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cobas infinity central lab

Roche cobas infinity central lab User manual

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cobas
®
infinity IT solutions
User Manual Version 3.0
Software version 1.2.0
cobas infinity IT solutions
Roche Diagnostics
2 User Manual · Version 3.0
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.
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
3.0 1.2.0 April 2015 New features of
software version
1.2.0. Chapters
reorganization and
edition.
Table 1 Revision history
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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 © 2013-2015, F. Hoffmann-La Roche Ltd. All rights reserved.
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
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
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.
Please note that the respective authorization is no longer valid according to the
corresponding legislation should any unauthorized changes be made to cobas
®
infinity IT solutions.
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 use. 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.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Spain
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Table of contents
Publication information 2
Contact addresses 3
Table of contents 5
Intended use 11
Symbols and abbreviations 11
What is new in software version 1.2.0 12
Online help system 13
Safety classifications 14
System safety information 14
Introduction
1 System overview
About cobas infinity 25
Working with tables 27
Printing 31
Using comments 35
2 Understanding the user interface
Screen framework 43
Generic user interface elements 51
Routine tasks
3 Managing orders
Creating orders 69
Entering orders and pre-orders with panels 74
Entering orders by batch 80
Order search 83
Preorders search 86
Collecting pre-orders 88
Rejection review 93
Order traces 96
4 Patient management
Patient entry/editing 103
Patient search 105
Patient merging 107
Patient history 110
5 Work areas and Validation
Warnings on work areas 115
Order and tube monitoring 116
Result entry and validation from work areas 127
Other validation tasks 154
6 Tasks with worklists
Printing worklists 159
Entering results through worklists 165
7 Printing reports
Report print 171
About the Printing control screen 175
8 Quality controls
Safety precautions for quality controls 179
Manual result entry 180
Result review 182
Levey-Jennings chart 190
Cumulative chart 194
9 Statistics
Statistical concepts 199
Statistics 200
Statistical closing 211
Tasks for administrator users
10 General settings
General parameters 217
Configurable screens 257
11 Users and permissions
Profiles 267
Users 279
12 Configuring demographic data
Definition of demographics 285
Enabling demographics 289
Editing patient demographics 292
Demographic correlation 295
13 Entering tests
Warnings on test configuration 301
Routine and emergency test entry 302
Urine test strip entry 324
Groups and supergroups: organization of the
tests by laboratory sections 328
14 Patient management
Patient ID1 333
15 Order entry
Order ID 339
Tube IDs 344
Label assignment 347
External data capture 348
Interview 350
Panels 355
Entry by panels screens 366
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16 Labels
Warnings on label configuration 373
Labels 374
Printers 378
Label assignment 380
17 Configuring comments
Defining comments 385
Assignment of groups of comments to tests 388
18 Validating results
Criteria 391
Filters 394
Validation profiles 396
Alarm types 397
19 Work areas for the General Lab and
Emergency Lab modules
Monitoring screens 401
Validation screens 404
Standard work areas 411
Special configuration 415
20 Configuring worklists
Creating worklists 421
About the worklists screen 424
Defining the format of worklists 425
About the formats of the worklists 427
Editing worklists 430
Creating worklist groupings 431
21 Configuring reports
General settings for reports 435
Configuring report formats 436
Designing reports 441
Demographics in reports 451
Configuring the report printing 454
22 Warnings and events
Warning management 463
System events 466
23 Rule engine
Variables 471
Rules 475
Examples of rule engine configuration 502
24 Application connection to network drives
and servers
Entering network drives 509
25 Quality control
QC basic settings 513
Reagents 514
Controls 516
Lots 521
Values per instrument 524
Rule assignment 527
Test association for traces 531
26 Monitoring
Rule engine 535
Sending messages between users 541
Delete/restore orders 542
End of day process 545
Monitoring charts 547
Order release 553
Microbiology module
27 Working in the Microbiology module
Order entry in the Microbiology module 559
Microbiology work areas 564
Antibiogram worklists 582
Microbiology queries 591
28 Configuration of the Microbiology module
Microbiology test entry 599
Microbiology result entry 605
Antibiogram entry 608
Microbiology profile entry 614
Assignment number 618
Sample IDs 620
Microbiology work areas 621
Microbiology worklists 625
Epidemiological reports 626
Lab Flow module
29 Working in the Lab Flow module
Sample tracking 633
Manual aliquot 638
Manual distribution 641
Archive 653
30 Configuration of the Lab Flow module
Warnings related to the Lab Flow settings 667
Target configuration 668
Target sorting 680
Manual aliquot definition 687
Workplace definition 689
Archives 690
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Total Quality Management module
31 Working in the Total Quality Management module
Document management 697
Audit management 707
Equipment management 743
32 Configuration of the Total Quality
Management module
Operator 751
Document management 753
Issue management 756
Configuring indicators 763
Equipment management 770
Appendixes
33 Appendix
Example of a report format configuration 781
Basic flows for order processing 791
Glossary
34 Glossary
Index
Index 809
Notes
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Intended use
The cobas® infinity IT solution is intended to be used for
o the configuration and connectivity management of instruments and software
o the management of data regarding
O Samples
O Technical validation including automatic release
O Quality Control (both qualitative and quantitative)
O Test results and their entry (offline workplaces)
o the management and storing of information, such as
O Samples Archiving Storage information
O Rule engine for technical validation
O Notifications from any part of the system
O Reagent and Calibrator management
O Turn Around Time management
O Production statistics
In addition to the above intended use, the cobas infinity IT solutions application is
intended for:
o the management of data regarding
O Order Data
O Patient Data
O Medical Validation support
O Result Consolidation and Reporting
O Billing support
o the management and storing of information, such as
O General statistics (Data Warehouse)
O Microbiology workflows and data for: (Microbiology module)
O human samples
Symbols and abbreviations
Symbols used in the publication
Symbol Explanation
Start of a procedure
End of a procedure
Table 2 Symbols used in the publication
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Abbreviations The following abbreviations are used:
What is new in software version 1.2.0
New screenshots We have added new screenshots to make tasks easier to follow. The screenshots from
previous versions have been updated.
Moved sections Some sections have been moved to service documentation. Major changes, among
others, concern: Instrument Connectivity Agent (ICA), Host Connectivity Agent
(HCA), ELSA configuration, and optical reader configuration.
Printing options update We have updated the information related to printing to reflect the changes
implemented in the application.
U Printing (p. 31).
Hematology counter update We have updated the information related to the hematology counter function to
reflect the changes implemented in the application.
U Validating results with charts (p. 135).
U About the hematology counter screen (p. 138).
U Configuring hematology counters (p. 415).
U About the Counter configuration screen (p. 416).
Items in a list
Cross-reference
Safety warning
Symbol Explanation
Table 2 Symbols used in the publication
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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Delta check update We have updated the information related to the delta check function to reflect the
changes implemented in the application.
U
About the validation on a single screen (p. 142).
U Configuring Delta check alarms (p. 316).
U About the delta check alarm (p. 318).
Validation screen update We have updated the information related to the new tabs in the validation screen to
reflect the changes implemented in the application.
U About the validation on a single screen (p. 142).
U List of Validation screen items (p. 408).
Quality Controls update We have updated the information related to Quality Controls to reflect the changes
implemented in the application.
U Result review (p. 182).
U Levey-Jennings chart (p. 190).
Work area configuration update We have updated the information related to work area configuration to reflect the
changes implemented in the application.
U Standard work areas (p. 411).
Rule engine update We have updated the information related to rule activation modes to reflect the
changes implemented in the application.
U List of activation modes (p. 479).
U Creating rules and activation modes (p. 478).
Dilution factor update We have updated the information related to dilution factor to reflect the changes
implemented in the application.
U About the validation on a single screen (p. 142).
U Creating actions or groups of actions (p. 493).
Lab Flow module update We have updated the information related to the Lab Flow module to reflect the
changes implemented in the application.
U Archive (p. 653).
U Target configuration (p. 668).
U Target sor ting (p. 680).
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.
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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.
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.
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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.
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.
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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 screens 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.
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.
WARNING
Backups and updates
r Before upgrading the software, make backups of all the databases and system
configurations.
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Instruments and reading devices
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.
NOTICE
Reading devices verification
If wrong information is entered during data entry or configuration procedures (test
properties, instrument configuration, patient demographics, 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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