Roche cobas infinity central lab User manual

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.

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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Roche cobas infinity central lab User manual

Roche cobas infinity central lab User manual

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