Roche cobas infinity central lab 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

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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

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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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

Roche cobas infinity central lab User manual

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