Roche cobas infinity central lab User manual

cobas infinity central lab
Roche
Brand
Roche
Model
cobas infinity central lab
Category
Software
Type
User manual
cobas
®
infinity IT solutions
User Manual Version 2.1
Software version 1.1.1
cobas infinity IT solutions
Roche Diagnostics
2 User Manual · Version 2.1
Publication information
Edition notice
This publication is intended for users of the cobas
®
infinity IT solutions application.
Every effort has been made to ensure that all the information is correct at the time of
publishing. However, Roche Diagnostics reserves the right to change this publication
as necessary and without notice as part of ongoing product development.
Where to find information The User Manual and the Online Help focus on routine operation and
configuration. The chapters are organized according to the normal operation
workflow.
The Workflow Guide is a summary of the main procedures to use the application.
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 administration actions unless you have received
training from Roche Diagnostics. Leave tasks that are not described in the user
documentation to trained Roche Service representatives.
Screenshots The screenshots in this publication have been added exclusively for illustration
purposes. Configurable and variable data, such as tests, results, or path names visible
therein 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.
Publication version Software version Revision date Change description
1.0 1.0.0 September 2013 First edition
1.1 1.0.0 September 2013 Process format
improvements
1.2 1.0.0 October 2013 Corrupted screenshot
corrected
1.3 1.0.0 January 2014 Some incorrect
symbols deleted
2.0 1.1.0 July 2014 New features of
software version 1.1.0
2.1 1.1.1 November 2014 Chapters
reorganization and
edition
Table 1 Revision history
Roche Diagnostics
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Copyright © 2014, Roche Diagnostics International Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS P, and LIFE NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective owners.
Feedback Every effort has been made to ensure that this publication fulfills the intended
purpose as mentioned above. All feedback on any aspect of this publication is
welcome and is considered during updates. Contact your Roche representative,
should you have any such feedback.
License information
The cobas
®
infinity IT solutions software is protected by contract law, copyright law,
and international treaties. cobas
®
infinity IT solutions contains a user license between
Roche Diagnostics GmbH 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.
Commercial open source software
cobas
®
infinity IT solutions 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 cobas
®
infinity IT solutions, refer to the electronic distribution included with this product.
This product and cobas
®
infinity IT solutions as a whole can constitute a device
regulated in accordance with applicable law. For more detailed information, refer to
the user manual and labeling.
Remember that the respective authorization is no longer valid according to the
corresponding legislation should any unauthorized changes be made to cobas
®
infinity IT solutions.
Contact addresses
Authorized manufacturer and
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
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4 User Manual · Version 2.1
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cobas infinity IT solutions
Table of contents
Publication information 2
Contact addresses 3
Table of contents 5
Preface 11
Intended use 11
Symbols and abbreviations 12
Online help system 13
Safety classifications 13
System safety information 14
Introduction
1 System overview
About cobas infinity 23
Working with tables 25
Printing 29
Using comments 33
2 Understanding the user interface
Screen framework 41
Generic user interface elements 49
Routine tasks
3 Managing orders
Entering orders 67
Entering orders and pre-orders with panels 75
Entering orders by batch 82
Order search 86
Preorders search 89
Collecting pre-orders 91
Rejection review 96
Order traces 99
4 Patient management
Patient entry/edition 105
Patient merging 107
Patient search 110
Patient history 113
5 Work areas and Validation
Warnings on work areas 119
Order and tube monitoring 120
Result entry and validation from work areas 131
Other validation tasks 156
6 Tasks with work lists
Printing work lists 161
Entering results through work lists 167
7 Printing reports
Report print 173
About the Printing control screen 177
8 Quality controls
Safety precautions for quality controls 181
Manual result entry 182
Result review 184
Levey-Jennings chart 192
Cumulative chart 196
9 Statistics
Statistical concepts 201
Statistics 202
Statistical closing 213
Tasks for administrator users
10 General settings
General parameters 221
Configurable screens 269
11 Users and permissions
Profiles 279
Users 291
LDAP access configuration 294
12 Configuring demographic data
Definition of demographics 299
Enabling demographics 303
Editing patient demographics 306
Demographic correlation 309
13 Entering tests
Warnings on test configuration 315
Routine and emergency test entry 316
Urine test strip entry 337
Groups and supergroups: organization of the
tests by laboratory sections 341
14 Patient management
Patient ID1 347
15 Order entry
Order ID 353
Tube identifiers 358
Label assignment 361
External data capture 362
Interview 364
Panels 369
Entry by panels screens 380
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16 Labels
Warnings on label configuration 387
Labels 388
Printers 392
Label assignment 394
17 Configuring comments
Defining comments 399
Assignment of groups of comments to tests 402
18 Validating results
Criteria 405
Filters 408
Validation profiles 410
Alarm types 411
19 Work areas for the General Lab and
Emergency Lab modules
Monitoring screens 415
Validation screens 418
Standard work areas 423
Special configuration 427
20 Configuring work lists
Creating work lists 431
About the work lists screen 434
Defining the format of work lists 435
About the formats of the work lists 437
Editing work lists 440
Creating work list groupings 441
21 Configuring reports
General settings for reports 445
Configuring report formats 446
Designing reports 451
Demographics in reports 461
Configuring the report printing 464
22 Warnings and events
Warning management 473
System events 476
23 Rule engine
Variables 481
Rules 485
Examples of rule engine configuration 511
24 Host connectivity (HCA)
Warnings related to HCA 517
Basic HCA configuration 518
Incoming and outgoing messages 534
Host-module association 546
Configuring patient import and export
actions 549
Mapping items used for general
communication with the host 564
Mapping items specific to the Microbiology
module 570
HCA monitoring 574
25 Instrument connectivity (ICA)
Warnings related to ICA 593
Basic configuration: entering instruments 594
Configuring General Lab options 607
Configuring Microbiology options 617
Configuring sample type mapping 619
Configuring the instrument image directory 620
ICA monitoring 622
26 Application connection to network drives
and servers
Entering network drives 645
27 Connecting the application to optical readers
Mark forms 649
Optical readers 650
28 Quality control
QC basic settings 657
Reagents 658
Controls 660
Lots 665
Values per instrument 668
Rule assignment 671
Test association for traces 676
29 ELSA configuration
Main ELSA features 679
ELSA settings 680
Patches 683
Events 686
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30 Monitoring
Rule engine 689
Optical reader control 695
Sending messages between users 698
Configuring the historical database 699
Delete/restore orders 701
End-of-day process 704
Monitoring charts 706
System events 712
Log record 713
Save/restore configuration 715
Data export for support 717
Order release 718
Configuration traces 720
Microbiology module
31 Working in the Microbiology module
Order entry in the Microbiology module 727
Microbiology work areas 732
Antibiogram work lists 750
Microbiology queries 759
32 Configuration of the Microbiology module
Microbiology test entry 767
Microbiology result entry 773
Antibiogram entry 776
Microbiology profile entry 782
Assignment number 786
Sample identifiers 788
Microbiology work areas 789
Microbiology work lists 793
Epidemiological reports 794
Lab Flow module
33 Working in the Lab Flow module
Sample tracking 801
Manual aliquot 806
Manual distribution 809
Archive 821
34 Configuration of the Lab Flow module
Warnings related to the Lab Flow settings 835
Target configuration 836
Target sorting 847
Manual aliquot definition 852
Workplace definition 854
Archives 855
Total Quality Management module
35 Working in the Total Quality Management module
Document management 861
Audit management 871
Equipment management 907
36 Configuration of the Total Quality
Management module
Operator 915
Document management 917
Issue management 920
Configuring indicators 927
Equipment management 934
Appendixes
37 Appendix
Example of a report format configuration 945
Basic flows for order processing 955
Glossary
38 Glossary
Index
Index 973
Notes
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User Manual · Version 2.1 11
cobas infinity IT solutions
Preface
This publication includes descriptions of the cobas infinity features and operating
concepts, as well as the specification of its features and work and configuration
procedures.
This manual describes the entire cobas
®
infinity IT solutions. Depending on the
modules installed in your center, there will be parts of this document that do not
apply to you.
Intended use
cobas
®
infinity IT solutions is a laboratory information system that covers work flow
and data management with connected preanalytical, analytical, and postanalytical
instruments, including processes from order entry to report printing. This
management involves order entry and report printing processes, among others.
cobas
®
infinity IT solutions can be connected to one or several:
1. Roche preanalytical instruments.
2. Roche postanalytical instruments.
3. Roche and non-Roche analytical instruments (biochemistry, immunology, urine
analysis, coagulation, hematology, and molecular diagnostics).
4. Laboratory Information Systems (LIS).
5. Hospital Information Systems (HIS).
6. Electronic Health Record Systems (EHRS).
7. Work area solutions for hematology, clinical chemistry, and urinalysis. Roche and
non-Roche analytical instruments.
8. Point-of-care devices and software.
9. Export of quality control results to commercial benchmarking tools: QC results
are sent to an external QC validation system for validation. The results of the
validation can be integrated into the solution.
10. Clinical Decision Support Systems (CDSS) and Risk Calculation Software (e.g.
Astraia, Viewpoint, SsdwLab).
11. Billing systems.
12. Intensive care systems.
13. Non-HIS order entry systems.
14. Picture Archiving Systems (PACS).
15. Document Management Systems (DMS).
Connectivity between the solution and the aforementioned instruments or systems
enables the exchange of data uni- or bidirectionally via interface.
Uni- and bidirectionally transmitted data contain patient information, order data,
and result data.
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12 User Manual · Version 2.1
Patient information includes patient demographics and identifying information.
Order information contains test requests.
It is essential that the user reads this manual carefully before using the system, since it
contains relevant information for the correct use and configuration of the software,
as well as security warnings that should be taken into account to guarantee patient
safety.
Symbols and abbreviations
Visual queues are used to help locate and interpret information in this document
quickly. This section explains the formatting conventions used in this document.
Symbols The following symbols are used:
Abbreviations The following abbreviations are used:
Symbol Explanation
Start of a procedure
End of a procedure
Items in a list
Cross-reference
Safety warning
Table 2 Symbols
Abbreviation Definition
ANSI American National Standards Institute
CS Communication Server
e.g. for example
EC European Community
EN European Norm
HCA Host Connectivity Agent
ICA Instrument Connectivity Agent
QA Quality Assurance
QC Quality Control
SOP Standard Operating Procedure
TAT Turnaround Time
UPS Uninterruptible power supply
Table 3 Abbreviations
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Online help system
cobas
®
infinity IT solutions features online help with context-sensitive information
serving as a guide for the system operation. In this way, no matter where you are in
the software, the help feature displays the text or screenshot related to the application
area being viewed.
The online help is a quick and convenient means of finding information: descriptions
of screens and dialog boxes, instructions on how to perform certain procedures, and
so on.
F1 help To access the online help, press the F1 key or choose the Help icon on the upper part
of the screen.
Safety classifications
This section explains how the preventive information is introduced in this user
manual.
The safety precautions and important observations for the user are classified
according to the ANSI Z535.6 standard. Familiarize yourself with the following
symbols and their meanings.
WARNING
Warning
r Indicates a possible dangerous situation that, unless prevented, may cause death or
severe injuries.
CAUTION
Caution
r Indicates a possible dangerous situation that, unless prevented, may cause mild or
minor injuries.
NOTICE
Notice
r Indicates a possible dangerous situation that, unless prevented, may cause damages to
the device.
The following symbol signals important information that does not apply to safety:
Q
Recommendations
Indicates additional information on the correct use of the system or useful advice.
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14 User Manual · Version 2.1
System safety information
Roche Diagnostics has established a series of recommendations with the aim of
allowing the user to work with the application under safe conditions and
guaranteeing the correct operation and proper performance of the communication
network in which this product has been installed.
Q
Read the following recommendations carefully for the correct operation of the application
and cobas infinity communication network.
Security
WARNING
Secure infrastructure
r A secure infrastructure for the application network must be established and security
policies must be defined to address potential problems or system failures.
WARNING
Enabled security parameters
r All security parameters (profiles, access restrictions, and so on) are enabled by default.
Remember that disabling security parameters may lead to potentially major risks, for
example unqualified personnel may change instruments or system configurations or
unauthorized users may access confidential information.
UPS
WARNING
Application shutdown
r There should only be standard procedures to shut down the application. Users must
exit the application before shutting down the computer on a daily basis. Having a UPS
installed that can perform a safe shutdown mitigates the risk of data loss due to power
failure.
WARNING
UPS usage
r It is recommended that a UPS is used in order to avoid interruptions to the power
supply that may affect software performance and data storage.
r Upon enabling the UPS, a safe shutdown of the system will start before the power
supply is interrupted.
r It is recommended that the UPS software is periodically upgraded and the correct
operation of the device is checked on a regular basis.
User settings
WARNING
Restricting access to critical functions
r It is also advisable to restrict access to critical system functions (for example,
configuration screens) only to qualified users. If only qualified users work with the
application, the risk of issues related to the configuration of the system is dramatically
reduced.
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WARNING
Access to the application and user accounts
r Access to the application should only be granted to users who have been trained and
assigned a user name and password. The password must be confidential and must
comply with the usual security principles. It must be changed periodically to prevent
unauthorized parties from gaining access.
r It is recommended that you develop SOP to ensure that only qualified personnel access
the application.
r One account per user: do not create generic user accounts to be used by more than
one person. Create a different account for each user, even if they have the same
access rights.
WARNING
Passwords, access, and system shutdown
r Only authorized personnel should install this software. Personnel must ensure they do
not disclose internal Roche passwords to unauthorized parties.
r Access to application files and folders on any computer should also be restricted to
authorized personnel only.
r For security reasons and for patient confidentiality, all users must exit the application or
lock their computer before leaving their workplace.
NOTICE
System configurations
r The preconfigured settings in the system must only be used as a reference. It is
recommended that they are not used as default settings, since they should be modified
to suit the system and the health center requirements.
General
WARNING
System performance
r To ensure the operation of the system at full capacity, avoid connecting more users or
instruments than your infrastructure supports.
CAUTION
Servers and application performance
r Use servers that are correctly dimensioned to the needs of your installation in order to
guarantee the best performance of the application. It is recommended to configure the
servers using a high availability and data redundancy system. The existence of a
second server avoids data loss in case of severe or critical failures in the system.
CAUTION
Alarms in validation screens and reports
r To prevent users from validating results without noticing system or instrument alarms,
always configure alarms for validation screen and reports.
WARNING
Use of barcodes on the tubes
r In order to help locate the tubes, it is highly advisable to always use primary and
secondary tubes with barcodes whenever possible. If no barcode labels are used, take
special care not to misplace tubes when samples are put in the racks.
r It is strongly recommended to have appropriate Standard Operating Procedures (SOP)
to avoid an incorrect handling of tubes.
r It is recommended to use barcode labels to archive trays.
Q
All the changes made in the system are recorded using an audit trace.
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16 User Manual · Version 2.1
Backups
CAUTION
Backup protocol
r It is strongly recommended to make regular backups (preferably daily) of the whole
system.
r Confirm that the files and directories backup has been carried out successfully and
store the backup in a safe place.
r Always check that a backup log has been created or check the result in Monitoring
> Log record.
WARNING
Backups and updates
r Before upgrading the software, make backups of all the databases and system
configurations. For more information about how to make backups, see the Monitoring
module.
WARNING
Journaling
r Enable the journaling feature and resize it depending on the capacity of the hard drive.
Instruments and reading devices
WARNING
Hosts and instruments
r It is recommended that the connection with host systems and/or instruments is made
via TCP/IP instead of via a RS-232 interface whenever possible.
r Check each connection and its associated configuration to guarantee correct data
transfer.
NOTICE
Connections
r When the application is connected to analyzers through a RS-232 serial port interface,
the cable should be as short as possible, in order to avoid any noise or electromagnetic
interference that may affect communication.
r It is recommended that the application and the instruments connected to it are placed
in a network segment separated from the rest of the network devoted to other uses.
Additionally, it is also recommended to use firewalls to ensure isolation.
NOTICE
Data sent by instruments
r Verify that all the data sent by the different devices are correctly saved in the test
(units, operator, flags, and so on) and perform a correct configuration in order to
prevent incomplete tests from being validated.
CAUTION
Receiving data
r In the event that the instruments do not show the time at which the results were sent,
note that receiving successive results with the same value could be due to data being
transmitted twice and not due to a repetition of the result.
r Use the appropriate controls to check which results have not been received and to
forward those that have been lost after a connection problem or after switching off the
instrument.
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CAUTION
Automatic aliquoters and labeling
r It is recommended to use automatic aliquoters. Be careful when handling labware
(tubes, disks, and so on) and pay attention to the labeling of the orders, since a
labeling error could lead to confusion of results.
NOTICE
Reading devices verification
If wrong information is entered during data entry or configuration procedures (test
properties, instrument configuration, patient data, and so on), results could be
misinterpreted.
r It is recommended that you use reading devices (optical readers, barcode readers, card
readers, etc.) and check that they are operating correctly before using them in real
environments.
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18 User Manual · Version 2.1
Introduction
1 System overview ............................................................................................................................... 21
2 Understanding the user interface .................................................................................................... 39
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Roche cobas infinity central lab User manual

cobas infinity central lab
Roche
Brand
Roche
Model
cobas infinity central lab
Category
Software
Type
User manual
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