasks
Figure 5-18 Certification Tasks
screen
Field definitions
Stage
Task
Completion
Owner
Expiration Date
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Certification stage (i.e.
Pending
,
Interim
or
Certified
)
Certification task set when setting up the certification (i.e. tasks set in the fields
QC Level 1 (#)
to
QC Level 4 (#)
,
Patient Samples (#)
,
Freetext Criterion 1
to
Freetext
Criterion 3
,
Competency required
,
OTS
and/or
Exam reqired
)
Fulfillment status of the certification task in the following format: number of sucessfully completed certification tasks / total number of certification tasks required
Defines who is responsible for completing the task
Possible values: o
User
(operator can perform this task on his own) o
Supervisor
(supervisor needs to perform this task)
Date until the certification task has to be fulfilled to prevent expiration of the certification
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Expiration Status
Status
Exam Attempts
Graphical indicator for the expiration status of the certification task u
Status of certification task. If checked, the certification task is active.
Possible values: o
Active o
Inactive
Shows the number of exam attempts (if
Task
=
Exam
) in the following format: number of exam attempts taken / maximum number of exam attempts q
If
Task
=
Exam
and
Owner
=
Supervisor
, and the current number of attempts taken is equal to the maximum (e.g. 5 / 5)., the instrument user failed his or her last exam attempt.
The POCC (Supervisor) will need to reset the exam attempts to allow the instrument user to retake the exam.
Tasks
From this screen, you can perform the following tasks: o
Access
cobas
academy o
Reset the exam attempts counter o
Check the import of exam results from a 3 rd
party learning management system
(LMS) o
Export a list of all certification tasks q
Information regarding cobas academy cobas
academy allows to manage: o
Online courses o
Virtual OTS introduction o
Free text criteria
cobas
academy has to be installed and configured by Roche Service.
View Exam in cobas academy
Clicking the
View Exam
button opens
cobas
academy in a separate browser window requesting information corresponding to the user and the course.
q
The
View Exam
button is only active for
cobas
academy exam tasks.
This button is greyed out if
cobas
academy is not installed.
p
To open cobas academy
1
Choose
Organization > Certification Tasks
.
2
Select a
cobas
academy exam in the list.
3
Click the
View Exam
button.
The system automatically opens
cobas
academy in a separate browser window.
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Resetting the exam attempts counter
When failing the predefined number of exam attempts, the user is not allowed to retake his or her exam. By clicking the
Reset Exam Attempts
button the attempts counter can be reset.
Note:
If
cobas
academy is installed, the resetting of the exam attempts counter will be synchronized automatically, enabling the user to take the exam again.
For a 3 rd
party LMS, enabling the user to take the exam again may require an action from the POCC on both systems: o on the 3 rd
party LMS to allow the user to retake the exam, o on
cobas IT
1000 application to inform the system it should accept and process the new exam results.
p
To reset the attempts counter
1
Choose
Organization > Certification Tasks
.
2
Select an exam task in the list.
3
Click the
Reset Exam Attempts
button.
4
Click the
Filter
button to refresh the screen.
The attempts counter is set to 0.
s
Importing exam results from a 3
rd
party learning management system (LMS)
If
cobas
academy is not installed,
cobas IT
1000 application allows the import of exam results exported from another LMS. In this way, exam results of several users can be updated automatically.
Exam results input file
The following rules apply to the exam results input file: o
The exam results input file must be saved as plain text file (e.g. txt or csv file).
o
The content of the input file must be UTF-8 encoded.
o
All string columns in the input file are case-insensitive.
o
The Windows CR/LF line breaking character (i.e., the [Return] key) must be used as row separator.
o
The input file must at least contain columns with the following user data (one row per user):
First name column
Last name column
The first name of the user, as listed in
cobas IT
1000 application
The last name of the user, as listed in
cobas IT
1000 application
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q
Course name column
Exam date column
Exam result column
The name of the training course, as listed in the
Course
Name
field of the certification in
cobas IT
1000 application
Note:
The exam must be a certification task for the corresponding user for successful exam results import.
Date and time when the exam was taken
Note:
The exam date must be in the observation timeframe of the corresponding certification for successful exam results import.
Result of the exam o
The formatting of the user data in the input file depends on an LMS configuration file set up by Roche Service. o
Make sure to use the right formatting in the input file. Ensure with the 3 rd
party
LMS administrator that data is exported from the LMS with the right formats, especially regarding the exam date.
o
Contact Roche Service, if the LMS configuration file needs to be changed.
The following figure shows an example of an input file using the default formatting:
NOTICE
Figure 5-19
Example of input file using default formatting
For default and possible values for the configurable formats see
(p. 425). If no configuration file is set up, the default values must be used
in the input file.
Incorrect data
Mistakes in the LMS input file can result in erroneous or failed exam results import, leading to incorrect data in
cobas IT
1000 application.
r
Make sure that the input file contains the correct user data in the right formatting.
r
Check correct import of exam results.
u
To import exam results from a 3rd party LMS
u
Correcting failed imports of exam results
p
To import exam results from a 3 rd
party LMS
1
Place the exam results input file into the following folder, where
<drive:>
is the drive
cobas IT
1000 application is installed on:
<drive:>\cobasIT1000\Services\Lms\Import
cobas IT
1000 application automatically checks the
Import
folder every minute for importable files, processes the file(s) and deletes them.
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Certification Tasks
q
2
Check for successful exam results import in the
Certification Tasks
screen of
cobas IT
1000 application.
The corresponding certification tasks are updated after successful import.
o
Set the filter on the
Completion
column to
All
to see fulfilled certification tasks in the
Certification Tasks
screen.
o
If the same training course is required for different certifications, all corresponding certification tasks are updated during the import.
s
Correcting failed imports of exam results
NOTICE
If the import of LMS exam results fails,
cobas IT
1000 application generates an error file in the
Input
folder. The error file contains detailed information about why the import has failed.
LMS error file
The LMS error output file is saved in the same folder as the original LMS input file
(
...\cobasIT1000\Services\Lms\Import
). The error file keeps the name of the corresponding input file with the prefix
FAILED_ example is provided below.
o
Original LMS input file:
LMSInputFile.csv
o
LMS error output file:
FAILED_LMSInputFile_20150423140000.csv
q
To save storage space, delete error files after successful import of the exam results.
Failed LMS exam results imports due to expiring certifications
Expiring certifications and not updated exam tasks in
cobas IT
1000 application can lead to failed imports of LMS exam results.
r
In the
Import
folder, regularly check for LMS error files.
r
In the error files, check the following: o
The exam name matches the definition in
cobas IT
1000 application.
o
The user’s first and last name match the names in
cobas IT
1000 application.
o
The exam date and time is in the OTF of the user's certification.
o
The exam result values in the
Lms.Config
3rd party LMS.
To correct failed imports, either fix the errors directly in the error file, or make the necessary changes in the
cobas IT
1000 application.
u
u
To modify the cobas IT 1000 application
p
To correct the LMS error file
1
Find the LMS error output file in the
Import
folder.
2
Correct the errors in the error file and save it under the name of the original LMS input file in the
Import
folder.
cobas IT
1000 application reprocesses the file and completes the import.
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p
To modify the cobas IT 1000 application
1
Find the LMS error output file in the
Import
folder.
2
Identify the errors and make the necessary changes in the
cobas IT
1000 application.
3
Re-import the original LMS input file.
cobas IT
1000 application processes the re-imported input file and completes the import.
s
Exporting a list of certification tasks
Export the list of certification tasks that is displayed on the screen into a Microsoft
Excel file. This file is enhanced with further information than the information that is shown in the
Certification Tasks
List area.
p
To export list of certification tasks
1
Choose
Organization > Certification Tasks
.
2
Apply the filters so that the screen displays the list of certification tasks to be exported.
3
Click
Export List
.
The system automatically launches Microsoft Excel, displaying the list of certification tasks in a spreadsheet.
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Certification
As part of a comprehensive quality assurance program, it is necessary to establish a protocol for certifying users on the POC instruments used at the site.
Use this component to set up, control and maintain user certifications for all connectable instrument types.
The assignment of certifications to users enables the standardization of the certification procedure for different user groups.
The application enables you to assign a specific certification to a group of people, instead of the assigning certifications separately to each user.
The certification history is stored for each user within the application.
Individual assignment of certifications can also be done in the
Organization > User
Management > Individual (Certifications) > Add Certifications
screen.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Use this option to create new certificate types which will be used to standardize the assignment of instrument certifications to users. A certificate type covers general information, which is important for any instrument certification, such as instrument type for which the certification is given, validity of certification, instrument access levels (privileges) and permissions for test types (QC, patient, all) to be run on the selected instrument type.
Organization > Certification
(
Data > Certification
)
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Figure 5-20 Certification
screen
Tasks
o
Adding certifications of different certificate types to determine a new combination of usage rights for one or more instrument types.
o
Querying for certificate type information to see the details of a certificate type.
o
Activate certifications so that they can be used within the application to certify users.
o
Deactivate certifications so that they cannot be used in other screens within the application.
o
Copy a certification.
o
Editing a certification.
o
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.
o
Specifying automatic recertifying criteria for the selected certificate type in the tabs
Pending
,
Interim
and
Certified
.
Note:
The
Auto-Recertifying
check box in the
General
tab of the Detail area must be activated.
o
Access the
User Certifications
screen to review an existing certification, to deactivate/activate users of a specific certification, to add new users to a specific certification and to decertify users.
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Certification concept
In
cobas IT
1000 application, there are the following kinds of certificate types: o
Non-expiring certification: once issued, users assigned to this certification stay always certified. Such certifications can be used to create master certifications for a certain instrument and test type. These master certifications can then be copied and edited to create different user certifications. u see
Creating a new certification from an existing one
o
Expiring certification without auto-recertifying: once expired, the POCC has to issue a new certification for users to stay certified.
A user with an expired certification is not downloaded to the respective connected instrument requiring operator list.
o
Expiring certification with auto-recertifying: the instrument user becomes or stays certified automatically, if he fulfills certain certification criteria before the certification expires.
A user with a long-term expired certification is not downloaded to the respective connected instrument requiring operator list.
Certification stages for autorecertifying certifications
Auto-recertifying means the instrument user has to fulfill certain tasks during a specified time to become or to stay certified. The corresponding certification criteria and observation timeframe (OTF) are managed by
cobas IT
1000 application. To handle users with different level of experience,
cobas IT
1000 application differs between the following three certification stages for auto-recertifying certifications: o
Pending stage: Intended for not yet certified instrument users in order to achieve certification for the first time. In pending stage, the instrument user has only limited access to instruments. The instrument user is able to perform QC tests and observed test sequences (OTS) only (for applicable instruments), but is not allowed to run patient tests. After fulfilling the certification criteria, instrument users advance to the interim stage (optional) or certified stage. o
Interim stage: Intended for new instrument users after becoming certified for the first time. Treated as fully certified, but with limitations on certification duration
(e.g. 6 months) and not allowed to act as observer for OTS. After fulfilling the certification criteria, instrument users advance to the certified stage. o
Certified stage: Intended for fully certified instrument users with full certification duration. After fulfilling the certification criteria, instrument users stay in certified stage.
All stages use automatic (re-)certification criteria. No POCC intervention is required to move through stages, unless competencies are used and the instrument user exceeds the maximum number of exam attempts.
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A B C cobas IT 1000 application
D E
F
A
Pending stage (observation timeframe starts with first passed activity)
B
Interim stage
C
Observation timeframe for interim stage
D
Certified stage
E
Observation timeframe for in-stage check
F
Observation timeframe for end-stage check
Figure 5-21
Certification stages for auto-recertifying certifications
Certification details
The certification details, including the duration of validity and the (re-)certification criteria, are defined in the Detail area of the
Certification
screen.
The Detail area of the
Certification
screen is divided into 6 tabs: q
Depending on the selected instrument type and the selected settings on the
General
tab, the other tabs are active or inactive.
o
General
tab o
Privileges
tab o
Pending
tab
This tab is available, when the
Auto-Recertifying
check box is selected on the
General
tab for expiring certificate types.
o
Interim
tab
This tab is available, when the
Auto-Recertifying
check box and the
Use Interim
Stage
check box are selected on the
General
tab for expiring certificate types.
The interim stage is an optional stage between the pending and the certified stage.
o
Certified
tab
This tab is available, when the
Auto-Recertifying
check box is selected on the
General
tab for expiring certificate types.
o
Reminder
tab
This tab is available, when the
Non-Expiring
check box is not selected on the
General
tab.
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General tab
On the
General
tab, the basic settings for the certification are defined.
Figure 5-22
Instrument Type
Non Expiring
Valid (Months)
Auto-Recertifying
Use Interim Stage
Is Observer
Certificate Type
Comment
Organization > Certification > General
tab
Instrument type and test parameter
Defines whether the certification will be expiring or nonexpiring o
For expiring certification: validity of the certification o
For expiring certification with auto-recertifying: validity of the certification in certified stage (starts with instrument user entering certified stage)
Used to calculate the expiration date of the certification.
Defines whether the certification uses auto-recertifying
(if the
Non-Expiring
check box is not selected). Activates
/ deactivates tabs
Pending
,
Interim
and
Certified
Activates / deactivates tab
Interim
(if the
Auto-
Recertifying
check box is selected)
Defines whether the holder of a valid certification can act as an observer for OTS and free text criteria tasks for certifications of the same instrument types
Note:
To prevent unwanted sign-off of OTS, create one certification for general instrument users with unchecked
Is Observer
check box, and a different certification for observers with checked
Is Observer
check box.
Name of the certification
Recommendation: Prefix with SiteID in multisite installations
Comments regarding this certification
Privileges tab
Depending on the instrument type, a set of user privileges can be defined on the
Privileges
tab.
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Figure 5-23 Organization > Certification > Privileges
tab
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Privileges determine which functions a certified user can access on instruments of this type (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.
The Patient Test – OTS
check box needs to be selected in order to allow the instrument user to perform OTS.
The
Proficiency Test
check box needs to be selected in order to allow the instrument user to perform proficiency testing.
q
Proficiency testing is not available for all instruments.
If a user holds different certifications, the effective privileges are derived from the combination of privileges.
Example for Glu2 tests on
Accu-Chek Inform II
: o
One certification for general instrument users with checked
Glucose Results
check boxes, but unchecked
Proficiency Test
check box o
One certification for certain instrument users with unchecked
Glucose Results
check boxes, but checked
Proficiency Test
check box
An instrument user holding both certifications can do all Glucose tests on the instrument, including Glucose Proficiency Tests.
Predefined certifications for an instrument type define a subset of supported tests and privileges.
Examples for
Accu-Chek Inform II
:
Predefined certifications
ACI2 Glucose
ACI 2 Pregnancy
ACI2 Visual UA
ACI2 Rapid Strep
Table 5-4
Privileges
Glucose patient test, Glucose control test, ...
Pregnancy test, Pregnancy control
Visual UA test, Visual UA control
Rapid Strep test, Rapid Strep control
Examples of predefined certifications
Supported tests
Glu2
Preg
Col VUA, Clar VUA, …
Rstrep
Pending tab
On the
Pending
tab, observation time and tasks can be defined for the pending stage of the certification.
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Figure 5-24 Organization > Certification > Pending
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Observation Time (Days)
QC Level
OTS
Freetext Criteria
Freetext Criterion
Competency required
5 Organization
Certification
Observation time in which all tasks have to be fulfilled.
Starts with the first passed activity
Number of required QC samples for levels 1-4 (if applicable)
In the
Materials > Material Definition
screen, it is possible to define that a certain QC material does not count for QC results
Observed test sequence – Defines whether a patient measurement must be performed under supervision of a certified instrument user (“explicit OTS”).
Note:
Only some instruments support OTS directly on the instrument itself (“direct OTS”). For all other instruments, OTS needs to be logged into
cobas IT
1000 application via
cobas
academy (“virtual OTS”).
Number of free text criteria to be fulfilled. Enables the corresponding number of
Freetext Criterion
fields.
Activities are to be reported via
cobas
academy
Criterion to be fulfilled and reported via
cobas
academy
Defines whether competency is required, e.g. classroom training
Training can be documented via
cobas IT
1000 application (
Organization > Competencies
), including the upload of training records
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Certification
Exam required
Course Name
Maximum Attempts cobas IT 1000 application
Defines whether an exam managed by a learning o management system (LMS) is required:
If
cobas
academy is installed, the checkbox is readonly. It will be set automatically once a training course including an exam is linked to the certification.
A training course without an exam can be linked to the certification as well, but will not set this check box.
o
If a 3 rd
party LMS is installed in the hospital network, the checkbox has to be set manually to link a training course to the certification.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
o
Name of the training course as defined in the LMS: o
If
cobas
academy is installed, the
Course Name
field is read-only. It will be filled in automatically once a training course is linked to the certification.
If a 3 rd
party LMS is installed in the hospital network, the
Course Name
field has to be filled in manually to link a training course to the certification.
If the
Exam required
checkbox is set, the
Course
Name
field is mandatory.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
Maximum number of permitted exam attempts as defined in the LMS: o
If
cobas
academy is installed, the
Maximum
Attempts
field is read-only. It will be filled in automatically once a training course is linked to the certification.
o
If a 3 rd
party LMS is installed in the hospital network, the
Maximum Attempts
field has to be filled in manually to link a training course to the certification
(possible values: integer
>
1). In case the number of exam attempts shall not be limited, set this value to a high number (eg. 9999).
If the
Exam required
checkbox is set, the
Maximum
Attempts
field is mandatory.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
If the user fails his or her last exam attempt, the user’s supervisor becomes the owner of this certification task.
u
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The pending stage does not have a preset duration. When an instrument user is in pending stage and passes the first activity,
cobas IT
1000 application will start the defined observation timeframe (OTF) and will calculate the expiration date of the remaining certification tasks of this certification accordingly.
Examples: o
A passed observed test sequence (OTS) will start the OTF, a failed OTS will not start the OTF. o
The first QC sample will start the OTF, even if the instrument user has to do several QC samples of the same level.
The observation timeframe of the pending stage is a maximum time period. If the instrument user completes all tasks of this certification before the expiration date, the instrument user advances immediately to the interim stage (if used) or the certified stage.
If the instrument user does not complete every task of this certification until the expiration date,
cobas IT
1000 application will restart the observation timeframe and will recalculate the expiration date based on the activity that was completed secondly.
The certification activities done before the start of the new OTF are no more valid and have to be done again.
Example for certification requiring 3 QC samples level 1: o
Instrument user does first QC sample on day 1:
O expiration date: calculated based on day 1
O status QC samples: 3 required, 1 done o
Instrument user does second QC sample on day 2 (day 2 being inside the OTF):
O expiration date: unchanged
O status QC samples: 3 required, 2 done o
Instrument user does not do third QC sample until expiration date is reached:
O expiration date: recalculated based on day 2 (day second activity was completed)
O status QC samples: 3 required, 1 done (the first one done on day 1 is no longer valid and has to be done again)
If the instrument user does not complete every task of this certification until the expiration date and no other completed certification activity is available to calculate a new expiration date,
cobas IT
1000 application sets the expiration date to empty, the expiration state to valid and resets the task fulfillment.
Freetext criteria will appear in
cobas
academy as a task:
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Figure 5-25
Freetext criterion in
cobas
academy
Figure 5-26
Supervisor login in
cobas
academy
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Figure 5-27
OTS result and supervisor evaluation comments in
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academy
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Figure 5-28
Completed freetext criterion in
cobas
academy q
How to set up certificates that only need a cobas academy exam as criterion
o
Create a certification and assign a dummy task, e.g. OTS, to the pending (if used), interim (if used) and certified stages in
cobas IT
1000 application.
o
Create a training with an exam in
cobas
academy and map it to the related certification and stage.
o
Edit the certification in
cobas IT
1000 application and remove the dummy task configured in the first step.
Interim tab
On the
Interim
tab, observation time, duration and tasks can be defined for the interim stage of the certification.
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Figure 5-29 Organization > Certification > Interim
tab
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Observation Time (Days)
QC Level
Patient Samples
OTS
Duration (Months)
Freetext Criteria
Freetext Criterion
Competency required
Observation time in which all tasks have to be fulfilled.
The observation time is started the defined number of days before the expiration date of the certification.
Number of required QC samples for levels 1-4 (if applicable)
In the
Materials > Material Definition
screen, it is possible to define that a certain QC material does not count for QC results
Number of required patient samples
Observed test sequence – Defines whether a patient measurement must be performed under supervision of a certified instrument user (“explicit OTS”).
Note:
Only some instruments support OTS directly on the instrument itself (“direct OTS”). For all other instruments, OTS needs to be logged into
cobas IT
1000 application via
cobas
academy (“virtual OTS”).
Duration of the interim stage used to calculate the expiration date of the certification. Starts with the instrument user entering interim stage
Number of free text criteria to be fulfilled. Enables the corresponding number of
Freetext Criterion
fields.
Activities are to be reported via
cobas
academy
Criterion to be fulfilled and reported via
cobas
academy
Defines whether competency is required, e.g. classroom training
Training can be documented via
cobas IT
1000 application (
Organization > Competencies
), including the upload of training records
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Exam required
Course Name
Maximum Attempts
5 Organization
Certification
Defines whether an exam managed by a learning o management system (LMS) is required:
If
cobas
academy is installed, the checkbox is readonly. It will be set automatically once a training course including an exam is linked to the certification.
A training course without an exam can be linked to the certification as well, but will not set this check box.
o
If a 3 rd
party LMS is installed in the hospital network, the checkbox has to be set manually to link a training course to the certification.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
o
Name of the training course as defined in the LMS: o
If
cobas
academy is installed, the
Course Name
field is read-only. It will be filled in automatically once a training course is linked to the certification.
If a 3 rd
party LMS is installed in the hospital network, the
Course Name
field has to be filled in manually to link a training course to the certification.
If the
Exam required
checkbox is set, the
Course
Name
field is mandatory.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
Maximum number of permitted exam attempts as defined in the LMS: o
If
cobas
academy is installed, the
Maximum
Attempts
field is read-only. It will be filled in automatically once a training course is linked to the certification.
o
If a 3 rd
party LMS is installed in the hospital network, the
Maximum Attempts
field has to be filled in manually to link a training course to the certification
(possible values: integer
>
1). In case the number of exam attempts shall not be limited, set this value to a high number (eg. 9999).
If the
Exam required
checkbox is set, the
Maximum
Attempts
field is mandatory.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
If the user fails his or her last exam attempt, the user’s supervisor becomes the owner of this certification task.
u
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Certified tab
On the
Certified
tab, observation time, tasks and the periodicity of in-stage checks can be defined for the certified stage of the certification.
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Figure 5-30 Organization > Certification > Certified
tab
Observation Time (Days)
QC Level
Patient Samples
OTS
QC every
Freetext Criteria
Freetext Criterion
Competency required
Observation time in which all tasks have to be fulfilled.
The observation time starts the defined number of days before the expiration date of the certification.
Number of required QC samples for levels 1-4 (if applicable)
In the
Materials > Material Definition
screen, it is possible to define that a certain QC material does not count for QC results
Number of required patient samples. If a certification is expired, the instrument user can fulfill this criterion by performing one OTS (“implicit OTS”), if the instrument supports OTS or if
cobas
academy is installed.
Observed test sequence – Defines whether a patient measurement must be performed under supervision of a certified instrument user (“explicit OTS”).
Note:
Only some instruments support OTS directly on the instrument itself (“direct OTS”). For all other instruments, OTS needs to be logged into
cobas IT
1000 application via
cobas
academy (“virtual OTS”).
Allows to request in-stage checks at which the defined number of QC results have to be performed within the observation timeframe; i.e. the instrument user has to fulfill the QC sample criterion multiple times to stay certified
Number of free text criteria to be fulfilled. Enables the corresponding number of
Freetext Criterion
fields.
Activities are to be reported via
cobas
academy
Criterion to be fulfilled and reported via
cobas
academy
Defines whether competency is required, e.g. classroom training
Training can be documented via
cobas IT
1000 application (
Organization > Competencies
), including the upload of training records
User Manual · Version 4.7
cobas IT 1000 application
Exam required
Course Name
Maximum Attempts
5 Organization
Certification
Defines whether an exam managed by a learning o management system (LMS) is required:
If
cobas
academy is installed, the checkbox is readonly. It will be set automatically once a training course including an exam is linked to the certification.
A training course without an exam can be linked to the certification as well, but will not set this check box.
o
If a 3 rd
party LMS is installed in the hospital network, the checkbox has to be set manually to link a training course to the certification.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
o
Name of the training course as defined in the LMS: o
If
cobas
academy is installed, the
Course Name
field is read-only. It will be filled in automatically once a training course is linked to the certification.
If a 3 rd
party LMS is installed in the hospital network, the
Course Name
field has to be filled in manually to link a training course to the certification.
If the
Exam required
checkbox is set, the
Course
Name
field is mandatory.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
Maximum number of permitted exam attempts as defined in the LMS: o
If
cobas
academy is installed, the
Maximum
Attempts
field is read-only. It will be filled in automatically once a training course is linked to the certification.
o
If a 3 rd
party LMS is installed in the hospital network, the
Maximum Attempts
field has to be filled in manually to link a training course to the certification
(possible values: integer
>
1). In case the number of exam attempts shall not be limited, set this value to a high number (eg. 9999).
If the
Exam required
checkbox is set, the
Maximum
Attempts
field is mandatory.
A linked training course enables the import of exam results data from the LMS to
cobas IT
1000 application.
u
Importing exam results from a 3rd party learning management system (LMS)
If the user fails his or her last exam attempt, the user’s supervisor becomes the owner of this certification task.
u
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Depending on the period chosen in the
QC every
field, the instrument user has to perform the mandatory QC tests already during an in-stage observation timeframe in order to stay certified.
cobas IT
1000 application shows the following behavior with certifications using the
QC every
field: o
cobas IT
1000 application uses the first due recertification task to calculate the expiration date of the certification. I.e. for certifications with a mandatory instage check, the expiration date is earlier than can be expected from the value in the
Valid (Months)
field.
o
cobas IT
1000 application does not differentiate between an in-stage OTF triggered by the use of the
QC every
field and the end-stage OTF, which can cause misleading notifications.
u see
o
cobas IT
1000 application recalculates the expiration date and expiration status of the certification on the day after the in-stage observation timeframe is over, not after completion of the in-stage certification tasks.
Reminder tab
On the
Reminder
tab, it can be defined how the notifications related to the certification tasks will be done.
Figure 5-31 Organization > Certification > Reminder
tab
Remind user by E-mail cc Supervisor
Remind user by Letter
Defines whether the user is notified about certification tasks by e-mail
Allows selection of the notification template to be used u see
Defines whether the supervisor will receive the user notification e-mail as well
Defines whether a letter is printed out that can be sent to the user to notify about certification tasks
Allows selection of the notification template to be used u see
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Remind user on Instrument
Remind supervisor
Supervisor is
Defines whether the user is notified about certification tasks on the instrument (only available for instruments supporting user notification)
Allows selection of the notification template to be used u see
Defines whether the supervisor is notified about certification tasks by e-mail
Allows selection of the notification template to be used u see
Defines who the supervisor for the user is: o o
Supervisor of user’s home location
o
Supervisor of all locations the user is assigned to
Administrator of user’s workgroup
A user can be a supervisor, if the user is assigned to a
User Profile
having administrator rights.
u see
u see
If the
by E-mail
option is selected for a certification, the following four notifications are successively sent to the instrument user: o
Upcoming certification: when entering the observation timeframe, i.e. on the start date of the observation timeframe o
Pending certification: when entering the medium observation timeframe o
Urgent certification: when entering the narrow observation timeframe o
Expired certification: when entering the recently expired observation timeframe
The medium observation timeframe, narrow observation timeframe and expired observation timeframe are calculated from the general settings defined under
System
> General Settings.
u
A B C D
E F G H
A
Duration of validity of certification
B
Observation timeframe
C
Recently expired certification timeframe
D
Certification in status long-time expired
Figure 5-32
E
F
G
H
Start of observation timeframe: notification for upcoming certification
Start of medium observation timeframe: notification for pending certification
Start of narrow observation timeframe: notification for urgent certification
Start of recently expired observation timeframe: notification for expired certification
Example for observation timeframe
In the pending stage, the notification for upcoming certification is sent after the user passed the first certification activity, starting the observation timeframe.
Additionally, supervisors can be notified about upcoming, pending and expired certifications by warnings presented in the Warning area of the
cobas IT
1000 application. Clicking these warnings forwards the supervisor to the unfulfilled certification tasks.
u
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NOTICE
u
Misleading notifications cobas IT
1000 application does not differentiate between an in-stage OTF triggered by the use of the
QC every
field on the
Certified
tab and the end-stage OTF. Therefore, in-stage notifications can be misleading in two ways:
First, in-stage notifications remind about all certification criteria, even those that can only be fulfilled later during the end-stage OTF (e.g. patient samples).
Second, in-stage certifications are sent even after the instrument user has performed the mandatory QC tests because of the other “unfulfilled” certification criteria. These notifications only stop after the in-stage OTF is over. r
If such in-stage checks are of no interest to the facility’s certification policy, create certifications without use of the
QC every
field on the
Certified
tab.
OTS on
Accu-Chek Inform II
The following picture sequence shows an observed test sequence (OTS) on
Accu-
Chek Inform II
instrument as an example of a certification task.
q
Note that this feature is only available in instrument software version 03.04.xx or higher.
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Adding a certification
Use this option to create a new certification. q
An auto-recertifying certification can be saved, if the number of patient and QC samples is set to 0 and no other criteria are defined. But an internal error will be raised when assigning this certification to a user.
p
To add a certification
1
In the List area of the
Organization > Certification
screen, click the
Add
button.
The Detail area is displayed.
2
Fill in the fields of the Detail area, and click
OK
.
The new certification information is displayed in the List area and stored into the database.
s
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Editing a certification
NOTICE
cobas IT 1000 application
Use this option to change an existing certification.
Possible change of certification status
Editing expiring certifications (e.g. prolonging the validity plus adding a criterion) may change the certification status of assigned users from expired to certified.
r
Do not edit an active certification. Instead, copy the certification and make the changes to the copy. u see
To create a new certification from an existing one
q
Error message
If you edit privileges of a certification that is assigned to a big number of users, an
Internal
Error
message may pop up.
This error message merely indicates a time-out on the user interface. The process continues in the background. No action is required.
p
To edit a certification
1
In the List area of the
Organization > Certification
screen, double-click the certification to be edited.
The Detail area is displayed.
2
Make the necessary changes in the fields of the Detail area, and click
OK
.
If users of
cobas IT
1000 application are affected by the changes, the
Affected
Users
screen is displayed.
3
If necessary, confirm the
Affected Users
screen with OK.
The edited certification information is displayed in the List area and stored into the database.
s
Creating a new certification from an existing one
Use this option to create a new certification while using an existing one as template. q
You can use a non-expiring certification as template for all certifications for the same instrument type.
p
To create a new certification from an existing one
1
In the List area of the
Organization > Certification
screen, select the record that you want to copy and click the
Copy
button.
2
On the
Instrument Type
field of the Detail area, click the drop-down list box and assign an instrument type to the certification.
3
Fill in the fields of the Detail area, and click
OK
.
The updated certification information is displayed in the List area and stored into the database.
s
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Exporting certifications
Export the list of certifications that is displayed on the screen enhanced with further user information (e.g. ID, assigned locations and postal address).
p
To export certifications
1
Choose
Organization > Certification
.
2
Apply the filters so that the screen displays the list of certifications to be exported.
3
In the Global area, click
.
The export options open.
4
Choose the desired export format, option and directory. u see
s
User Certifications
Use this option to review an existing certification, to deactivate/activate users of a specific certification and to add new users to a specific certification. This certification covers: the certification date, comments to the certification, and the users, to whom the certification is assigned. q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Expiration Status symbols
Certification is valid.
Certification is expired or long-time expired.
Certification is non-expiring.
Certification is upcoming, urgent or pending.
A user with a (long-time) expired certification is not downloaded to the respective connected instrument requiring operator list.
Organization > Certification > User Certifications
(
Data > Certification > User Certifications
)
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Figure 5-33 User Certifications
screen
Tasks
o
Querying for certification information to see the details and users assigned to a specific certification.
o
Deactivate/activate users of a specific certification.
o
Accessing the
Add/Remove Users
screen to add users to a specific certification.
Adding users to a certification
Use this option to add a single user or a group of users to a certification, to remove a single user or a group of users from a certification and to decertify a single user or a group of users of a certification.
Prerequisites
o
Certifications must have been previously defined.
o
Users must have been previously defined and assigned to a location and/or workgroup.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > Certification > User Certifications > Add/Remove Users
(
Data > Certification > User Certifications > Add/Remove Users
)
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Figure 5-34 Organization > Certification > User Certifications > Add/Remove Users
screen
You can grant a certification to a user or group of users so that they have the right to use the related instrument type.
p
To add users to a certification
1
In the
Organization > Certification > User Certifications > Add/Remove Users
screen, select the locations to which the user belongs from the
Locations
dropdown list.
All users in that location appear in the lower list box.
2
Select the user or users to be added.
3
In the Detail area fill in the
Certification Date
and choose the
Stage
.
4
Click
OK
.
The updated certification information is displayed in the List area and stored into the database. q
Expiration date for expiring certifications
The date in the
Expiration Date
column may be earlier than expected, if the certification date falls on a day that does not exist in the month of the expiration date.
E.g., if the certification date is the 31st of January and the certification is valid for 1 month, the expiration date is the 27th of February instead of the 28th of February.
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Remove users
cobas IT 1000 application
You can remove selected users from a certification.
p
To remove users
1
In the
Organization > Certification > User Certifications > Add/Remove Users
screen, select the locations to which the user belongs from the
Locations
dropdown list.
All users in that location appear in the lower list box.
2
Deselect the user or users, and then click
OK
.
s
Decertify users
You can decertify selected users of a certification.
p
To decertify users
1
In the
Organization > Certification > User Certifications > Add/Remove Users
screen, select the locations to which the user belongs from the
Locations
dropdown list.
All users in that location appear in the lower list box.
2
Select the user or users to be decertified, and then click the
Decertify Selected
Users
button.
A confirmation message appears. Click
OK
to confirm. The user is decertified.
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Competencies
5 Organization
Competencies
Use this option to document classroom trainings.
In this screen new competencies can be added and attached files of already existing competencies can be viewed. Additionally, the list of competencies can be filtered by a specific User ID. Then the application will only show competencies that this user attended.
q
You must have administrator rights to make changes in this screen.
Organization > Competencies
Figure 5-35 Competencies
screen
Tasks
From this screen, you can perform the following tasks: o
Add a competency o
View the attached file of a competency
Adding a competency
Click
Add
to add a competency. The following fields have to be defined: o
Certificate Type
o
Date
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NOTICE
cobas IT 1000 application
o
Competency
o
Stage
Furthermore, a file can be attached and participating users can be added to the competency. For example, the uploaded file could be a scanned attendance list in which the instrument users prove with their signature that they have attended the classroom training.
Notice
If a competency is added, it cannot be modified anymore.
q
The maximum size of the attached file can be defined in
System > General Settings
under
Size warning limit for Competency files (MB)
(default: 10 MB).
u
p
To add a competency
1
Go to
Certification > Competencies
.
2
Click the
Add
button.
3
Select the
Certificate Type
.
4
Set the date, when the competency was achieved.
5
Optional: attach a file.
6
Click the
Users
button.
7
Filter for applicable users (only users holding a certificate of this type and stage will be displayed).
8
Assign users. q
Once one or several users are assigned to a competency, it is no longer possible to modify that competency q
9
Click the
<<
button.
10
Click
OK
.
The competency is shown in the List area.
It is not possible to add an additional competency for the same combination of
Certificate Type - Date - Stage.
Selecting a competency with attached file in the List area, activates the
View File
button. Clicking the
View File
button will show/download the attached file. s
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Notification Templates
Notification Templates
Use this component to create notification templates for e-mails and letters.
By default the application provides the following predefined notification templates: o
Instrument user notification by e-mail o
Instrument user notification by letter o
Supervisor notification by e-mail o
Instrument user notification on instrument (for each instrument type) q
Templates for instrument user notifications are provided by the driver installers.
q o
For a new notification template it is recommended to create a copy of a predefined template. o
Only active notification templates can be copied.
o
Do not to change or overwrite a predefined notification template.
Notification templates are edited in a template editor. According to the selected notification type the template editor provides different settings.
q
You must have administrator rights to make changes in this screen.
Organization > Notification Templates
Figure 5-36 Notification Templates
screen
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Notification Templates
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Field descriptions
Notification Type
Name
Last Updated
Status
Copied from
Attach List
Table Layout
Send Notification
The notification type of the notification template.
Possible values:
User E-mail
,
Supervisor E-mail
,
User Letter
,
User Instrument
The name of the notification template.
The date of the last modification.
The status of the notification template. If checked the notification template is active.
The copied predefined notification template is displayed for manually created notification templates.
A list of the certification tasks is send as attachment.
Defines which data fields are included.
Possible values: o o
Daily
Weekly
o
By-Weekly
Tasks
From this screen, you can perform the following tasks: o
Copy a selected notification template.
o
Edit the properties of an existing notification template.
o
Edit the content of an existing notification template.
o
Activate or deactivate a notification template.
Copying notification templates
p
To copy a notification template
q
Only active notification templates can be copied.
1
In the List area select the designated notification template.
2
Click
Copy
.
3
In the Detail area change the name of the new notification template.
4
Click
OK
in the Detail area to save the new notification template.
The new notification template is now available in the List area and can be edited.
5
Click
Edit
to modify the new notification template.
To modify the new notification template click
Edit
. The notification templates are modified in the template editor.
s
Editing notification templates
Notification templates are modified in the template editor.
The most important functions are: o
Definition of subject and body of the message o
Introduction of system parameter placeholders o
Definition of conditions to show/hide lines
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Notification Templates
o
Preview of the template with “real” data o
For e-mails intended for supervisors, definition of a table containing a list of certification tasks related with supervised user
Organization > Notification Templates > Edit
Figure 5-37
Template editor
There are predefined placeholders and conditions available in the template editor via the
Fields
menu: o
Fields > Insert Merge Field
:
Placeholders are used to fill the template with the correct information. In the definite notification,
cobas IT
1000 application replaces the placeholders with the corresponding values out of the database. o
Fields > Insert Conditional Field
:
Conditions are used to show or to hide information. One condition per paragraph can be added in the template editor. In the definite notification,
cobas IT
1000 application only displays the conditional paragraphs if the corresponding condition is fulfilled.
Depending on the template type, different placeholders and conditions are available.
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p
To edit a notification template
q
Only active notification templates can be edited.
1
In the List area, select the designated notification template.
2
Click
Edit
.
The template editor opens showing the content of the template.
3
Modify the notification template with the functions of the template editor.
According to the notification type, the template editor provides different functions and settings. In general, enter free text and predefined fields.
4
Click
Fields > Preview
to get an on-screen preview of the notification template, filled with “real” data.
5
For e-mail templates, click the
Preview
button to get an off-screen preview of the notification template, filled with “real” data.
The application sends an e-mail to the user who is currently editing.
6
Click
Save
to save the notification template.
s
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HIS Location Import
HIS Location Import
Use this component to import location records from an external file into the application.
Import files must be plain text format files.
If the text contains headings, assign each heading to the corresponding field; if it does not contain headings, assign the data belonging to the first record to the corresponding field. The application automatically identifies the rest of the records.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Organization > HIS Location Import
Figure 5-38 HIS Location Import
screen
Importing location information
Import location definitions from an external file to introduce new data fast and easily.
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p
To import location information
1
Choose
Organization > HIS Location Import
.
2
Click
Browse
and choose the file to be imported.
3
Fill in the fields in the upper part, and then click
Analyze
.
The data from the file is added into the drop-down lists in the Detail area.
4
Fill in the fields in the Detail area with the imported data, and then click
OK
.
The
Location Import Summary
screen appears reporting duplicated and erroneous records found during the import process.
s
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User Import
CAUTION
NOTICE
5 Organization
User Import
Use this component to import records with user profile data from an external file into the application. Using the import function saves the time it would otherwise take to enter each record individually. When re-importing individual user data, existing user information is updated.
Apart from general user information, such as user ID or name, this function enables you to import the location or locations that are to be assigned to the user and instrument certifications.
q
You must have administrator rights to make changes in this screen.
Data overwrite
r
Imported data partially overwrite the information that is already stored in the database!
r
If the field in the file consists only of "", then the application will delete the existing value(s) in the database!
r
If the field in the file is empty, then the application will not delete the existing value(s) in the database! This value will be left as it is.
No upload of operator list to instruments
If users without an associated location are imported, there will be no upload of new or updated users to instruments requiring operator lists. This could result in unauthorized use of instruments.
r
Always import users with associated location for instruments requiring operator lists.
Required file format: Imported files must be csv or txt files o
If the text contains headings, assign each heading to the corresponding field; if it does not contain headings, assign the data belonging to the first record to the corresponding field. The application automatically identifies the rest of the records.
o
More than one location can be assigned to each user in one record by using a specific separator for locations in the source file.
o
Only one certification can be imported for each user in one record. If more than one certification is to be imported, the source file must contain one record for each certification.
o
Mandatory fields must be included in the source file.
o
If no value is to be added in a field, the field may be left blank, but the field delimiter must be set in the record.
o
When importing a location, profile, workgroup or certification name, they must already exist in the database. Otherwise, the record will not be imported.
o
It is recommended that the import files should not contain any special characters or country specific letters.
o
, units replaced by locations o
The user ID can contain uppercase letters (A to Z), numbers (0 to 9), and the additional characters +,/,_,-,$,\,@.
Note:
When importing a user, the user ID is not converted to uppercase. It is therefore possible to import user IDs which only differ in latter case.
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o
The password can only consist of letters (A to Z) and numbers (0 to 9). No special characters or country specific letters are recommended.
Note:
It is recommended to observe the instrument specific guidelines for passwords. o
Home location is imported in addition to the locations. If all available locations are already selected for
Fixed
import, the
Home Location
selection field remains empty.
o
If no value is added to the
LDAP
field when importing a record, LDAP will be disabled by default.
Organization > User Import
(
Import > User Import
)
Figure 5-39 User Import
screen
Importing user information
p
To import user information
1
From the Navigation tree, select
Organization > User Import
.
The
User Import
screen appears
2
Click
Browse
and select the file to be imported.
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User Import
q
3
Fill in the fields in the upper part, and then click
Analyze
.
The data from the file is added into the drop-down lists in the Detail area.
4
Assign the suitable information to each field, and then click
OK
.
The
User Import Summary
screen is displayed, showing a report of duplicated and erroneous records found during the import process.
Note:
the Network ID is not imported under the following conditions: o
The Network ID is not unique.
o
The Network ID is equal to the user ID of another user.
o
The Network ID s not provided (empty field) and LDAP is enabled for this user. s
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Table of contents
Materials
6 Materials
6
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You can find all the information on the materials used with the instruments in the
Materials
module. This information is required to allow the validation of QC or patient test results with respect to the material that was used to perform the QC or patient test on an instrument. Material information such as material name, material type, lot numbers, QC ranges, expiration dates, and so on, provide a satisfactory validation of QC or patient test results. New material types can be defined in the
Materials > Material Definition
component of the
Materials
module. You must define materials, and their lot numbers with the corresponding reference ranges in order to perform quality control successfully.
In this chapter
Chapter
6
207
6 Materials
Table of contents
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Material Definition
Material Definition
Use the
Materials > Material Definition
component to define types of material used for each test. Specific test materials used by each instrument type must be defined in order to receive QC results from that instrument type in the
Quality Control
module.
The available fields change according to the material type that it is being defined.
For Radiometer instruments, not all results sent by the instrument are defined for the related materials. This is on purpose as some results (Temp and Baro) do not have ranges, and other values are considered calculated values.
For a QC material that does not reference a specific test material as “Reference Test”,
(indicating that the QC ranges are maintained with the test lots), it is possible to select QC ranges as: o dependent on test lots, or o independent of test lots.
This is set by selecting or clearing the check box labeled
Test Lot Independent
.
Materials for connectable instrument types are defined by default.
Remove test in Material Definition prior to deactivating test in Test
Definition
Prior to deactivating a test, it should be removed from materials defined in
Materials
> Material Definition
as well as (depending on the instrument type): o
Instruments > Configuration > Driver Configuration
, and/or o
Instruments > Instrument Assignment > Driver Configuration
.
Prerequisites
o
Instrument type and tests must have been previously defined.
o
Test materials must be defined before defining QC or linearity materials.
o
The combination of 'Material Name' and 'Instrument Type' must be unique.
u
The two paths provided above refer to the different navigation structures available. For more information on how to change the navigation structure, see
Switching between navigation structures
Materials > Material Definition
(
Quality Control > Material Definition
)
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Figure 6-1
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Material Definition
screen
Field Descriptions
Material ID
Long Name
Manufacturer
Instrument Type
Material Type
Level name
Number of Levels
Test Material Reference
Test Lot Independent
LOT Length
Name applied to the material (max. 10 characters).
Brief description of the material (max. 50 characters).
Name of the material manufacturer (max. 30 characters).
Type of instrument with which the material is used.
Types of material: o
Test
o
Control
o
Linearity
Reserved for future use
Number of levels to be provided with this material.
Test taken as a reference. The check box
Test Lot
Independent
on the right must be deselected to activate this field.
For a QC material that does not reference a specific test material as “Reference Test”, (indicating that the QC ranges are maintained with the test lots), selecting this check box indicates that the QC range is independent of the test lot.
Number of alphanumeric or numeric characters that make up the lot number for this material (max. value is
15).
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CAUTION
6 Materials
Material Definition
Alphanumeric
Instrument Material ID
Peer Review Material ID
Number of SDs
Not applicable for certification
Tests
Test Materials
It indicates whether alphanumeric lot numbers are allowed.
Material identifier used in instrument communications
(max. 30 characters).
Note:
Users should not change this setting without consulting Roche Service – as changes will affect instrument communication
Reserved for future use
SD range that is covered by the given target ranges.
Default value is 3.
Allows the user to set for each QC material (type
Control
), if certification tasks shall be counted or not.
When adding a new material and selecting
Control
as the material type, this material is not marked automatically to be excluded from counting.
Tests related to the specific material.
Name of test materials of that specific material type.
Tasks
o
Creating a new material definition. o
Viewing the details of a particular material. o
Activating a material definition record so that it is available or visible in other screens within the application where it may be required. o
Deactivating a material definition record so that it is not available or visible in other screens within the application.
o
Modifying an already existing material definition to change its properties.
Existing material definitions
r
Existing material definitions should only be changed after consulting Roche Service
Engineer, as changes will affect instrument communication.
Defining a new material
p
To define a new material
1
In the
Materials > Material Definition
screen click the
Add
button.
The fields in the lower panel become active.
2
In the details area, enter the required material description and click
OK
to save.
s
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Lot Management
Lot Management
cobas IT 1000 application
Use this component to add new material lot information, or to maintain information for existing material lots, such as lot number, expiration date, target values (expected mean), QC ranges and lab established deviations. When adding a material lot, the
QC, test or linearity material name can be selected from a list. Depending on the material and instrument type, information such as target values, QC ranges and lab established deviations can be defined for single or multiple levels.
1. Instrument type must have been previously defined.
2. Materials must have been previously defined.
O
In the
Ranges
tab, for QC result ranges you can define minimum and maximum values for numeric results (target and deviation are automatically calculated by the system).
3. For Linearity, target and deviation values must be entered.
O
QC and linearity ranges are maintained with either test lots, QC lots or both in combination. This behavior is defined in
Materials > Material Definition
and is determined by the measuring and communication technology of the respective instrument type and material.
O
When defining qualitative QC levels, only the target is to be entered.
Standard QC model (Westgard QC):
O
For QC result ranges minimum and maximum values can be defined for numeric results (target and deviation are automatically calculated by the system).
O
For Linearity target and deviation values must be entered.
RiliBÄK 2008 mode:
O
If a test is mapped to a RiliBÄK test, only the target value is to be entered.
O
If a test is not mapped to a RiliBÄK test, the minimum and maximum range values must be entered.
q
QC range for cobas h 232 Trop-T level 1
The
cobas IT
1000 application automatically sets up the range for Troponin-T level 1 QC results received from the
cobas h
232 system quantitatively while the result is qualitative.
This causes the
cobas IT
1000 application to trigger an alarm. To overcome this, do the following: o
Go to
Materials > Lot Management
.
o
Double click the new control lot for TropQC-232.
o
Select the
Ranges
tab.
o
Click the
Qualitative
check box.
o
Enter “< 50.000” for
Target
.
o
Click the
OK
button.
If any changes to a record are pending to be saved, the
Ranges
tab cannot be accessed.
For
Accu-Chek Inform
instruments the
Ranges
tab is only editable for
Test
type materials. In this tab, related quality control and linearity ranges are defined for each level.
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When using materials not introduced in the database with the
Accu-Chek Inform
, a new registry is automatically created in this screen. The expiry date and reference ranges of the material must be defined before it can be uploaded to other
Accu-Chek
Inform
instruments.
When adding material lots for the
Accu-Chek Inform
(from the instrument or from the application), you must define as many levels as set up in the
Materials > Material
Definition
screen for the selected material.
Ranges for each one of these levels must also be defined in the
Ranges
tab. If these levels or ranges are not defined, the
Accu-Chek Inform
fails to display the material lot.
New materials not introduced in the database before use must be set as reviewed so that no alarms are displayed in the
Quality Control > Result Management
screen.
u
Alphanumeric QC results are not included in LJ Charts or statistics and the QC rules are not applied. Alphanumeric results are only accepted if they match exactly the value defined as
Target Mean
in the
Ranges
tab.
For
cobas h
232 instruments IQC control lots must be set up before a control is run on the instrument.
For
Roche Cardiac Reader
instruments, control and test lots which are not related to
IQC and their ranges must be set up before a control can be run on the instrument.
For
Roche Cardiac Reader
instruments, control lots which are not related to IQC must be set up using the six digit lot number. For
Roche Cardiac Reader
instruments, qualitative ranges (e.g. Negative) for control lots must be set up with the quantitative range listed in the test material insert sheet defining the qualitative range. For
Roche Cardiac Reader
instruments, test lots which are not related to IQC must be set up using the four digit code number. For
Roche Cardiac Reader
instruments, a
DDimer
test lot must not be mapped to more than 20 active control lots. For
Roche Cardiac Reader
instruments, a
Troponin T
,
proBNP
or
Myoglobin
test lot must not be mapped to more than 10 active control lots.
When operating in RiliBÄK 2008 mode, all QC results received are converted to and reported in the unit defined for a lot combination, test and level (if the necessary conversion information is available in the
System > Test Definition
).
q
Lot numbers as DEF
For some instrument types, if the instrument does not provide lot number information, the system generates lots with
DEF
in the lot number automatically. These lots must not be deactivated as otherwise QC ranges cannot be applied and no level information would be stored.
Materials > Lot Management
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Figure 6-2 Lot Management > General
Materials > Lot Management > Ranges
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Figure 6-3 Lot Management > Ranges
Materials > Lot Management > Locations
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Figure 6-4 Lot Management > Locations
Figure 6-5 Lot Management > Locations > Assign
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Figure 6-6 Lot Management > General
Field description
Buttons
LED
*
Filter
Add
Deactivate
Table 6-1
Description
Opens a window in which you can manage a lab established deviation related to this material lot. Only available in
RiliBÄK 2008 mode.
Enables you to filter.
Enables you to add a new material lot.
Deactivates the selected test material and makes it unavailable.
Buttons description
Columns in List area
(RiliBÄK only)
LED Status
empty
Table 6-2
Description
The LED Status indicates whether or not there are LED proposals for a lot maintaining QC ranges.
An empty column indicates that there are no acceptable LED proposals.
A yellow dot indicates that there are acceptable voluntary
LED proposals.
Columns description
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Columns in List area
(RiliBÄK only)
Man. LED
Vol. LED
Table 6-2
Description
A red dot indicates that there are acceptable mandatory LED proposals or that the same lot has both voluntary and mandatory LED proposals.
Indicates the number of proposed acceptable mandatory
LEDs. Proposals for mandatory LEDs are proposals based on completed control cycles.
Indicates the number of proposed voluntary LEDs. Proposals for voluntary LEDs not based on completed control cycles. If the instrument is set for RMSE calculation, these LED proposals are based on incomplete control cycles. If the instrument is not set for RMSE calculation, these LED proposals are based on results not associated with control cycles.
Columns description
General tab Description
Instrument Type
Material ID
Material Type
Type of instrument for which the material is defined.
Name of the material.
Type of material of the selected material. (Automatically filled in by the system.)
Expiration date of the material.
Expiration Date
LOT
Material Long Name
Provider
Activation Date
Deactivation date
Lot number. The lot number length and type are defined in the
Materials > Material Definition
window.
Full name of the material.
Manufacturer or supplier of the material.
Date when the material was activated.
Date when the material was deactivated.
Source Instrument S/N
Reviewed
Table 6-3
Viewable when uploaded from an instrument. The serial number of the instrument from which the lot information originates.
It defines whether the material information uploaded from an instrument is new.
General
tab description
Ranges tab
Type
Material ID
LOT
Test
Level
Qualitative
Table 6-4 Ranges
tab
Description
Type of material as set in the
Materials > Material
Definition
screen.
Specific name of the material.
The lot number of the associated test lot. This is only viewable if the range and target value information is maintained in combination with the test and QC lot.
Tests selected in the
Materials > Material Definition
screen when defining the material and the unit in which results are displayed. (Automatically filled in by the system.)
The QC level.
Indicates whether a QC result is not a quantitative numeric result, but a qualitative result, e.g.: positive, negative. When this field is selected, the fields
Min.
,
Max.
, and
Dev.
are disabled.
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Ranges tab
Min.
Max.
SDs
Target
Dev.
Table 6-4 Ranges
tab
Description
Lower limit of the QC range.
Upper limit of the QC range.
SD range that is covered by the given QC ranges.
Target value.
The allowed deviation for standard QC mode results. It is the expected standard deviation value calculated by dividing the distance between the target and minimum/maximum values by the kSD value. For linearity it is the allowed deviation.
Not shown for RiliBÄK 2008.
The system displays the value type (either an absolute value or a percentage) to the right of the deviation value.
Locations tab Description
Assigned Location(s)
Table 6-5
If the material lot is assigned to one or more locations, it appears on instruments assigned to these locations only. By default a material lot is not assigned to any location.
Locations
tab
Tasks
o
Creating a new lot record to introduce more specific data for the existing material types.
o
Querying for material lot information to see the details of the selected record.
o
Activating a material lot record so that quality control can be performed on that material.
o
Deactivating a material lot record so that quality control cannot be performed on the selected material.
o
Modifying a material record to change its characteristics.
o
Defining the acceptable RiliBÄK 2008 QC ranges for tests performed on this instrument.
o
Assigning the lot material to one or more active locations of different sites.
Note:
The availability of this functionality is dependent on the installed instrument driver versions.
Adding a new lot
This procedure is used for instrument types where the QC ranges are entered in relation to the QC and test lot combination. q
Test lots for instrument types using code key information (e.g.
Accu-Chek Inform II
) cannot be added manually to the database, but only on the instruments using the code key reader.
p
To add a new lot
1
Choose
Materials > Lot Management
.
2
Double-click the QC material lot record to which an additional test lot will be mapped.
Details for the selected record appear in the Detail area.
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3
Click the
Ranges
tab and click
New LOT
.
A new row to define control ranges is shown.
4
Enter the test lot number and range values and click
OK
.
The updated information is displayed on the Detail area and stored in the database.
s
Laboratory Established Deviation
Quality Control (RiliBÄK) > QC Test Mapping
component. RiliBÄK 2008 Table
B 1 specifies an allowed deviation for the tests listed in this table. These tests are referred to as RiliBÄK tests in the
cobas IT
1000 application. For tests which are not listed in Table B 1, laboratory established deviations (LED) can be defined. The LED functionality of the
cobas IT
1000 application automatically calculates and proposes
LEDs for non-RiliBÄK tests. The calculation is using the algorithm defined in the
RiliBÄK regulation. A proposed LED is always associated with a combination of instrument, test, material lot (combination) and level. If no LED is defined, the standard QC range is applied.
Workflow overview
The following paragraphs provide an overview of the steps and scenarios involved in establishing and managing proposed LEDs.
Accept and activate proposed LED
Even if an LED is proposed automatically, this does not mean that the LED is already applied. For a proposed LED to be applied, it needs to be active. A proposed LED only becomes active once it is accepted. The application provides two possibilities to accept proposed LEDs: o
To accept a proposed LED manually
o
Automatic acceptance.
To accept a proposed LED automatically
Review proposed LED
If a proposed LED has not been accepted automatically, it can be declined, deleted or manually updated. You may also trigger a recalculation or accept an LED manually.
If a proposed LED has already been accepted automatically, it can still be declined or manually updated. It is also possible to trigger a recalculation.
For more information on reviewing proposed LEDs, refer to the following procedures: u
u
To accept a proposed LED manually
u
u
To delete a proposed or a declined LED
u
To change a proposed LED manually
u
u
No proposal available
If no LED proposal s are displayed, check whether you need to adjust the calculation rules under
System > General Settings
.
u
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QC results or calculation rules changed for existing LED proposal
If the QC result set or the calculation rules associated with an existing LED proposal are changed, an automatic recalculation is triggered.
u
Automatic recalculation upon changes on QC result set or calculation rules
u
No automatic recalculation for active LEDs
Actions
Recalculate
LED handling overview
The following table provides an overview of the interrelationship between the states of an LED and the possible user actions.
Accepted Proposal No proposal possible Declined Deleted
Accept
Decline
Delete
Details
Add manually
Update manually
Table 6-6
LED calculation principles
Prerequisites for automatic calculation
For an automatic LED proposal to be calculated, the following requirements have to be met: o
Material and QC lot need to be defined.
o
The set of QC results for the instrument QC test, material lot (combination) and level contains at least 15 calendar days having accepted QC results. Depending on the settings (defined under General settings), these 15 days may need to be within the last control cycle or in the current control cycle.
QC results used for calculation
o
Only one QC result per calendar day is used.
o
The 15 calendar days do not have to be consecutive.
The settings concerning the rules about which results are used for calculation are defined under
System > General Settings
.
o
An LED proposal is displayed only after a completed control cycle (after the end of the month), if the selected calculation method is
Most recent completed control cycle results only
.
o
An LED proposal is displayed as soon as 15 days within the current control cycle with accepted QC results are available even if the control cycle is not finished, if the selected calculation method is
Current control cycle results/non-control cycle results also
.
For a more detailed description of the calculation rule settings, see the corresponding description under
System > General Settings
: u
QC result set used for automatic LED proposal calculation
u
QC result (per calendar day) for LED proposal calculation
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u
Numeric value of n (for LED proposal calculation)
Automatic recalculation upon changes on QC result set or calculation rules
An already existing LED proposal may be deleted and recalculated automatically.
Two scenarios trigger deletion followed by recalculation: o
If the underlying QC result set has changed that already has an LED proposal associated with it (i.e. there is a new completed control cycle or the current control cycle now contains additional QC results).
o
If calculation rules are changed which are already applied to LED proposals.
After deletion, a new LED proposal is automatically calculated based on the current settings.
No automatic recalculation for active LEDs
No automatic recalculation upon change of the QC result set or calculation rule is being triggered, if the related LED has already been accepted and is active or is declined.
LED proposal: largest possible
When a LED proposal is generated, the largest possible LED is calculated. The largest possible LED is the LED which, if used to calculate an effective QC, would lead to the widest QC range not exceeding the actual QC range. In the List area, the
% of QC
Range
column is used to indicate how large the proposed LED is in relation to the largest possible LED value.
Calculation of Max. LED
Max. LED
is the maximal allowed LED in percent for the selected test, derived from the QC range.
The formula used to calculate the Max. LED:
ABS(1-(minRange/Target)*100)
The numerical precision of the Max. LED (and consequently of the proposed LEDs) is defined as follows: o
Number of digits before the decimal separator of the target value plus the number of decimal digits of the system test.
o
Leading zeros before the decimal separator are not counted.
Example: QC range: 98.0-100.0. Target: 99.0. Significant digits: 3Max LED [%]=(1-
98/99)*100=(0.010)*100=1.0
LED related warnings
Warning for LED proposals not based on complete control cycle
A warning can be defined to inform the user that one or more LED proposal(s) are not based on a complete control cycle. The warning is raised for acceptable LEDs only.
u
For more information on the warning on LED proposals not based on a complete control cycle, see
List of predefined alarms used as system alarms
Warning on LED proposals based on complete control cycle
A warning can be defined to inform the user that one or more LED proposal(s) were created, based on a complete control cycle. The warning is raised for acceptable LEDs only.
u
For more information on the warning on LED proposals based on a complete control cycle, see
List of predefined alarms used as system alarms
Materials > Lot Management > LED
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Figure 6-7 Lab-established Deviation
screen
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Color code
Red text
Orange text
Black text
Grey text
Buttons
Recalculate
Accept
Decline
Delete
Details
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Filter
Filter criteria
Instrument Name
Test
Level
Automatic
Mandatory
Status
Status Date/Time
Deleted
Field definitions
Instrument Name
Test
Level
Test Lot
Max. LED cobas IT 1000 application
Acceptable LED proposals based on a completed control cycle.
Acceptable LED proposals based on something else than a completed control cycle.
Accepted LEDs
Other LED status (declined, deleted, non-proposal).
Allows to manually trigger recalculation of an LED proposal.
Accepts a selected proposed LED.
Allows to manually decline a proposed or active LED. To decline an LED, a reason needs to be provided.
Deletes a proposed or declined LED.
Deleting a proposed or a declined LED
Opens the
Details
dialog box. The
Details
dialog box provides information on the ID of the user who entered or updated the LED value and date/time when the LED was last updated.
Applies the filter criteria defined in the List area.
To filter by the instrument name for which the LED has been proposed.
To filter by the test for which the LED was proposed.
To filter by the QC level for which the LED was proposed.
Choose
No
to filter for the LEDs which have been entered manually. Choose
Yes
to filter LEDs that were calculated by the system automatically.
To filter for LED proposals that were calculated based on complete control cycles. Values:
All, Yes
,
No
.
To filter by Status. Possible values:
All
,
Declined
,
P
roposed (mandatory LED)
,
Proposed (voluntary
LED)
,
No proposal possible
,
Accepted
,
Deleted
.
To filter for LEDs where the last status change was within a defined time frame.
To filter for LEDs that have been deleted. Values:
All
,
Yes
,
No
.
Name of the instrument.
Identification of the system test.
The QC level number.
The test lot number. This column is visible for QC lots maintaining QC range information in combination with test lots only. (e.g.
cobas h
232 QC material lots).
The maximum LED in percent for the selected test, derived from the QC range.
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LED
Not enough results
Not enough results with selected rule
Exceeding QC limits
Displays either a numeric value proposed by the system, a reason for declination, or why no LED proposal can be calculated. If no proposal could be calculated (Status:
No
Proposal possible
), the reason is displayed instead of the value.
Insufficient total number of results.
The number of results is insufficient due to the result selection criteria applied.
The LED proposed based on the current result selection and LED calculation criteria would lead to an effective
QC range exceeding the actual QC range.
Effective range equal to target
% of QC Range
Automatic
The LED proposed based on the current result selection and LED calculation criteria would lead to an effective
QC range containing only the target value.
Indicates how large the proposed LED is in relation to the largest possible LED value (Max. LED).
The check box is active, if the LED proposal was generated automatically. The check box is inactive, if the
LED proposal was edited or entered manually.
Mandatory
Mandatory LED proposals are proposals that were calculated based on complete control cycles.
Indicates the status of an LED. Possible values:
Status
Declined
Proposal (mandatory LED)
A proposed LED is an LED that has been calculated but not yet accepted. Once accepted, it becomes active.
Proposal (voluntary LED)
No Proposal possible
Accepted
Deleted
Status Date/Time
Deleted
Indicates the date and time when the LED was set to the current status.
Indicates whether or not a LED was deleted.
Adding an LED manually
Manually adding an LED is only possible for LEDs with status
No Proposal possible
.
p
To add an LED manually
1
Choose
Materials > Lot Management
.
2
Choose the required QC lot and click the
LED
button.
The
Lab-established Deviation
screen opens.
3
Double-click into the respective
LED
field.
4
Enter the value. The value may not exceed the value defined in column
Max.
LED
.
5
To accept the manually entered LED value, click outside of the field.
The entered LED value is displayed in the field. The status changes to
Accepted
.
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Changing a proposed LED manually
Manual change is not possible for LED proposals with status
No Proposal possible
.
p
To change a proposed LED manually
1
Choose
Materials > Lot Management
.
2
Choose the required QC lot and click the
LED
button.
The
Lab-established Deviation
screen opens.
3
Double-click into the respective
LED
field.
4
Enter the value. The value may not exceed the value defined in column
Max.
LED
.
5
To accept the manually entered LED value, click outside of the field.
The entered LED value is displayed in the field. The status changes to
Accepted
.
s
Recalculating an LED
For a proposed LED, recalculation can be triggered manually. For the recalculation, the calculation criteria can be redefined.
Materials > Lot Management > LED > Recalculate
Figure 6-8 Recalculation criteria
dialog box
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Field definitions
Standard criteria
Recalculation criteria n k (extension factor)
The current value as defined under
QC result (per calendar day) for LED proposal calculation
in
General
Settings
.
Calculation criteria you want to apply for the recalculation. Possible values:
1st Result
,
n-th Result
,
Last Result
,
Random Result
.
Numeric value of
n
, if
n-th Result
is selected as recalculation criteria.
By default, the extension factor is set to 3, as defined in the RiliBÄK regulations. If needed, a different extension factor can be entered for recalculation. The extension factor is used to define an LED that is large enough to provide an effective QC range that is wider than just the target value but does not exceed the actual QC range.
p
To recalculate an LED
1
Choose
Materials > Lot Management
.
2
Choose the required QC lot and click the
LED
button.
The
Lab-established Deviation
screen opens.
3
Choose the LED proposal you wish to recalculate and click the
Recalculate
button.
The
Recalculation criteria
dialog box opens.
4
Enter the calculation criteria you want the application to use for the recalculation.
5
To save the entered criteria, click
OK
.
A new LED proposal is calculated and displayed in the List area.
s
Accepting a proposed LED
Proposed LED become active and are applied only after acceptance.
q
Migrated LEDs to be accepted manually
If you have been upgrading from an old application release: o the migrated LEDs are treated as manually added LEDs.
o the migrated LEDs are accepted automatically.
p
To accept a proposed LED manually
1
Choose
Materials > Lot Management
.
2
Choose the required QC lot and click the
LED
button.
The
Lab-established Deviation
screen opens.
3
Choose the proposed LED you want to accept and click the
Accept
button.
The status of the LED changes to
Accepted
.
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p
To accept a proposed LED automatically
1
Choose
System > General Settings
.
2
Double-click on
Apply proposed LED automatically
.
3
Change the
Current value
to
Yes
.
All future proposed LEDs are accepted and become active automatically.
u
Apply proposed LED automatically
s
Declining a proposed LED
p
To decline a proposed LED
1
Choose
Materials > Lot Management
.
2
Choose the required QC lot and click the
LED
button.
The
Lab-established Deviation
screen opens.
3
Choose the respective LED proposal and click the
Decline
button.
The
Decline LED
dialog box opens, prompting you to provide a reason for decline.
4
In the text box, enter the reason and click
OK
.
In the List area, the decline reason is now displayed in the
LED
field. The LED status has changed to
Declined
.
s
Deleting a proposed or a declined LED
p
To delete a proposed or a declined LED
1
Choose
Materials > Lot Management
.
2
Choose the required QC lot and click the
LED
button.
The
Lab-established Deviation
screen opens.
3
Choose the proposed or declined LED you want to delete and click the
Delete
button.
The LED entry is now marked as deleted. User ID, date and time are stored.
s
What if...
o
If the corresponding result set has changed since the underlying LED proposal was generated.
o
If the deleted LED had been entered manually
In these two cases, a new LED proposal is calculated automatically.
If the corresponding result set has not changed since the underlying LED proposal was generated, the LED calculation is done as part of the normal RiliBÄK control cycle handling.
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Viewing the LED details
The LED details can be viewed irrespective of an LED status. The details can also be viewed for deleted LED proposals.
p
To view LED details
1
Choose
Materials > Lot Management
.
2
Choose the required QC lot and click the
LED
button.
The
Lab-established Deviation
screen opens.
3
Choose the LED you want to view and click the
Details
button.
The
LED details
screen opens.
4
Click the
<<
button to return to the
Lab-established Deviation
screen.
s
LED details screen
Materials > Lot Management > LED > Details
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Figure 6-9 LED details
dialog
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Field description
Depending on the status of the LED, some of the fields may not be displayed. For example, no grid with
Value
is displayed, if the LED was entered/edited manually.
Calculation criteria
Calculated on
Entered by
Entered on
Proposed by
Proposed on
Declined by
Deleted by
Declined on
Deleted on
Date/Time
Value
Shows the calculation criteria the selected LED proposal is based on.
k
stands for the expansion factor. The default value is 3.
Date and time of last automatic calculation.
ID of the user who manually changed or entered the LED proposal.
Date and time when the LED proposal was last changed manually.
SYSTEM LEDCALC
: The LED was proposed automatically by the system.
Date and time when the LED was proposed by the system.
ID of the user who declined the LED proposal.
ID of the user who deleted the LED proposal.
Date and time when the LED proposal was last declined.
Date and time when the LED proposal was last deleted.
Date and time of QC results used in the calculation of
LED proposal.
Values of the QC results used for the calculation of LED proposal.
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Table of contents
Instruments
7 Instruments
7
The settings configured in this module affect the functioning of the instruments connected to the application. Not all instruments are available in all regions.
Throughout the chapter, you may find references to instruments which are not available in your region. Instrument name, number and serial number must be unique per instrument. The
Instrument > Status
and the
Instrument
> Maintenance
components are the most used to gain an overview of the status of the instruments and to keep track of whether maintenance tasks have been performed.
The remaining components are used to install and configure instruments.
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Chapter
7
Copying an instrument configuration from an existing one................................. 247
231
7 Instruments
Table of contents
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Status
Status
Display of instrument events
Use the
Status
component to get a quick overview of the current status of all the instruments connected to the application. Any instrument event (warnings, exceptions, errors or required actions on an instrument) will be displayed in the
Status
component in detail.
q
In the
Instrument > Status
screen an updated
Last Communicated
date can only be seen when a successful synchronization has occurred. This is different for each instrument type.
Locking an instrument
Depending on the instrument type, this component can be used to lock or unlock individual instruments, either manually or automatically. Currently, the
Lock
function is only available for
Accu-Chek Inform
instruments.
o
If the instruments are not connected when changing the status or adding events, the changes remain pending to be performed, and they are performed as soon as the instrument is connected.
o
The instrument status screen has two grids: the upper one displays instrument status information, the lower one displays instrument events.
o
When the application is used to block an instrument, the instrument cannot even run STAT tests. If the instrument is blocked from the instrument itself, STAT tests can still be run.
o
As default, all instruments appear in the instruments list.
Prerequisites
Instruments must have been previously configured.
These are the different symbols used in the
Instrument > Status
screen:
Instruments grid
Column
Event
Instrument Lockout
Status
Symbol Meaning
The instrument has some event which has not yet been acknowledged.
Instrument locked by the system.
Instrument locked manually by user.
Instrument locked by a maintenance task being performed.
Instrument auto-lockout.
Communication
Status
Table 7-1
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”.
Symbols in Instrument grid
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Status
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Column
Instrument Status
Symbol Meaning
System ready.
System not ready.
System awaiting user action.
Table 7-1
Event grid
Column
Reported...
Symbols in Instrument grid
Symbol Meaning
Event was automatically generated by the system.
Event was manually entered by the user.
A message was sent to the instrument.
Event was automatically generated by maintenance task configuration.
Event was automatically generated by the instrument.
QC event “test not found” was automatically generated by the instrument (only in the
cobas h
232 POC system instrument status). For
cobas h
232 POC systems this QC event is logged for each synchronisation with the
cobas IT
1000 application.
Symbols in Event grid
Table 7-2
q
The firmware version in the
Status
screen will only be shown for some instrument types
(for example
Accu-Chek Inform II
,
CoaguChek XS Plus
,
CoaguChek XS Pro
,
cobas h
232, or
cobas b
123).
Instruments > Status
(
Data > Status
) u
The two calling sequences provided above refer to the different navigation structure available. For more information on how to change the navigation structure, see
Switching between navigation structures
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A
7 Instruments
Status
B
A
Filter on
Event
column
Figure 7-1 Instruments > Status
screen
B
User name as tooltip q
Content of Status screen depending on access way
The filter on the
Event
column in the Instruments grid depends on the way of accessing the
Status
screen: o
When choosing
Instruments > Status
, the filter of the
Event
column is set to
All
.
o
When accessing the
Status
screen by clicking a warning in the Warning area, the filter of the
Event
column is set to
Yes
.
The
User Name
column in the Event grid contains the user ID. The user name in the format “Last Name, First Name” is displayed as tooltip when hovering the mouse over an entry in this column.
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Status
Locking an instrument
cobas IT 1000 application
p
To lock an instrument
q
This feature is not available on all instruments. Refer to the release notes of the individual instruments for details.
1
Choose
Instruments > Status
.
2
Enter search criteria and click the
Filter
button to retrieve instrument records.
3
Select the instrument that you want to lock and click the
Lock
button.
The selected instrument is locked for use.
s
Resetting an instrument’s memory
q
This feature is not available on all instruments. p
To reset an instrument’s memory
1
Choose
Instruments > Status
.
2
Enter search criteria and click the
Filter
button to retrieve instrument records.
3
Select the instrument that you want to reset and click the
Reset Instrument
button.
The selected instrument’s memory is reset by triggering a re-synchronization with
cobas IT
1000 application.
s
Sending a message to an instrument
Send a message to an instrument so that the person using that specific instrument will read it.
q
Not all instruments can receive messages.
p
To send a message to an instrument
1
Choose
Instruments > Status
.
2
Enter search criteria and click the
Filter
button 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.
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Status
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.
s
Querying the instrument event list
You query the instrument event list to see the details of the events related to one particular instrument.
p
To query the instrument event list
1
Choose
Instruments > Status
.
2
If necessary, set a filter to display specific records.
3
Select the record whose events are to be queried.
Events assigned to that instrument appear on a list in the Detail area.
4
If necessary, set a filter on that list to display specific events.
s
Viewing the events of all the instruments
In the instrument and instrument event lists, records are sorted by location/instrument, type/instrument, name/date and time by default.
p
To view the events of all the instruments
1
Choose
Instruments > Status
.
2
Click
All
.
Events related to all instruments are displayed on the list in the Detail area.
3
Text on the button toggles to
Selected
.
4
Click it to display only those events of the instrument selected on the list above.
s
Adding an event to an instrument
You add an event to an instrument to create a new action or comment related to a specific instrument.
p
To add an event to an instrument
1
Choose
Instruments > Status
.
2
If necessary, set a filter to display specific records.
3
Select the instrument to which an event is to be added, and click
Add Event
.
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Status
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4
Double-click the new record under the comment column to add a comment, and click
OK
.
The updated information is automatically stored into the database.
s
Changing an instrument’s status
Modify an instrument status indicating whether one particular instrument is online or whether it is locked.
Locked instruments cannot be reset.
p
To change an instrument’s status
1
Choose
Instruments > Status
.
2
On the instrument list, select the instrument whose status is to be modified.
3
Do one of the following: o
To lock or unlock the instrument click the
Lock
/
Unlock
button.
or, o
To connect or disconnect the selected instrument from the application click the
Go Online
/
Go Offline
button.
or, o
To reset the instrument to default click the
Reset Instrument
button.
4
Click the
OK
button.
The updated instrument status information is displayed in the List area and is stored into the database.
s
Modifying the instrument event list
Modify the instrument event list to edit the comment assigned to the event or to acknowledge a given event.
p
To modify the instrument event list
1
Choose
Instruments > Status
.
2
On the Instrument list select the instrument whose events are to be modified.
3
Select the event to be changed.
4
Do one of the following: o
To modify the comment assigned to the event click the
Edit Event
button. or, o
To accept the selected event click the
Acknowledge
button.
The current date and time is set as
Acknowledge Date
.
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Status
5
Click the
OK
button.
The updated instrument status information is displayed in the Detail area and is stored into the database.
s
Refreshing the screen
p
To refresh the screen
1
Click the
Refresh
button.
The information displayed on the screen is updated.
s
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7 Instruments
Maintenance
Maintenance
cobas IT 1000 application
Proper maintenance of diagnostic instruments is essential to support high standards in the quality of point of care testing. Use this component to review, document and comment the execution of maintenance tasks for individual instruments.
Individual maintenance tasks will be generated automatically by the system, based on standardized maintenance tasks as they have been assigned to the instrument profiles.
Maintenance information transmitted from an instrument is displayed in
Instruments > Status
.
Instruments will present one of the following status: o
Scheduled
: from the moment the task is created until it is predicted to start. It is highlighted in green.
o
Pending
: if the predicted start has passed and the task has not begun. It is highlighted in red.
o
Open
: from the beginning of the maintenance task until it ends. It is highlighted in orange.
o
Closed
: if the maintenance task has been finished.
o
Cancelled
: if a pending maintenance task is not to be performed.
Maintenance tasks done on
Accu-Chek Inform II
instruments for which a
Pending
or
Scheduled
task exists are reported here. Maintenance tasks done on
Accu-Chek
Inform II
instruments for which no
Pending
or
Scheduled
task exists in the application are reported as instrument events in
Instruments > Status
.
Maintenance tasks done on
Accu-Chek Inform
instruments for which
Pending
or
Scheduled
task exists or not in the application, are always reported as events in
Instruments > Status
.
Prerequisites
o
Instruments must have been previously configured o
Maintenance tasks must have been previously defined.
o
Maintenance tasks must have been previously assigned to an instrument configuration in the
Instruments > Configuration > Tasks
screen.
Instruments > Maintenance
(
Data > Maintenance
)
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Maintenance
Figure 7-2 Maintenance
screen
Field definitions
Location
ICA Number
Type
Started
Test # started
Comment
Skipped By
Status
Instrument Type
Task
Scheduled
Completed
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Location to which the instrument that is being maintained belongs.
ICA number of the instrument.
Indicates whether it is measured by time or by number of tests (read-only).
Date when the maintenance task begins.
Test number at which the maintenance task is begun.
User’s comment on the instrument status or the maintenance task.
User who cancelled a predicted or pending task.
New status to which the instrument is changed
(automatically generated by the system).
Type of instrument to which the maintenance task is performed.
Name of the maintenance task that has to be or has been performed on the selected instrument.
Date when the task is scheduled to run.
Date when the maintenance task is finished.
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Maintenance
cobas IT 1000 application
Test # completed
Performed By
Skipped Date
Number of tests at which the maintenance task is finished.
User name of the person who performed the maintenance task.
Date when the predicted or pending task was cancelled.
Notifying the beginning of a maintenance task
Indicate that a maintenance task has begun so that it is known that the maintenance task status is set to
Open
.
If the
Maximum duration
field is set to “0” in the maintenance task configuration o
The current date becomes the value both in the field
Start Date
and
End Date
.
o
The current number of test becomes the value both in the field
Test # started
and
Test # completed
.
o
The final status of the task will be
Closed
.
p
To notify the beginning of a maintenance task
1
Choose
Instruments > Maintenance
.
2
In the List area, select a predicted maintenance task and click
Start
.
3
Fill in the
Performed By
field and, if necessary, add a comment and click
OK
.
The current date becomes the
Start Date
and the current number of test becomes the
Test # started
field. The current user is displayed in the
Performed By
field.
s
Notifying the completion of a maintenance task
You indicate that a maintenance task has already finished to acknowledge that the maintenance task is closed.
p
To notify the completion of a maintenance task
1
Choose
Instruments > Maintenance
.
2
In the List area, select an open maintenance task and click
Complete
.
3
If necessary, add a comment in the
Comment
field and click
OK
.
The current date becomes the value in the
End Date
field and the current number of test becomes the value in the
Test # completed
field. A new task for that instrument is added to the list as
Pending
task.
s
Canceling
You cancel a predicted or pending maintenance task when the task is not to be performed.
You can cancel only tasks for which the maintenance task has not begun.
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Maintenance
p
To cancel a maintenance task
1
Choose
Instruments > Maintenance
.
2
In the List area, select a predicted or pending maintenance task and click
Cancel
.
3
If necessary, add a comment in the
Comment
field, then click
OK
.
The current date becomes the value in the
Cancelled Date
field. The current user becomes the value of the
Cancelled By
field.
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Configuration
Configuration
cobas IT 1000 application
Use this component to create new instrument configurations, or to maintain information for existing instrument configurations.
Instrument profiles
Instrument profiles represent a group of settings, which control the behavior of a certain instrument type (e.g. such as
Accu-Chek Inform
).
Such typical instrument configurations are defined based on the requirements of the location where individual instrument is to be used.
A predefined configuration has to be assigned during the setup of each individual instrument.
By changing a single instrument configuration, the behavior of all instruments assigned to this configuration can be modified.
NOTICE
Be careful when changing instrument configuration
Changing instrument configuration can result in loss of data and malfunctioning of the application.
r
Create a copy of the predefined configuration and modify the copy, if necessary.
For instrument configuration changes, contact Roche Service.
q
Activate the Result Upload option in the Instrument tab
Activate the
Result Upload
option before deletion in order to avoid test result loss in the event of communication problems between the instrument and the application.
q
Configure instruments to enter patient IDs manually in the Patient tab
Configure instruments to enter patient IDs manually, in case instrument connectivity failure happens. To do so, select
Keyboard Prompt
on the
Patient ID Mode
list.
The
Last Change
and
Changed by
fields are automatically filled in by the system.
Depending on the instrument type and the driver version, a different set of fields will be activated in the Detail area.
Instruments > Configuration
(
Definition > Configuration
)
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Configuration
Figure 7-3 Configuration
screen
Field definitions
General
tab
Instrument Type
Configuration ID
Driver Version
Description
Last Change
Changed By
Configuration Key
Default Configuration
Type of instrument to which the configuration is applied.
ID given to the configuration.
Driver version used in the configuration.
Short text describing the configuration.
Last time when changes were done on the configuration.
Define the user which is displayed by default in instruments that do not support the sending of user ID.
Users that appear in the list are only those in the same site as the analyzer.
Required password to access the
Setup
submenu of the
Maintenance
menu in the
Accu-Chek Inform
.
Select this box if the configuration shall be considered the default configuration for the instruments of that same instrument type.
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Configuration
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Firmware File Path
Repeat Time Interval
User
POCT
QC Interval (h)
RMSE evaluation
Start of daily routine
Write the path and the filename of a firmware update file.
The path entered must be an absolute path on the computer running the PCommunicator component.
Back slashes have to be used (“\”), not forward slashes
(“/”). File name must be included.
This field is only available for instruments for which firmware updates are supported, e.g.
CoaguChek XS
Plus
and
cobas h
232.
Define for each instrument type configuration the amount of minutes when, if a repeated result is sent, it will be marked as repeated.
Repeated results are flagged with the system alarm
TRR
and set to status
Pending
.
The setting
Detect repeat results
has to be activated in the
General Settings
.
u see
Name of the user that is in charge of the instrument.
Select this box if the instruments you are configuring are to be operated in point of care testing (POCT) mode. If you select this, the QC interval and RMSE evaluation fields appear.
This field is only available in RiliBÄK 2008 mode for instruments that can be operated in POCT mode.
The maximum number of hours between QC tests.
This field is only available in RiliBÄK 2008 mode. By default, the QC interval is set to 168 hours. A maximum of 999 hours can be set.
Select this check box if instruments configured this way will also be evaluated using RMSE calculations.
This field is only available in RiliBÄK 2008 mode.
This field appears when the POCT check box is not selected or the associated instrument type cannot be operated in POCT mode. You can set the time at which instruments theoretically start their daily routine. This time may for example be 7am or 1am depending on your ward’s shift schedule. It is used as a reference for when the first QC test run is expected to be performed for the day.
This field is only available in RiliBÄK 2008 mode.
Tasks
o
Creating an instrument configuration to determine the setup features for a certain instrument type. Several configurations are allowed for one instrument type.
o
Querying for instrument configurations to see the setup details of the selected configuration.
o
Activating an instrument configuration so that this configuration can be used with the suitable devices for data transmission.
o
Deactivating an instrument configuration so that this configuration cannot be assigned to any instruments.
o
Modifying an instrument configuration to change the data transmission setup features.
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o
Configuring tasks to assign or un-assign predefined maintenance tasks to the selected instrument profile.
o
If operating in RiliBÄK 2008 quality control mode, you can define whether an instrument is operated in POCT mode. If you select the
POCT
check box, you see different fields compared to if you do not select the
POCT
check box.
Copying an instrument configuration from an existing one
Copy an existing instrument configuration to create a new one with similar features.
p
To copy an instrument configuration from an existing one
1
Choose
Instruments > Configuration
.
2
Click
Add
.
The
Copy Configuration
screen appears.
3
Select an existing configuration and click
OK
.
The system automatically fills out the detail information for the selected configuration in the Detail area of the
Instrument Type Configuration
screen.
4
Change the name of the configuration.
5
If necessary, edit the fields in the Detail area.
6
Click
OK
.
The updated instrument configuration information is displayed in the List area is stored in the database.
s
Task Configuration
Use this option to assign or un-assign predefined maintenance tasks to the selected instrument profile.
o
This screen is accessed through the
Instruments > Configuration
screen.
o
All the modifications made in this screen affect the instrument configuration selected on the
Instruments > Configuration
screen.
Prerequisites
Maintenance tasks must have been previously defined under
Instruments
> Maintenance Definition
.
Instrument > Configuration > Task Configuration
(
Definition > Configuration > Tasks
)
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Figure 7-4 Tasks
screen
Assigning a task
Assign a task to an instrument configuration to determine the maintenance tasks for those instruments with that specific configuration.
p
To assign a task
1
Select the tasks to be assigned to the instrument configuration, click the
Applied
option for that task, and then click
OK
.
The task is assigned.
s
Removing a task
Assign a task to an instrument configuration to determine the maintenance tasks for those instruments with that specific configuration.
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p
To remove a task
1
Select the tasks to be removed from the instrument configuration, click the
Not
Applied
option for that task, and then click
OK
.
The task is removed.
s
Tasks Users
Use this option to assign or un-assign individuals to the defined maintenance tasks for the selected instrument profile.
This screen is accessed through the
Instruments > Configuration > Tasks
screen. If no user is in charge of a maintenance task all warning messages will be sent to the location manager.
All the modifications made in this screen apply to the task selected on the previous screen (
Instruments > Configuration > Tasks
).
Prerequisites
Users must have been previously assigned to locations and/or workgroups.
Instruments > Configuration > Task Configuration > Users
(
Definition > Configuration > Task Configuration > Users
)
Figure 7-5 Users
tab
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Adding a user to a task
Add a user to a task to determine the users who are allowed to perform that particular maintenance task. Their names will appear in the
Made By
field in the
Instruments
> Maintenance
screen.
p
To add a user to a task
1
Select a record from the
Workgroup
or
Location
drop-down list.
Users assigned to each record appear on the users list below.
2
Select the users to be added from the user list on the left and then click the buttons between the two user lists, and click
OK
.
All the information is automatically stored into the database. A check mark appears in the
Users Assigned
column on the
Instruments > Configuration
> Tasks
screen indicating that there are users assigned to the task.
q
The box is only checked, if the user sets the task to applied, even though it seems to be applied by default. s
Removing a user from a task
Remove a user from a task in order to deny a user’s permission to perform a particular maintenance task.
p
To remove a user from a task
1
Select the user to be removed from the user list on the right, then click the buttons between the two user lists, and then click
OK
.
The user is removed from the task.
s
Driver Configuration
Instruments > Configuration > Driver Configuration
Use this option to configure specific settings for the software driver controlling the data exchange between the selected diagnostic instrument type and the software application.
q
The
Driver Configuration
button is only available for mobile instruments such as the
Accu-Chek Inform
.
Modifications made in this screen apply to the record selected on the previous screen
(
Instruments > Configuration
).
Prior to deactivating a test it should be removed from materials defined in
Materials
> Material Definition
as well as (depending on the instrument type) in
Instruments
> Configuration > Driver Configuration
.
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CAUTION
CAUTION
Do not change driver configuration yourself
Changing driver configuration can result in loss of data and malfunctioning of the application.
r
For driver configuration changes, contact Roche Service.
Actions
o
Access
General
tab to handle the basic conditions of instrument configuration.
u see
o
Access
Tests
tab to handle specific instrument tests.
u see
o
Access
Results Mod.
tab to manage alphanumeric, formula and range result modification.
u see
Alphanumeric Results Modification
r
Alphanumeric result modifications made here are not applied to numeric results.
WARNING
Device Configuration
Use this option to configure specific settings of instruments, for example the
Accu-
Chek Inform II
,
CoaguChek XS Plus
,
CoaguChek XS Pro
or
cobas h
232.
Modifications made on this screen apply to the record selected on the previous screen
(
Instruments > Configuration
).
The sending of patient and user IDs to the instrument depend also on proper settings of parameters in the
System > General Settings
screen.
q
Configure instruments to use the Visit ID
There is the option to select the
Visit ID
as the source of IDs to be used in the patient upload to the instruments.
o
For instrument types that support
Device Configuration
, it can be configured in the
Patient ID Mapping
section.
o
For
Accu-Chek Inform
, it can be configured in
Instruments > Configuration
.
o
For other instrument types, the general setting
Instrument Patient ID
will apply.
u
Incorrect assignment of patient results
Changing the patient ID mapping for an instrument configuration can lead to incorrect assignment of patient results. When changing the patient ID mapping, always do the following: r
Before changing the patient ID mapping, connect the affected instruments with
cobas
IT
1000 application to synchronize pending results with the current patient ID mapping.
r
Change the patient ID mapping.
r
Re-dock the affected instruments to implement the new patient ID mapping.
r
Ensure correctness of patient result assignment according to the new patient ID mapping.
o
Make a patient measurement with an instrument.
o
Dock the instrument and synchronize the result.
o
Check whether the patient result is correctly assigned.
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q
Language configuration
For the
CoaguChek XS Plus
or
cobas h
232 POC system, the terminology used in this manual is British English. The terminology may change when you configure the systems to
American English.
Instruments > Configuration > Device Configuration
(
Definition > Configuration > Device Configuration
)
Figure 7-6 Device Configuration
screen
Tasks
o
Modifying an instrument configuration to meet the requirements of the POCC.
o
Restoring an instrument configuration to its default configuration by clicking
Default Values
.
q
Password from instrument to the cobas IT 1000 application
If a user sets his password on an
Accu-Chek Inform II
instrument, the user record is updated in the
cobas IT
1000 application accordingly.
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Accu-Chek Inform II
Instrument > Main Menu Format
You can configure this instrument for proficiency testing. Select the check box
Proficiency
to enable proficiency testing for instrument users certified for proficiency testing. Clear it to disable it.
EAP security
You can enable this instrument to use EAP security when communicating with
cobas
IT
1000 application via WLAN.
q
For the
Accu-Chek Inform II
to support EAP security, the instrument needs to have software version 03.05.00 or higher installed.
To enable EAP security, do the following:
1. Choose
Instrument > WLAN Communication
and select the
WLAN
Communication
check box.
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screen
253
7 Instruments
Configuration
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2. Choose
WLAN > Security
and choose the
EAP
entry from the
Security Type
drop-down list.
q
Figure 7-8 WLAN > Security
screen
The settings in the
Device configuration
screen enable EAP security on the instrument.
For an instrument to effectively use EAP security for WLAN communication with
cobas IT
1000 application, the following needs to be done additionally: o
Define an EAP setting in the
Instruments > EAP Settings
screen.
u
o
Assign the instrument to the EAP setting in the
Instruments > EAP Settings
Assignment
screen.
u
To assign an EAP setting to instruments
Only active instruments assigned to a configuration with EAP security enabled are displayed in the
Instruments > EAP Settings Assignment
screen and can be assigned to an EAP setting.
Bayer 1200
Disable Parameters for analysis
You can prevent this instrument from performing specific analysis by disabling them here. Select the check box to disable a parameter. Clear it to enable it.
pH/H+
PCO
2
PO
2
Na+
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K+
Ca++
Cl-
Glucose tHb
Lactate
Patient
Patient ID mapping. Select the patient ID mapping from the drop down list.
Bayer 400
Disable Parameters for analysis
You can prevent this instrument from performing specific analysis by disabling them here. Select the check box to disable a parameter. Clear it to enable it. pH/H+
PCO
2
PO
2
Na+
K+
Ca++
Cl-
Glucose tHb
HCT
Patient
Patient ID mapping. Select the patient ID mapping from the drop down list.
Medtronic ACT Plus
Patient
Patient ID mapping. Select the patient ID mapping from the drop down list.
ABX Micros CRP
Patient
Patient ID mapping. Select the patient ID mapping from the drop down list.
Sysmex KX-21N
Patient
Patient ID mapping. Select the patient ID mapping from the drop down list.
QC lot mapping
QC lot number matching the instrument QC file number.
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EAP Settings
EAP Settings
cobas IT 1000 application
An EAP setting defines the security used by instruments assigned to this setting when communicating with
cobas IT
1000 application via WLAN.
Basic terms and concepts
EAP
EAP (Extensible Authentication Protocol) is an authentication framework. It enables the communication between server and client in wireless networks for authentication purposes.
RADIUS server
The authentication process is handled by a dedicated RADIUS server (Remote
Authentication Dial-In User Service). The use of a RADIUS server allows centralized management of user information and authentication processes.
EAP types
The EAP types are the specific methods used for authentication. They differ in what is demanded for authentication, i.e. authentication via certificates and/or passwords, and from which side it is demanded, i.e. from the server and/or the client. The following EAP types are supported by
cobas IT
1000 application: o
PEAP (Protected Extensible Authentication Protocol):
This EAP type uses the TLS protocol only to authenticate the server to the client, so only the server has to have a certificate. The client only needs a user name and password to validate to the server.
o
TLS (Transport Layer Security):
TLS is based on the authentication of both sides, so each client has to have its own certificate as well. Also the client private key and the client private key password have to be set when using TLS.
o
TTLS (Tunneled Transport Layer Security):
TTLS is very similar to the PEAP type. It will typically be used instead of PEAP if the RADIUS server should not be directly accessible through the WLAN.
Therefore, an EAP-TTLS server will be used as a proxy, forwarding the messages in a non-wireless bounded way to the RADIUS server itself. If the first step of authentication to the EAP-TTLS server should be separated to the final user name/password to the RADIUS server, a general anonymous user name can be specified. So the user name/password will only be used to authenticate against the
RADIUS server when a secure communication has already been established.
Digital certificate
A digital certificate is an electronic document proving ownership of a public key, which is used during information encryption. Digital certificates are issued by a certification authority (CA).
cobas IT
1000 application supports X.509 certificates in a Base64 .pem format.
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EAP Settings
Cipher type
The cipher type is the algorithm used for encrypting and decrypting. During the encryption procedure a key is applied to information converting it from plain text into cipher text. The following cipher types are supported by
cobas IT
1000 application: o
CCMP (WPA2 AES):
Counter Cipher Mode with Block Chaining Message Authentication Code
Protocol
CCMP is the standard encryption protocol for use with the current WPA2 standard specifying security mechanisms for wireless networks.
o
TKIP (WPA TKIP):
Temporal Key Integrity Protocol
TKIP is a security protocol used with the older WPA standard allowing to keep hardware not suitable for use with CCMP.
o
CCMP TKIP (allow both):
Enables both CCMP and TKIP.
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EAP Settings
Overview of common EAP workflows
cobas IT 1000 application
($3VHFXULW\ZRUNÁRZVIRU:/$1FDSDEOHLQVWUXPHQWV
Set-up of instruments for using EAP security
Maintenance of instruments using EAP security
Retiring instruments from using EAP security
Prerequisites
3&RPPXQLFDWRUYHUVLRQRUODWHU LVLQVWDOOHG LVFRQÀJXUHGIRUXVLQJ($3VHWWLQJVLQ FREDV,7 1000 application (contact Roche service) and is running
7KHDXWKHQWLFDWLRQVHUYHU5$',86VHUYHULVDYDLODEOHDQGFRQÀJXUHG
A WLAN access point is available
Access with administrator rights to the &RQÀJXUDWLRQ , 'HYLFH&RQÀJXUDWLRQ , ($36HWWLQJV , ($36HWWLQJV$VVLJQPHQW , and ,QVWUXPHQW
$VVLJQPHQW
screens in
FREDV,7
1000 application (in default installations, this requires both the IT Manager and the POCC user)
1
,QVWUXPHQWV
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&RQÀJXUDWLRQ
Create a new instrument
FRQÀJXUDWLRQIRU($3
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,QVWUXPHQWV
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Add new and/or modify existing EAP settings
1
,QVWUXPHQWV
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FRQÀJXUDWLRQWRWKHLQVWUXPHQWVRU one that does not use EAP)
2
,QVWUXPHQWV > &RQÀJXUDWLRQ >
'HYLFH&RQÀJXUDWLRQ
,QWKH($3LQVWUXPHQWFRQÀJXUDWLRQ enable WLAN and choose EAP as security type
3
,QVWUXPHQWV > ,QVWUXPHQW
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Add the instruments to
FREDV,7
1000 application by docking (if necessary)
Assign the EAP instrument
FRQÀJXUDWLRQWRWKHLQVWUXPHQWV
3
,QVWUXPHQWV > ($36HWWLQJV
Delete unused EAP settings
4
,QVWUXPHQWV > ($36HWWLQJV
Import EAP settings and assignments
Add new and/or modify existing EAP settings
4
Allow instruments to synchronize the new settings via WLAN (if possible) or dock the instruments for synchronization
5
,QVWUXPHQWV > ($36HWWLQJV
$VVLJQPHQW
Assign EAP settings to instruments
2
,QVWUXPHQWV > ($36HWWLQJV
$VVLJQPHQW
Change the EAP settings assignments to instruments
Instruments use changed EAP settings for
WLAN communication
2
Allow instruments to synchronize the new settings via WLAN (if still applicable) or dock the instruments for synchronization
Instruments stop using EAP security for
WLAN communication
6
Dock the instruments to synchronize the new settings
Instruments use EAP security for WLAN communication
Figure 7-9
Overview of common EAP workflows
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EAP Settings
EAP Settings screen functionalities
Use the
Instruments > EAP Settings
screen to set up, maintain and delete EAP settings.
Use the
Import
function to manage EAP settings and assign them to instruments simultaneously.
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Instruments > EAP Settings
(
Definition > EAP Settings
)
Figure 7-10 EAP Settings
screen
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EAP Settings
cobas IT 1000 application
Field definitions for all EAP types
Name
SSID
Cipher Type
EAP Type
User Name
CA Certificate
Name of the EAP setting. Name is mandatory and must be unique. It is used in the
Instruments > EAP Settings
Assignment
screen to identify the EAP setting. u
SSID (service set identifier) to be used for the communication, i.e. the name of the wireless network, via which PCommunicator can be connected to
Possible cipher types: o o
CCMP (WPA2 AES)
TKIP (WPA TKIP)
o
CCMP TKIP (allow both)
o
The EAP type to be used for the communication:
PEAP (Protected Extensible Authentication
Protocol)
o
TLS (Transport Layer Security)
o
TTLS (Tunneled Transport Layer Security)
User name for the RADIUS server
Browse for the digital certificate file of the certification authority (CA) used to authenticate the server to the client
Supported are X.509 certificates in a Base64 .pem format
Depending on the chosen EAP type (PEAP, TLS or TTLS), different additional fields are enabled in the Details area and have to be filled with the corresponding information.
Field definitions for PEAP
Password
Password Confirmation
Password to authenticate the user name on the RADIUS server
Type in the same Password again
Field definitions for TLS
Client Certificate
Client Private Key
Client Private Key Password
Client Private Key Password
Confirmation
Browse for the digital certificate file used to authenticate the client to the server
Supported are X.509 certificates in a Base64 .pem format.
The digital certificate file containing the private key of the client
Supported are X.509 certificates in a Base64 .pem format
Password needed to access the content of the client private key file
Type in the same Password again
Field definitions for TTLS
Password
Password Confirmation
Anonymous User
Password to authenticate the user name on the RADIUS server
Type in the same Password again
Anonymous user name used by EAP-TTLS as outer identity to rout the user's login request to the RADIUS server before authenticating with the inner identity (the user name and password) through an encrypted connection.
The anonymous user shall provide the domain name to rout the request to the RADIUS server (e.g.
“[email protected]” or “domain\anonymous”).
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EAP Settings
Tasks
o
Adding a new EAP setting o
Searching for an EAP setting o
Modifying an EAP setting o
Deleting an EAP setting o
Importing EAP settings
Adding an EAP setting
Add a new EAP setting.
p
To add an EAP setting
1
Choose
Instruments > EAP Settings
.
2
Click
Add
.
3
Fill in the fields in the Detail area.
u
Field definitions for all EAP types
4
Click
OK
.
The new EAP setting is displayed in the List area and stored in the database.
s
Searching for an EAP setting
Search for an existing EAP setting.
p
To search for an EAP setting
1
Choose
Instruments > EAP Settings
.
2
Set filter criteria to find the desired EAP setting and click the
Filter
button.
q
You can use the asterisk * as a placeholder, when setting filter criteria in the free text fields.
s
Modifying an EAP setting
NOTICE
Modify an existing EAP setting.
p
To modify an EAP setting
Instrument connection to cobas IT 1000 application
When modifying an existing EAP setting, all instruments assigned to this setting will use the modified setting after the next synchronization with
cobas IT
1000 application.
1
Choose
Instruments > EAP Settings
.
2
Double-click an EAP setting from the list.
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q
3
Edit the details of the EAP setting in the Detail area.
The EAP type is not modifiable. If you want to have an EAP setting with a different EAP type, you have to add a new EAP setting.
u
4
Click
OK
.
The modified EAP setting is stored in the database. The modified setting is transferred to the assigned instruments with the next synchronization.
s
Deleting an EAP setting
NOTICE
Delete an existing EAP setting.
p
To delete an EAP setting
Instrument connection to cobas IT 1000 application
When deleting an existing EAP setting, all instruments previously assigned to this setting are unassigned in
cobas IT
1000 application and marked for required synchronization.
1
Choose
Instruments > EAP Settings
.
2
Choose one or multiple EAP settings from the list.
3
Click the
Delete
button.
A confirmation message is displayed. Click
OK
.
If any of the EAP settings to be deleted is still assigned to instruments, that are configured to use EAP security, a warning message is displayed as those instruments will be unassigned once the EAP settings are deleted and will require a new one. Click
OK
to confirm the deletion, or
Cancel
to be able to review the assigned instruments before deleting.
The database is updated. Instruments previously assigned to a deleted EAP setting are unassigned and marked as not applied in the
EAP Settings Assignment
screen.
u
s
Importing EAP settings
You can import EAP settings data from an external file into
cobas IT
1000 application and assign these settings to instruments, that are identified by serial number.
Using the import function saves the time it would otherwise take to enter each data set individually. When re-importing individual data, existing information is updated in the database.
Prerequisite
The instruments must have been previously added to
cobas IT
1000 application by docking them.
Instruments > EAP Settings > Import
(
Definition > EAP Settings > Import
)
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EAP Settings
Figure 7-11 EAP Settings Import
screen
The following rules apply to the import function for EAP settings: o
Required file format: Imported files must be csv or txt files.
o
If the text contains headings, map each heading to the corresponding field; if it does not contain headings, map the data belonging to the first row to the corresponding field. The application automatically identifies the rest of the rows in the file.
o
Mandatory fields must be included in the source file or must be provided with a fixed value.
o
If a fixed prefix is provided for the EAP names,
cobas IT
1000 application automatically generates unique names for the imported EAP settings using the prefix followed by consecutive numbers. E.g. prefix “EAP” will generate names like “EAP001”, “EAP002”, ... (the number of digits will depend on the number of different EAP settings imported).
o
Importing EAP settings overwrites existing settings if the EAP name, that is provided in the import file, matches one in the database.
Automatically generated names do not overwrite existing settings. The generated numbers will continue an existing sequence.
o
If the same EAP setting shall be assigned to multiple instruments during import, the import file has to contain one row for each instrument serial number. Such duplicate EAP settings in the import file will be imported as a single EAP setting definition, and assigned to multiple instruments.
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q o
If no value is to be added in a field, the field may be left blank, but the field delimiter must be set in the row of the import file.
o
It is recommended that the import files should not contain any special characters or country specific letters. Alternatively, use UTF-8 encoding to ensure special characters are imported properly.
o
The columns
CA Certificate
,
Client Certificate
and
Client Private Key
can contain a file name (and possibly the path).
o
Due to a Silverlight security restriction, the user needs to explicitly browse for the digital certificate files to upload. The path provided in the import file will be used as a hint to browse for the digital certificate files, but it is not mandatory.
o
It is not allowed to have several different files with the same file name (with different paths).
o
The file name is case sensitive, e.g. “ClientCertificate.pem” and
“CLIENTCERTIFICATE.PEM” will be considered to be different.
p
To import EAP settings
1
Choose
Instruments > EAP Settings
. Click the
Import
button.
The
EAP Settings Import
screen is displayed.
2
Click the
Browse
button and select the file to be imported.
3
Fill in the fields in the upper part and then click the
Analyze
button.
The data from the file is added into the drop-down lists in the Detail area.
4
Assign the suitable information to each field, and then click
OK
.
A confirmation message is displayed informing the user about possible data overwrite in the database. Click
OK
to confirm the data import.
5
If upload of digital certificate files is required, click the corresponding
Browse
button.
The
Browse
dialog box displays a list of file names that need to be uploaded.
6
Choose the digital certificate files for upload.
q o
You can upload several files from one folder at a time.
o
You can browse for the files in a different folder than the one initially stated in the import source file.
o
You can open the
Browse
dialog box as many times as needed to provide all the requested files, especially if the files are located in different folders.
o
If you provide more files than required, the unnecessary files will be ignored.
An information message is displayed stating successful or failed import. If the import failed, the information message includes the line of the import source file that caused the failure.
s
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EAP Settings Assignment
Use this component to assign EAP settings to instruments. Instruments configured to use EAP security in WLAN communication with
cobas IT
1000 application need to have an EAP setting assigned, that will be transferred to the instrument at the next synchronization.
q o
The instrument needs to be docked on a connected base station to be able to synchronize for the first time.
o
WLAN communication using EAP security is not available for all instruments.
Prerequisites
o
Instruments must have been previously added to
cobas IT
1000 application by docking them.
o
An instrument configuration enabling EAP must have been previously configured (
Instruments > Configuration > Device Configuration
). o
Instruments must have been previously assigned to the instrument configuration enabling EAP security (
Instruments > Instrument Assignment
).
o
An EAP setting must have been previously defined (
Instruments > EAP
Settings
).
q
Application administrator rights required
You must have administrator rights to make changes in this screen.
Instruments > EAP Settings Assignment
(
Definition > EAP Settings Assignment
)
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Figure 7-12 EAP Settings Assignment
screen
Field definitions
Selected
Serial Number
Location
Site
EAP Setting (column)
Applied
EAP Setting (field)
Check box to choose instruments for assigning EAP setting
Serial number of the instrument
Location the instrument is assigned to
Site the instrument is assigned to
Name of the previously assigned EAP setting
Indicates if the instrument has synchronized and acknowledged it has got the latest changes in its EAP setting
Name of the EAP setting to be assigned newly
Task
o
Assigning an EAP setting to instruments q
It is not possible to “unassign” an instrument from its EAP setting in the
EAP Settings
Assignment
screen. In order to stop an instrument from using EAP security (retiring an instrument), the instrument has to be assigned to a different, previously defined instrument configuration that does not use EAP security (
Instruments > Instrument Assignment
).
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Assigning an EAP setting to instruments
Assign an EAP setting to selected instruments for the first time or change the EAP setting assigned to certain instruments.
q
Only active instruments assigned to a configuration with EAP security enabled are displayed in the List area of the
EAP Settings Assignment
screen.
p
To assign an EAP setting to instruments
1
Choose
Instruments > EAP Settings Assignment
.
2
To find the respective instruments, define filter criteria for the Serial Number,
Location, Site, and/or EAP Setting columns and click the Filter button.
q
When searching for a Serial Number, you can use the asterisk * as a placeholder.
q
3
In the List area, select the instruments to be assigned: o
Use the
Select All
and
Deselect All
buttons.
or, o
Select one or multiple entries by selecting the corresponding check boxes in the
Selected
column.
o
The
Select All
and
Deselect All
buttons will (de-)select all instruments listed on the
EAP Settings Assignment
screen. Not only the ones visible in the current page of the screen.
o
The selection is maintained across pages. Selected records are kept when changing the page.
4
From the
EAP Setting
drop-down list, select the EAP setting to be assigned to the selected instruments.
5
Click
OK
.
If the instruments are already assigned to a different EAP setting, a confirmation message is displayed. Click
OK
.
The EAP setting assignment is stored in the database. The assignment is transferred to the instruments with the next synchronization. After successful synchronization, the instruments are marked as applied in the
Applied
column in the
EAP Settings Assignment
screen.
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Instrument Assignment
Instrument Assignment
cobas IT 1000 application
Use this component to perform the required individual setup of an instrument connected for the first time to the system to guarantee the correct registration of the individual instrument within the application.
To enable a correct management of the instrument, specific information such as instrument name, instrument configuration status, assigned location and others has to be provided in the
Instrument Assignment
.
All setup information can be modified at any time after the initial setup.
Prerequisites
Instrument types, configurations and locations must have been previously defined.
Instruments > Instrument Assignment
(
Definition > Instrument Assignment
)
Figure 7-13
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Instrument Assignment
screen
Tasks
o
Defining a new configuration for a specific instrument.
o
Activating an instrument configuration record so that it can be used with the
cobas IT
1000 application.
o
Deactivating an instrument configuration record so that the selected instrument cannot be used with the
cobas IT
1000 application. For ICA instruments (ICA =
Srv_ICA), the connection needs to be set offline in
Instruments
>
Status
first.
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Instrument Assignment
o
Modifying a defined configuration.
o
If operating in RiliBÄK 2008 mode, it is possible to define whether an instrument is operated in POCT (Point of Care Testing) mode. If you select the
POCT
check box, you see different fields to fill in compared to if you do not select the
POCT
check box.
q
For more information on the different settings for POCT versus non-POCT instrument configuration see the following fields definitions list. These definitions apply to instruments whose settings are configured in the
Instruments > Configuration
component. These field definitions are for your information only. If you want to edit the configuration of these instruments, this can be done in the
Instruments > Configuration
component.
Adding a new instrument automatically
CAUTION
Any
cobas IT
1000 application user can automatically add a new instrument when connecting the instrument for the first time.
When a new instrument is docked for the first time, the
Auto Setup
field in the
Instrument Assignment
screen is checked. After any manual change, for example assigning the instrument to a location, the
Auto Setup
field is cleared.
p
To add a new instrument automatically
1
Connect the new instrument to the system and wait until communication is completed.
The system will automatically fill in the fields in the Detail area. A warning message will be displayed in the Warning area for the System Administrator to trace the new instrument information.
Delay of results
Adding a new instrument with a serial number that is already used by an existing instrument leads to a false linkage between patient results and instruments, which can delay results.
r
Check whether the new instrument has a unique serial number before adding the instrument.
r
Do not add a new instrument that has not a unique serial number.
s
Copying an instrument setup information
You copy an instrument setup to create a new one with very similar features.
You can to set up
Drivers
or
Modules
for offline instruments, or to create new offline instruments by copying the settings of existing ones. Therefore, these buttons are disabled when the
Instrument Assignment
screen is accessed from the
Instruments
> Off-Line Instruments
screen.
p
To copy an instrument setup information
1
Choose
Instruments > Instrument Assignment
and click
Copy From
.
2
In the List area select an instrument type and, on list below, select the instrument from which to copy the new configuration.
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Instrument Assignment
Driver Configuration
Use this screen to setup all the required parameters for instrument communication with the system. Move through the different tabs to configure each type of parameters.
The default settings are set by the driver (or defined by Roche Service). It is not recommended to alter any default driver settings.
Modifications made in this screen apply to the record selected on the
Configuration
screen.
Prior to deactivating a test it should be removed from materials defined in
Materials
> Material Definition
as well as (depending on the instrument type): o
Instruments > Instrument Assignment > Driver Configuration
o
General
tab to handle the basic conditions of an instrument setup.
o
Tests
tab to manage the control of sample correlations and to handle specific instrument tests.
o
Results Mod.
tab to manage alphanumeric, numeric and range-based result modifications.
o
Maintenance Definition
tab to manage received, desired and system comments.
General
cobas IT 1000 application
3
Click
OK
.
The system automatically closes the
Copy Instrument
screen and fills out the detailed information for the selected instrument in the Detail area of the
Instrument Assignment
screen.
4
Modify the fields in the Detail area. Remember that the configuration name, the instrument serial number and the IP address must be unique and click
OK
.
The updated instrument information is displayed in the List area. All the information is automatically stored in the database.
s
Use this option to set up general options for the instrument driver.
It requires previous installation of the proper driver. Each connection setup is only applicable to one instrument. This tab is opened by clicking the
General
tab on the
Driver Configuration
screen. Modifications made in this screen apply to the record selected on the
Configuration
screen.
q
It is strongly recommended to activate
Control checksum
in communication protocol in communication with all instruments that support BCC. This system helps reduce communication problems.
Instruments > Instrument Assignment > Driver Configuration > General
(
Definition > Instrument Assignment > Driver Configuration > General
)
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Instrument Assignment
Figure 7-14 General
screen
Editing basic conditions of connections
Use this option to edit connection basic conditions already stored in the database.
p
To edit basic conditions of connections
1
In the
Instrument Assignment > Driver Configuration
screen, click the
General
tab.
Basic conditions for the previously selected instrument are displayed.
2
Edit the available fields and click
OK
.
The updated basic conditions information is stored into the database.
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Instrument Assignment
Connections
cobas IT 1000 application
Use this screen to setup and manage all the possible types of instrument connections.
q
Connection speed
In case of communication problems between the system and the instruments, reduce transmission speed.
This screen is accessed through the
General
tab in the
Driver Configuration
screen.
Modifications made in this screen apply to the instrument selected on the
Instrument Assignment
screen.
The fields displayed in the Detail area change according to selected connection type.
Connection types available change depending on the instrument driver.
Instruments > Instrument Assignment > Driver > General > Connections
(
Definition > Instrument Assignment > Driver > General > Connections
)
Figure 7-15
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Connections
screen
Tasks
o
Creating a new instrument connection to configure a new type of connection.
o
Querying for instrument connections to see the details assigned to the selected connection type.
o
Activating an instrument connection type so that it can be used and applied to a given instrument.
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Instrument Assignment
o
Deactivating an instrument connection type so that it cannot be used.
o
Modifying an instrument connection to change the features of that specific connection type.
o
Deleting an instrument connection if it is no longer going to be used.
Tests
Use this option to define the relationship between instrument test and test definitions used within the application. A one-to-one relationship has to be defined between instrument and application test definitions to allow proper processing of instrument test results.
o
It requires previous installation of the proper driver.
o
It requires previous definition of system Test IDs.
o
It requires previous definition of sample types in the
Sample
tab.
o
This tab is opened by clicking the
Tests
tab on the
Driver Configuration
screen.
o
Modifications made in this screen apply to the record selected on the previous screen (
Instrument Assignment
).
Instruments > Instrument Assignment > Driver Configuration > Tests
(
Definition > Instrument Assignment > Driver Configuration > Tests
)
Figure 7-16 Tests
screen
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Tasks
o
Creating a new test so that the system knows the selected instrument must perform that test.
o
Querying for tests to see the details of the tests that can be performed by the selected instrument.
o
Activating a test so that the tests can be performed by the instrument.
o
Deactivating a test so that the tests cannot be performed by the instrument.
o
Modifying a test to change the test parameters.
o
Deleting a test if that instrument is no longer to perform that particular test.
o
Creating a new flag record to determine a new test flag for the selected instrument.
o
Querying for flags information to see the details of test flag of the selected instrument.
o
Activating a flag record so that the test flag is in use for that instrument.
o
Deactivating a flag record so that the test flag is not applied to tests performed by the selected instrument.
q
Use the
Test Selection
dialog to fill in the field
Test
.
Results Modification
Use this option to systematically modify numeric and alphanumeric instrument test results, while they are transmitted from the instrument to the application. Systematic modification of results might be necessary in case the instrument results presentation does not fit to test setup within the application (e.g. alphanumeric difference, location differences, etc.).
Modification of test results is done within the instrument connectivity driver based on different rules as defined in the next sections.
This tab is opened by clicking the
Results Mod.
tab on the
Instruments >
Instrument Assignment > Driver Configuration
screen.
Modifications made in this screen apply to the record selected on the previous screen.
Prerequisites
Tests must have been previously defined.
From this screen three different types of result modifications can be selected: o
Alphanumeric Results Modification
o
Numeric Results Modification
o
Range Based Results Modification
You can also apply a mathematical (basic) operation to instrument test results. For example in order to correct offsets or to transform test units (e.g. mg/dL to mmol/L).
The correction factor defined on this screen is applied to both patient test results and
QC test results to ensure that coherent values are used at all times. It requires previous definition of tests in the instrument. This function is started by choosing
Numeric Results Modification
from the upper-left list on the
Results Mod.
screen.
You can also transform instrument test results, which are located within a given result range, into a single (discrete) test result, which will then be used in the application. It requires previous definition of tests in the instrument. This function is started by choosing
Range Based Results Modification
from the upper-left list on the
Results Mod.
screen.
Instruments > Instrument Assignment > Driver Configuration > Results Mod.
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(
Definition > Instrument Assignment > Driver Configuration > Results Mod.
)
Figure 7-17 Results Mod.
screen
Alphanumeric Results
Modification
o
Create a new
Alphanumeric Results Modification
to establish new modification parameters applied to the results from the selected instrument.
o
Query for
Alphanumeric Results Modifications
to see the details of the results modification parameters of the instrument.
o
Activate an
Alphanumeric Results Modification
so that the modifications can be applied to the results yielded by the instrument.
o
Deactivate an
Alphanumeric Results Modification
so that it is not applied to the results from that particular instrument.
o
Edit the contents of an
Alphanumeric Results Modification
record.
o
Delete an
Alphanumeric Results Modification
record.
q
Alphanumeric results modifications work for results which are in alphanumeric format only.
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Numeric Results Modification
o
Creating a new
Numeric Results Modification
to apply a new correction factor to the results received from a particular instrument.
o
Querying for
Numeric Results Modifications
to see the details of numeric modifications.
o
Activating a
Numeric Results Modification
so that this result modification is applied to the values received from the instrument. o
Deactivating a
Numeric Results Modification
so that the result modification is not applied to the results from the selected instrument.
o
Modifying a
Numeric Results Modification
to change the formula settings.
o
Deleting a
Numeric Results Modification
if it is no longer going to be used.
Range Based Results Modification
o
Creating a new
Range Based Results Modification
to define a new range of results to be modified by the system.
o
Querying for
Range Based Results Modifications
to see the details of an existing range for the selected instrument. o
Activating a
Range Based Results Modification
so that it can be applied to the results received from the selected instrument.
o
Deactivating a
Range Based Results Modification
so that it is not applied to the results received from that particular instrument. o
Modifying a
Range Based Results Modification
to change the ranges to which the modification is applied.
o
Deleting a
Range Based Results Modification
if it is no longer going to be used.
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Maintenance Definition
Maintenance Definition
Use this component to define new maintenance tasks, or to maintain information for existing maintenance tasks.
Maintenance tasks can be defined to regulate and control continuous procedures to be executed with the POC instruments, such as cleaning, inspection or service.
To assign a maintenance task in a standardized way, maintenance tasks will be assigned to instrument configurations and not to individual instruments.
o
On the
Periodicity
tab, the values in the
Period
and
Maximum Duration
fields have to be consistent with the selected units (number of tests or time).
Instruments > Maintenance Definition
(
Definition > Maintenance Definition
)
Figure 7-18 Maintenance Definition
screen
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Field description
Periodicity tab
Type
Period
Restart Period
Manually Closable
Date/Time
Reminder tab
Threshold
Reminder Text
Pending tab
User Alarm
Alarm Text cobas IT 1000 application
Measurement unit used to calculate the period of time or number of tests from one maintenance task to the next one.
Frequency of maintenance task performance. It can be either a period of time or a certain number of tests.
If units is set to
Time
, these will be the options: o o
Hourly
Daily
o
Weekly
o
Monthly
o
Annually
When a specific time frequency is selected, it is then necessary to define more specific information below.
If checked the period restarts after the defined number of tests.
Manually closable, i.e. if this check box is selected, this enables you to separately record the start and finish time of the task performed on the instrument. This is recommended for tasks that are relatively long and should be recorded as such.
If unchecked the start time is recorded also as the finish time for the task.
The default setting is unchecked.
It indicates whether the number of tests at the beginning of the next maintenance task is set to zero (0) whenever a maintenance is performed.
Define the period before a warning is generated.
Introduce the text to be displayed by the system.
It indicates whether to create an alarm to be displayed when maintenance tasks are pending.
Introduce the text for the alarm.
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Maintenance Definition
Lockout
QC Alarm
Validation Alarm
It indicates whether the instrument should be locked out when maintenance tasks are pending for a specific instrument.
It indicates what type of alarm the system is to generate in the QC module when a maintenance task is pending.
o
Warning
: an alarm appears in the QC results screen.
You must validate it manually.
o
Error
: the result is not automatically validated. You must validate it manually.
It indicates what type of alarm the system is to generate in the validation process when a maintenance task is pending.
o
Information
: an alarm appears in the
Result Query
screen, test results are automatically validated so they do not appear in the
Validation
screen.
o
Warning
: an alarm appears in the
Result Query
screen, test results are automatically validated so they do not appear in the
Validation
screen.
o
Error
: the result is not automatically validated. You must validate it manually.
Tasks
o
Creating a new maintenance task for the instruments.
o
Querying for maintenance task information to see the details of the selected maintenance task.
o
Activating a maintenance task so that it can later be assigned to an instrument configuration.
o
Deactivating a maintenance task so that it cannot be applied to a configuration.
o
Modifying a maintenance task to edit any of the various parameters of the task.
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Comment Assignment
Comment Assignment
cobas IT 1000 application
Enables you to create new instrument comments, or to maintain information for existing instrument comments (predefined comments). The setup of instruments within the application is used to align the selection of comments for different instrument types. If supported by the instrument type, comments will be made available on individual instruments to provide standardized comments with QC or patient test results reporting.
o
For each comment it can be defined, if it is an “error” comment by selecting the
Mark as Erroneous
check box. If the comment is marked as erroneous, the system displays the
Marked as erroneous by operator (comment)
(
OCE
) alarm.
The alarm must be mapped for this specific instrument type for the system to display it.
u
q
The comment must not be longer than 20 characters for the system to be able to raise the
Marked as erroneous by operator (comment)
alarm. o
More than one comment can be defined for each instrument type and result type combination.
o
Comments must be unique.
o
The
Order of Display
is unique for each instrument type. When changing it for one comment, all other comments will be automatically rearranged.
o
The predefined comments from
System > Comment Definition
screen come already mapped and with predefined display sort order for the
Accu-Chek
Inform
.
u
Instruments > Comment Assignment
(
Definition > Comment Assignment
)
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Comment Assignment
Figure 7-19 Comment Assignment
screen
Prerequisites
o
Instrument types and comments must have been previously defined.
o
Comments can only be set up for instruments supporting the use of comments.
Field definitions
Instrument Type
Comment
Order of Display
Mark as Erroneous
Result Type
Assigned Location(s)
Type of instrument to which the comment applies.
Comment that will appear on screen related to the instruments.
Order in which the comments should appear on screen.
Indicates that the comment is of type error.
Type of result to which the comment is applied.
The locations in which the selected comment will be used.
Tasks
From the
Instruments > Comment Assignment
screen, you can perform the following tasks: o
Create a new instrument comment that can be later used within the instrument module.
o
Query for instrument comments to see the details of the selected comment.
o
Activate an instrument comment so that it is available.
o
Deactivate an instrument comment so that it is not available.
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o
Modify an instrument comment to change any of the settings of an existing comment.
o
Assign location(s) in which the selected comment will be used.
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Off-Line Instruments
Off-Line Instruments
An offline instrument does not have an online connection to the
cobas IT
1000 application, and QC test results are entered manually. Use this component to add new offline instruments, configure them and assign tests.
o
The offline instrument license must be correctly installed (to be acquired separately).
o
All offline instruments are managed in this module. Although the
Instrument
Assignment
and the
Test
screens that can be accessed through this screen look similar to the previously described ones, they are independent screens.
q
Offline instrument type IDs (5 characters) must start with “X_”. Individual offline instruments are always regarded as POCT instruments in RiliBÄK 2008 mode.
Instruments > Off-Line Instruments
Definition > Off-Line Instruments
Figure 7-20 Off-Line Instruments
screen
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Off-Line Instruments
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Field definitions
Instrument types
Type ID
Instrument Type Name
ID code for the offline instrument type that is being created or edited.
Name of the currently active offline instrument type.
Configurations
Configuration ID
Configuration Description
Last Changed
Status
Name of the configuration for the selected offline instrument.
Description of the selected offline instrument configuration.
Date when the selected configuration was last changed
(automatically filled in by the system.)
The status of the instrument.
Tasks
o
Add a new Instrument Type by clicking the
Add
button on the left.
o
Add a new Instrument Type Configuration by clicking the
Add
button on the right.
o
Make a query for Instrument Types or Instrument Type Configurations by clicking the
Filter
button below each grid.
o
Setup the individual instrument configuration by clicking
Add Instrument
. u see
o
Configure the tests associated with the selected Instrument Type Configuration.
u see
Creating a new configuration from an existing one
p
To create a new configuration from an existing one
1
Choose
Instruments > Off-Line Instruments
.
The
Off-Line Instruments
screen is displayed.
2
Double-click an
Instrument Type
from the list on the left.
The configurations defined for the selected instrument type are displayed in the grid on the right.
3
Select the configuration to be copied from the second grid, and than click
Copy
From
.
The Detail area becomes editable.
4
Change the
Name
and
Description
for the new configuration, and click the
OK
button.
The new configuration is saved with the same details as the original one. The tests associated to the newly-created configuration can be changed.
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Table of contents
Quality Control
8 Quality Control
8
In this chapter you find information about: Quality Control, results management,
Levey-Jennings chart, cumulative chart, Levey-Jennings review, linearity review, multirules, manual result entry, QC test mapping.
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Chapter
8
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8 Quality Control
Table of contents
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Quality Control module
Quality Control module
This module provides all functionality required for reviewing and validating quality control results received either from instruments connected to the application, or manually entered into the application.
The
Quality Control
module ensures the quality management for all instruments and related patient test results by generating system warnings and exceptions, and by interacting with the
Materials
and the
Results & Patients
module.
You can review single quality control results graphically through a Levey-Jennings graph. You can compare multiple sets of QC results in the cumulative chart. You can assign individual quality control multirules for different test parameters.
Important operational principles: o
Quality control materials must have been added and reviewed in the
Materials
module.
o
Specific test materials used by each instrument type must have been defined in order to receive QC results from that instrument type.
o
Quality control in this version does not track the unit of measurements. Users must:
O
Configure the correct system unit initially before receiving QC results in
System > Test Definition
.
O
While using the system, do not change the unit as the
Quality Control
module in this version does not take into consideration such a change. If changed, all statistics will be compromised as the system will store results with the new unit of measurement without recalculating in the old unit.
Proficiency testing
Proficiency testing is an external assessment of measurement accuracy. The authorities provide a sample to be measured. The results have to be sent back for evaluation.
cobas IT
1000 application can receive and handle proficiency test results.
Instruments must have been previously configured for proficiency testing. u
q
Proficiency testing is not available for all instruments.
The following principles apply to proficiency test results in
cobas IT
1000 application: o
Proficiency data is displayed in the
Result Management
screen of the
Quality
Control
module as follows:
O
In the
Type
column, proficiency test data is marked as
Proficiency
.
O
In the
Control LOT
column, the sample ID used to process the proficiency sample on the instrument is recorded.
O
In the
Status
column, proficiency data is always marked as
OK
.
O
In the
Review Status
column, proficiency data is always marked as
Accepted
.
O
In the
Alarms
column, there are no system alarms associated with proficiency test data.
O
In the
Graph
column, proficiency test data is not displayed. o
Proficiency data is not used for any other functionality in the
Quality Control
module, i.e. it is not used to review or validate quality control results.
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Quality Control module
o
Proficiency data is not included in reports. u see
o
Proficiency data is not sent to HIS/LIS. o
Proficiency data cannot be printed.
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Result Management
Result Management
Enables you to review QC results that have been transmitted by instruments or that have been entered manually into the application. The detailed status of each QC result is given, based on the automatic result validation performed by the system.
You can manually accept, reject, put on hold or block QC results and their corresponding patients results. When a QC result has been flagged the release of related patient test results is blocked. You can configure multiple rules (“multirules”) that work together to validate or block results automatically.
When a QC result is uploaded from an instrument, it is automatically checked against: o
User: The validation process takes into account the validity of the user that has performed the measurement (i.e. certification, correct user ID, etc.).
o
Material: The validation process takes into account the validity of the material used to perform the measurement (i.e. unknown LOT, expired material, etc.).
o
Instrument: The validation process takes into account instrument flags sent with the test result. This process also checks the comments transferred with the test results.
o
Reference Ranges: The validation process takes into account the QC reference ranges as they have been defined with the materials.
o
Multirules: The validation process takes into account the QC multirules as they have been defined on an instrument and parameter basis.
Operational principles
o
Numeric results are accepted when they are within the defined ranges; alphanumeric results are only accepted when they match the
Target Mean
defined in the
Materials > Lot Management
screen.
o
If an instrument sends an alphanumeric result from a material lot with a numeric range defined, or vice versa, the result is stored in the database, but not accepted.
o
An alarm is displayed if the material lot of the result received is unknown to the system. The new material lot should be set as reviewed in the
Materials > Lot
Management
screen so that the alarm is not displayed when receiving future results. See
o
Only accepted control results are included in statistics. Rejected are not.
Prerequisites
o
Test materials and their lot numbers must have been previously defined and reviewed.
o
To be able to store level information, QC lots must have been previously set up in
Materials > Lot Management
for instruments not transmitting ranges (e.g.
CoaguChek Pro/DM,
Roche Cardiac Reader
, Radiometer 500 series, Radiometer
600 series, Radiometer 700 series,
Urisys
1100, Roche Reflotron Plus,
Roche Reflotron Sprint, Sysmex POCh-100i, ITC Hemochron Jr Signature,
IL GEM Premier 3000, OPTI CCA and ABX Micros CRP).
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Status column
OK.
No errors or warnings occurred.
QC results are automatically accepted and sent to HIS/LIS.
Warning.
There are one or more alarms with severity warning associated to the
QC result or it violated a multirule with severity warning.
QC results are automatically accepted and sent to HIS/LIS.
Error.
There are one or more alarms with severity error associated to the
QC result or it violated a multirule with severity error or it was out of range.
QC results are not automatically accepted and not sent to LIS/HIS. q
Alarms with patient results
o
If a QC result has associated warnings, a QCW system alarm will be raised for related patient results.
o
If a QC result has associated errors, a QCE system alarm will be raised for related patient results.
o
Depending on the mapping of the QCW and QCE system alarms in the
System
> System Alarm Assignment
screen, the patient results will be flagged or blocked.
Review Status column
Result accepted.
Accepted results are automatically sent to the HIS/LIS.
Result rejected.
Rejected QC results are not sent to the HIS/LIS. Results may only be rejected if the measurement is considered to have been not performed correctly. Rejected results are considered to contain no information on patient or instrument.
Result has been put on hold.
Quality Control > Result Management
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Result Management
Figure 8-1 Result Management
screen
If an instrument is deactivated, the QC results transmitted before deactivation are still shown on the
Result Management
screen. The name of the deactivated instrument is still shown in the
Instrument Name
column and can be used as filter criterion.
Graph description
The measured values are displayed in the graph to visualize their status in terms of
QC ranges. The displayed values are color-coded.
Black line
Orange line
Red line
Measured value is within normal range. (Ranges must have been previously defined under
Materials > Lot
Management > Ranges
).
Measured value is out of range.
Measured value is considered as critical low or critical high.
Field definitions
Result Date/Time
Performed by
Validation Date/Time
Validated By
Target Value
Date and time when the QC test was run.
User who run the QC test or entered the result manually.
Date and time when the QC result was validated.
User who validated the QC result.
Current target value for the lot based on initial definitions and pre-calculations based on QC existing results for this instrument test/control/control lot/test lot.
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Range
Result Deviation
Location
# Entries in Statistics
Violated Rules
Current range for the lot based on initial definitions and pre-calculations based on QC existing results for this instrument test/control/control lot/test lot.
Comparison of the result with the target value expressed in a percentage.
Location where the instrument that run the QC test is located.
Number of results for this instrument test/control/ control lot/test lot currently counted for statistics.
Enumeration of the multirules that the current result is violating.
Tasks
o
Managing and validating QC results.
o
Viewing QC results in a Levey-Jennings chart.
o
Viewing QC results in a cumulative chart.
o
Reviewing QC results in a Levey-Jennings chart.
o
Reviewing linearity results in a chart.
o
Adding QC results manually.
o
Setting up QC multirules.
o
Viewing the details of QC results of the selected record.
o
Adding, querying and editing comments to the selected QC result.
Accepting QC results
p
To accept QC results
1
Choose
Quality Control > Result Management
.
QC results are displayed in the List area.
2
Optionally, filter for the QC results you want to accept.
3
Select the result(s) to be accepted, and click the
Accept
button.
Accepted results are automatically sent to the HIS/LIS.
q o
Already rejected results can also be selected, but the action of accepting results only applies to pending and on-hold results.
o
The
Accept
button is disabled unless there is a pending or on-hold result within the selection. q
Note:
Accepting QC results containing invalid characters in the user ID (alarm ID OII) can lead to parsing errors when the data is sent to the HIS/LIS.
s
Rejecting QC results
You reject a result when the measurement has not been performed correctly. Rejected results are considered to contain no information on patient or instrument.
q
It is not possible to reject a previously accepted QC result.
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To reject QC results
1
Choose
Quality Control > Result Management
.
QC results are displayed in the List area.
2
Optionally, filter for the QC results you want to reject.
3
Select the result(s) to be rejected, and click the
Reject
button.
The QC result(s) is rejected. Rejected QC results are not sent to the HIS/LIS.
q o
Already accepted results can also be selected, but the action of rejecting results only applies to pending and on-hold results.
o
The
Reject
button is disabled unless there is a pending or on-hold result within the selection. s
Putting a QC result on hold
You put a QC result on hold to accept or reject it later.
p
To put a QC result on hold
1
Choose
Quality Control > Result Management
.
QC results are displayed in the List area.
2
Optionally, filter for the QC results you want to put on hold.
3
Select the result(s) to be put on hold, and click the
Hold
button.
The QC result(s) is put on hold.
s
Blocking a test result
Block sets QC status of the instrument to “lock”, which triggers QCE alarms with patient results.
p
To block a test result
1
Choose
Quality Control > Result Management
.
QC results are displayed in the List area.
2
Optionally, filter for the test result you want to block.
3
Select the result(s) to be blocked, and click the
Block
button.
The test result(s) is blocked.
s
Releasing a test result
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p
To release a test result
1
Choose
Quality Control > Result Management
.
QC results are displayed in the List area.
2
Optionally, filter for the test result you want to release.
3
Select the result(s) to be released, and click the
Release
button.
The test result(s) is released.
s
Viewing QC alarms details
p
To view QC alarms details
1
Choose
Quality Control > Result Management
.
The
Result Management
screen is displayed.
2
Optionally, filter for the QC result for which you want view alarms.
3
In the List area, click the
Alarms
column.
The
Alarm description
window is displayed.
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Levey-Jennings Chart
Levey-Jennings Chart
CAUTION
This component enables to view up to three different Levey-Jennings charts based on customized filters like date range, instrument type, instrument name, test, test material, test lot, control, control lot and level.
A detailed analysis of the QC statistics for each of the selected QC data is provided.
If a field of the three chart selections is selected/un-selected, the specific chart is displayed/removed.
Statistics
r
The displayed statistics are calculated based on accepted results for the whole set of data and not on the selected date range.
r
If a selected combination of instrument, lot and level does not have any accepted results, no row for the selection will be shown in the statistics.
Quality Control > Levey-Jennings Chart
Figure 8-2 Levey-Jennings Chart
screen
NOTICE
Graph
Graph also includes non-accepted results.
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Field definitions
M (exp) cobas IT 1000 application
N
M
SD
CV
Bias
The target mean of the QC results. The result for the expected mean is rounded to one more decimal than defined for each test
Number of measurements.
Calculated mean. The result of the mean is rounded to one more decimal than defined for each test and unit, see
Standard deviation. The result of the standard deviation is rounded to one more decimal than defined for each test and unit, see
Percent value of the standard deviation.
Relative deviation of the calculated mean from the expected mean.
Viewing a Levey-Jennings chart
You can view details of a given individual point in the chart by pointing to it.
p
To view a Levey-Jennings chart
1
Choose
Quality Control > Levey-Jennings Chart
.
2
Fill in the fields at the top of the screen to filter the chart. The fields must be filled from left to right because each selection restricts the next one.
3
Select the date range to be shown and the type of view (
Each
,
Daily
or
Monthly
), and click the
Show
button.
The chart is displayed at the bottom of the screen according to the set values.
Statistics for each chart indicating the mean and standard deviation for the selected period of time are displayed above the chart.
s
Printing a Levey-Jennings chart
p
To print a Levey-Jennings chart
1
Choose
Quality Control > Levey-Jennings Chart
.
2
Fill in the fields at the top of the screen to filter the chart. The fields must be filled from left to right because each selection restricts the next one.
3
Select the date range to be shown and the type of view (
Each
,
Daily
or
Monthly
), and click the
Show
button.
The chart is displayed at the bottom of the screen according to the set values.
Statistics for each chart indicating the mean and standard deviation for the selected period of time are displayed above the chart.
4
Click
.
A PDF file with the set values and the chart is opened.
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In the PDF file click
.
A report is sent to the printer.
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Cumulative Chart
Cumulative Chart
cobas IT 1000 application
This component enables you to view a cumulative chart of QC results, based on customized filters for instrument type, instrument name, test, control material, and control lot, test material, test lot and level. The application provides a detailed analysis of the QC statistics for each cumulative data point.
The
Quality Control
module is constantly cumulating statistical information; therefore, the information displayed is always updated.
Prerequisites
Instrument type, instrument name, test, QC and QC lot must have been previously defined.
Quality Control > Cumulative Chart
Figure 8-3 Cumulative Chart
screen
Viewing the cumulative chart
You can view details of a given individual point in the chart by pointing to it.
p
To view the cumulative chart
1
Choose
Quality Control > Cumulative Chart
.
2
Fill in the fields at the top of the screen to filter the chart. The fields must be filled from left to right because each selection restricts the next one.
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Cumulative Chart
3
Click the
Show
button.
The chart is displayed at the bottom of the screen according to the set values.
Statistics for each chart indicating the mean and standard deviation for the selected period of time are displayed above the chart.
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Levey-Jennings Review
Levey-Jennings Review
cobas IT 1000 application
Review of QC data by means of Levey-Jennings charts is rated as the gold standard to distinguish between random and systematic errors in the field of laboratory and point of care testing. Ensure that all instruments, tests and QC have been properly reviewed and none were missed.
This component provides a list of all monthly Levey-Jennings charts that can be generated. Use this component to review all QC test combinations in a systematic approach, based on a monthly review schedule. The review will be documented by the system. Individual comments can be added to each of the Levey-Jennings charts.
o
Status icons in the list are color-coded:
O
red:
it indicates that the specific monthly chart has not yet been accepted, or that changes have been introduced after acceptance.
O
yellow:
it indicates that the chart cannot yet be generated, most frequently because the month is not yet finished so not all results are available.
O
green:
it indicates that the chart has already been accepted o
Status icons in the list get a yellow frame, if a comment was added to the Levey-
Jennings chart.
o
Accepted charts in the list (green icon) show you, who accepted them and when they were accepted.
Quality Control > Levey-Jennings Review
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Levey-Jennings Review
Figure 8-4 Levey-Jennings Review
screen
If a result has comments associated, a page icon is shown next to the corresponding data point in the L-J chart. The user can mouse over the comment to see the comment and information about the result is was associated with.
From this screen you can open the
Comment
screen to add, query or edit comments to the selected L-J chart.
Displaying Levey-Jennings charts
p
To display Levey-Jennings charts
1
Choose
Quality Control > Levey-Jennings Review
.
2
In the list, select the month to be shown.
The chart of the selected month appears at the bottom of the screen.
3
If necessary, accept a chart or add comments to it.
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Accepting Levey-Jennings charts
cobas IT 1000 application
p
To accept Levey-Jennings charts
1
Choose
Quality Control > Levey-Jennings Review
.
2
In the list, select the month whose chart will be accepted.
The chart of the selected month appears at the bottom of the screen.
3
Click the
Accept
button.
The icon in this list entry turns green.
s
Printing Levey-Jennings charts
p
To print Levey-Jennings charts
1
Choose
Quality Control > Levey-Jennings Review
.
2
In the list, select the month for which you want to print the chart.
The chart of the selected month appears at the bottom of the screen.
3
Click the
button.
The
Document Settings
window is displayed.
4
Define the PDF settings and choose the
OK
button.
A PDF file opens containing information about the selected record, statistics, and the Levey-Jennings chart.
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Levey-Jennings Review by Lot
Levey-Jennings Review by Lot
This component is based on the
Levey-Jennings Review
. The differentiation is that the grouping factor is the lot.
u
q
The acceptance of a record in the
Levey-Jennings Review by Lot
screen has no effect on the other
Levey-Jennings Review
screens.
Quality Control > Levey-Jennings Review by Lot
Figure 8-5 Levey-Jennings Review by Lot
screen q
Note:
The number of results (N) displayed in the
Levey-Jennings Review by Lot
screen may differ from the number displayed in the
Quality control > Result management
screen. This discrepancy happens when you assign an instrument to a new site. The results of the reassigned instrument are also assigned to the new site and are no longer displayed for the old site in the
Quality control > Result management
window. By contrast, all results generated by the instrument are still displayed in the
Levey-Jennings Review by
Lot
window.
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q
When reviewing by lot the graph only displays dots without connectivity lines to increase readability.
From this screen you can open the
Comment
screen to add, query or edit comments to the selected L-J chart by lot.
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Linearity Review
8 Quality Control
Linearity Review
Use this component to review linearity runs by means of linearity charts, including target values and allowed deviations. For the identification of linearity runs, the application groups all linearity results of the same instrument done on the same day using the same lots into a chart. The component provides a list-view to show all linearity charts that can be generated.
Use this component to review all linearity test results in a systematic approach. The review will be documented by system, and individual comments can be added to each of the linearity charts.
Above the chart, detailed data of the selected linearity run is displayed.
o
Status icons in the list are color-coded:
O
red:
it indicates that the specific daily chart has not yet been accepted, or that changes have been introduced after acceptance.
O
yellow:
it indicates that the chart cannot yet be generated, most frequently because the calendar day on which the results were received is not yet over, so some results may not be available, and the graph may not be complete.
O
green:
it indicates that the chart has already been accepted o
Status icons in the list get a yellow frame, if a comment was added to the Levey-
Jennings chart.
o
Accepted charts in the list (green icon) show you, who accepted them and when they were accepted.
Quality Control > Linearity Review
Figure 8-6 Linearity Review
screen
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Graph description
x-axis y-axis
Grey dashed line
Blue dots
Blue dashed line/graph
Light blue shaded area
Target values. Measurement unit as 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.
From this screen you can open the
Comment
screen to add, query and edit comments to the selected linearity chart.
Displaying linearity charts
The number shown in the information window regarding QC pending linearity graphs, indicates how many different instrument linearity levels are pending review.
p
To display linearity charts
1
Choose
Quality Control > Linearity Review
.
2
In the list, select the day for which you want to display the linearity chart.
The chart of the selected day appears at the bottom of the screen.
3
If necessary, accept a chart or add comments to it.
s
Accepting linearity charts
p
To accept linearity charts
1
Choose
Quality Control > Linearity Review
.
2
In the list, select the day for which you want to accept the linearity chart.
The chart of the selected day appears at the bottom of the screen.
3
Click the
Accept
button.
The icon in this list entry turns green.
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Linearity Review
Printing a linearity chart
p
To print a linearity chart
1
Choose
Quality Control > Linearity Review
.
2
In the list, select the day for which you want to print the linearity chart.
The detailed data and the chart of the selected day appears at the bottom of the screen.
3
Click the
button.
The detailed data and the chart are printed.
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Multirules
Multirules
cobas IT 1000 application
Multirules are used to considerably extend the single value determination of QC test results, and to allow a sensitive detection of multiple kinds of instrument QC error trends and variations. A wide range of common QC rules, such as 1-2s, 2-2s, R-4s,
10x and others are supported by the application, and can be combined with multirules at an instrument and parameter level. Use this component to assign new multirules, or to change existing multirules definitions.
Use this component to assign new multirules, or to change existing multirules definitions.
o
If a rule is not to be executed, leave it inactive.
o
Rules must be unique.
o
Click the blue box once to activate a warning and the warning icon will appear.
o
Click the blue box twice to activate an error and the error icon will appear.
Icons in this screen
Active warning. An MRW system alarm is raised if the rule is violated.
u
Depending on the mapping of the MRW system alarm in the
System > System Alarm Assignment
screen, the QC test result is flagged or blocked.
u
Active error. An MRE system alarm is raised if the rule is violated.
u
Depending on the mapping of the MRE system alarm in the
System > System Alarm Assignment
screen, the QC test result is flagged or blocked.
u
q
Alarms with patient results
o
A flagged QC result, i.e. a QC result with associated warnings, will raise an QCW system alarm with related patient results.
o
A blocked QC result, i.e. a QC result with associated errors, will raise an QCE system alarm with related patient results.
o
Depending on the mapping of the QCW and QCE system alarms in the
System
> System Alarm Assignment
screen, the patient results will be flagged or blocked.
Selection of
Apply Rules to
option determines which fields in the Detail area are enabled:
Apply Rules To option
Selected instrument test
Instrument Type Instrument Name Test
Table 8-1
Fields are enabled according to the option in
Apply Rules To
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Apply Rules To option
All tests of selected instrument
Instrument Type Instrument Name Test
All instruments of selected type
Selected test
Table 8-1
Fields are enabled according to the option in
Apply Rules To
Prioritization of rules
More specific rules have priority over less specific ones, meaning if more than one rule can be applied to one single result, only the most specific rule is applied. Priority is set as follows: o
Instrument Type
,
Instrument Name
and
Test
o
Instrument Type
and
Instrument Name
o
Instrument Type
o
Test
Quality Control > Multirules
Figure 8-7 Multirules
screen
Tasks
o
Adding a new instrument type rule, instrument rule or instrument test rule so that they can be used with the different instrument types connected to the system.
o
Querying for rule definitions to see the details assigned to one specific rule.
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o
Modifying an existing rule definition in the database.
o
Deleting a rule definition stored in the database that shall no longer be used.
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Manual Result Entry
Manual Result Entry
This component enables you to enter and maintain QC test results which are processed on instruments or workplaces not connected to the
cobas IT
1000 application. Manually entered QC results are processed internally the same as if they had been transferred from an online instrument via an electronic interface.
Saved results cannot be edited. Enter results before adding comments.
Quality Control > Manual Result Entry
(
Configuration > Manual Result Entry
)
Figure 8-8 Manual Result Entry
screen
Entering a QC result manually
You enter a QC result manually for those instruments that are not connected to the
cobas IT
1000 application. You can also add comments to the manually entered QC results. If a record is modified but no result is introduced yet the changes are saved when clicking
OK
but the record still appears in the grid. No date or time is introduced. The system fills out these fields automatically.
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p
To enter a QC result manually
1
Choose
Quality Control > Manual Result Entry
.
2
Fill out the fields at the top of the screen to filter the search, and click the
Add
button.
The system displays those records matching the information introduced in the fields above that do not have any results.
3
Select the QC result for which you want to enter the result value manually, and then click the
OK
button.
The result is saved in the database.
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QC Test Mapping
QC Test Mapping
This screen is used to map individual tests with generic tests. Generic tests are used in instrument types that can run several types of tests (such as blood gas instruments) but use one QC test only. By mapping these tests to an already defined generic test of an instrument type, the QC result is valid for all — the generic and the mapped tests.
One test can only be assigned to an instrument type once, but it can be assigned to different instrument types more than once.
Prerequisites
o
Instruments must be previously defined in the database.
o
Tests must be previously defined in the database. Generic tests must be created in order to map instrument tests to them.
o
A test material must be previously created for the generic test. A QC material must be previously associated with the test material and the generic test.
Quality Control > QC Test Mapping
(
Configuration > QC Test Mapping
)
Figure 8-9 QC Test Mapping
screen
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QC Test Mapping
Querying for an existing mapping configuration
cobas IT 1000 application
You check existing mapping definitions to see the tests assigned to a specific generic test.
p
To query for an existing mapping configuration
1
Choose
Quality Control > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area
2
Expand the instrument type and select the generic test to be checked.
All the tests associated to this generic test are displayed in the List area on the right.
s
Adding a generic test
p
To add a generic test
1
Choose
Quality Control > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area
2
Click
Add
.
3
Choose the instrument type from the list in the Detail area, and click the magnifying glass to access the
Test Selection
screen
4
In the
Test Selection
screen, select the generic test and click
OK
.
The
Test Selection
screen is closed and the system goes back to the
QC Test
Mapping
screen.
5
Click
OK
.
s
Mapping tests to existing generic tests
It enables you to add a new test to an already existing generic test.
p
To map tests to existing generic tests
1
Choose
Quality Control > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area
2
Expand the instrument type branch where you find the generic test, select the generic test to which a test is to be added, and then click
Add
.
The
Test Selection
screen is displayed.
3
Choose the instrument type from the list in the Detail area, and click the magnifying glass to access the
Test Selection
screen
4
Select the test or tests to be added from the list, and click
OK
.
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QC Test Mapping
Deleting a generic test
It enables you to delete a generic test associated with an instrument type and all the associated test mappings. This does not erase the test definition from the system.
p
To delete a generic test
1
Choose
Quality Control > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area
2
Expand the instrument type branch where you find the generic test, select the generic test to be deleted, and then click
Delete
.
3
On the confirmation message, click
OK
.
The test is removed from the tree structure and is no longer a generic test for the current instrument type.
s
Deleting a test mapping
It enables you to delete a test associated to a generic test if it is no longer to be mapped with that generic test. This does not delete the test definition from the system p
To delete a test mapping
1
Choose
Quality Control > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area
2
Expand the instrument type branch where you find the generic test, select the generic test from which a test mapping will be removed, select the test to be removed and then click
Delete
.
3
On the confirmation message, click
OK
.
The test mapping is deleted.
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Table of contents
Quality Control (RiliBÄK)
9 Quality Control (RiliBÄK)
9
In this chapter you find information about: Quality Control (RiliBÄK 2008), results management, Levey-Jennings chart, cumulative chart, Levey-Jennings review, manual result entry RiliBÄK test assignment, Result Alarm Monitor, QC Test
Mapping, RMSE Alarm Monitor, Effective QC Range Review, and QC test mapping.
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In this chapter
Chapter
9
317
9 Quality Control (RiliBÄK)
Table of contents
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Activating a warning on un-reviewed effective QC ranges................................... 354
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Quality Control (RiliBÄK) module
Quality Control (RiliBÄK) module
As of April 1st 2008 new quality control regulations came in to effect, according to the standards prescribed by the German medical association. RiliBÄK 2008 quality control mode enables institutions to perform quality control procedures accordingly.
The
Quality Control (RiliBÄK)
module provides all functionality required for reviewing and controlling quality test results either received from instruments connected to the application, or quality control results that have been entered manually into the application. By the generation of system warnings and exceptions, as well as by interacting with the material and the test module, the RiliBÄK module assures the quality management for all instruments and related patient test results.
Besides reviewing single quality control results, it is possible to graphically review multiple results by use of a Levey-Jennings graph, or to compare multiple sets of QC results by use of the cumulative chart.
When configuring the system, a time period must be defined for QC tests to be run. If an instrument has not run the defined tests within the established period of time, results are flagged. Likewise, results are also flagged if no scheduler is defined for that specific instrument and test.
Prerequisites
Quality control materials must have been added in the
Materials
module.
o
Specific test materials used by each instrument type must have been defined in order to receive QC results from that instrument type.
o
When modifying a QC range ensure that the lab established deviation is within the modified QC range.
Proficiency testing
Proficiency testing is an external assessment of measurement accuracy. The authorities provide a sample to be measured. The results have to be sent back for evaluation.
cobas IT
1000 application can receive and handle proficiency test results.
Instruments must have been previously configured for proficiency testing. u
q
Proficiency testing is not available on all instruments. Refer to the release notes of the individual instruments for details.
The following principles apply to proficiency test results in
cobas IT
1000 application: o
Proficiency data is displayed in the
Result Management
screen of the
Quality
Control
module as follows:
O
In the
Type
column, proficiency test data is marked as
Proficiency
.
O
In the
Control LOT
column, the sample ID used to process the proficiency sample on the instrument is recorded.
O
In the
Status
column, proficiency data is always marked as
OK
.
O
In the
Review Status
column, proficiency data is always marked as
Accepted
.
O
In the
Alarms
column, there are no system alarms associated with proficiency test data.
O
In the
Graph
column, proficiency test data is not displayed. o
Proficiency data is not used for any other functionality in the
Quality Control
module, i.e. it is not used to review or validate quality control results.
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Quality Control (RiliBÄK) module
o
Proficiency data is not included in reports. u see
o
Proficiency data is not sent to HIS/LIS. o
Proficiency data cannot be printed.
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Result Management
Result Management
Enables you to review QC results that have been transmitted from the instruments or that have been added manually to the application. The detailed status of each QC result is given, based on the automatic result validation performed by the system.
Manual review of QC can be performed by accepting, rejecting or blocking the individual results. A direct interaction to related patient test results is given with the block and release functionality in case a QC result for a certain instrument has been flagged. With the ability to define ranges for individual tests, the automatic QC validation procedure considerably extends the commonly used single value determination, and allows the sensitive detection of various kinds of instrument QC error trends or variations.
When a QC result is uploaded from an instrument, it is automatically checked against: o
User: The validation process takes into account the validity of the user that has performed the measurement (i.e. certification, correct user ID, etc.).
o
Material: The validation process takes into account the validity of the material used to perform the measurement (i.e. unknown LOT, expired material, etc.).
o
Instrument: The validation process takes into account instrument flags sent with the test result. This process also checks the comments transferred with the test results.
o
Reference Ranges: The validation process takes into account the QC reference ranges as they have been defined with the materials.
o
Column 3a limit: The validation process takes into account the column 3a limit as it has been defined on test basis.
Evaluation of pre-migration results
Please note: QC results received after migration from RiliBÄK 2001 to RiliBÄK 2008 are always evaluated using the RiliBÄK 2008 rule set, independent of whether the result has been done before the migration (but transmitted after migration) or whether it has been actually done after the migration.
Operational principles
o
Test materials and their lot numbers must have been previously defined.
o
To be able to store level information, QC lots must have been previously set up in
Materials > Lot Management
for instruments not transmitting ranges (e.g.
CoaguCheck XS Pro/DM,
Roche Cardiac Reader
, Radiometer 500 series,
Radiometer 600 series, Radiometer 700 series, Urisys 1100, Roche Reflotron Plus,
Roche Reflotron Sprint, Sysmex POCh-100i, ITC Hemochron Jr Signature, IL
GEM Premier 3000, OPTI CCA and ABX Micros CRP).
o
Comments must be added to a result before rejecting it.
o
An alarm is displayed if the material lot of the result received is unknown to the system. The new material lot should be set as reviewed in the
Materials > Lot
Management
screen so that the alarm is not displayed when receiving future results.
o
Accepted control results are included in statistics while rejected results are not.
Quality Control (RiliBÄK) > Result Management
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Result Management
cobas IT 1000 application
Figure 9-1 Result Management
screen
If an instrument is deactivated, the QC results transmitted before deactivation are still shown on the
Result Management
screen. The name of the deactivated instrument is still shown in the
Instrument Name
column and can be used as filter criterion.
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Result Management
Graph description
The measured values are displayed in the graph to visualize their status in terms of
QC ranges. The displayed values are color-coded.
Black line
Orange line
Red line
Measured value is within normal range. (Ranges must have been previously defined under
Materials > Lot
Management > Ranges
).
Measured value is out of range.
Measured value is considered as critical low or critical high.
Field definitions (List area)
Test LOT
Control Material ID
Control LOT
Date & Time
Review Status
Alarms
Level
Value
Test reagent lot.
The control material used in the follow-up test.
The control material lot.
The date and time at which the follow-up result was received.
Alarm status symbol. This shows whether the test has triggered any alarms. For further information on alarm status symbols see
Review status of the test result (
Accepted
,
Rejected
,
On
Hold
or
Pending
).
Alarm texts associated with follow-up test result.
QC level.
Follow-up QC result value.
Field definitions (Detail area)
Result Date/Time
Performed by
Validation Date/Time
Validated By
Target Value
Range
Result Deviation
Location
# Entries in Statistics
Violated Rules
Date and time when the QC test was run.
User who run the QC test or entered the result manually.
Date and time when the QC result was validated.
User who validated the QC result.
Current target value for the lot based on initial definitions and pre-calculations based on QC existing results for this instrument test/control/control lot/test lot.
Current range for the lot based on initial definitions and pre-calculations based on QC existing results for this instrument test/control/control lot/test lot.
Comparison of the result with the target value expressed in a percentage.
Location where the instrument that run the QC test is located.
Number of results for this instrument test/control/ control lot/test lot currently counted for statistics.
Enumeration of the multirules that the current result is violating.
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Result Management
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Tasks
o
Selecting multiple results in a list.
o
Viewing, accepting, rejecting, holding, and releasing QC results.
o
Blocking an instrument test.
o
Viewing follow-up QC results.
o
Viewing, editing and deleting comments on a selected QC result.
o
Adding a comment to selected QC results.
o
Viewing result related QC alarms.
q
If a result already contains a comment, e.g. that was entered at the instrument, you are not required to enter any further comment before rejecting a result.
Selecting multiple results in a list
p
To select multiple results in a list
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Do one of the following: o
To select all results in the list, click [Ctrl]+A.
or, o
To select a range of results, click the first result you want to select, then while pressing the [Shift] key click the last result that you want to select.
or, o
To select individual results, press the [Ctrl] key and click the results you want to select. s
Viewing follow-up QC results
A follow up result is a non-rejected result from the same instrument, with the same test, and done after the original test.
p
To view follow-up QC results
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Select the QC result for which you want to view follow-up results.
3
Click the
Follow-up
button.
The
Follow-up results
dialog opens
4
To return to the previous window use the back-arrow.
s
Viewing and editing a QC result comment
p
To view and edit a QC result comment
1
Choose
Quality Control (RiliBÄK) > Result Management
.
QC results are displayed in the Work area.
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Result Management
2
Enter search criteria to narrow down the returned number of results and click
Filter
.
3
Select the result or results for which you want to view or edit a comment, and click the
Comment
button and view or edit your comment.
4
Click
OK
to save.
5
To exit without saving your changes, click
Cancel
.
s
Adding a comment to a QC result
p
To add a comment to a QC result
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Select the result to which you want to comment.
3
Click the
Add Comment
button.
The
Add Comment
dialog opens.
4
Select one or more appropriate comments from the
Predefined
list of comments and/or type your own comments in the
Free Text
field.
5
Click
OK
to save.
6
To exit without saving your changes, click
Cancel
.
s
Accepting QC results
Accepted results are automatically sent to the HIS/LIS.
For each accepted QC result with an RBE alarm an alarm will be logged in the
Quality Control (RiliBÄK) > Result Alarm Monitor
component.
q
It is not possible to reject a previously accepted QC result.
p
To accept QC results
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Optionally, filter for the QC results you want to accept.
3
Select the result(s) to be accepted, and click the
Accept
button.
Accepted results are automatically sent to the HIS/LIS.
q
Note:
Accepting QC results containing invalid characters in the user ID (alarm ID OII) can lead to parsing errors when the data are sent to the HIS/LIS.
s
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Result Management
Rejecting QC results
cobas IT 1000 application
You reject a result when the measurement has not been performed correctly. Rejected results are considered to contain no information on patient or instrument.
p
To reject QC results
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Optionally, filter for the QC results you want to reject.
3
Select the result(s) to be rejected, and click the
Reject
button.
The QC result(s) is rejected. Rejected QC results are not sent to the HIS/LIS.
s
Putting a QC result on hold
You put a QC result on hold to accept or reject it later.
p
To put a QC result on hold
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Optionally, filter for the QC results you want to put on hold.
3
Select the result(s) to be put on hold, and click the
Hold
button.
The QC result(s) is put on hold.
s
Blocking a test result
NOTICE
Block sets QC status of the instrument to “lock”, which triggers QCE alarms with patient results.
Wrongly calculated RMSE warning
Rejected but blocked QC results still count for the calculation of RMSE warnings until released by the user.
r
Do not reject and block QC results at the same time. p
To block a test result
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Optionally, filter for the test result you want to block.
3
Select the result(s) to be blocked, and click the
Block
button.
The test result(s) is blocked.
s
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Result Management
Releasing a test result
Release sets the QC status of the instrument test to “unlocked”, which triggers QCE alarms with patient results.
p
To release a test result
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Optionally, filter for the test result you want to release.
3
Select the result(s) to be released, and click the
Release
button.
The test result(s) is released.
s
Viewing QC alarms details
p
To view QC alarms details
1
Choose
Quality Control (RiliBÄK) > Result Management
.
2
Optionally, filter for the QC result for which you want view alarms.
3
In the List area, double-click the alarm codes in the
Alarms
column.
The
Alarm Description
window is displayed.
s
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Levey-Jennings Chart
Levey-Jennings Chart
cobas IT 1000 application
For full quality control process, monthly Levey-Jennings charts must be accepted on the
Levey-Jennings Review
screen.
Use this component to view up to three different Levey-Jennings charts based on customized filters like date range, instrument type, instrument name, test, test material, test lot, control, control lot and level. You can view a detailed analysis of the
QC statistics for each of the selected QC data is provided.
q
If a field of the three chart selections is selected/un-selected, the specific chart is displayed/removed.
Quality Control (RiliBÄK) > Levey-Jennings Chart
Figure 9-2 Levey-Jennings Chart
screen
Field definitions
M (exp)
N
M
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The target mean of the QC results. The result for the expected mean is rounded to one more decimal than defined for each test and unit, in
Number of measurements.
Calculated mean. The result of the mean is rounded to one more
decimal than defined for each test and unit, in
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SD
CV
Bias
9 Quality Control (RiliBÄK)
Levey-Jennings Chart
Standard deviation. The result of the standard deviation is rounded to one more decimal than defined for each test and unit,
Percent value of the standard deviation.
Relative deviation of the calculated mean from the expected mean.
Viewing a Levey-Jennings chart
You can view details of a given individual point in the chart by pointing to it.
p
To view a Levey-Jennings chart
1
Choose
Quality Control (RiliBÄK) > Levey-Jennings Chart
.
2
Fill in the fields at the top of the screen to filter the chart. The fields must be filled from left to right because each selection restricts the next one.
3
Select the date range and the chart dots to be shown (
Each
,
Daily
,
Weekly
or
Monthly
), and click the
Show
button.
The chart is displayed at the bottom of the screen according to the set values, statistics for each chart indicating the mean and standard deviation for the selected period of time are displayed above the chart.
s
Printing a Levey-Jennings chart
p
To print a Levey-Jennings chart
1
Choose
Quality Control (RiliBÄK) > Levey-Jennings Chart
.
2
Fill in the fields at the top of the screen to filter the chart. The fields must be filled from left to right because each selection restricts the next one.
3
Select the date range to be shown and the type of view (
Each
,
Daily
,
Weekly
or
Monthly
), and click the
Show
button.
The chart is displayed at the bottom of the screen according to the set values.
Statistics for each chart indicating the mean and standard deviation for the selected period of time are displayed above the chart.
4
Click
.
A PDF file with the set values and the chart is opened.
5
In the PDF file click
.
A report is sent to the printer.
s
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Cumulative Chart
Cumulative Chart
cobas IT 1000 application
This component enables you to view a cumulative chart of QC results, based on customized filters for instrument type, instrument name, test, control material, and control lot, test material, test lot and level. The application provides a detailed analysis of the QC statistics for each cumulative data point.
Instrument type, instrument name, test, control and control lot must have been previously defined.
The QC module is constantly cumulating statistical information; therefore, the information displayed is always updated.
q
If no specific value is selected in a drop-down field QC performance can be compared
Quality Control (RiliBÄK) > Cumulative Chart
Figure 9-3 Cumulative Chart
screen
Viewing the cumulative chart
You can view details of a given individual point in the chart by pointing to it.
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Cumulative Chart
p
To view the cumulative chart
1
Choose
Quality Control (RiliBÄK) > Cumulative Chart
.
2
Fill in the fields at the top of the screen to filter the chart. The fields must be filled from left to right because each selection restricts the next one.
3
Click the
Show
button.
The chart is displayed at the bottom of the screen according to the set values, statistics indicating the mean and standard deviation are displayed above the chart.
s
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Levey-Jennings Review
Levey-Jennings Review
cobas IT 1000 application
Review of QC data by means of Levey-Jennings charts is rated as the gold standard to distinguish between random and systematic errors in the field of laboratory and point of care testing. Ensure that all instruments, tests and QC have been properly reviewed and none were missed.
This component provides a list of all monthly Levey-Jennings charts that can be generated. Use this component to review all QC test combinations in a systematic approach, based on a monthly review schedule. The review will be documented by the system. Individual comments can be added to each of the Levey-Jennings charts.
o
Status icons in the list are color-coded:
O
red:
it indicates that the specific monthly chart has not yet been accepted, or that changes have been introduced after acceptance.
O
yellow:
it indicates that the chart cannot yet be generated, most frequently because the month is not yet finished so not all results are available.
O
green:
it indicates that the chart has already been accepted o
Status icons in the list get a yellow frame, if a comment was added to the Levey-
Jennings chart.
o
Accepted charts in the list (green icon) show you, who accepted them and when they were accepted.
Quality Control (RiliBÄK) > Levey-Jennings Review
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Levey-Jennings Review
Figure 9-4 Levey-Jennings Review
screen
From this screen you can open the
Comment
screen to add, query or edit comments to the selected L-J chart.
Displaying Levey-Jennings charts
p
To display Levey-Jennings charts
1
Choose
Quality Control (RiliBÄK) > Levey-Jennings Review
.
2
In the table, select the month to be shown.
The chart of the selected month appears at the bottom of the screen.
3
If necessary, accept a chart or add comments to it.
s
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Levey-Jennings Review
Accepting Levey-Jennings charts
cobas IT 1000 application
p
To accept Levey-Jennings charts
1
Choose
Quality Control (RiliBÄK) > Levey-Jennings Review
.
2
In the list, select the month whose chart will be accepted.
The chart of the selected month appears at the bottom of the screen.
3
Click the
Accept
button.
The icon in this list entry turns green which means the chart is accepted.
s
Printing Levey-Jennings charts
p
To print Levey-Jennings charts
1
Choose
Quality Control (RiliBÄK) > Levey-Jennings Review
.
2
In the table, select the month for which you want to print the chart.
The chart of the selected month appears at the bottom of the screen.
3
If necessary, accept a chart or add comments to it.
4
Click the
button.
s
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Manual Result Entry
Manual Result Entry
This component enables you to enter and maintain QC test results which are processed on instruments or workplaces not connected to the
cobas IT
1000 application. Manually entered QC results are processed internally the same as if they had been transferred from an online instrument via an electronic interface.
Saved results cannot be edited. Enter results before adding comments.
Quality Control (RiliBÄK) > Manual Result Entry
(
Configuration > Manual Result Entry
)
Figure 9-5 Manual Result Entry
screen
Entering a QC result manually
You enter a QC result manually for those instruments that are not connected to the
cobas IT
1000 application. You can also add comments to the manually entered QC results.
If a record is modified but no result is introduced yet the changes are saved when clicking
OK
but the record still appears in the grid. No date or time is introduced.
The system fills out these fields automatically
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Manual Result Entry
cobas IT 1000 application
p
To enter a QC result manually
1
Choose
Quality Control (RiliBÄK) > Manual Result Entry
.
2
Fill out the fields at the top of the screen to filter the search, and click the
Add
button.
The system displays those records matching the information introduced in the fields above that do not have any results.
3
Select the QC result for which you want to enter the result value manually, and then click the
OK
button.
The result is saved in the database.
s
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RiliBÄK Test Assignment
RiliBÄK Test Assignment
You must first map Quality Control (RiliBÄK) tests with tests defined in the system, so that the quality control process using the materials defined for each test can have an associated range that is the basis for QC validation.
Quality Control (RiliBÄK) > RiliBÄK Test Assignment
Figure 9-6 RiliBÄK Test Assignment
screen
Use this component to map Quality Control (RiliBÄK) tests with system tests. Some tests are already defined by default, however, users may change these definitions and add new ones from this screen. Here, you can also define the parameters for RiliBÄK quality control process.
o
System tests must be previously defined.
o
Ranges can be defined in absolute values (ABS) or in percentage (%).
o
Each Quality Control (RiliBÄK) test can have more than one system test assigned.
o
But each system test can only belong to one Quality Control (RiliBÄK) test.
o
Quality Control (RiliBÄK) test ranges cannot be deactivated, but should be deleted instead.
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RiliBÄK Test Assignment
cobas IT 1000 application
o
If two defined ranges overlap, the system applies the most specific one in the validation process.
o
When a Quality Control (RiliBÄK) test mapping is activated or deactivated the mapping and all the associated ranges are activated or deactivated.
Field definitions
RiliBÄK test
Target type
Column 3 limit
Column 3a limit
Range type
Range
(upper fields in Detail area)
Range
(lower fields in Detail area)
Lab Unit
Measurement
Name of the RiliBÄK test. The term “RiliBÄK test” refers to the tests for which an allowed deviation is specified in the RiliBÄK 2008 Table B 1.
Target type as defined in the RiliBÄK regulations.
SW - Verfahrensabhängiger Sollwert
RMW - Referenzmethodenwert
The maximum extent to which the calculated RMSE is allowed to deviate from the target. (Called Column 3 because it refers to column 3 for tests listed in table B 1 of the 2008 RiliBÄK regulations.
Limit for effective QC range, applied to QC results for raising alarms.
Specifies whether the defined range is absolute (
ABS
) or relative (
%
).
Note:
If the target is set to zero, then the corresponding
RiliBÄK test needs to be specified as absolute (
ABS
) range type.
Define the lower limit (= from value) of the QC range.
Inserted values are assigned to the
Op.
and
Range
columns in the
RiliBÄK Test Assignment
screen.
Note:
If the QC range has no lower limit, leave these fields empty and specify the upper limit of the QC range as “< x” or “<= x” (see below).
Define the upper limit (= to value) of the QC range.
Inserted values are assigned to the
To Op.
and
To Range
columns in the
RiliBÄK Test Assignment
screen.
Note:
If the QC range has no upper limit, leave these fields empty and specify the lower limit of the QC range as “> x” or “>= x” (see above).
The field is currently not applicable.
Measurement unit of the RiliBÄK test.
q
Make sure to insert the upper and lower limit of the QC range into the correct
Range
field.
Tasks
o
Making a query to view the different mappings and their values.
o
Creating new test mappings (RiliBÄK) for the existing system tests.
o
Modifying existing test mappings and ranges to adapt them to changing needs.
o
Activating test assignments or ranges so that the system uses them in the quality control process.
o
Deactivating test assignments or ranges if you do not want them to be considered in the QC observation process.
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RiliBÄK Test Assignment
Adding a new range for an existing test assignment
p
To add a new range for an existing test assignment
1
Choose
Quality Control (RiliBÄK) > RiliBÄK Test Assignment
.
2
Select the mapping to which you want to add an additional range and click
Add
Range
.
The Detail area is enabled with the test assignments information already filled in.
3
Enter the required information, and then click
OK
.
Updated information is displayed in the List area under the corresponding
Quality Control (RiliBÄK) test.
s
Deleting a range from a test mapping
p
To delete a range from a test mapping
1
Choose
Quality Control (RiliBÄK) > RiliBÄK Test Assignment
.
2
Select the range to be deleted and click
Del Range
.
The Detail area is enabled with the test assignments information already filled in.
3
In the confirmation dialog click
OK
.
The range is deleted.
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Result Alarm Monitor
Result Alarm Monitor
cobas IT 1000 application
You must define the target value (Column 3a limit) and the range within which the
QC results must fall. If the result falls outside the defined range, it is flagged with an
RBE alarm.
This screen enables you to view the RiliBÄK alarms and their details.
o
When accessed from the Navigation area, this screen displays a history of the generated alarms.
o
When accessed from the Warning area, this screen displays alarms which have the severity indicated in the selected warning.
Quality Control (RiliBÄK) > Result Alarm Monitor
Figure 9-7 Result Alarm Monitor
screen
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Result Alarm Monitor
Severity column
Warning
Error
Severe Error
(Flashing)
Filter criteria
Alarm Type
Instrument Type
Instrument
Test
Date
Acknowledgement Date
The type of alarm you want to investigate on. It can be chosen from
Warning
,
Error
,
Severe Error
or
All
.
Type of instrument for which the alarm is generated.
Name of the instrument for which the alarm was generated.
(Abbreviated) name of the test with which the alarm is associated with.
The time frame during which the chosen type of alarm was generated.
Date and time when the RiliBÄK alarm was acknowledged.
Field & button definitions
Instrument Type
Instrument
Test
Alarm
Date
Acknowledged
Comment
Add Comm.
Select All
Acknowledgement Date
Type of instrument for which the alarm is generated.
Name of the instrument for which the alarm was generated.
(Abbreviated) name of the test with which the alarm is associated with.
RiliBÄK alarm that was generated.
Date when the alarm was generated.
User who acknowledged the RiliBÄK alarm.
Comment associated to the selected alarm. If a comment is too long and cannot be fully displayed in the column, place the mouse on the comment in the grid and the full comment is displayed in a tool tip.
Click this button to enter a comment quickly.
Click this button to select all alarms visible on the screen.
You cannot multi-select RiliBÄK alarms with the status
Severe Error
.
Date and time when the RiliBÄK alarm was acknowledged.
Tasks
o
Selecting multiple alarms in a list.
o
Adding comments to an alarm before it is acknowledged.
o
Viewing, editing and deleting comments on alarms.
o
Acknowledging alarms.
o
Filtering and searching through alarm data.
q
Only alarms that have a comment assigned can be acknowledged.
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Result Alarm Monitor
Selecting multiple alarms in a list
cobas IT 1000 application
p
To select multiple alarms in a list
1
Do one of the following: o
To select all click
Select All
.
or, o
On your keyboard press [Ctrl] and select the alarms that you want to select.
or, o
Click the first alarm in the list, then while pressing the [Shift] click the last alarm in the list.
s
Acknowledging a new alarm
p
To acknowledge a new alarm
1
Choose
Quality Control (RiliBÄK) > Result Alarm Monitor
.
2
Select the alarm to be acknowledged, and click
Acknowledge
.
The alarm is acknowledged.
s
Filtering Result Alarm Monitor data
p
To filter Result Alarm Monitor data
1
Choose
Quality Control (RiliBÄK) > Result Alarm Monitor
.
2
In the drop-down lists at the top of the screen, choose the option wanted for each filter criterion, and then click
Filter
.
s
Acknowledging RiliBÄK QC alarms
p
To acknowledge RiliBÄK QC alarms
1
Choose
Quality Control (RiliBÄK) > Result Alarm Monitor
.
2
Select the alarm to be acknowledged, and click
Acknowledge
.
The alarm is acknowledged.
s
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Adding a comment to an alarm
p
To add a comment to an alarm
1
Choose
Quality Control (RiliBÄK) > Result Alarm Monitor
.
2
Select the alarm to which you want to add a comment, and click
Add Comm.
button.
The
Add Comment
dialog opens.
3
Select one or more appropriate comments from the
Predefined
list of comments and/or type your own comments in the
Free Text
field.
4
To save and close the comments click
OK
.
5
To close the dialog without saving your comments, click
Cancel
.
s
Viewing and edit a QC alarm comment
p
To view and edit a QC alarm comment
1
Choose
Quality Control (RiliBÄK) > Result Alarm Monitor
.
2
Select the alarm for which you want to view or edit a comment, and click the
Comment
button.
The
Comment
dialog opens.
3
To save click
OK
.
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QC Test Mapping
QC Test Mapping
cobas IT 1000 application
This screen is used to map individual tests with generic tests. These generic tests are used in instrument types that can run several types of tests (such as blood gas instruments) but use one QC test only. Thus, by mapping these tests to an already defined generic test of an instrument type, the QC result is valid for all — the generic and the mapped tests.
o
Instruments must be previously defined in the database.
o
Tests must be previously defined in the database. Generic tests must be created in order to map instrument tests to it.
o
A test material must be previously created for the generic test. A QC material must be previously associated with the test material and the generic test.
o
One test can only be assigned to an Instrument type once, but it can be assigned to different Instrument types more than once.
Quality Control (RiliBÄK) > QC Test Mapping
(
Configuration > QC Test Mapping
)
Figure 9-8 QC Test Mapping
screen
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Field definitions
Test ID
Test Abbreviation
Full Test Name
Sample Type
Instrument Type
9 Quality Control (RiliBÄK)
QC Test Mapping
The system test identification number assigned to a
RiliBÄK test.
The abbreviated name of the test.
e.g. Glu2 for
Accu-Chek Inform II
glucose tests.
The fully displayed name for the test. e.g.
Accu-Chek Inform II
glucose tests for Glu2.
The type of sample on which the test is performed.
The type of instrument on which the test can be performed
Querying for an existing mapping configuration
You check existing mapping definitions to see the tests assigned to a specific generic test.
p
To query for an existing mapping configuration
1
Choose
Quality Control (RiliBÄK) > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area
2
Expand the instrument type and select the generic test to be checked.
All the tests associated to this generic test are displayed in the List area on the right.
s
Adding a generic test
p
To add a generic test
1
Choose
Quality Control (RiliBÄK) > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area
2
Click
Add
.
3
Choose the instrument type from the list in the Detail area, and click the magnifying glass to access the
Test Selection
screen.
4
In the
Test Selection
screen, select the generic test and click
OK
.
The
Test Selection
screen is closed and the system goes back to the
QC Test
Mapping
screen.
5
Click
OK
.
s
Mapping tests to existing generic tests
It enables you to add a new test to an already existing generic test.
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QC Test Mapping
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p
To map tests to existing generic tests
1
Choose
Quality Control (RiliBÄK) > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area.
2
Expand the instrument type branch where you find the generic test, select the generic test to which a test is to be added, and then click
Add
.
The
Test Selection
screen is displayed.
3
Select the test or tests to be added from the list, and click
OK
.
The
Test Selection
screen is closed and the added tests appear on the grid.
s
Deleting a generic test
It enables you to delete a generic test that is associated with an instrument type and all the associated test mappings. This does not erase the test definition from the system.
p
To delete a generic test
1
Choose
Quality Control (RiliBÄK) > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area.
2
Expand the instrument type branch where you find the generic test, select the generic test to be deleted, and then click
Delete
.
3
On the confirmation message, click
OK
.
The test is removed from the tree structure and is no longer a generic test for the current instrument type.
s
Deleting a test mapping
It enables you to delete a test associated to a generic test if it is no longer to be mapped with that generic test. This does not delete the test definition from the system.
p
To delete a test mapping
1
Choose
Quality Control (RiliBÄK) > QC Test Mapping
.
All instrument types are displayed on the tree structure to the left of the List area.
2
Expand the instrument type branch where you find the generic test, select the generic test from which a test mapping will be removed, select the test to be removed and then click
Delete
.
3
On the confirmation message, click
OK
.
The test mapping is deleted.
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RMSE Alarm Monitor
RMSE Alarm Monitor
When a new flag is generated, it is displayed in the Warning area. From the Warning area, you can directly access the
Alarm Monitor
screen and see the new alarms (only the new alarms are displayed). Use this screen to see the RMSE RiliBÄK 2008 alarms and their details. For the QC results to be released, you are required to add a comment and acknowledge the alarm.
q
For blood gas instruments
When the predefined value for empty QC results is set to the default “-” or another qualitative value and the QC result is accepted and released, QC results with an empty result value (e.g. “-”) are included in the RMSE warning calculation as if they would have a value of 0.
Alarm list varies depending on access path
When accessed from the Navigation area, this screen displays a history of the generated alarms.
When accessed from the Warning area, this screen displays alarms which have the severity indicated in the selected warning.
Severity column
Warning
Error
Severe Error
(Flashing)
Quality Control (RiliBÄK) > RMSE Alarm Monitor
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RMSE Alarm Monitor
cobas IT 1000 application
Figure 9-9 RMSE Alarm Monitor
screen
Filter criteria
Alarm Type
Instrument
Test
Date
Acknowledgement Date
The type of alarm you want to investigate on. It can be chosen from
Warning
,
Error
,
Severe Error
or
All
.
Name of the instrument for which the alarm was generated.
(Abbreviated) name of the test with which the alarm is associated with.
The time frame during which the chosen type of alarm was generated.
Date and time when the RiliBÄK alarm was acknowledged.
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Field definitions
Calculated
Allowed
Method
Instrument
Test
Level
Lot
Date
Alarm
Acknowledge
Comment
Acknowledgement Date
Calculated
Allowed
Method
9 Quality Control (RiliBÄK)
RMSE Alarm Monitor
The calculated RMSE deviation associated with the
RMSE alarm. A numeric “From...To” filter option is available to restrict the value range to be displayed in the list.
The allowed RMSE deviation associated with the RMSE alarm. A numeric “From...To” filter option is available to restrict the value range to be displayed in the list.
The method that was used to check the RMSE deviation.
You can filter for the following check methods: o o
QC range
o
LED
: lab-established deviation
Col. 3a
: effective QC range applied to QC results for raising alarms (as defined under
Quality Control
(RiliBÄK) > RiliBÄK Test Assignment
).
Name of the instrument for which the alarm was generated.
(Abbreviated) name of the test with which the alarm is associated with.
QC Level
The test, QC lot or combination of test lot and QC lot, of the alarmed time frame.
The time frame during which the chosen type of alarm was generated.
RiliBÄK RMSE alarm that was generated.
User who acknowledged the RiliBÄK warning.
Comment associated to the selected alarm. If a comment is too long and cannot be fully displayed in the column, place the mouse on the comment in the grid and the full comment is displayed in a tool tip.
Date and time when the RiliBÄK alarm was acknowledged.
The calculated RMSE deviation associated with the
RMSE alarm. If there is a
QC result(s) pending/on hold
alarm, the field remains empty.
The allowed RMSE deviation associated with the RMSE alarm. For RMSE alarms triggered for the current control cycle, the value defined under
System > General Settings
> Extension
(in percent) of the allowed deviation/range for running RMSE is applied as a percentage deviation to the allowed RMSE deviation used to evaluate control cycles upon completion. If there is a
QC result(s) pending/on hold
alarm, the field remains empty.
The method that was used to check the RMSE deviation.
You can filter for the following check methods: o o
QC range
LED
: lab-established deviation o
Col. 3a
: effective QC range applied to QC results for raising alarms (as defined under
Quality Control
(RiliBÄK) > RiliBÄK Test Assignment
).
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RMSE Alarm Monitor
Acknowledging a new alarm
cobas IT 1000 application
p
To acknowledge a new alarm
1
In the Warning area, click a
RiliBÄK RMSE warning
,
RiliBÄK RMSE Error
or
RiliBÄK Severe RMSE Error
.
2
Select the alarm to be acknowledged, and click
Comment
.
The system enables the
Comment
area.
3
Enter a comment, click
OK
, and then click
Acknowledge
.
The system saves the ID of the user who acknowledged the alarm.
s
Filtering RMSE Alarm Monitor data
p
To filter RMSE Alarm Monitor data
1
Choose
Quality Control (RiliBÄK) > RMSE Alarm Monitor
.
2
At the top of the screen, from the drop-down lists select an option for each filter criterion wanted, and click
Filter
.
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Effective QC Range Review
Effective QC Range Review
This screen is used to view and review the effective QC ranges. An effective QC range is displayed for a material lot, level, and test combination, if the following conditions are met: o
The material lot (combination) is active.
o
The material lot (combination) and level is used by an instrument.
o
A QC range or numerical target value is defined.
o
The system test is active.
Display by instrument
The effective QC ranges will be displayed for each instrument individually, if the following conditions are met: o
At least one active lot for a material exists.
o
This lot has at least one instrument specific LED
The
Effective QC Range Review
screen provides the following information: o
Upper and lower range limit of the effective QC ranges.
o
Date and time since when the effective QC range is valid.
o
The source of the effective QC range (column 3a, actual QC range or an LED).
o
User ID of the user having marked the effective QC range as “reviewed”.
Quality Control (RiliBÄK) > Effective QC Range Review
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Effective QC Range Review
cobas IT 1000 application
Figure 9-10 Effective QC Range Review
screen
Prerequisites
Instrument type, instrument name, test, control, control lot and upper and lower range limits must have been previously defined
Field definitions
Instrument Type
Instrument Name
Test LOT
Material ID
Control LOT
Test
Level
Min.
Max.
Unit
Type of instrument used to carry out the QC.
Name of the instrument used to carry out the QC.
Lot number of the test material with which the test has been performed.
Test material (short name) with which the QC test has been performed, e.g. Glucose strip.
Control material LOT.
(Abbreviated) name of the system test with which the alarm is associated.
QC level number.
Lower range limit of the effective QC range.
Upper range limit of the effective QC range.
Measurement unit.
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Effective QC Range Review
Delivered from
Reviewed
Reviewed by
The source of the effective QC range (column 3a, Actual
QC range, LED)
The check box is selected if the effective QC range has been reviewed.
User name of the user who reviewed the effective QC range.
Display order
o
By default, un-reviewed entries are displayed on top.
o
Effective QC ranges belonging to one group are displayed in sequence.
o
By default, the groups of effective QC ranges are sorted by latest date and time in descending order.
o
Effective QC ranges relating to the same material lot (combination), level and individual instrument belong to the same group.
Calculation of lower and upper range limits
The following example explains how
cobas IT
1000 application calculates the lower and upper limits for the "Effective QC Range".
The calculation of the range limits depends on the defined precision (number of decimal places) of the test result, and the allowed limits of deviation from the target value (Column 3/3a limit).
u
u
RiliBÄK Test Assignment screen
Example calculation
For a given test (i.e., tHb for
cobas b
123 instrument), the following settings are defined:
Parameter
Number of Decimal places
Column 3 limit
Column 3a limit
Range type
Table 9-1
Value
1
4,0
4,0
%
Reference
u
u
RiliBÄK Test Assignment screen
If the instrument sends a target value of 7,2,
cobas IT
1000 application calculates the values for the lower and upper QC range according to the following algorithm.
With an allowed deviation of 4.0%,
cobas IT
1000 applicationon uses 4.04999%
(deviation not to be rounded up to 4.1) and then rounds the upper limit down and the lower limit up as follows:
Min.: 7,2 - 7,2*4.04999% = 6,908401 => 7.0 (round lower limit up)
Max.: 7,2 + 7,2*4.04999% = 7.491599 => 7,4 (round upper limit down)
The values 7 and 7.4 are displayed when hovering over the
Graph
column in the
Quality Control (RiliBÄK) > Result Management
window as indicated below:
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Effective QC Range Review
cobas IT 1000 application
Figure 9-11
q
Note: cobas IT
1000 application always uses the absolute values to decide whether a QC result is in range nor not. With an upper limit of 7.4992 (rounded value = 7.4), a QC result with a displayed value of 7.5 (rounded) can therefore be rejected in one case (absolute value =7.500), but accepted in another case (absolute value = 7.488).
Reviewing an effective QC range
p
To review an effective QC range
1
Under
Quality Control (RiliBÄK) > Effective QC Range Review
, choose one or multiple entries of the effective QC range(s) you wish to review.
2
Choose the
Review
button
The
Reviewed
check box is active for the respective QC ranges.
s
Activating a warning on un-reviewed effective QC ranges
p
To activate warning on un-reviewed effective QC ranges
1
Under
My Settings > Warnings configuration > Un-reviewed effective QC ranges
, click the
Active
check box and select the
Severity
level.
Warnings on un-reviewed effective QC ranges are then displayed in the Warning area.
2
To view the un-reviewed effective QC ranges, click the
Unseen effective QC
Ranges
warning in the Warning area.
The
Effective QC Range Review
screen opens. Only the un-reviewed QC ranges are listed now.
u
For more information on activating a warning on unseen effective QC ranges, see
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Table of contents
Results & Patients
10 Results & Patients
10
This chapter provides information about results validation and patient management.
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In this chapter
Chapter
10
Editing patient’s demographic and visit information data .................................... 362
355
10 Results & Patients
Table of contents
cobas IT 1000 application
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Results & Patients module
Results & Patients module
This module provides all functionality required for reviewing and validating patient test results either received from instruments connected to the application, or entered manually in the application. The behavior of the components in this module is influenced by the parameters and configurations defined in other modules.
Only those tests with alarms with severity error appear in the
Results & Patients
> Result Validation
screen so that they can be validated or rejected by the user. All other results, even if they have alarms with severity warning or information, are automatically validated by the system and they are displayed in the
Results &
Patients > Result Query
screen only.
u
For more information about alarm severity, see
Generic patient
The demographics for the generic patient (default settings’ Patient ID 1: 999999) must not be edited. If required, a different ID can be assigned by Roche Service.
No patients associated with the first ID provided in the generic patient (default settings’ Patient ID 1: 999999) general setting can be added.
q
Generic patient
Results are associated with the generic patient if they cannot be associated with a specific patient ID. This happens if o
Samples are measured or entered without a patient ID or visit ID o
Patient ID 2
,
Patient ID 3
or
Visit ID
are used as
Instrument 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 ADT information has not yet been updated by the HIS)
Patient cleaner process
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: o
Patient Class Groups starting with the admission date and time o
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.
o
If set to
Yes
and the selected visit is not the only visit from the patient, the application deletes the visit.
o
If set to
Yes
and the selected visit is the only visit from the patient, the application deletes the visit and its associated patient.
o
If set to
No
, the application sets the visit from admitted to discharged.
u
If the same patient IDs are used across multiple sites, the site ID is added as a prefix to the patient ID displayed in the
cobas IT
1000 application in order to create a unique identifier. This is done by Roche Service. On instruments, the patient ID is displayed without prefix. Patient IDs that are sent to the LIS as part of result messages do not contain the prefix.
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Sample Validation
Sample Validation
CAUTION
CAUTION cobas IT 1000 application
Use this screen to validate all the tests in one specific sample. The screen displays all the samples that have tests with pending validation. After selecting the sample, the user accesses the validation screen to validate all test results for that sample.
This is an easier way to validate the results from those instruments that send many test results from just one sample.
o
If the current user does not have permissions to validate one specific result, then the result is displayed on a blue background and sample validation is not possible. o
Make sure that you have permissions for all tests of a sample when validating results. Otherwise, the sample stays in the
Sample Validation
screen waiting for complete validation.
o
Only samples with one or more non-validated test results are displayed on this screen.
o
When clicking
Accept
,
Reject
or
Hold
on the subsequent validation screen, the system validates, rejects or puts on hold all the tests in the selected sample regardless of their status.
o
When going back to the
Sample Validation
screen validated samples are not shown in the list any longer. If a sample has been put on hold, it is still displayed in the grid.
Empty test results
r
If one or more tests of the selected sample do not have results, they will still be validated. Remember that when a test result is validated, it cannot be modified.
Resetting sample ID
r
The sample ID counter is reset depending on the timestamp format selected for the sample ID; sample ID format can only be changed by Roche Service.
q
Note:
Accepting patient results containing invalid characters in the user ID (alarm ID OII) or patient ID (alarm ID PII) can lead to parsing errors when the data are sent to the HIS/LIS.
Results & Patients > Sample Validation
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Sample Validation
Figure 10-1 Sample Validation
screen
Field definitions
Reception Date/Time
Patient ID
The date and time the sample results were received by the application.
Identification number (
Patient ID 1
) of the patient. If the same patient IDs are used across multiple sites, the site ID is added as a prefix to the patient ID in order to create a unique identifier in the application. This is done by Roche Service.
Instrument Patient ID
Instrument Patient ID
contains the ID sent by the instrument
(depending on the configuration of the instrument it will be
Patient ID 1
,
Patient ID 2
,
Patient ID 3
or
Visit ID
).
For manually entered samples, the
Instrument Patient ID
will be empty.
Visit identification number of the patient.
Visit ID
Patient Name
Instrument Type
Instrument Name
Location
Internal Sample ID
Last name, First name of the patient.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
The location to which the instrument is currently assigned.
Identification number of the sample. Automatically generated by the application.
From this screen, you can access the
Result Validation
screen by clicking the
Review
button.
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10 Results & Patients
Patient Query
Patient Query
cobas IT 1000 application
CAUTION
This component enables you to query for test results for current patients and visits, and test results for previous patients and visits, stored in the system.
Patient record
r
Do not add or modify patient records manually when the application is configured to receive patient information from several host systems in parallel.
The demographic fields in this screen are defined in the
System > Demographic
Assignment
screen. They can be defined for patient and samples.
Results & Patients > Patient Query
Figure 10-2 Patient Query
screen
Field definitions
Patient ID 1
First Name
Last Name
Middle Initial
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Identification number (
Patient ID 1
) of the patient. If the same patient IDs are used across multiple sites, the site ID is added as a prefix to the patient ID in order to create a unique identifier in the application. This is done by
Roche Service
Patient’s first name.
Patient’s last name
The patient’s middle name first letter.
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cobas IT 1000 application 10 Results & Patients
Patient Query
Age
Date of Birth
Sex
Visit ID
HIS Location
Admission Date/Time
Discharge Date/Time
Attending Physician ID
Attending Physician Name
Admitted Status
Patient Class
SampleID
Register Date
Use
Register Hour
RegisterYear
Instrument
Location ID
Age of the patient, in years. If a patient is less than 1 year old, then the age is shown in days in format: yy.ddd which is not a decimal value but a year/day representation.
Patient’s date of birth.
Gender of the patient (male/female).
Visit identification number of the patient
Where the patient is located
Date and time of admission
Date and time of discharge
Identification number of the attending physician
Name of the attending physician
Indicates whether the patient is admitted (check marked) or not. It also indicates whether this patient will be uploaded to instruments supporting patient list functionality (e.g. Accu-Chek Inform family instruments).
Patient class of the patient. The patient class is used to specify the attendance of a patient.
Identification number of the sample automatically generated by the application.
Date on which the application received the sample results.
Application receiving the sample results. Always
cobas
IT
1000 application.
Time of reception of the sample results by the application.
Year during which the sample results where received by the application.
Name of the instrument at which the test has been run.
The location to which the instrument is currently assigned.
Tasks
o
Add new patients and visits.
o
Modify existing patients and visits.
o
Remove patients and visits.
o
View the status of the samples related with a patient/visit.
o
Deleting a sample.
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Patient Query
cobas IT 1000 application
Querying for the status of patient’s samples for a visit
Query for status of patient’s samples for a visit to see whether the results of the samples have been validated, sent to the HIS/LIS or locked. For each visit it is possible to see the status of all related samples.
Figure 10-3 Sample Status
screen p
To query for the status of patient’s samples for a visit
1
Choose
Results & Patients > Patient Query
.
2
Set a filter to display specific records.
3
In the List area, select the patient record whose sample status is to be queried.
4
Click the
Sample Status
button under the patient demographic data list.
The
Sample Status
window appears.
s
Editing patient’s demographic and visit information data
p
To edit patient’s demographic and visit information data
1
Choose
Results & Patients > Patient Query
.
2
Set a filter to display specific records.
3
Select the patient record to be edited, and click
Edit
.
The
Single Patient Edit
screen appears.
u see
4
Modify the fields for patient and visit information, and click
OK
.
The modified patient demographic and visit information is saved.
s
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Patient Query
Adding a new patient
p
To add a new patient
1
Choose
Results & Patients > Patient Query
.
2
Click
Add Patient
.
The
Single Patient Edit
screen appears.
u see
3
Enter the required information, and click
OK
.
The patient’s data is automatically filled in when you go back to the
Patient
Query
screen.
s
Querying for status of samples
You query for the status of individual samples to see whether the results of specific tests have been validated, sent to the HIS/LIS or locked.
p
To query for status of samples
1
Choose
Results & Patients > Patient Query
.
2
If necessary, set a filter to display specific patients.
3
Double-click the patient’s record.
The samples for the selected patient appear in the list of the Detail area.
4
Select the sample whose test status is to be queried, and under the list in the Detail area click the
Status
button.
The
Sample Status
window is displayed.
q
Clicking the
Results
button next to the
Status
button displays the
Result Query
screen showing the results belonging to the selected sample. s
Searching for a patient
p
To search for a patient
1
Choose
Results & Patients > Patient Query
.
2
Set a filter to find the desired patient and click
Filter
.
s
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Searching for a visit
p
To search for a visit
1
Choose
Results & Patients > Patient Query
.
2
Set a filter to find the desired visit and click
Filter
.
s
cobas IT 1000 application
Deleting a visit
When deleting a visit, information of the related samples status is provided in the
Sample Status
screen and a confirmation is requested to delete the visit.
If the selected visit is the only visit of the patient, the confirmation message will warn that the process will delete the associated patient too.
If the deletion of the visit has been confirmed, the application will delete the visit and all associated sample results. Additionally, the patient if he has no more visits in the application.
p
To delete a visit
1
Choose
Results & Patients > Patient Query
.
2
Set a filter to find the desired visit and click
Filter
. Highlight the desired visit in the List area.
3
Click the
Delete Visit
button.
Information of the related samples status is provided in the
Sample Status
screen and a confirmation is requested to delete the visit.
4
Confirm with the
OK
button to delete the visit.
s
Deleting a patient
p
To delete a patient
1
Choose
Results & Patients > Patient Query
.
2
Set a filter to find the desired patient and click
Filter
. Highlight the desired patient in the List area.
3
Click the
Delete Patient
button.
Information of the related visits is provided in the
Patient Visit Status
screen and a confirmation is requested to delete the patient.
4
Confirm with the
OK
button to delete the patient and all associated visits and sample results.
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Single Patient Edit
WARNING
CAUTION
10 Results & Patients
Single Patient Edit
The
Single Patient Edit
screen can be opened in three modes: o
“Add patient mode”
Accessible with the
Add Patient
button. Add a patient by entering the patient demographic data and the corresponding visit information data.
o
“Add visit mode”
Accessible with the
Add Visit
button. Add a visit to an existing patient.
o
“Edit patient and visit details”
Accessible with the
Edit
button. Edit the patient and visit details.
This component enables you to review and maintain existing patient demographic data and visit information data, and to add new patients and visits to the system. The demographic fields and related functionality (e.g. mandatory, select lists, etc.) as they have been assigned in the
System > Demographic Assignment
component of the
System
module. o
The demographic fields in this screen are defined in the
System > Demographic
Assignment
screen. o
Two or more patients with the same
Patient ID 1
cannot be entered in the database. o
If automatic numbering is specified in the
General Settings
screen, the
Patient
ID 1
number is automatically generated when clicking
OK
.
o
Select the
Always send Patient List to instruments
check box if the currently selected patient is to be sent to the instrument along with the existing patient list, according to the setup on the
System > General Settings
and
Instruments
> Configuration
screen. It is only applicable to instruments such as the
Accu-
Chek Inform
instrument family, the
CoaguChek XS Plus
, the
CoaguChek XS
Pro
or the
cobas h
232.
u see
Always send Patient List to instruments
Incorrect patient data
Entering incorrect patient information can affect result validation criteria, which can lead to false result interpretations.
r
Ensure that you enter patient ID, age, and sex correctly.
Results & Patients > Patient Query > Add Patient
/
Add Visit
/
Edit
Invalid Patient ID/Visit ID
Manual entry of Patient ID/Visit ID on instruments can lead to invalid characters or string length resulting in rejected results. To avoid delays, ensure the following: r
Use the patient-list or barcode reader to enter the Patient ID/Visit ID if available on the instrument.
r
Check for invalid characters when manually entering a Patient ID/Visit ID.
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Figure 10-4 Single Patient Edit
screen
Field definitions Patient
Information
Patient ID 1
First Name
Last Name
Date of Birth
Age
Sex
Field definitions Visit Information
Visit ID
HIS Location
Admission Date/Time
Discharge Date/Time
Attending Physician ID
Identification number of the patient. If the same patient
IDs are used across multiple sites, the site ID is added as a prefix to the patient ID in order to create a unique identifier in the application. This is done by Roche
Service.
Patient’s first name
Patient’s last name
Patient’s date of birth
Age of the patient. The display can be switched between years and days.
Gender of the patient
Visit identification number of the patient
Where the patient is located.
Date and time of admission
Date and time of discharge
Identification number of the attending physician
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Attending Physician Name
Admitted Status
Patient Class
Name of the attending physician
Indicates whether the patient is admitted (check marked) or not. It also indicates whether this patient will be uploaded to instruments supporting patient list functionality (e.g. Accu-Chek Inform family instruments).
Patient class of the patient. The patient class is used to specify the attendance of a patient.
q
Patient class
The patient class is used to specify the attendance of a patient (e.g. “outpatients” which can be used for patients which need no bed).
The patient class is a patient demographic. It can be changed through the
System
> Demographic Definition
screen.
The patient class can be configured in
System > General Settings
. These settings are also important for the automatic “Patient cleaner” process.
u
What if...?
o
The
Patient ID 1
does not match the setup parameters for this field.
O
A warning message is displayed prompting to accept a system-generated
Patient ID.
o
You need to add another patient.
O
Click
Cancel
when the screen is in edit mode. Now the screen is ready to add another patient.
Viewing a new patient record
CAUTION
Patient records
r
Do not add patient records manually when the application is configured to receive patient information from one or several host systems in parallel.
p
To add a new patient record
1
Choose
Results & Patients > Patient Query > Add Patient
/
Add Visit
.
2
Fill in the fields with the patient’s data, and click
OK
.
The patient information is displayed in the screen and fields are still editable.
s
Deleting patient records
p
To delete patient records
1
Choose
Results & Patients > Patient Query
.
2
Enter the
Patient ID 1
of the record to be deleted.
3
Click
Filter
.
The information assigned to this record is displayed.
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Editing patient records
Edit a patient’s record to change the demographic data maintained in the database.
Patient ID 1
fields are not editable.
q
When connected to one or more host systems providing patient information (ADT), you should only make changes to eliminate inconsistencies between records stored on these hosts and in the application. Changes made in the
cobas IT
1000 application will not be sent to the HIS/LIS, so if an update message comes from the HIS/LIS it will overwrite what is in the
cobas IT
1000 application.
p
To edit patient records
1
Choose
Results & Patients > Patient Query
.
2
Enter the
Patient ID 1
of the record to be edited.
3
Click
Filter
.
4
Click
Edit
.
The information assigned to this record is displayed.
5
Edit the necessary fields and then click
OK
.
The modified patient record is saved.
s
Editing Patient ID
4
Click
Delete Patient
.
The patient sample status appears.
5
Click
OK
.
The patient record is deleted.
s
Edit a patient’s ID to change this specific data.
p
To edit patient records
1
Choose
Results & Patients > Patient Query
.
2
Enter the
Patient ID 1
of the record to be edited and click
Filter
.
3
Click
Edit
.
4
Click
Edit Patient
.
The
Patient ID 1
,
Patient ID 2
or
Patient ID 3
fields become editable.
5
Edit the necessary fields, and then click
OK
.
The modified patient ID is saved.
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Result Validation
Result Validation
CAUTION
This component enables you to review and validate patient test results. Patient demographics assigned to each test result can be reviewed, completed, or even exchanged, in case a patient demographics mix-up has occurred on the instrument.
The detailed status of each patient test result is given, based on the automatic results validation, which is done by the system. Flagged test result can be validated manually.
Non-validated results cause slow performance
A backlog of non-validated results can cause slow performance.
r
Validate results regularly. q
Multi-select behavior on the Result validation screen
o
If one or multiple result(s) are selected which are in pending state (NOT accepted or rejected) and the
Accept
or
Reject
button is clicked, the results are sent to the database.
o
If one or multiple result(s) are selected which are accepted or rejected and the
Accept
or
Reject
button is clicked, the results are not sent to the database.
o
If multiple results are selected with different states and the
Accept
or
Reject
button is clicked, only the results which are in pending state are sent to the database.
o
If multiple results are selected of which 1 or more are either in the
on Hold
state, or have no state assigned, the
Hold
,
Reject
,
Accept
, and
Host
buttons are active.
o
If multiple results are selected of which all have either been
validated
or
rejected
, only the
Hold
and
Host
buttons are active.
q
Non-validated results
If the number of non-validated test results grows beyond expectation, check whether the application is configured according to the desired POCT workflow and/or additional instrument user training is necessary.
q
Unreviewed test results warning appears to be counting incorrectly
When an instrument is assigned to a location from a different site, the warning and screen access are based on the new site. The
cobas IT
1000 application counts the pending results of the current instrument location, but the validation screen shows the pending results of the previous instrument location.
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When a test result is uploaded it is automatically checked against: o
User: The validation process takes into account the validity of the user that has performed the measurement (i.e. certification, correct user ID).
o
Material: The validation process takes into account the validity of the material that has been used to perform the measurement (i.e. unknown LOT, expired material).
o
Quality Control: The validation process takes into account the test status evaluated by the quality control multirules.
o
Instrument: The validation process takes into account instrument flags sent with the test result. This process also checks the comments transferred with the test results.
o
Reference and Critical Ranges: The validation process takes into account the reference ranges that have been defined for the specific test parameter in accordance with the demographic attributes of the patient, such as sex, age, physiological group, physiological period, ethnic group and others.
o
Patient Information: The validation process checks the integrity of the patient information that has been transmitted with the result, as for example, missing or wrong demographic information.
q
It is also possible to just pass the patient test results from the application to the host interface (e.g. HIS/LIS) without applying any validation to the results - in this case, the results are not marked as validated.
Operational Principles
o
When the screen is accessed, the filters are activated. Set the search criteria and apply them to see the desired results.
o
User, test and patient records must be available in the database, before manually adding test results. o
The system automatically validates all tests results and sets the results as validated or not validated. It also checks for alarms.
o
If the system finds any error alarms during the automatic validation, those results will not be automatically validated and user must manually validate them. If the system finds warning or information alarms, results will be automatically validated but alarms will be listed in the alarm column.
o
When a result is outside the normal range, the result is shown in red. When it is outside the critical range, the result is highlighted in red background.
o
If the current user does not have permissions to validate one specific result, then the result is displayed on a blue background.
o
If the Test LOT material is not valid (MTE Alarm active), the Test LOT number in the table is displayed in red.
o
If a result shows '(!)' it means that no result is assigned to that test, and it contains a comment only. Automatic validation will occur unless alarms are found.
o
On save, automatic validation is performed on modified results.
o
When you change screens you must save the changes first.
o
Validated results are automatically sent to the host. If they are sent twice the date and time when they were first sent must be registered in the record.
o
On request, Roche Service can define whether a specific column is displayed or not. You can define its order of appearance and its width in the
Result Validation
screen.
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q
If the patient is younger than 1 year, age is shown in days. In the
Result Validation
screen, when the age is shown in days, it is presented in a decimal format. Zero being the years, and expressing the number of days after the decimal separator. It is not a calculation expressed in decimal figures!
However, this format is not used in other screens, such as the
Patient Query
screen, where it is already indicated whether age is expressed in days or years.
Accessing from Result Validation screen
The functions of modifying test results, adding samples, adding tests and displaying all results of a sample are disabled.
Results & Patients > Result Validation
Figure 10-5 Result Validation
screen
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Validation alarm symbols
cobas IT 1000 application
Field definitions
Date & Time
Patient ID
Visit ID
Last Name
Location
Test
Result
OTS
Alarms
Comments
User
Test LOT
Instrument Name
Serial Number
System or user validation (depending on the column).
Without alarms.
With alarms.
Manually rejected result. Results may only be rejected if the measurement is considered to have been not performed correctly. Rejected results are considered to contain no information on patient or instrument.
Result that has been put on hold.
Date and time the test was done. For some instrument types a part of this information is based on when the result was received by the application, e.g. Sysmex pocH-100i instruments report the date only, the time is the time of reception by the application.
Identification number (
Patient ID 1
) of the patient. If the same patient IDs are used across multiple sites, the site ID is added as a prefix to the patient ID in order to create a unique identifier the application. This is done by Roche Service.
Visit identification number of the patient.
Patient’s last name.
The location to which the instrument is currently assigned.
Abbreviation of the test performed.
Result value.
Validation status of the result.
u
For OTS results, a graphical indicator (green/red) indicates if the result was approved by the supervisor.
Drag the mouse over the indicator to get additional information: o
User ID of the observing user o
User ID of the observed user o
Any comments provided by the observer during the validation of the result.
List of alarm IDs having occurred with this result, separated by commas. Clicking it displays the list of alarms including description and severity.
Added comments.
The ID of the individual who has performed the test.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument results. If the
Test LOT
is displayed in red, this means that the
Material is not valid (MTE Alarm active for the corresponding result).
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
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Reviewed by
Reviewed Date
Host Sent Date
ID of the individual having reviewed the result. The value is
“~system~” if automatically validated by the application. Also set if the result has been put on status
Hold
.
Date on which the test was reviewed in the application. Also set, if the test was put on status
Hold
.
Date and time at which the result was posted for sending to the
LIS or similar host system.
Details
Measured Unit
Reference Range (2nd U)
Instrument Patient ID
Primary Unit
Critical Range (2nd U)
Physiol. Type
Result unit reported by the instrument.
Reference range defined in the application for this test and demographic group.
u
The patient ID entered by an operator on the instrument during a measurement
Primary result unit defined for this test in
System > Test
Definition
.
Critical range defined in the application for this test and demographic group.
u
Alternate notation of the patient gender. Currently not used in the application.
Reviewing test results
You use this option to display test results information.
p
To review test results
1
Choose
Results & Patients > Result Validation
.
The
Result Validation
screen is displayed with editable filter fields.
2
Set a filter to display test results.
3
Double-click the test to be queried.
Details assigned to this record are displayed in the Detail area.
s
Reviewing test details
You use this button to display more detailed test results information.
p
To review test details
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select the test to be queried, and click the
Details
button.
The system displays the
Test Details
screen, which is just for consultation.
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Querying for patient details
p
To query for patient details
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select a test record, and choose the
The
Single Patient Edit
screen is displayed.
s
Changing the patient
4
To add a comment to a test, click
Comment
.
The
Comment
screen is displayed.
s
cobas IT 1000 application
button.
Use the button to change the patient to whom the selected test belongs.
p
To change the patient
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select 1 or more test records, and choose the
The
Patient Query
screen is displayed.
4
Set a filter to find the patient to be added.
5
Select the patient and choose the
Select
button.
s
button.
Displaying all results of a sample
Enables you to display all the test results belonging to the same sample.
p
To display all results of a sample
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select a test record, and click the
Samples
button.
The resulting screen is read-only.
s
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Displaying all results of a patient
Enables you to display all the tests results of all the samples belonging to the selected patient.
p
To display all results of a patient
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select a test record belonging to the patient whose tests results are to be queried, and click the
Results
button.
The resulting screen is read-only.
s
Re-sending test results to the HIS/LIS
Enables you to send test results the to the HIS/LIS which are already flagged as sent.
p
To re-send test results to the HIS/LIS
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select one or more tests that had already been sent to the host, and click the
Host
button.
The system sends the results to the HIS/LIS.
s
Putting test results on hold
Enables you to leave one or more test results on hold, therefore they are not sent to the HIS/LIS.
p
To put test results on hold
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select one or more test results, and click the
Hold
button.
The results display with the on-hold mark in the
Validation
column.
s
Rejecting test results
Enables you to reject test results that have not been validated or are on hold. Only reject a result, if the measurement has not been performed correctly. Rejected results are considered to contain no information on patient or instrument.
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p
To reject test results
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select one or more test results, and click the
Reject
button.
The results display with the red cross mark in the
Validation
column.
s
Accepting test results
Enables you to accept validated test results.
p
To accept test results
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
In the List area, select one or more test results, and click the
Accept
button.
The results display with the check mark in the
Validation
column.
q
Note:
Accepting patient results containing invalid characters in the user ID (alarm ID
OII) or patient ID (alarm ID PII) can lead to parsing errors when the data are sent to the
HIS/LIS.
s
Displaying the alarm description
Enables you to display the
Alarm Description
window for a selected test.
p
To display the alarm description
1
Choose
Results & Patients > Result Validation
.
2
Set a filter to display test results.
3
Click on the Alarm codes in the
Alarms
column.
The
Alarm Description
window is displayed.
s
Adding comments to a result
In the List area, a mark next to the result or the patient’s name appears if there is a comment assigned to them. When pointing to the comment mark, the comment is displayed as a tool tip. The length of the text shown in the tool tip can be defined in the
General Settings
screen.
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Result Validation
p
To add comments to a result
1
Choose
Results & Patients > Result Validation
.
2
Select the result you want to comment on and click the
Comment
button.
The
Comment
dialog opens.
3
Click the
Add Coded Comment
button to select one or more comments from the predefined list of comments and/or type your own comments in the
Text
field.
4
Click
OK
.
The comment is saved.
Uncoded comments
Not all instruments support coded comments such as Accu-Chek Inform II.
s
Result Validation Alarms
From the
Result Validation
screen the following alarms may appear: o
Information: an alarm appears, but result is automatically validated.
o
Warning: an alarm appears but result is automatically validated.
o
Error: an alarm appears and result is not automatically validated. Manual validation by the user is required.
Comments
This option enables you to add predefined or free-text comments to the selected test result or the selected patient in the
Results & Patients
module, or to QC results and
Levey-Jennings or Linearity charts in the
Quality Control
module. All comments related to the selected record will be shown. You can add a new free-text comment, and/or choose from a set of predefined comments.
u
Comments currently being added or modified are shown in red letters in the list. Text changes into black when comments are saved.
Prerequisites
Predefined comments must have been previously defined to be able to use them in this screen.
Results & Patients > Result Validation > Comment
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Figure 10-6 Comment
screen
Tasks
o
Adding new comments for a selected result.
o
Modifying existing comments.
o
Activating a comment so that it is available and/or visible in other screens.
o
Deactivating a comment so that it is not available or visible in other screens.
o
Checking comments to see the details.
Adding a predefined comment
You can add predefined comments by typing the code of the desired comment and pressing Enter. More than one predefined comment can be added. The system will not recognize the predefined comment if the Enter key is not pressed after typing the code.
p
To add a predefined comment
1
Choose
Results & Patients > Result Validation > Comment
screen.
2
In the Detail area of the
Comment
screen, click
Add Coded Comment
.
The
Add Coded Comment
window appears.
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3
Double-click the desired comment.
The system automatically goes back to the
Comment
screen and the comment is added to the
Text
panel.
4
Type free text in the
Text
field if needed
5
Click
OK
.
The comment is added.
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Result Query
cobas IT 1000 application
NOTICE
You use this component only for patient test results review. You can query patient test results and attached comments, but you cannot validate test results or change patient demographics in this screen. This component is intended for users who are interested in the test result data, but who will have no permissions to modify the data.
o
Although this screen has the same appearance as the
Results & Patients > Result
Validation
screen, it is read-only and no changes can be applied, so the only available buttons are those that are for data consultation only.
o
This screen displays both validated and non-validated results. Use the
Results &
Patients > Result Validation
screen to manually validate results.
o
The number of rows that can be displayed is limited to 1000 rows. In this particular case, the Data volume setting defined under
Organization > User
Profiles > Data Volume
does not apply.
Incorrect display of measurement time
If instrument and client are located in a different time zone than the application server, the
Date & Time
field of the
Result Query
screen shows the time of a measurement in server time instead of instrument time. However, the instrument time is stored in the database and sent to the HIS/LIS.
Results & Patients > Result Query
Figure 10-7
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Result Query
screen
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Tasks
o
Querying for user comments to the selected patient or the selected test result.
o
Re-sending test results to the HIS/LIS
o
o
o
o
Displaying all results of a sample
o
Displaying all results of a patient
o
Displaying the alarm description
o
o
Sample unvalidation
Unvalidation process
q
Unvalidation process
In
System > General Settings
the following settings allow to configure the sample unvalidation process: o
Enable sample unvalidation
o
Timeframe for sample unvalidation (Hours)
o
Detect repeat results
o
Sample unvalidation - additional information entry - name of first parameter
o
Sample unvalidation - additional information entry - status of first parameter
o
Sample unvalidation - additional information entry - name of second parameter
o
Sample unvalidation - additional information entry - status of second parameter
o
Sample unvalidation - additional information - text pattern
u
Select an accepted patient sample sent to the host, which is in the acceptable timeframe for unvalidation, and click the
Unvalidate
button.
o
A sample cancellation message is sent to host.
o
If a comment is needed for unvalidation, enter the information in the
Sample
Unvalidation
window.
o
The status of the sample gets back to “open” and all related results are set “on hold”.
o
If configured, the
Patient Query
screen appears.
q
Revalidation process
To revalidate reaccept all results related with the sample. If configured, a new sample ID will be created to replace the previous ID. The sample is sent to the host as a standard accepted sample.
Repeated results detection
The detection of repeated results process detects repeated results and flags the original and the repetition, so that it is possible to validate one of them manually.
The general setting
Detect repeat results
allows to configure the repeated results detection process. u
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Result Query
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If enabled, it is possible to define for each instrument type configuration in the field
Repeat Time Interval
the amount of minutes when, if a repeated result is sent, it will be marked as repeated.
Repeated results are flagged with the system alarm
TRR
and set to status
Pending
.
The result must fulfill the following conditions to be detected as a repeated result: o
Measured for the same patient o
The patient is not a generic patient o
The same system test is done o
Received in the application during the
Repeat Time Interval
of the instrument
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Table of contents
Reports
11 Reports
11
This module enables you to generate predefined reports for the entire application, based on your defined search criteria. Reports are generated in a PDF, Word, or Excel format. The generated reports serve various purposes, such as paper based documentation, review of data, or sharing of data with people that have no access to the application. Generated reports can be automatically stored within the reports log.
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Chapter
11
QC Summary (By Location and Instrument) ................................................... 401
QC Summary (By Instrument Type and Location).......................................... 403
Monthly QC Summary (By Location) ............................................................... 404
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Sample Count (by Instrument and Location) ................................................... 412
Test/Sample Count (by Location and Instrument type) .................................. 413
Test Count (by Location and Instrument type) ................................................ 414
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Report Generation
Report Generation
Use this component to extract information from the application in a standardized report, 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. Each generated report will be stored in the application for internal logging if
Save a log upon generation of the report
has been selected.
q
Report logic and user interface logic
o
To avoid on-screen data overload, some of the windows are limited to show only the first 1000 records matching the selected criteria. The printed report includes all.
o
The “Location” used with result-related reports is not meant to be the current instrument location but the “Sending location” to which the instrument was assigned at the time the results were sent. This may not be the same location to which the instrument is currently assigned.
o
New types of reports cannot be created.
o
Set filter criteria for report generation.
o
If you do not have sufficient rights to view some of the records to be included in the report, these records are not included in the report.
o
Available reports are only those of installed modules.
Reports > Report Generation
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Report Generation
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Figure 11-1 Report Generation
screen
Tasks
o
Activating a report type so that it is available when generating reports.
o
Deactivating a report type so that it is not available when generating reports.
Generating reports
If you do not have sufficient rights to view some of the records to be included in the report, these records are not included in the report.
p
To generate reports
1
Choose
Reports > Report Generation
.
2
Double-click the report type to be generated.
Details assigned to this type of report are displayed in the Detail area.
3
Set the filter criteria in the Detail area, and click
View
.
The report is generated in PDF, Word, or Excel format, according to the set parameters.
s
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Report Generation
Saving the report as a log file
p
To save the report as a log file
1
Choose
Reports > Report Generation
.
2
Double-click the report type to be generated.
Details assigned to this type of report are displayed in the Detail area.
3
Set the filter criteria in the Detail area, and click
Store & View
.
The report is generated and saved in a log file.
s
To set a report as favorite
p
To set a report as favorite
1
Choose
Reports > Report Generation
.
2
Set a filter to view non-favorite reports.
3
Select the report type to be set as favorite, and click
Favorite
.
The report is set as favorite.
s
To set a report as not a favorite
p
To set a report as not a favorite
1
Choose
Reports > Report Generation
.
2
Set a filter to view favorite reports.
3
Select the report type to be set as not a favorite, and click
No Favorite
.
The report is set as not a favorite.
s
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Report Log
Report Log
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Use this component to review reports that have been stored in the application’s report log. The report log contains the generation date, the user who generated the report, and the historic query criteria applied to generate the report.
Reports shown here are historic documents and will not be updated with data which has been added to the system following the initial generation of the report!
q
Reports generated in the
Report Generation
screen must have been previously saved.
Reports > Report Log
Figure 11-2 Report Log
screen
From this screen you can query for generated reports to see the details of the selected report.
Previewing reports
p
To preview reports
1
Choose
Reports > Report Log
.
2
If necessary, set a filter.
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3
To view the specific details of a report, double-click its entry in the list.
4
Select the record to be displayed, and click
View
.
The report is displayed in PDF format.
s
11 Reports
Report Log
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Types of Reports
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Predefined types of reports cannot be edited. New types of reports cannot be created.
Filter criteria have to be established so that reports show only information that is relevant for the purpose of the report. Some terms are repeated but the meaning is different depending on the context, such as Date, Time, Location. The sequence of the definitions goes line after line from left to right, as shown in this diagram:
Figure 11-3
Report example q
Predefined report types
The report types available are predefined in the
cobas IT
1000 application, according to the field practice. You cannot add or personalize any type of report other than the ones provided.
q
Instrument-specific reports
To create reports for specific instruments, refer to the user documentation provided along with the respective instrument.
All Results
These reports cover all types of results. They can be generated in two modes: o
By Date
o
By Location and Instrument
All Results (By Date)
This report provides a listing of all results (Test, QC, Linearity) 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.
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Filter criteria
Site
Location ID
Date Range From
Date Range To
Validation Status
Alarm Group
Instrument Type
Instrument Name
Serial Number
User ID
Test
Test LOT
QC LOT
Sending status
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Material ID
Patient Results
QC Results
Linearity Results
Report fields
Site
Location
Instrument Type
Instrument Name
Serial Number
Result Type
Test
Test LOT
QC LOT
Performed by
11 Reports
Types of Reports
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
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.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On Hold
,
System Lock
*
(*automatic validation has generated an alarm. Applies to patient results only).
Groups of alarms triggered by the result.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
The ID of the individual who has performed the test.
The abbreviated name of the test.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
This filter is reserved for future functionality, intended to be used to report results of specific sending condition such as: sent (unidirectional), sent (acknowledged), sent pending acknowledge, or will not be sent.
Test material (short name) with which the test has been performed, e.g. Glucose strip.
Choose one (or more) of the result types to be included in the report. There, the field Result Type will show the type of the respective result.
Name of the site which reported the test results.
Name of the organizational location that reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Type of the reported results. (
Patient
,
Control
,
Linearity
).
The abbreviated name of the test.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
The ID of the person who performed the test.
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Certified
Result Date
Result Time
Primary Patient ID
Level
Result Value
Unit
Range
Alarms
Validation Status
Sending Status
Reviewed by
Review Date
Test Material
Test LOT Activation
Test LOT Deactivation
Test LOT Expiration
Result Comment
Instrument Comment
(Reserved for future functionality.) Intended to indicate
(
Yes
/
No
) whether the user was certified for this instrument type at the time the test was done.
The date the test was performed.
The time the test was performed.
Patient ID 1 of the patient for whom the test was performed.
The QC/linearity level this result belongs to. Does not apply to patient tests.
The result value (qualitative or quantitative) of the performed test.
The measurement unit of the test.
For patient results: The normal/reference range defined for this test and the patient's demographic criteria. For QC and linearity results: The QC range used to evaluate this result.
List of the IDs of the alarms triggered by this result.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On Hold
,
System Lock
*
(*automatic validation has generated an alarm. Applies to patient results only).
Specific sending condition such as: sent (unidirectional), sent (acknowledged), Sent pending acknowledge, or will not be sent. Reserved for future functionality.
ID of the individual who last changed the validation status of the result. If the current status was set automatically by the application, this value is indicated as “~system~” or
“SYSTEM_VALDAEMON” (depending on the result type).
The date the current validation status of the result was set.
Test material (short name) with which the test has been performed, e.g. GLU-T for
Accu-Chek Inform
Glucose strips.
The date at which the test lot with which the test has been performed has been set ready for use. (Does not apply to patient results.)
The date at which the test lot with which the test has been performed has been manually deactivated. (Does not apply to patient results.)
The date at which the validity of the test lot with which test has been performed will end. (Does not apply to patient results.)
The comment on the result entered by the users who performed/reviewed the result.
General comment related to the specific instrument with which the test has been performed.
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All Results (by Location and Instrument)
This report provides the same information as the report above, but the results are grouped together by location and instrument, and not chronologically by date.
Filter criteria
Site
Location ID
Date Range From
Date Range To
Validation Status
Alarm Group
Instrument Type
Instrument Name
Serial Number
User ID
Test
Test LOT
QC LOT
Reviewed by
Material ID
QC Status
Patient Results
QC Results
Linearity Results
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
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.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On Hold
,
System Lock
*
(*automatic validation has generated an alarm. Applies to patient results only).
Groups of alarms triggered by the result.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
The ID of the individual who has performed the test.
The abbreviated name of the test.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
ID of the individual who last changed the validation status of the result.
Test material (short name) with which the test has been performed, e.g. Glucose strip.
The instrument test QC status resulting from the QC or linearity result. Does not apply to patient tests.
Choose one (or more) of the result types to be included in the report. There, the field Result Type will show the type of the respective result.
Report fields
Site
Location
Instrument Type
Instrument Name
Serial Number
Result Type
Test
Test LOT
Name of the site which reported the test results.
Name of the organizational location that reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Type of the reported results. (
Patient
,
Control
,
Linearity
).
The abbreviated name of the test.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
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Control
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QC LOT
Performed by
Certification
Result Date
Result Time
Primary Patient ID
Level
Result Value
Unit
Range
Alarms
Validation Status
Reviewed by
Review Date
Test Material
Test LOT Activation
Test LOT Deactivation
Test LOT Expiration
Result Comment
Instrument Comment
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
The ID of the person who performed the test.
(Reserved for future functionality.) Intended to indicate
(Yes/No) whether the user was certified for this instrument type at the time the test was done.
The date the test was performed.
The time the test was performed.
Patient ID 1 of the patient for whom the test was performed.
The QC/linearity level this result belongs to. Does not apply to patient tests.
The result value (qualitative or quantitative) of the performed test.
The measurement unit of the test.
For patient results: The normal/reference range defined for this test and the patient's demographic criteria. For QC and linearity results: The QC range used to evaluate this result.
List of the IDs of the alarms triggered by this result.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On Hold
,
System Lock
*
(*automatic validation has generated an alarm. Applies to patient results only).
ID of the individual who last changed the validation status of the result. If the current status was set automatically by the application, this value is indicated as “~system~” or
“SYSTEM_VALDAEMON” (depending on the result type).
The date the current validation status of the result was set.
Test material (short name) with which the test has been performed, e.g. GLU-T for
Accu-Chek Inform
Glucose strips.
The date at which the test lot with which the test has been performed has been set ready for use. (Does not apply to patient results.)
The date at which the test lot with which the test has been performed has been manually deactivated. (Does not apply to patient results.)
The date at which the validity of the test lot with which test has been performed will end. (Does not apply to patient results.)
The comment on the result entered by the users who performed/reviewed the result.
General comment related to the specific instrument with which the test has been performed.
These reports contain quality control related information.
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LOT Statistics (By Instrument Type)
This report is a summary of the statistical analysis of all test-material lots performance, based on controls run on the test lots. This report contains also rejected tests.
Filter criteria
Site
Name of the site which reported the test results.
Instrument Type
Material ID
The type of instrument on which the test was performed.
Test material (short name) with which the test has been performed, e.g. Glucose strip.
Material Status
Test LOT
Status (
Active
,
Inactive
or
Expired
) of the test material for which the statistics are to be calculated.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Test
Material Activation Date
From
Material Activation Date
To
Material Deactivation Date
From
Material Deactivation Date
From
The abbreviated name of the test.
A filter to produce a report including statistics on material lots which have been activated between these two dates (inclusive).
A filter to produce a report including statistics on material lots which have been deactivated between these two dates
(inclusive).
Report fields
Site
Instrument Type
Result Type
Test Material
Test LOT
QC LOT
Test Material Status
Test LOT Activation
Test LOT Deactivation
Test LOT Expiration
Test
Level
N
Mean
Name of the site which reported the test results.
The type of instrument on which the test was performed.
Type of the reported results. (
Patient
,
Control
,
Linearity
).
Test material (short name) for which the statistics have been calculated, e.g. GLU-T for
Accu-Chek Inform
glucose strip.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
Status (
Active
,
Inactive
or
Expired
) of the test material for which the statistics have been calculated.
The date at which the test lot for which the statistics have been calculated has been set ready for use.
The date at which the test lot for which the statistics have been calculated has been manually deactivated.
The date at which the validity of the test lot for which statistics have been calculated ends.
The abbreviated name of the test.
The QC/linearity level this result belongs to. Does not apply to patient tests.
Number of QC results for this combination of instrument, test lot, QC lot, test and level.
Calculated mean value of all accepted results for this combination of instrument, test lot, QC lot, test and level.
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SD
CV[%]
Target
Min.
Max.
Inside Range
Outside Range
Rejected
Calculated standard deviation of all accepted results for this combination of instrument, test lot, QC lot, test and level.
Calculated coefficient of variation for this combination of instrument, test lot, QC lot, test and level.
Target value for this combination of instrument, test lot, QC lot, test and level.
Lower limit of the range for this combination of instrument, test lot, QC lot, test and level.
Upper limit of the range for this combination of instrument, test lot, QC lot, test and level.
Number of results (and their percentage) being within range for this combination of instrument, test lot, QC lot, test and level.
Number of results (and their percentage) being outside of the range for this combination of instrument, test lot, QC lot, test and level.
Number of rejected results.
LOT Listing (By Materials)
This report provides a quick overview on all material that is maintained in the system. If no filter is used, all 3 material types (
Test
,
QC
,
Linearity
) will be shown one after the other (divided into different sections of the report).
Filter criteria
Site
Instrument Type
Material Type
LOT
Material Status
Name of the site which reported the test results.
The type of instrument on which the test was performed.
The type of material for which to list lot information.
Lot number of the material with which ranges are maintained* for which to list lot information.
* Depending on the material definition this can be a test or
QC material.
Status (
Active
,
Inactive
or
Expired
) of the test material for which the statistics are to be calculated.
Report fields
Instrument Type
Material Type
Material
LOT
Material Status
Review Status
Activation Date
Deactivation Date
Expiration Date
The type of instrument on which the test was performed.
The type of material for which to list lot information.
Short name of the range-maintaining material for which lot information is listed.
Lot number of the material with which ranges are maintained* for which to list lot information.
* Depending on the material definition this can be a test or
QC material.
Status (
Active
,
Inactive
or
Expired
) of the test material for which the statistics are to be calculated.
Indicates whether the range-maintaining material lot has been reviewed and released for general usage.
The date at which the range-maintaining material lot for which the lot information is listed has been set ready for use.
The date at which the range-maintaining material lot for which the lot information is listed has been manually deactivated.
The date at which the validity of the range-maintaining material lot for which the lot information is listed will end.
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Test
Level
Min.
Max.
N
Mean
Target Value
Test LOT
QC LOT
Related Material's Type
Related Material
Material LOT
Dev./SD
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
The type (
Test
,
QC
or
Linearity
) of the non-range maintaining material.
The name of the non-range-maintaining material.
The lot number of the non-range-maintaining material. Only listed, if the range is only valid for a specific combination of test and QC or linearity lot.
The abbreviated name of the test.
The QC/linearity level this result belongs to. Does not apply to patient tests.
Lower limit of the range for this combination of instrument, test lot, QC lot, test and level.
Upper limit of the range for this combination of instrument, test lot, QC lot, test and level.
Number of QC results for this combination of instrument, test lot, QC lot, test and level.
Calculated mean value of all accepted results for this combination of instrument, test lot, QC lot, test and level.
Target value for this combination of instrument, test lot, QC lot, test and level. The mean of the upper and lower range limits.
For QC ranges the expected SD (calculated by dividing the difference between the upper limit and the target by kSD), used with multirules and an absolute value. For linearity, the allowed deviation (expressed as percentage) of the result to the target.
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Levey-Jennings Graph
Levey-Jennings charts are graphs that show the accepted QC test results in relation to expected mean and standard deviation.
Filter criteria
Site
Location ID
Date Range From
Date Range To
Instrument Type
Instrument Name
Serial Number
Test Material
Test LOT
QC Material
QC LOT
Test
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
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.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Test material (short name) with which the test has been performed, e.g. GLU-T for
Accu-Chek Inform
Glucose strips.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Long name (e.g.
Accu-Chek Inform
Glucose Control Solution) of the control material to graph QC results for.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
The abbreviated name of the test.
Report fields
Site
Location
Instrument Type
Instrument Name
Serial Number
Test Material Name
Test LOT
QC Material Name
QC LOT
Test
Level
Accepted Results
Date/Time
Result Value
Name of the site which reported the test results.
Name of the organizational location that reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Long name (e.g.
Accu-Chek Inform
Glucose Test Strips) of the test material on which the QC tests have been performed.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Long name (e.g.
Accu-Chek Inform
Glucose Control
Solution) of the control material with which the QC tests have been performed.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
The abbreviated name of the test.
The QC/linearity level this result belongs to. Does not apply to patient tests.
The list of accepted QC results.
The date at which the QC test has been performed.
The result value of the performed QC.
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Target
Range
Deviation
Deviation(%)
Performed by
Comment
Rejected Results
Date/Time
Result Value
Target
Range
Deviation
Deviation(%)
Performed by
Comment
Date/Time
Pending/On Hold Results
Date Range Summary
N
Mean
Target
Bias(%)
SD
CV(%)
Inside Range
Outside Range
Rejected
Lot Lifetime Summary
N
Mean
Target
Bias
The expected mean/target value of the QC results.
The range within which the QC result has to be.
The deviation of the (quantitative) result value to the
(quantitative) target, expressed in expected SD.
The deviation of the (quantitative) result value to the
(quantitative) target, expressed in percent.
The ID of the person who has performed the test.
Comment(s) relating to this QC test.
The list of rejected QC results.
The date at which the QC test has been performed.
The result value of the performed QC.
The expected mean/target value of the QC results.
The range within which the QC result has to be.
The deviation of the (quantitative) result value to the
(quantitative) target, expressed in expected SD.
The deviation of the (quantitative) result value to the
(quantitative) target, expressed in percent.
The ID of the person who has performed the test.
Comment(s) relating to this QC test.
The date at which the QC test has been performed.
The list of QC results with status Pending or On Hold.
This statistics provides data derived from the set date range.
Number of accepted QC results.
Calculated mean of the accepted QC results, in the unit of the test with a precision of 1 digit more than the set up for this test in
System Tests
.
The expected mean/target value of the QC results.
Calculated bias of the calculated mean from the expected mean of all accepted tests expressed in percent with precision of
2 decimal digits.
Standard deviation of the accepted QC results in the unit of the test with a precision of 1 digit more than the set up for this test in
System Tests
.
Coefficient of variation of the accepted QC results in percent with a precision of 2 decimal digits.
Number of results being within range.
Number of results being outside of range.
Number of rejected results.
This statistic provides data derived from the entire lifetime of the lot combination.
Number of accepted QC results.
Calculated mean of the accepted QC results, in the unit of the test with a precision of 1 digit more than the set up for this test in
System Tests
.
The expected mean/target value of the QC results.
Calculated bias of the calculated mean from the expected mean of all accepted tests expressed in percent with precision of 2 decimal digits.
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SD
CV
Inside Range
Outside Range
Rejected
Standard deviation of the accepted QC results in the unit of the test with a precision of 1 digit more than the set up for this test in
System Tests
.
Coefficient of variation of the accepted QC results in percent with a precision of 2 decimal digits.
Number of results being within range.
Number of results being outside of range.
Number of rejected results.
Linearity
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This report test linearity results against linearity target values defined for the material lot.
Filter criteria
Site
Location ID
Date Range From
Date Range To
Instrument Type
Instrument Name
Serial Number
Test Material
Test LOT
Linearity Material
Linearity LOT
Test
User ID
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
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.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Test material (short name) with which the test has been performed, e.g. GLU-T for
Accu-Chek Inform
Glucose strips.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Long name (e.g.
Accu-Chek Inform
Glucose Linearity Kit) of the linearity material with which the linearity tests were performed.
Lot number of the linearity material with which the linearity test have been performed, e.g. lot number of the
Accu-Chek
Inform
Glucose Linearity Kit.
The abbreviated name of the test.
The ID of the individual who has performed the tests.
Report fields
Site
Location
Instrument Type
Instrument Name
Serial Number
Test Material Name
Test LOT
Name of the site which reported the test results.
Name of the organizational location that reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Long name (e.g.
Accu-Chek Inform
Glucose Test Strips) of the test material on which the QC tests have been performed.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
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Linearity Material
Linearity LOT
Test
Level
Performed By
Date
Level
Target
Linearity
Time
Mean
Lin. Allow Variation
Lin. Calc Variation
Long name (e.g.
Accu-Chek Inform
Glucose Linearity Kit) of the linearity material with which the linearity tests were performed.
Lot number of the linearity material with which the linearity test have been performed, e.g. lot number of the
Accu-Chek
Inform
Glucose Linearity Kit.
The abbreviated name of the test.
The QC/linearity level this result belongs to. Does not apply to patient tests.
The ID of the person who has performed the tests.
The date when the linearity tests were performed.
The linearity level this result belongs to.
Target value of this level.
The linearity test result value.
The time when the linearity test was performed.
The calculated mean value of the linearity results for this level.
Mathematically ideal “Lin. Calc. Variation”, indicating perfect linearity, always 1.00.
The covariance of target and measured values divided by the product of the standard deviations of target and measured values (multiplied by the number of result values divided by the number of result values minus one). The lower the value the less perfect the linearity of the run, ideal value would be 1.00.
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.
Filter criteria
Site
Location ID
Instrument Type
Instrument Name
Serial Number
Material ID
Test LOT
Material Status
QC LOT
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Short name of the material (e.g. GLU-T for
Accu-Chek Inform
glucose test strips) on which the QC tests were performed.
Lot number of the test material on which the QC tests have been performed.
Status (
Active
,
Inactive
or
Expired
) of the test material on which the QC tests have been performed.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
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Material Activation Date
From
Material Activation Date
To
Material Deactivation Date
From
Material Deactivation Date
From
Test
A filter to produce a report including statistics on material lots which have been activated between these two dates (inclusive).
A filter to produce a report including statistics on material lots which have been deactivated between these two dates
(inclusive).
The abbreviated name of the test.
Report fields
Site
Location
Instrument Type
Instrument Name
Serial Number
Test Material
Test LOT
QC LOT
Test Material Status
Test LOT Activation
Test LOT Deactivation
Test LOT Expiration
Test
N
Mean
SD
CV(%)
Target
Min.
Max.
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Short name of the test material on which the QC tests have been performed.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
Status (
Active
,
Inactive
or
Expired
) of the test material on which the QC tests have been performed.
The date at which the test material lot has been set ready for use.
The date at which the test material lot has been manually deactivated.
The date at which the validity of the test material lot ends.
The abbreviated name of the test.
Number of QC results for this combination of instrument, test lot, QC lot, test and level.
Calculated mean value of all accepted results for this combination of instrument, test lot, QC lot, test and level.
Calculated standard deviation of all accepted results for this combination of instrument, test lot, QC/linearity lot, test and level.
Calculated coefficient of variation for this combination of instrument, test lot, QC/linearity lot, test and level.
Target value for this combination of instrument, test lot,
QC/linearity lot, test and level.
Lower limit of the range for this combination of instrument, test lot, QC/linearity lot, test and level.
Upper limit of the range for this combination of instrument, test lot, QC/linearity lot, test and level.
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Inside Range
Outside Range
Rejected
Number of results (and their percentage) being within range for this combination of instrument, test lot, QC/linearity lot, test and level.
Number of results (and their percentage) being outside of the range for this combination of instrument, test lot, QC/linearity lot, test and level.
Number of rejected results.
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.
Filter criteria
Site
Location ID
Instrument Type
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
The type of instrument on which the test was performed.
Material ID
Short name of the material (e.g. GLU-T for
Accu-Chek Inform
glucose test strips) on which the QC tests were performed.
Test LOT
Lot number of the test material on which the QC tests have been performed.
Material Status
Status (
Active
,
Inactive
or
Expired
) of the test material on which the QC tests have been performed.
Material Activation Date
From
Material Activation Date
To
Material Deactivation Date
From
Material Deactivation Date
From
Test
A filter to produce a report including statistics on material lots which have been activated between these two dates (inclusive).
A filter to produce a report including statistics on material lots which have been deactivated between these two dates
(inclusive).
The abbreviated name of the test.
Report fields
Site
Instrument Type
Location
Test Material
Test LOT
QC LOT
Test Material Status
Test LOT Activation
Test LOT Deactivation
Name of the site which reported the test results.
The type of instrument on which the test was performed.
Name of the organizational location which reported the test results.
Short name of the test material on which the QC tests have been performed.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
Status (
Active
,
Inactive
or
Expired
) of the test material on which the QC tests have been performed.
The date at which the test material lot has been set ready for use.
The date at which the test material lot has been manually deactivated.
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Test LOT Expiration
Test
N
Mean
SD
CV(%)
Target
Min.
Max.
Inside Range
Outside Range
Rejected
The date at which the validity of the test material lot ends.
The abbreviated name of the test.
Number of QC results for this combination of instrument, test lot, QC lot, test and level.
Calculated mean value of all accepted results for this combination of instrument, test lot, QC lot, test and level.
Calculated standard deviation of all accepted results for this combination of instrument, test lot, QC/linearity lot, test and level.
Calculated coefficient of variation for this combination of instrument, test lot, QC/linearity lot, test and level.
Target value for this combination of instrument, test lot,
QC/linearity lot, test and level.
Lower limit of the range for this combination of instrument, test lot, QC/linearity lot, test and level.
Upper limit of the range for this combination of instrument, test lot, QC/linearity lot, test and level.
Number of results (and their percentage) being within range for this combination of instrument, test lot, QC/linearity lot, test and level.
Number of results (and their percentage) being outside of the range for this combination of instrument, test lot, QC/linearity lot, test and level.
Number of rejected results.
Monthly QC Summary (By Location)
This report contains a QC summary by sending location and given month for each instrument type. The 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 one 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
These reports are generated taking into account those results that have received some corrective action.
Corrective Action Log
This report lists all QC or test results that have comments attached to the result. For example, for an analyzer like
Accu-Chek Inform
, the comment is the comment that the user enters (predefined or custom) after the test is performed.
Filter criteria
Site
Location ID
Date Range From
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
The starting date (inclusive) of the results to be included in the report.
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Alarms Group
Validation Status
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Instrument Type
Instrument Name
Serial Number
Test
Test LOT
User ID
Patient results
QC results
Linear results
Report fields
Site
Result Date
Location
Instrument Type
Instrument Name
Serial Number
Result Type
Test
Test LOT
QC LOT
Performed by
Certified
Result Time
Primary Patient ID
Level
Result Value
Unit
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The ending date (inclusive) of the results to be included in the report.
Groups of alarms triggered by the result.
Note:
Do not filter for the
Alarms Group
criterion. Results may be different than expected.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On hold
,
System Lock
*
(*automatic validation has generated an alarm. Applies to patient results only).
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
The abbreviated name of the test.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
The ID of the individual who has performed the test.
Choose one (or more) of the result types to be included in the report. There, the field Result Type will show the type of the respective result.
Name of the site which reported the test results.
The date the test was performed.
Name of the organizational location that reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Type of the reported results. (
Patient
,
Control
,
Linearity
).
The abbreviated name of the test.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
Lot number of the QC or linearity material with which a control test has been performed. Does not apply to patient tests.
The ID of the person who performed the test.
(Reserved for future functionality.) Intended to indicate
(
Yes
/
No
) whether the user was certified for this instrument type at the time the test was done.
The time the test was performed.
Patient ID 1 of the patient for whom the test was performed.
The QC/linearity level this result belongs to. Does not apply to patient tests.
The result value (qualitative or quantitative) of the performed test.
The measurement unit of the test.
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Range
Alarms
Validation Status
Sending Status
Result Comment
Instrument Comment
For patient results: The normal/reference range defined for this test and the patient's demographic criteria. For QC and linearity results: The QC range used to evaluate this result.
List of the IDs of the alarms triggered by this result.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On hold
,
System Lock
*
(*automatic validation has generated an alarm. Applies to patient results only).
Specific sending condition such as: sent (unidirectional), sent
(acknowledged), sent pending acknowledge, or will not be sent.
Reserved for future functionality
The comment on the result entered by the users who performed/reviewed the result.
General comment related to the specific instrument with which the test has been performed.
Instruments
These reports are related to the instruments, the alarms they generate and the instruments’ maintenance.
Instrument Alarm Log
The instruments events log report provides an overview of all alarms that occurred to any instrument within a certain time-frame.
Filter criteria
Site
Location ID
Date Range From
Date Range To
Instrument Type
Instrument Name
Serial Number
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
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.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
Report fields
Site
Location
Instrument Type
Instrument Name
Serial Number
Event Date
Event Time
Instrument error text
Name of the site which reported the test results.
Name of the organizational location that reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
The date the alarm/event occurred on the instrument.
The time the alarm/event occurred on the instrument.
The alarm/event message occurred on the instrument.
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Patient
These report groups together patient-related information.
Patient History
This report contains test results for the selected patient(s). Analytes are listed along with the testing dates, their corresponding results and the visit information. Using
Result Flags
,
Validation Flags
and
Validation Status
as filters, you can query patient results that have some abnormal values or that have caused an exception. You can print reports of results that have not been validated or have been rejected.
Filter criteria
Site
Location ID
Patient ID
Test
Result Alarms
Alarms Group
Validation Status
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
Patient identification number (
Patient ID 1
).
The abbreviated name of the test.
Severity of the alarms triggered for the results
Groups of alarms triggered by the result.
Note:
Do not filter for the
Alarms Group
criterion. Results may be different than expected.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On hold
,
System Lock
*
(*automatic validation has generated an alarm.
Report fields
Site
Location
Instrument Type
Instrument Name
Patient Primary ID
Date of Birth
Sex
HIS Location
Result Date
Result Time
Test
Result Value
Unit
Normal Range
Test LOT
Performed by
Instrument Type
Instrument Name
Name of the site which reported the test results.
Name of the organizational location that reported the test results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Patient identification number (Patient ID 1).
Patient’s date of birth.
Gender of the patient.
Location of the patient.
The date the test was performed.
The time the test was performed.
The abbreviated name of the test.
The result value (qualitative or quantitative) of the performed test.
The measurement unit of the test.
The normal/reference range defined for this test and the patient's demographic criteria.
Lot number of the test material with which the test has been performed, e.g. strip lot for
Accu-Chek Inform
instrument family results.
The ID of the person who performed the test.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
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Serial Number
Alarms
Validation Status
Result Comment
Instrument Comment
Serial number of the instrument on which the test was performed.
List of the IDs of the alarms triggered by this result.
Current validation status of the results:
Pending
,
Accepted
,
Rejected
,
On hold
,
System Lock
*
(*automatic validation has generated an alarm. Applies to patient results only).
The comment on the result entered by the users who performed/reviewed the result.
General comment related to the specific instrument with which the test has been performed.
QC RiliBÄK
These reports are generated based on RiliBÄK 2008 quality control logic.
2008 Monthly Report
This report is only available when operating in RiliBÄK 2008 QC mode.
This report documents QC in a way that enables your laboratory to meet RiliBÄK
2008 requirements.
o
Only QC results of the one, selected month are shown in the monthly summary report.
o
Only QC results received before the completion of the respective control cycle are documented in the monthly summary report.
o
No linearity results are included in the monthly summary report.
o
Only results received after the conversion to RiliBÄK 2008 are included in this report.
Filter criteria
Month
The calendar month in which the QC tests were performed.
Only test from the past can be displayed. It is not possible to select the current or future months.
Location ID
Name of the organizational location which reported the test results.
Instrument Type
Material ID
The type of instrument on which the test was performed.
Short name of the material (e.g. GLU-T for
Accu-Chek Inform
glucose test strips) on which the QC tests were performed.
Test LOT
Material Status
Lot number of the test material on which the QC tests have been performed.
Status (
Active
,
Inactive
,
Expired
) of the test material on which the QC tests have been performed.
Material Activation Date
From
Material Activation Date
To
Material Deactivation Date
From
Material Deactivation Date
From
Test
A filter to produce a report including statistics on material lots which have been activated between these two dates (inclusive).
A filter to produce a report including statistics on material lots which have been deactivated between these two dates
(inclusive).
The abbreviated name of the test.
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Report fields
Location
Location name*
Instrument Type
Instrument Name
S/N
Test abbreviation*
RiliBÄK test name*
Unit
Measurement method*
Test material name
QC material provider
Test lot
QC material name
Level
Date/Time
Result
Target
Dev. ()
Allowed ()
LED (%)
Low
High
QC lot
Eval.
Status
Performed by
Name of the organizational location which reported the test results.
The long name of the organizational location that reported the results.
The type of instrument on which the test was performed.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the QC tests were performed.
The short name of the control test performed.
The name of the test as listed in table B 1 of the 2008 RiliBÄK regulations. For tests not listed in table B 1, the long test name and the sample type.
The measurement unit of the QC results.
The test measurement method, e.g. through conductivity or photometry etc.
The long name of the test material on which the QC tests were performed.
Name of the company that provided the QC material.
The ID of the test material lot on which the QC tests were performed.
The long name of the QC material with which the QC tests were performed.
The QC/linearity level this result belongs to. Does not apply to patient tests.
The date and time at which the QC test was performed.
The actual result of the QC test.
The value of the expected mean. This column is only displayed, if the system tests are mapped to RiliBÄK tests. If the allowed deviation (columns 3a) is defined as “relative”, the allowed and the actual relative deviation are also displayed. If the allowed deviation (columns 3a) is defined as “absolute”, the allowed and the actual absolute deviation are also displayed.
The actual deviation of the QC result relative to the target. The parentheses contain a percentage sign if the deviation is expressed relatively and the unit if the deviation is an absolute value.
The maximum deviation allowed from the target. The parentheses contain a percentage sign if the deviation is expressed relatively and the unit if the deviation is an absolute value.
The maximum relative deviation the QC result is allowed to differ from the target result.
The lowest limit of the acceptable range for this QC result.
The highest limit of the acceptable range for this QC result.
The identifier of the QC material lot used to perform the QC tests.
The outcome of the result evaluation against the target result, allowed deviation, LED% and/or QC range. Possible outcomes are
OK
or
nOK
.
The validation status of the result, e.g. Accepted, rejected, pending or on hold.
The ID of the person who performed the test.
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Comments
Time frame
Calculated
Allowed
Evaluation
Comments related to the QC test entered either on the instrument or the application.
The status of the calculation and evaluation of the control cycle.
This is calculated using the root mean square of the error of measurement comparison and is updated automatically overnight.
The root mean square of the error of measurement (RMSE) calculated for the control cycle.
The maximum extent to which the calculated RMSE is allowed to deviate from the target. (Column 3 for tests listed in table B 1 of the 2008 RiliBÄK regulations.)
The outcome of the evaluation i.e. whether the calculated
RMSE exceeds the allowed deviation or not. Possible outcome can be
OK
or
nOK
.
q
The field names above followed by an asterisk (*) are not explicitly written in the report. For example the measurement method “Photometric” would be written without further indication of what this term describes.
Display order
The results displayed in the report are ordered by date and time ascending. The results are grouped by the following criteria: o sending location o instrument o test and QC lot o
QC level
Information on RMSE check
NOTICE
QC results used for RMSE check
Only QC results of the one month selected for report generation are documented in the
RiliBÄK 2008 Monthly Report. However, QC results from up to 3 previous month(s) are used for RMSE calculation, if there are not enough QC results in the reported month.
For each group of listed results, the reports provides the following information on the executed RMSE check:
Not applicable
Not enough results to establish control cycle
Control cycle not yet complete
Selected control cycle contains pending results, unable to calculate control cycle.
Control cycle calculated and checked
Timeframe
Calculated
Allowed
Evaluation
Comment
RMSE is not calculated and checked for this instrument and calendar month.
The data is not part of a control cycle.
The control cycle is not complete.
The control cycle contains pending results.
The control cycle has been calculated and checked. In this case, the application provides the following information: o o o the time frame covered by the control cycle the calculated RMSE o the allowed RMSE evaluation of the RMSE (OK, nOK)
Displays the comment associated to the alarm in the
Quality Control (RiliBÄK) > RMSE Alarm Monitor
(RiliBÄK)
screen. If applicable.
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RMSE comments if results are pending
If an associated instrument has pending results, the report displays one of the following comments underneath the results table: o
“Root mean square of measurement comparison error: control cycle contained pending results during most recent check, unable to calculate control cycle up to now”.
o
“Root mean square of measurement comparison error: control cycle Not yet complete.” for instruments excluded from RMSE.
After acceptance of the pending results, the report will show the correct comment:
“Root mean square of measurement comparison error: not Applicable.”
QC result graph
The graph displayed below the RMSE check information is related to the accepted
QC results provided in the list above the RMSE check information. In analogy to a
Levey-Jennings graph, the QC result graph charts the result deviations against the allowed deviation and the expected mean.
LED Status History Report
The LED Status History report provides information about how a LED was defined, when it was used and shows the current status of an LED. It provides information on whether or not a LED was repeatedly declined, why it was declined and what criteria were used for calculation.
The LED Status History is only available when operating in RiliBÄK 2008 QC mode.
Filter criteria
Instrument Type
Location
Instrument Name
QC LOT
Test LOT
Lot (combination) status
Level
Test
LED Status
The type of instrument on which the test was performed.
Name of the organizational location which reported the test results.
Name of the instrument on which the test was performed.
The ID of the QC material with which the QC tests have been performed.
The ID of the test material lot on which the QC tests were performed.
Status (
Active
,
Inactive
) of the LOTs with which the QC tests have been performed.
The QC level with which the tests were performed.
The abbreviated name of the test.
Status of the LED. Possible values are
Active
,
Deleted
,
Declined
,
No proposal possible
, P
roposal (mandatory LED)
,
Proposal (voluntary LED)
.
Report fields
Location
Instrument Type
Instrument Name S/N
Test
Measurement method*
QC material ID
Level
Unit
Name of the organizational location which reported the test results.
The type of instrument on which the test was performed.
Name / Serial Number of the instrument on which the QC was performed.
The abbreviated name of the test.
The test measurement method, e.g. through conductivity or measurement of hydrogen ion concentration.
The name of the QC material for which the LED was established.
The QC level with which the tests were performed.
The measurement unit of the QC results.
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Test LOT
Control LOT
LED Status
LED
Max. allowed LED (%)
Status since
Status set by
Results used for calculation
Calculation criteria
The ID of the test material lot on which the QC tests were performed.
The lot number of the QC material used.
Status of the LED. Possible values are
Accepted
,
Deleted
,
Declined
,
No proposal possible
,
Proposal (mandatory LED)
,
Proposal (voluntary LED)
.
Value of the LED.
The maximum LED in percent for the selected test, derived from the QC range.
Date and time when the LED was last calculated.
ID of the user who triggered the last calculation.
The QC results that were used for automatic calculation.
Possible values:
Complete control cycle
;
Current/non-control cycle
.
Value of the QC result used per day for calculation; Expansion factor k. Per default, the expansion factor is set to 3. It can be altered in the
Recalculation criteria
dialog.
System
These reports are generated based on system-related information.
Sample Count (by Instrument and Location)
This report provides information about the amount of tests, performed on individual instrument, sorted by location and instrument type.
In combination with the 'Validation Flag(s)' 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.
Filter criteria
Site
Location
Date Range From
Date Range To
Alarm group
Instrument Type
Include empty results
Name of the site which reported the test results.
Name of the organizational location which reported the test results.
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.
Groups of alarms triggered by the result.
The type of instrument on which the test was performed.
Allows to include the empty patient result records in the report.
By default, the empty result records are not included in the report.
Report fields
Site
Instrument Type
Patient
Name of the site which reported the test results.
The type of instrument on which the test was performed.
The number of patient samples performed on instruments of this type in the selected organizational location in the given time frame.
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QC
Linearity
Alarms
WIth Comments
Total (Instrument Type)
Grand Total (Location)
The number of QC samples performed on instruments of this type in the selected organizational location in the given time frame.
The number of linearity samples performed on instruments of this type in selected location in the given time frame.
The number of patient, QC and linearity samples performed on instruments of this type in the selected organizational location in the given time frame having had alarms.
The number of patient, QC and linearity samples performed on instruments of this type in the selected organizational location in the given time frame having had comments.
The number of patient, QC and linearity samples performed on instruments of this type in the selected organizational location in the given time frame.
The number of patient, QC and linearity samples performed in the selected organizational location in the given time frame.
Test/Sample Count (by Location and Instrument type)
The 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: o
For QC results: During upgrade the Sending Location could not clearly be identified because there was no patient results for that period.
o
For both, QC and patient result: 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
Include empty results
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.
Allows to include the empty patient result records in the report.
By default, the empty result records are not included in the report.
Report fields
Sending Location
Name of the organizational location for which the statistics were calculated.
The type of instrument on which the test was performed.
Instrument Type
Patient
Results
Samples
The number of patient tests done, listed by status (
Accepted
,
Rejected
,
Pending
/
On Hold
) and in total.
The number of patient samples done, listed by status
(
Accepted
,
Rejected
,
Pending
/
On Hold
) and in total.
QC
Results
Samples
The number of QC tests done, listed by status (
Accepted
,
Rejected
,
Pending
/
On Hold
) and in total.
The number of QC samples done, listed by status (
Accepted
,
Rejected
,
Pending
/
On Hold
) and in total.
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Linearity
Results
Samples
Total
Results
The number of linearity tests done, listed by status (
Accepted
,
Rejected
,
Pending
/
On Hold
) and in total.
The number of linearity samples done, listed by status
(
Accepted
,
Rejected
,
Pending
/
On Hold
) and in total.
Samples
The number of tests done (sum of patient, QC and linearity tests done), listed by status (
Accepted
,
Rejected
,
Pending
/
On
Hold
) and in total.
The number of samples done (sum of patient, QC and linearity tests done), listed by status (
Accepted
,
Rejected
,
Pending
/
On
Hold
) and in total.
Test Count (by Location and Instrument type)
The report shows statistics on the number of performed tests for a specific time frame by location and instrument type. You can select a single location, all locations or “no
Location”.
The location is unknown in the following cases: o
For QC results: During upgrade the Sending Location could not clearly be identified because there was no patient results for that period.
o
For both, QC and patient result: The measurement has been taken while the instrument assignment to a location was not done (yet).
Filter criteria
Location
Test
Date Range From
Date Range To
Instrument Type
Include empty results
Name of the organizational location which reported the test results.
The abbreviated name of the test.
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.
The type of instrument on which the test was performed.
Allows to include the empty patient result records in the report.
By default, the empty result records are not included in the report.
Report fields
Site
Location ID
Location Description
Location Manager
Information
Manager
Phone
Instrument Name
Serial Number
Test
Patient Tests
Name of the site the results were done at.
Name of the organizational location the results were done at.
The description of the organizational location the results were done at.
Information of the manager for the organizational location the results were done at.
Manager’s full name.
Manager’s telephone number.
Manager’s e-mail address.
Name of the instrument on which the test was performed.
Serial number of the instrument on which the test was performed.
The abbreviated name of the test performed.
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Accepted
All
STAT
QC Results
Accepted
All
Linearity
Accepted
All
Sum
The number of accepted patient test results.
Total number of patient test results.
The number of patient tests run as STAT.
The number of accepted QC test results.
Total number of QC test results.
The number of accepted linearity test results.
Total number of linearity test results.
The number of test results done (sum of patient, QC and linearity tests), listed by accepted status and in total.
Sample Count (by Panel)
The Sample Count (by Panel) report provides a summary of all samples (Patient, QC,
Linearity) run over the defined period of time.
Filter criteria
Date Range From
Date Range To
Location
Instrument Type
Include empty results
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.
The type of instrument on which the test was performed.
Allows to include the empty patient result records in the report.
By default, the empty result records are not included in the report.
Report fields
Location
Date range
Instrument Type
Include empty results
Serial Number
Patient Samples
Panel
All
Accepted
Rejected
Hold/Pending
Total
Quality Control
Level
All
Accepted
Name of the organizational location which reported the test results.
The starting (inclusive) and the ending date of the results in the report.
The type of instrument on which the test was performed.
Allows to include the empty patient result records in the report.
By default, the empty result records are not included in the report.
Serial number of the instrument on which the test was performed.
Number of patient samples separated by:
Number of samples done with each panel.
Number of samples done across panels.
Number of accepted patient samples.
Number of rejected patient samples.
Number of Hold/Pending patient samples.
Total number of patient samples.
Number of QC results separated by:
Number of samples done with each QC level.
Number of samples done across levels.
Number of accepted QC samples.
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Rejected
Hold/Pending
Total
Quality Linearity
All
Accepted
Rejected
Hold/Pending
Total
Number of rejected QC samples.
Number of Hold/Pending QC samples.
Total number of QC samples.
Number of linearity results separated by:
Number of Linearity samples across levels.
Number of accepted Linearity samples.
Number of rejected Linearity samples.
Number of Hold/Pending Linearity samples.
Total number of Linearity samples.
POCT Monthly Feedback
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.
This report includes statistical information about QC results only if control material and lot remained unchanged during the reported calendar month.
Filter criteria
Report Name
Month
From
To
Location
Instrument Type
Instrument Name
Serial Number
Test
Number of Users
User
The name of the report chosen by the user. By default POCT
Monthly Feedback will appear in the report if no name is entered.
The calendar month to analyze. Current or future months cannot be selected.
The month beginning with the report is done for.
The month ending with the report is done for.
On different occasions, an instrument can be assigned to different locations. Results from one instrument can therefore be associated with multiple locations.
For patient test results: Name of the organizational location which reported the test results.
For QC test results: Name of the organizational location of the instrument (at the time of report generation) that reported the test results.
The type of instrument on which the test was performed.
Names of the instruments on which the statistics is performed.
The user can select multiple instrument names. User can only filter for Instrument Names if the
Serial Number
filter is not used.
Serial numbers of the instruments on which the statistics is performed. The user can select multiple Instrument S/N if the
Instrument Name
filter is not used.
Abbreviated names of the tests on which to perform the statistics. Only tests used in the definition of an active
QC/Linearity material can be selected.
The number of generic users for which user specific statistics are reported. When selecting a number other than 0, the IDs of the generic users can be entered.
The user ID of the generic user for which user specific statistics are to be reported.
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Report fields
Number of Patients
Patient
Include empty results
Site
Location
Month
Instrument Type
Instrument Name
Serial Number
Test
Include empty results
Patient Results
Quality Control Results
Level
N
N (Rejected)
Mean
SD
CV [%]
Bias [%]
User Information
User ID
User Name
Patient Results
The number of patients for which patient specific statistics are reported. When selecting a number other than 0, the IDs of the patients can be entered.
The Patient ID of the patient for which patient specific statistics are to be reported.
Allows to include the empty patient result records in the report.
By default, the empty result records are not included in the report.
Name of the site the results were done at.
Name of the organizational location which reported the test results.
The calendar month in which the tests were performed.
The type of instrument on which the test was performed.
Name of the instrument on which tests were performed.
Serial number of the instrument on which the test was performed.
Abbreviated name of the test which was performed.
Allows to include the empty patient result records in the report.
By default, the empty result records are not included in the report.
Number of patient results, including the number of results for tests mapped to this test via a QC test mapping. These are listed under
Total:
Total number of patient tests.
Rejected:
Number of rejected patient tests.
STAT:
Number of patient tests marked as STAT test.
With Comment:
Number of tests with corrective actions.
Without Patient:
Number of patient tests having been done without patient ID entry.
The number of QC results by level, listed as:
Note:
Statistics for QC results are only included in the report if control material and lot remained unchanged during the reported calendar month.
The QC level of the results.
Number of accepted QC results.
Number of rejected QC results.
Calculated mean of all accepted results.
Calculated standard deviation of all accepted results.
Calculated coefficient of variation of all accepted results expressed in percent with precision of 2 decimal digits.
Calculated bias of the calculated mean from the expected mean of all accepted results expressed in percent with precision of 2 decimal digits.
The user activity statistics.
The ID of the user for which the activity statistics is performed.
The name of the user for which the activity statistics is performed.
Number of performed patient tests including tests which are related to the shown test via a QC test mapping for the related instrument type.
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QC Results
Patient Information
Patient ID
Patient Name
Accepted
Rejected
Number of QC tests performed.
The patient activity statistics.
The ID of the patient for which the activity statistics is performed.
The name of the patient for which the activity statistics is performed.
Number of accepted tests, including tests which are related to the shown test via QC test mapping for the related instrument type.
Number of rejected tests, including tests which are related to the shown test via QC test mapping for the related instrument type.
User
These reports generate logs with user-based information.
User Certification History
This report is used to document the history of users and their certifications, requested tasks and their completion status.
Filter criteria
User ID
User’s Home Location
Assigned Location
Certificate Name
Instrument Type
Date Range From
Date Range To
Name
The unique identification number assigned to the selected user.
Note:
Filtering for User ID may be very slow and inefficient, depending on the number of users in the system.
Home Location of the user
Name of the organizational location which reported the test results.
The type of certificate that is to be issued. Certificate types are defined and assigned to users by the administrator under
Organization > Certification
.
The type of instrument on which the test was performed.
The starting date (inclusive) of the certifications to be included in the report.
The ending date (inclusive) of the certifications to be included in the report.
The name of the user.
q
If a date range is set to filter the User Certification History, only users with one or more active certifications will be included during this timeframe.
Report fields
The following figure shows a (fictitious) example of a
User Certication History
report and the contained information.
u
For more information about certifications, refer to:
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A
B
C
D
E
11 Reports
Types of Reports
F
G H
A
Details of queried user (user ID, user name, workgroup, assigned locations)
B
Certification associated with the queried user
C
Details of the certification (instrument and test type, queried user’s current certification stage, observation timeframe for
(re)certification, issuer and date of last (re)certification)
D
Privileges of the certification
Figure 11-4
Example of
User Certification History
report
E
Certification date of last (re)certification
F
Expiration date of the current stage of the certification
G
Certification tasks required for (re)certification
H
Completion status and number of required certification tasks
User Statistics
This report is used to analyze QC and patient results per user. The statistics is sorted by sites and instrument types.
Filter criteria
User Name
User’s Home Location
Assigned Location
Instrument Type
Date Range From
Date Range To
First and last name of the user for which the statistics is performed.
Home Location of the user.
Name of the organizational location which reported the test results.
The type of instrument that is included in the statistics.
The starting date (inclusive) of the QC and patient results to be included in the report.
The ending date (inclusive) of the QC and patient results to be included in the report.
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Report fields
User Name
Home Location
Quality Control
Patient Results cobas IT 1000 application
First and last name of the user.
Home location of the user.
Run
: Total number of QC results.
Out of range
: Number of QC results that are out of range.
Out of range
: Percentage of QC results that are out of range.
All
: Total number of patient results.
Critical
: Number of critical patient results. A patient result is reported as “critical” by
cobas IT
1000 application based on system alarms and ranges, i.e. results falling outside the defined critical reference ranges and triggering the system alarms
TPL
(
Result below lower critical range
) or
TPH
(
Result above upper critical range
).
Critical with comments
: Number of critical patient results with comments attached.
Misidentified samples
: Number of misidentified samples. A misidentified sample is a sample with unknown patient information.
Compliance with patient identification
: Percentage of non-misidentified samples.
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Appendix
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Table of contents
12 Formats for exam results input files
Formats for exam results input files
12
In this chapter
Chapter
12
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Configurable formats
Configurable formats
Configuration
Header exists
Column separator
Column headers / column positions
Exam result
Error message language
LmsId Reference Field
FirstName 1
LastName 2
CourseName 3
ExamDate 4
ExamResult 5
PASS
FAIL en
The following table lists default and possible values for the configurable formats of the exam results input files. If no configuration file is set up, the default values must be used in the input file.
Default value
TRUE
TAB
LmsId /
6
Exam date and time format
YYYY-MM-DD hh:mm:ss
Comment
Possible values
TRUE
FALSE
TAB
Description
Determines if a header row must exist in the input file
Determines which delimiter must be used as column separator in the input file
String
String
String
Date Time
String
If "header exists =
TRUE" in the input file must be a header row containing the defined column headers
(in any order)
If "header exists =
FALSE" with user data in the input file must follow the defined order
Optional field
The format of the exam date and time used in the input file:
Comment, Email, or User ID
YYYY-MM-DD
YYYY/MM/DD
MM/DD/YYYY
MM-DD-YYYY
DD/MM/YYYY
DD-MM-YYYY
DD.MM.YYYY
24-hour clock, local time: hh:mm hh:mm:ss
12-hour clock, local time: hh:mmAM/PM hh:mm:ssAM/PM
24-hour clock, local time with offset from OTC: hh:mm:ss+/-hh:mm hh:mm+/-hh:mm
24-hour clock, UTC: hh:mmZ hh:mm:ssZ
In the configuration, one date format must be combined with one time format
Note:
Separate exam date and time with a space character in the input file
String
Language code
Comment, Email, or User ID as defined in
Organization > User
Management
Expressions for "exam passed" and
"exam failed" used in the input file
Language of error messages in the error file in case of failed import
The corresponding language pack must be installed to make this entry effective
If the LmsId Reference Field is enabled,
cobas IT
1000 application identifies the user solely by the Comment, Email, or
User ID as defined in
Organization
> User Management
.
Table 12-1
Formatting for the LMS input file
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Configurable formats
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Note:
In the LMS configuration file, only the formats listed in the table above are supported. It is recommended that the input files exported from the LMS have dates that match the exact format selected in the configuration, but be aware that the parsing of the dates may be flexible: o
When you configure the date formats as
MM-DD-YYYY
American date format will also be accepted in the input files.
o
When you configure the date formats as
DD-MM-YYYY
or character, or with no date separators will also be accepted in the input files.
o
If the year is missing, the current year will be assumed.
o
If the time is missing, midnight will be assumed (00:00:00).
The unambiguous American date formats are:
MM/DD
MM-DD
MM DD
MM/DD/YY
MM-DD-YY
MM DD YY
MM/DD/YYYY
MM-DD-YYYY
MM DD YYYY
YYYYMMDD
YYMMDD
YYYY-MM-DD
YYYY MM DD
The unambiguous European date formats are:
DD/MM
DD-MM
DD MM
DD/MM/YY
DD-MM-YY
DD MM YY
DD/MM/YYYY
DD-MM-YYYY
DD MM YYYY
YYYYMMDD
YYMMDD
YYYY-MM-DD
YYYY MM DD
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Glossary
This glossary is a compendium of technical terms used in conjunction with the
cobas IT
1000 application.
ADT
Admission, discharge & transfer. A patient information stream received from one or more hosts, typically hospital information systems.
Alarm
Warning notice either referring to system events or to test results that are out of the normal range.
Analyzer
Instrument.
Certificate
Defines which tasks (e.g. performing measurements and/or quality controls) an operator is allowed to do on a specific instrument type once he is issued a certification based upon this certificate.
Certificate types and period of validity are defined by the
POCC.
Client
A client is the software application installed on the laboratory computers. For the
cobas IT
1000 application only Microsoft Silverlight 5.1.30514.0 and
Microsoft Internet Explorer 8 or higher, supporting
Microsoft Silverlight 5.1.30514.0 are required. The client accesses the data on the application server and visualizes the information. In general, a license is required for each client.
Component
Subunit of a module. Second level in the hierarchy of the Navigation tree.
Container
Tube
Control
Quality Control
Current name
Name of the field as it is displayed in other screens of the application. The field names under
Current Name are usually translated, whereas the entries under System Name are not.
Delta check
Comparison of the current result with a previous result of the same test performed on the same patient. Used in medical validation for plausibility and/or for detection of a potentially critical condition of the patient.
EAP
Extensible Authentication Protocol.
Authentication framework, which enables the communication between server and client in wireless networks for authentication purposes. In
cobas IT
1000 application, EAP security can be configured for WLAN communication with instruments.
Filter
Query statement used to extract a single specific kind of records from the database. A query statement defines the conditions each record must meet in order to be retrieved and listed on the screen.
ADT - Instrument alarm
13
Generic patient
Results are associated with the generic patient(s) if they cannot be associated with a specific patient ID. This happens if: o
Samples are measured or entered without a patient
ID.
o
Patient ID 2 or 3 are used as instrument 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 ADT information has not yet been updated by the HIS)
By default, the generic patient is assigned the ID 999999.
A different ID or several IDs can be assigned in the
General Settings
.
HIS
Hospital information system. The host system software that usually belongs to the customer organization.
HIS location
The HIS location component links the patient data (retrieved from the HIS) to the location (as defined on the
cobas IT
1000 application). Each patient is admitted to a HIS location. Each HIS location is assigned to a location. In this way, the patient information is related to the individual instruments. HIS location names (e.g. room number) must be unique per
cobas IT
1000 application installation.
Host
An external information system of higher level which provides services or a connection to a wider network, e.g. LIS or HIS.
INR
International Normalized Ratio (INR) unit. INR =
(samples/normals) ISI, where “normal” is a pool obtained from healthy persons, ISI is the International
Sensitivity Index, designed to eliminate dependency on sensitivity of the reagents so that the international result is the same and recommendations for care are uniform.
Instrument
An analytical device from Roche or a third party supplier used for processing samples, i.e. performing tests. An instrument can only be assigned to one single location.
Instrument alarm
Alarm triggered by an instrument flag. Instrument alarm flags come with the Instrument and may differ from instrument type to instrument type.
Instrument alarm flags are mapped to Instrument
Alarms under Instrument Alarm Assignment.
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LDAP - Patient demographics
LDAP
LDAP is a protocol of active directory synchronization of users. A central system in the Lab that allows you to log in with all the users in the network not just in the system. The user can use the HIS or LIS password in the
cobas IT
1000 application - Integrated user name and password. The LDAP setting in
General
Settings
enables this functionality for all users, and the
LDAP setting in the
User management
screen enables
LDAP for a particular user.
LED
Laboratory established deviation. An LED is the maximum allowed deviation to the target value that you can enter based on statistics from your individual laboratory’s QC results. An LED is instrument, lot, test, and level specific. The LED functionality is available in
RiliBÄK 2008 mode only and uses the algorithm for the calculation defined in the RiliBÄK regulation. For some tests, the allowed deviation itself is specified in the
RiliBÄK 2008 chapter. Throughout the application, these tests are referred to as RiliBÄK tests.
LED, mandatory
Mandatory LED proposals are proposals based on complete control cycles for each Lot entry maintaining QC ranges.
LED, voluntary
Voluntary LED proposals are proposals based on non-complete control cycles for each
Lot entry maintaining QC ranges. If the instrument is set for RMSE calculation, these LED proposals are based on incomplete control cycles. If the instrument is not set for
RMSE calculation, these LED proposals are based on results not associated with control cycles.
LIS
Laboratory information system. Software for entering, managing and reporting laboratory information. Information includes, but is not limited to, patient demographics, test orders, and test results.
Definitions in the countries can differ: laboratory areas like microbiology, blood depot and pathology can also be covered by a LIS. See also HIS.
LMS
Learning management system. A 3 rd
party system for taking courses and exams, that can be set as certification tasks in
cobas IT
1000 application.
Location
Department in a hospital for the treatment of people with similar illnesses or conditions. Technically,
Locations are used to establish the relationship between user, instrument, patient and result data. Each location is assigned to a site. HIS locations, users and instruments are all assigned to a location. Location (department, ward) names must be unique per site. Due to their role as a unique identifier, location names are provided as query criteria in most areas of the application.
Material
Material used by the instruments to carry out the tests.
Material LOT
Refers to the 3 different types of logical material models supported by the application: o
QC range linked to test lot (e.g.,
Accu-Chek Inform
) o
QC range linked to QC lot (e.g., blood gas instruments) o
QC range linked to combination of test lot and QC lot (e.g.,
cobas h
232)
Module
The name assigned to a group of screens in the application where you can perform related functions, e.g. system, organization, instrument. The modules constitute the first level in the hierarchy of the
Navigation tree. They consist of subunits, the so-called
Components.
Offline instrument
An instrument that is not connectable to the
cobas IT
1000 application, but is set up there so that results can be entered manually
Operator
Person who physically interacts with the
POC instrument on regular basis. He or she is required to be certified for each instrument type. The user profile
“Operator” is used for individuals who do not have access to the
cobas IT
1000 application. An Operator is assigned to one or several locations.
OTS
Observed test sequence. A workflow where a supervising user (i.e. user trainer) observes an user doing the complete sequence of testing (including sampling site preparation, taking sample, user and patient identification) to evaluate and document how well the test sequence was performed by the supervised (i.e. trainee) user.
OTS, direct vs. virtual
o
Direct OTS: when the execution and documentation of OTS is supported to be done directly on the instrument.
o
Virtual OTS: when an instrument does not support a genuine OTS instrument concept (i.e. direct OTS), virtual OTS provides a way of documenting that a test has been performed under supervision.
OTS, explicit vs. implicit
o
Explicit OTS: an OTS done in response to an OTS being a task explicitly defined for a certificate.
o
Implicit OTS: an OTS done as a replacement for tasks defined for a certificate which the instrument user cannot do anymore because his certification has temporarily expired.
Patient
Person from which the samples are taken that undergo one or several tests. Person who is awaiting or under medical care or treatment. A patient is always assigned to one single HIS location.
Patient demographics
Patient-related data such as name, date of birth, and gender.
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POCC
Point-of-Care Coordinator. The person within a hospital organization who is responsible for management and assurance of quality of Point-of-Care testing.
POCT
Point-of-Care Testing. Diagnostic testing at or near the site of patient care. The driving notion behind
POCT is to bring the test conveniently and immediately to the patient.
Proficiency testing
Proficiency testing is an external assessment of measurement accuracy. The authorities provide a sample to be measured. The results have to be sent back for evaluation.
Profile
Set of features that define a group of individuals who share the same access rights.
QC
The quality monitoring procedure performed periodically to ensure that the whole testing procedure complies with the set standards.
QC bracketing
Setting in which a test result must be preceded by, and followed by, a successful QC result before it is released.
QC result
The result of a control measurement, i.e. the result of an analyte measured on an instrument for a distinct control material-control lot combination.
Quality Control
Summary term referring to the different result types used to assess the analytical quality of an instrument (linearity, proficiency, QC).
Report
Record of specific data that can be either printed out or stored electronically.
RiliBÄK tests
Term used in the application to refer to the tests for which the allowed deviation is specified in the RiliBÄK 2008 chapter.
RMSE
Root mean square of the error of measurement.
The mean square is calculated per control cycle.
Routine Period
A routine period is the time frame of
24 hours after the “start of routine” defined for an instrument.
Sample type
The kind of substance or material that is tested, such as blood, plasma, urine, etc. The module sample type definition in the application is only used for manual result entry to enter results for tests that are not defined per default.
Site
Building or a group of buildings that make up one virtual administrative and informative unit. Every system element belongs physically (location, unit) or virtually
(individuals) to one site. Site IDs must be unique.
Status
Condition of any of the records used in the application; usually, active or inactive.
POCC - Workgroup
System alarm
Flag triggered by the application (not by the instrument). System alarms need to be mapped to an instrument under
System > System Alarm Assignment
.
System name
Internal name for Roche predefined fields. Information can only be read in the List area. It is not editable. Other than the “Current name”, the System name is not translated with the user interface.
Test
The entire process of determining the value of a requested analyte in a sample. The term also refers to the clinical assay handled and managed by the application.
TOD
Time of day. Time in format hh:mm between
00:00 and 23:59.
Tube
The container of a sample used for testing. Tube definition is mandatory for all tests entered on the application. Every test needs to be assigned a tube, even if the instrument does not use a tube for sample analysis.
Location
Department in a hospital for the treatment of people with similar illnesses or conditions.
UPS
Uninterruptible power supply. A temporary, battery powered power supply that is used in case of unexpected interruption of mains power.
User
Person who physically interacts with the software and/or the instrument. A user is assigned to one or several locations. User access rights to instrument types are governed by means of certification. Access rights to the application are governed by means of user profiles.
The user profile “Operator” is used for individuals who do not have access to the application. An Operator is assigned to one or several locations.
Validate
To confirm that a result received from an instrument is valid.
Workgroup
With the workgroup attribute, it is possible to group individuals by a common criterion (e.g. profession). This criterion is independent of the location they are assigned to.
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Workgroup - Workgroup
cobas IT 1000 application
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Index
cobas IT 1000 application
Index
A
Application screen overview, 37
– Using the cobas IT 1000 application, 38
B
– Enabling application pop-ups, 27
C
– Creating a new certification from an existing one, 190
– Editing a certification, 190
– Exporting certifications, 191
– Export a list of certification tasks, 170
– Reset the exam attempts counter, 167
– View Exam in cobas academy, 166
– Quality Control (RiliBÄK 2008), 330
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D
E
EAP settings
Effective QC Range Review
– Quality Control (RiliBÄK 2008), 351
Enabling application pop-ups, 27
exam results
Exam results input file configuration, 425
Extensible Authentication Protocol, 256
F
Formats for exam results input file, 425
G
– Quality Control RiliBÄK 2008, 74
H
Index
433
Index cobas IT 1000 application
I
– Changing the user password, 30
– Predefined Configurations, 31
Instrument Alarm Assignment, 105
Instrument Alarm Definition, 95
Instrument Assignment
– Adding a new instrument automatically, 269
– Copying an instrument setup information, 269
– Copying an instrument configuration from an existing one, 247
– EAP Settings Assignment, 265
– Notifying the beginning of a maintenance task, 242
– Notifying the completion of a maintenance task,
– Adding an event to an instrument, 237
– Changing an instrument’s status, 238
– Modifying the instrument event list, 238
– Querying the instrument event list, 237
– Resetting / clearing an instrument’s memory, 236
– Sending a message to an instrument, 236
– Viewing the events of all the instruments, 237
L
– Changing the regional settings, 49
learning management system, 167
– Quality Control (RiliBÄK 2008), 328
– Quality Control (RiliBÄK 2008), 332
Levey-Jennings Review by Lot, 303
Location
– Laboratory Established deviation, 220
M
Maintenance
Manual Result Entry
– Quality Control (RiliBÄK 2008), 335
– Defining a new material, 211
N
O
Off-Line Instruments
– Creating a new configuration from an existing one, 284
Organization module components, 131
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cobas IT 1000 application
P
Patient Demographic Assignment, 93
– Defining personalizations, 57
Q
– Quality Control (RiliBÄK 2008), 344
Quality Control (RiliBÄK 2008), 317
Quality Control (RiliBÄK 2008) module, 319
– Effective QC Range Review, 351
– RiliBÄK Test Assignment, 337
– Levey-Jennings Review by Lot, 303
R
Remote Authentication Dial-In User Service, 256
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– Saving the report as a log file, 387
– To set a report as favorite, 387
– To set a report as not a favorite, 387
Reset exam attempt counter, 167
Result Alarm Monitor
– Quality Control (RiliBÄK 2008), 340
Result Management
– Quality Control (RiliBÄK 2008), 321
Results & Patients module, 357
RiliBÄK Test Assignment
– Quality Control (RiliBÄK 2008), 337
RMSE Alarm Monitor
– Quality Control (RiliBÄK 2008), 347
S
Safety information
– System safety information, 17
– Predefined Configurations, 31
Index
435
Index
Software overview
Status
System components
– Instrument Alarm Assignment, 105
– Instrument Alarm Definition, 95
– Patient Demographic Assignment, 93
– System Alarm Assignment, 107
T
U
– Define warnings for users, 158
– Resetting a user’s password, 159
User Manual
– Conventions used in this manual, 13
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436 cobas IT 1000 application
W
– Activating/deactivating a warning, 52
User Manual · Version 4.7
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Key features
Receives electronically: patient test results, quality control results, instrument messages and instrument maintenance events
Receives manually: quality control results and comments
Stores patient test results, quality control results, instrument messages and instrument maintenance events
Manages users & certifications
Sends patient test results and quality control results to customer IT systems (HIS&LIS)
Assessment of patient and quality control results to support compliance with the customer’s quality environment
Configuring the workflow of connected instruments
Reporting
Support for cobas® infinity POC mobile, access granted through connection to cobas® infinity POC mobile adapter. cobas® infinity POC Mobile is an App that uses already existing cobas IT 1000 application data and displays it on a mobile device, information displayed covers: POC devices, operators and certifications.
Frequently asked questions
The main functions are: Receiving electronically: patient test results, quality control results, instrument messages and instrument maintenance events. Receiving manually: quality control results and comments. Storing patient test results, quality control results, instrument messages and instrument maintenance events. Managing users & certifications. Sending patient test results and quality control results to customer IT systems (HIS&LIS). Assessment of patient and quality control results to support compliance with the customer’s quality environment. Configuring the workflow of connected instruments. Reporting. Support for cobas® infinity POC mobile, access granted through connection to cobas® infinity POC mobile adapter. cobas® infinity POC Mobile is an App that uses already existing cobas IT 1000 application data and displays it on a mobile device, information displayed covers: POC devices, operators and certifications.
The intended users of Roche cobas IT 1000 are Nurses/Nurse Educator, POC Coordinator and IT Manager.
User access rights to the application are governed by means of user profiles. User access rights to instrument types are governed by means of certification.