Roche cobas infinity blood safety User manual

cobas

®

infinity blood safety

User Manual Version 1.0

Software version 1.1.1

cobas infinity blood safety

Roche Diagnostics

2 User Manual · Version 1.0

Publication information

Edition notice

This publication is intended for users of the cobas

®

infinity blood safety 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.

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.

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.

Publication version Software version Revision date Change description

1.0 1.1.1 March 2015 First edition

Table 1 Revision history

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cobas infinity blood safety

License information

The cobas

®

infinity blood safety software is protected by contract law, copyright law,

and international treaties. cobas

®

infinity blood safety 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 blood safety 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 blood safety, refer to the electronic distribution included with this product.

This product and cobas

®

infinity blood safety 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 blood safety.

Contact addresses

Authorized manufacturer

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

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Roche Diagnostics

4 User Manual · Version 1.0

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cobas infinity blood safety

Table of contents

Publication information 2

Contact addresses 3

Table of contents 5

Preface 11

Intended use 11

Symbols and abbreviations 17

Online help system 18

Safety classifications 19

System safety information 19

Introduction

1 System overview

About cobas infinity blood safety 27

Working with tables 29

Printing 33

Using comments 37

2 Understanding the user interface

Screen framework 45

Generic user interface elements 53

Routine tasks

3 Managing orders

Entering orders 71

Entering orders and pre-orders with panels 79

Entering orders by batch 86

Order search 90

Preorders search 93

Collecting pre-orders 95

Rejection review 100

Order traces 103

4 Patient management

Patient entry/edition 109

Patient merging 111

Patient search 114

Patient history 117

5 Work areas and Validation

Warnings on work areas 123

Order and tube monitoring 124

Result entry and validation from work areas 135

Other validation tasks 160

6 Tasks with work lists

Printing work lists 165

Entering results through work lists 171

7 Printing reports

Report print 177

About the Printing control screen 181

8 Quality controls

Safety precautions for quality controls 185

Manual result entry 186

Result review 188

Levey-Jennings chart 196

Cumulative chart 200

9 Statistics

Statistical concepts 205

Statistics 206

Statistical closing 217

Tasks for administrator users

10 General settings

General parameters 225

Configurable screens 273

11 Users and permissions

Profiles 283

Users 295

LDAP access configuration 298

12 Configuring demographic data

Definition of demographics 303

Enabling demographics 307

Editing patient demographics 310

Demographic correlation 313

13 Entering tests

Warnings on test configuration 319

Routine and emergency test entry 320

Urine test strip entry 341

Groups and supergroups: organization of the

tests by laboratory sections 345

14 Patient management

Patient ID1 351

15 Order entry

Order ID 357

Tube identifiers 362

Label assignment 365

External data capture 366

Interview 368

Panels 373

Entry by panels screens 384

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16 Labels

Warnings on label configuration 391

Labels 392

Printers 396

Label assignment 398

17 Configuring comments

Defining comments 403

Assignment of groups of comments to tests 406

18 Validating results

Criteria 409

Filters 412

Validation profiles 414

Alarm types 415

19 Work areas for the General Lab and

Emergency Lab modules

Monitoring screens 419

Validation screens 422

Standard work areas 427

Special configuration 431

20 Configuring work lists

Creating work lists 435

About the work lists screen 438

Defining the format of work lists 439

About the formats of the work lists 441

Editing work lists 444

Creating work list groupings 445

21 Configuring reports

General settings for reports 449

Configuring report formats 450

Designing reports 455

Demographics in reports 465

Configuring the report printing 468

22 Warnings and events

Warning management 477

System events 480

23 Rule engine

Variables 485

Rules 490

Examples of rule engine configuration 516

24 Host connectivity (HCA)

Warnings related to HCA 523

Basic HCA configuration 524

Incoming and outgoing messages 540

Host-module association 552

Configuring patient import and export

actions 555

Mapping items used for general

communication with the host 570

Mapping items specific to the Microbiology

module 576

HCA monitoring 580

25 Instrument connectivity (ICA)

Warnings related to ICA 599

Basic configuration: entering instruments 600

Configuring General Lab options 613

Configuring Microbiology options 623

Configuring sample type mapping 625

Configuring the instrument image directory 626

ICA monitoring 628

26 Application connection to network drives

and servers

Entering network drives 651

27 Connecting the application to optical readers

Mark forms 655

Optical readers 656

28 Quality control

QC basic settings 663

Reagents 664

Controls 666

Lots 671

Values per instrument 674

Rule assignment 677

Test association for traces 682

29 ELSA configuration

Main ELSA features 685

ELSA settings 686

Patches 689

Events 692

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30 Monitoring

Rule engine 695

Optical reader control 701

Sending messages between users 704

Configuring the historical database 705

Delete/restore orders 707

End-of-day process 710

Monitoring charts 712

System events 718

Log record 719

Save/restore configuration 721

Data export for support 723

Order release 724

Configuration traces 726

Microbiology module

31 Working in the Microbiology module

Order entry in the Microbiology module 733

Microbiology work areas 738

Antibiogram work lists 756

Microbiology queries 765

32 Configuration of the Microbiology module

Microbiology test entry 773

Microbiology result entry 779

Antibiogram entry 782

Microbiology profile entry 788

Assignment number 792

Sample identifiers 794

Microbiology work areas 795

Microbiology work lists 799

Epidemiological reports 800

Lab Flow module

33 Working in the Lab Flow module

Sample tracking 807

Manual aliquot 812

Manual distribution 815

Archive 827

34 Configuration of the Lab Flow module

Warnings related to the Lab Flow settings 841

Target configuration 842

Target sorting 853

Manual aliquot definition 858

Workplace definition 860

Archives 861

Total Quality Management module

35 Working in the Total Quality Management module

Document management 867

Audit management 877

Equipment management 913

36 Configuration of the Total Quality

Management module

Operator 921

Document management 923

Issue management 926

Configuring indicators 933

Equipment management 940

Appendixes

37 Appendix

Example of a report format configuration 951

Basic flows for order processing 961

Glossary

38 Glossary

Index

Index 979

Notes

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cobas infinity blood safety

Preface

This publication includes descriptions of the cobas infinity blood safety features and

operating concepts, as well as the specification of its features and work and

configuration procedures.

NOTICE

Important information

r This manual describes the entire cobas

®

infinity blood safety solution and also some

features that are not available for blood donation testing labs. Depending on the

modules installed in your center, there will be parts of this document that do not apply

to you.

u For more information about the available features, see Indication for use (p. 16).

Intended use

The cobas

®

infinity blood safety solution is a Laboratory Operating Software (LOS)

for the diagnostic laboratory. Laboratories are located in Hospitals or run in private

ownership.

The supported connectivity is described in the Interfaces with other devices (p. 11)

section.

The solution manages the data in a central database.

Interfaces with other devices

The software solution can be connected to one or several:

1. Roche pre-analytical instruments.

2. Roche and non-Roche analytical instruments (biochemistry, immunology, urine

analysis, coagulation and hematology).

3. Roche and non-Roche molecular diagnostics.

4. Laboratory Information Systems.

5. Hospital Information Systems.

6. Electronic Health Record Systems.

7. Work area solutions for hematology, clinical chemistry, or urine-analysis. Roche

and non-Roche analytical instruments.

8. Export of quality control results to commercial benchmarking tools: QC results

are sent to an external QC validation system for validation, results of the

validation can be integrated into the solution.

9. cobas® infinity live view (customer dashboard displaying operational KPIs based

on data generated by cobas® infinity IT solutions).

10. Intensive care systems.

11. Clinical Decision Support System (CDSS).

12. Picture Archiving System (PACS).

13. Document Management System (DMS).

14. Business intelligence system.

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Connectivity between the solution and the instruments or systems mentioned above

enables exchange of data uni- or bi-directionally via interface.

Uni- and bi-directionally transmitted data contain patient information, order data

and result data.

Patient information includes patient demographics and identification. Order

information contains test requests.

Description

cobas

®

infinity blood safety is an IT solution that can cover the workflow and data

management with the previous described in section Interfaces with other devices

(p. 11) connected pre-analytical and analytical instruments.

The cobas

®

infinity blood safety solution is intended to be used for:

o the configuration and connectivity management of instruments and software

systems

o the management of data regarding

O Samples

O Technical validation including automatic release

O Quality Control (both qualitative and quantitative)

O Test results

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 blood safety solution is

intended for:

o the management of data regarding

O Order Data

O Patient Data

O Result tracking and consolidation

o the management and storing of information, such as

O General statistics

Features and functionalities

The solution will provide the following functionalities to the customers:

Connectivity Management o Connectivity to analytical instruments

The solution is able to connect to analytical instruments provided by Roche or

other manufacturers in the specialties described in the Interfaces with other

devices (p. 11) section. The solution is able to transfer test requests to the

instruments and receive test results.

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o Connectivity to pre-analytical instruments

The solution is able to control sample routing, sample sorting, aliquoting and

distribution on Roche and non-Roche pre-analytics automation systems and

connected instruments.

o Connectivity to Laboratory, Hospital Information Systems and Electronic Health

Record

O The Hospital Information System (HIS) and Electronic Health Record System

(EHR) send patient and order information via standard messages. The

message can result in the automatic creation of an order and the related

sample registration in the solution.

O Patient results are sent electronically to the HIS and EHR to complete the

requested order. Connectivity to one or multiple HIS and EHR are possible.

O Quality control results coming from the instruments can be forwarded to the

LIS.

O Sample information about current position and workflow status can be sent to

the LIS for the purpose of traceability

O Issues and Flags can be received from instruments and sent to the LIS/HIS for

the purpose of traceability.

o Connectivity to Work area solutions

The solution provides connectivity to other middleware solutions (e.g.

hematology work area solutions or urine analysis work area solutions). The

solution does not influence any validation of data performed by the connected

systems.

o Workflow Management

The solution is able to manage the distribution and routing of primary samples

and aliquots for pre-analytical devices, connected instruments and offline

workplaces.

o Connectivity to Clinical Decision Support Systems (CDSS)

Connectivity to Clinical Decision Support Systems (CDSS) is provided through

standard interfaces to send patient results to the CDSS and to integrate the result

of the CDSS (the result can be a recommendation or a calculated risk score).

o Connectivity to PACS

Connectivity to Picture Archiving and Communication System (PACS) is

provided through standard interfaces to send patient results.

o Connectivity to DMS

Connectivity to a Document Management System (DMS) is provided through

standard interface to send documents.

o Connectivity to production monitoring and Business intelligence systems

Connectivity to different systems such as cobas® infinity insights, cobas® infinity

live view and external business intelligence information analysis tools is

supported.

Data management o Sample Registration

The solution provides functionality to create samples manually and to edit and

delete existing samples.

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o Technical Validation

The solution provides support for the technical validation of patient results with a

set of tools including: reference range checking, delta checks, serum indices, rule

engine.

The parameters of the tools are set up in advance by the customers to allow

automatic release of the results to the other systems (e.g. LIS, HIS) or to trigger

additional actions (e.g. rerun, reflex, repeat). Results which are not automatically

released will require a manual validation.

o Quality Control

The management of Quality Control supports the technical validation by

handling QC data obtained from instruments. The solution administrates active

and in-active control materials, manages Roche- and Non-Roche control

materials and enables the analysis of QC results with support of graphics.

Quality Control functionality enables the solution to detect, reduce, and correct

deficiencies in a laboratory’s internal analytical process prior to the release of

patient results and improve the quality of the results reported by the laboratory.

Quality control is a measure of how well the measurement system reproduces the

same result over time and under varying operating conditions. Laboratory quality

control material is usually run at the beginning of each shift; after an instrument

is serviced; when reagent lots are changed; after calibration; and when patient

results seem inappropriate.

o Sample Archiving

After processing the sample, archiving enables the retention of sample storage

location for an assigned period. The duration of the archiving period is subject to

customers’ configuration.

The solution supports manual archiving of samples. The sample storage options

allow the user to locate samples at any moment, e.g. if an additional test is

requested whether the sample is being processed or stored in the archive.

o Order Data Management

Patient data can be created or updated manually or via interfaces. Inconsistencies

can be managed by merge of patient data.

o Patient Data Management

Patient data can be created, updated manually. The user can set search criteria to

retrieve patient related information and manually correct inconsistencies.

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o Result Reporting

The solution provides functionality to create result reports. Usually the reports

will be provided always by the connected LIS system, but this functionality could

be very useful if the LIS is momentarily not working or there is an urgent need to

get some information for a working patient order.

Result reports can be created manually or by batch using various selection

criteria. A wide variety of report forms that are highly configurable allows

adaption of presentation of the content to the customer needs. Result reports are

available for preliminary or final, single and cumulative result reports. Result

report templates can be customized by Roche or by customers’ staff to adapt the

result reports to the customer requirements.

Reporting is based on a customer configured data selection and display. The data

in the reports are results that have been received by an instrument. The results

that have been received from the instruments are already readable by users. The

reported data are kept in the system to allow exact reproducibility of result

reports.

Information Management o Rule Engine

The rule engine enables the user to define algorithms supporting the technical

validation.

The rules use the results provided by the instrument(s) and order or patient

related information. Rules trigger standard validation actions including rerun of

test with dilution, request of additional test, comment, release.

No pre-defined rules are loaded by default. The implementation, modification

and validation of the rules are under the customer's responsibility.

o System Overview

Notifications are shown on the screen of the solution if any action is required on

samples, results, QC or instruments. The notifications display a message

whenever a predefined event occurs. Definition of events that shall trigger the

display of a notification is under the customer’s responsibility.

o Reagent and calibrator management

The solution allows receiving reagents and calibrators life cycle data (e.g. lot

number). A sample retrieval feature enables users to retrieve patient sample data

from reagent or calibrator lot number and period.

o Maintenance Management

The solution allows managing tasks to maintain Roche and non-Roche analyzers.

Maintenance tasks are configured by the customer.

The solution allows to track each task (when, who) and to prevent oversights.

o Production statistics

Statistics can be extracted and reported, which are calculated on production

performance data, like Turn-Around-Time, throughput, system efficiency.

o Turn-around-time management

The laboratory production monitor allows tracking the timespans between each

step of the workflow which can be displayed in real-time and trigger alerts in case

of delays.

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o Data warehouse and business intelligence

The solution provides support to the customers to extract data about the

laboratory performance monitoring, the tests counting and order data. The

solution provides analyses of the processed samples to support the laboratory

with data in comparing periods, e.g. in regard of turn-around-time, number of

samples and tests per sender.

Patient information can be used to produce gradient analysis, trend analysis,

hygiene, and pathology statistics.

Solution modules o Total Quality Management Module (TQM)

The TQM module supports the laboratory to implement, maintain and improve

its quality system and demonstrate compliance to the applicable local and

national regulations.

The key functionalities of the TQM module are:

O Document management (Storage and versioning of documents)

O Audit management (preparation of audits)

O Non-conformities management (documentation of non-conformities)

O Preventive actions management (planning of preventive actions)

O Issue management (Documentation of issues)

O Indicator management (Defining and monitoring of KPIs)

O Equipment management (Scheduling and monitoring of repetitive tasks on

devices and instruments)

The TQM module does not manage nor affect analytical results.

Indication for use

The cobas

®

infinity blood safety solution is based on the cobas infinity® IT solutions

application. Those features of cobas infinity® IT solutions that are not intended for

blood donation testing labs cannot be used with the cobas

®

infinity blood safety

solution.

Connectivity management

Features and functionalities Clinical

Laboratories

Blood Donation

Testing Labs

Connectivity to analytical instrument ll

Connectivity to pre-analytics l

l

(1)

(1) c8100 and MPA shall not be installed, p312 / p512 / p612 is supported

Connectivity to post-analytics l –

Connectivity to Laboratory, Hospital Information

Systems and Electronic Health Record

ll

Connectivity to Work area solutions ll

The solution does not influence any validation of data

performed by the connected systems

ll

Workflow Management l

Partly

(2)

(2) c8100 and MPA shall not be installed, p312 / p512 / p612 is supported

Use of Non-barcoded tubes Optional –

Table 2 Indication for use - connectivity management

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Data management

Information management

Symbols and abbreviations

Visual cues 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:

Features and functionalities Clinical

Laboratories

Blood Donation

Testing Labs

Sample Registration l

Partly

(1)

(1) No manual order entry or patient demographics modification.

Technical Validation ll

Medical Validation l –

Result Entry or modification l –

Quality Control l Pass-through QC

for c6800/8800

Sample archiving l

cobas

®

infinity

blood safety is

able to support

manual archiving

of samples

(2)

(2) No automatic sample archive and retrieval, e.g. p501/701 or Rotastock.

Direct access l Limited / no

result or

demographics

modification

Table 3 Indication for use - data management

Features and functionalities Clinical

Laboratories

Blood Donation

Testing Labs

Rule Engine ll

System Overview ll

Turn Around Time management ll

Live View (Production statistics) ll

Microbiology Module Optional –

Table 4 Indication for use - information management

Symbol Explanation

Start of a procedure

End of a procedure

Table 5 Symbols

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Abbreviations The following abbreviations are used:

Online help system

cobas

®

infinity blood safety 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.

Items in a list

Cross-reference

Safety warning

Symbol Explanation

Table 5 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 6 Abbreviations

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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 blood safety 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.

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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

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.

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