Roche cobas IT middleware User manual

cobas

IT middleware

User Manual version 11.1

Software version 1.09

cobas IT middleware

Roche Diagnostics

2 User Manual · version 11.1

Document information

Editor’s note Every effort has been made to ensure that the information contained in this manual is

accurate at the time of printing. Not all functionality described in this manual may be

available to all users. Roche Diagnostics International Ltd reserves the right to make

any further required changes to software without prior notice. Such changes may not

immediately be reflected in this document.

Trademarks Recognized trademarks:

o ROCHE, COBAS, LIFE NEEDS ANSWERS, and COBAS INFINITY

o Roche and the Roche symbol are registered trademarks of the Roche group.

o All other trademarks are trademarks of their owners.

Feedback Every effort has been made to ensure that this manual fulfils its intended purpose as

mentioned above. All feedback on any aspect of this manual is welcome and is

considered during updates. Contact your Roche representative, should you have any

such feedback.

Intended use

This document is intended for the users of the cobas

IT middleware system, version

1.09.00.

The cobas

IT middleware solution is a Middleware Solution (MWS) for the

diagnostic laboratory. Laboratories are located in hospitals or run in private

ownership without any active access of any patient. Therefore there is no intended

patient population.

Manual version Software version Revision dates Main change

1.00.00 (revision 1) 1.00.00 January 2012 First version of the manual

1.01.00 (revision1) 1.01.00 August 2012 Software and manual updates

1.02.00 (revision1) 1.02.00 June 2013 Software and manual updates

Version 4 1.03.00 February 2014 Software and manual updates

Version 5 1.04.00 July 2014 Software and manual updates

Version 6 1.05.00 January 2015 Software and manual updates

Version 7 1.05.01 May 2015 Software and manual updates.

Version 8 1.06.00 September 2015 Software and manual updates

Version 9 1.07.00 May 2016 Software and manual updates

Version 10 1.08.00 March 2017 Software and manual updates

Version 11 1.09.00 January 2018 Software and manual updates

u What is new in publication version 11 (p. 10)

Version 11.1 1.09.00 May 2018 Minor manual updates

u What is new in publication version 11.1 (p. 10)

Table 1 Revision history

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cobas IT middleware

The cobas

IT middleware solution can be connected to one or several

o Roche and non-Roche pre-analytic instruments

o Roche and non-Roche post-analytic instruments

o Roche analytical instruments

o cobas

®

infinity live view (customer dashboard displaying operational KPIs based

on data generated by cobas

IT middleware)

o Non-Roche analytical instruments

o Laboratory Information Systems

o Hospital Information Systems

o Electronic Health Record sSystems

o Non-Roche work area management solutions for hematology, clinical chemistry,

or urine-analysis

Connectivity between the cobas

IT middleware solution and the instruments or

systems mentioned above endorse to exchange data uni- or bi-directionally via

interface.

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

result data.

Features and Functionalities

The cobas

IT middleware solution provides 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 following specialties: biochemistry, immunology,

urine analysis, coagulation, hematology and molecular diagnostics.

The solution is able to transfer test requests to the instruments and receive test

results.

o Connectivity to pre-analytics

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

distribution on pre-analytics automation systems and connected instruments

o Connectivity to post-analytics

The solution is able to connect to post analytics instruments and supports

archiving and manual retrieval of samples.

o Connectivity to Laboratory, Hospital Information Systems and Electronic Health

Record

O The Laboratory Information System (LIS), 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 LIS, HIS and EHR to complete the

requested order. Connectivity to one or multiple LIS, HIS and EHR is

possible.

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4 User Manual · version 11.1

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 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).

o The solution does not influence any validation of data performed by the

connected systems.

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 Workflow Management

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).

Data Management o Sample Registration

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

delete existing samples. This functionality is used in particular if the LIS is

momentarily not working.

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 Result Entry

The solution provides support to enter results obtained from offline work areas as

well as send results to analytic instruments

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, enables the analysis of QC results with support of graphics and allows

exporting quality control results to commercial benchmarking tools.

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.

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o Sample archiving

After processing the sample, archiving is a structured option to retain samples for

an assigned period. The duration of the archiving period is subject to customers'

configuration. The cobas

IT middleware solution is able to support manual and

automatic archiving of samples.

The sample storage and retrieval 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.

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 or if a sample is missing means order for a

sample has been received in the system, but sample has not been identified in the

lab yet. 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 Turn Around Time management

The 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

o Live View (Production statistics)

Statistics generated by the cobas

IT middleware solution can be extracted and

displayed on monitors, wallboards and mobile devices (accessible only within the

intranet). The statistics is calculated on production performance data, like Late

sample tracking, Turn-Around-Time, throughput, system efficiency and

connectivity status.

Indication for Use

cobas

IT middleware is intended for Clinical Laboratories and Blood Donation

Testing Labs.

Connectivity Management

Features and

Functionalities

Clinical Laboratories Blood Donation Testing Labs

Connectivity to analytical

instrument

ll

Connectivity to pre-analytics ll

Connectivity to post-

analytics

ll

Table 2 Indication for use - connectivity management

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6 User Manual · version 11.1

Data Management

Information Management

Contact addresses

Manufacturer

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 -

Features and

Functionalities

Clinical Laboratories Blood Donation Testing Labs

Table 2 Indication for use - connectivity management

Features and

Functionalities

Clinical Laboratories Blood Donation Testing Labs

Sample Registration ll

Technical Validation ll

Result Entry l -

Quality Control l Pass-through QC for

c6800/8800 (see chapter

3.5.1)

Sample archiving l

The cobas

IT middleware

solution is able to support

manual archiving of samples.

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

Table 4 Indication for use - information management

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

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cobas IT middleware

Table of contents

Document information 2

Intended use 2

Contact addresses 6

Table of contents 7

Using this manual 9

Introduction

1 System overview

About cobas

IT middlewarecobas

IT

middleware 21

Creating/deleting filters 26

Configuring the columns 28

Reviewing the error log files 29

Viewing the details of an error log 30

Task overview 31

2 Understanding the user interface

Main screen structure 39

Navigation bar 44

Tabs and panels 45

Generic user interface elements 48

Routine

3 Sample distribution and sample management

Sample activities before distribution 55

Sample distribution 65

cobas e flow tests 76

Offline workplaces 82

Sample archiving 85

Sample retrieval 92

Sample disposal 93

Late sample tracking 95

About closed samples 101

About repeat, rerun, and reflex 102

Ordering a rerun for aliquots 103

4 Test result processing

About result evaluation and release 107

5 Patient management

About patient management 119

Hematology Performance Suite

6 Overview of the hematology workplace

About the hematology workplace 127

Workflow 129

About locked samples 130

About filter criteria in the worklist 132

7 Hematology tasks

Ordering a morphology 135

Ordering a morphology review by a

pathologist 136

Performing a morphology 137

Assigning keys for manual diff 144

Viewing graphical results 145

Releasing hematology samples 149

Searching for samples by sample ID 151

Viewing morphology comments 153

Creating a hematology result report 156

Viewing the sample event history of

hematology samples 158

Updating a sample 160

Editing test results 161

Repeating a hematology test 163

QC

8 QC configuration and routine QC

About QC configuration 171

About multi-rules QC 182

About profiles 188

About QC study lots 197

About QC 198

About average of normals 225

About calibration 248

9 Consumption report

About the consumption report 251

Appendix

10 Glossary

Index

Index 263

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Using this manual

Ensure the following:

q

o Keep this manual in a place where it will not be damaged.

o Ensure that this document is available at all times.

o Do not carry out operation tasks or maintenance actions unless you have received

training from Roche Diagnostics.

o Leave maintenance, installation, or service that is not described in the manuals to

trained Roche Service representative.

Conventions used in this manual

You can find detailed information on each task in this User Manual or by choosing

the Assistance button in the global information area.

The following symbols and conventions are used in this manual.

Symbols The following symbols may be used to draw your attention to important information:

Abbreviations The following abbreviations are used:

Symbol Meaning

U Cross-reference

P Procedure start

S Procedure end

o List item

Q Tip

Safety alert

Table 5 Information symbols

Abbreviations Definitions

H

HIS Hospital information system

L

LIS Laboratory information system

M

Manual diff Manual differential

MPA MODULAR PRE- ANALYTICS

Q

QC Quality control

S

SD standard deviation

STAT short turnaround time

Table 6 Abbreviations

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10 User Manual · version 11.1

What is new in publication version 11.1

AON definition Update of the definition of Average of normals (AON)

u About average of normals (p. 225)

QC lot New information about the QC lot history

u Deleting a QC lot (p. 179)

What is new in publication version 11

QC for cobas e flow tests A new section has been added about the handling of QC results from cobas e flow

tests.

u cobas e flow tests (p. 76)

Printing barcode labels A new section about the automatic printing of barcodes has been added.

u About automatic printing of barcode labels (p. 85)

Archive racks The instruction how to create an archive rack has been updated.

u Creating an archive rack (p. 86)

Worklist filter criteria A new section describes the behavior of the filter "result is equal to" in the TLIS panel

when applied to alphanumeric results.

u About filter criteria in the worklist (p. 132)

Symmetric vs. asymmetric tests A new section explains the distinction between symmetric and asymmetric tests.

u About symmetric and asymmetric tests (p. 171)

QC lot creation The procedure how to create QC lots has been updated.

u To create a QC lot (p. 172)

u To calculate the reference values (p. 174)

QC multi-rules The QC rule Range check has been introduced for multi-rules QC with asymmetric

tests.

u About multi-rules QC (p. 182)

u Creating a QC rule (p. 184)

QC profiles The procedure how to create QC profiles has been updated.

u Creating a profile (p. 188)

Levey-Jennings chart The Levey-Jennings chart can display QC results from asymmetric tests.

u Viewing QC results in a Levey-Jennings chart (p. 198)

QC review The QC review list panel and QC review details panel have been adapted to display

QC results from cobas e flow tests.

u Reviewing QC results (p. 203)

u Viewing QC result details (p. 206)

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Activating /deactivating QC

results

Activation/deactivation of a QC result from

a cobas e flow embedded test

automatically activates/deactivates associated calculated QC results.

u Inactivating QC results (p. 212)

u Activating QC results (p. 213)

Manual entry of QC results You cannot enter QC results for cobas e flow tests manually.

u Entering QC results manually (p. 216)

Cumulative QC statistics Cumulative QC statistics are not supported for QC results of asymmetric tests.

u Cumulative QC statistics (p. 218)

Average of normals A new statistical method has been introduced using existing patient data to identify

systematic drifts of the measured test results.

u About average of normals (p. 225)

Consumption report The chapter “Consumption report” has been updated.

u Consumption report (p. 249)

What is new in publication version 10

Instrument connection Disconnect and reconnect instruments in the Overview menu.

u Disconnecting and reconnecting instruments (p. 33)

Instrument state View the instrument state in the Connection status tab.

u Viewing the state of instrument modules (p. 34)

Sample location state View if a sample has been loaded to, or unloaded from an instrument.

u Viewing the sample location state (p. 55)

Test status There are 4 new test statuses.

u Test status (p. 107)

Test status date You can view the time stamp when the “test status” has been set.

u Test status date (p. 108)

Hematology New functionality to perform tasks related to hematology samples

u Overview of the hematology workplace (p. 125)

u Hematology tasks (p. 133)

QC multi-rules Revised documentation of QC multi-rules

u About multi-rules QC (p. 182)

What is new in publication version 9

Unknown instrument flags New safety information about unknown instrument flags

u (p. 15)

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Printing barcode labels New procedure about how to print barcode labels when scanning a sample

u To print barcode labels when scanning a sample (p. 58)

Deleting a sample New task about how to delete a sample

u Deleting a sample (p. 60)

Viewing sample images New task about how to view sample images

u Viewing sample images (p. 68)

Updating the masking status New task about how to update the masking status of an instrument, or test

u Updating the masking status of an instrument or test (p. 73)

Double masking A test can be masked twice.

u Unblocking result release (p. 75)

cobas e flow tests New section about cobas e flow tests

u cobas e flow tests (p. 76)

Late sample rule New procedures about copying and editing late sample rules

u To copy a late sample rule (p. 98)

u Editing a late sample rule (p. 99)

Late sample tracking You can configure Late sample trackers to close automatically after a certain time.

u About automatic deletion of late sample trackers (p. 99)

Rerun of aliquots You can order a rerun only for an aliquot of a sample.

u Ordering a rerun for aliquots (p. 103)

Levey-Jennings chart New table explaining the meaning of the symbols used for QC results in the Levey-

Jennings chart

u Viewing QC results in a Levey-Jennings chart (p. 198)

Configuring column headers New procedure about how to configure column headers for the Review QC results

panel

u To configure the column headers (p. 201)

QC result comments in the Levey-

Jennings chart

New task about how to add QC result comments in the Levey-Jennings chart

u Adding QC result comments in the Levey-Jennings chart (p. 202)

What is new in publication version 8

Safety information The system safety information has been updated.

u System safety information (p. 14)

Quick search The global information area contains a new search field that allows you to search

quickly for samples based on sample ID, patient ID, or patient name.

u Searching for samples with Quick search (p. 40)

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Viewing sample archive positions You can view the current and previous archive positions of a sample in the Samples:

{0} panel.

u

Viewing the archive positions of a sample (p. 89)

Retrieving samples You can retrieve samples directly from the Samples: {0} panel.

u Retrieving samples manually (p. 92)

Late sample rules The configuration of the late sample rules is now explained in more detail.

u Configuring a late sample rule (p. 95)

Multi-rule QC type The Coefficient of variation is a new multi-rule QC type.

u About multi-rules QC (p. 182)

Viewing QC result comments You can view comments on QC results in the Levey-Jennings chart.

u Viewing QC result comments in the Levey-Jennings chart (p. 202)

Filtering cumulative QC statistics The number of days to calculate the QC statistics is a new filter criterion in the

Cumulative QC statistics overview panel.

Safety classifications

The following safety information applies to the system and is listed in accordance

with ANSI Z535.6. The Danger safety classification to indicate a situation that will

result in injury or death is not applicable to this system and is therefore not listed.

Safety alert symbol

r The safety alert symbol alone promotes awareness to hazards that are generic or direct

the reader to safety information provided elsewhere in the document.

These symbols and signal words are used for specific hazards:

WARNING

Warning

r Indicates a hazardous situation which, if not avoided, could result in death or serious

injury.

CAUTION

Caution

r Indicates a hazardous situation which, if not avoided, could result in minor or moderate

injury.

NOTICE

Notice

r Indicates a hazardous situation which, if not avoided, may result in damage to the

system.

Important information that is not safety relevant is indicated with the following icon:

q

Tip

Indicates additional information on correct use or useful tips.

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System safety information

Failure to observe the following safety information may result in incorrect results,

data corruption, and data losses.

NOTICE

Data loss or unavailability of the system due to malicious software or

unauthorized system access

Malicious software or unauthorized system access can result in data loss or system

unavailability.

To avoid infection by malicious software or the unauthorized access and misuse of the

system, the following recommendations are essential:

r Do not connect any external storage devices (such as USB flash drives or external hard

drives) to the system.

r Do not install and/or execute any other software on the system. Make sure other

computers and services on the network (for example, the LIS, archiving share, backup

share, or service) are properly secured and protected

r Make sure other computers and services on the network (for example, the LIS,

archiving share, backup share, or service) are properly secured and protected against

malicious software and unauthorized access.

r Customers are responsible for the security of their local area network, especially in

protecting it against malicious software and attacks. This protection might include

measures, such as a firewall, to separate the device from uncontrolled networks as well

as measures that ensure that the connected network is free of malicious code.

r The Roche-provided firewall is mandatory and part of the system.

r Restrict physical access to the system and all attached IT infrastructure (computer,

cables, network equipment, etc.).

r Make sure that system backup and archive files are protected from any unauthorized

access and disaster. This includes remote storage location; disaster recovery sites;

secure transfer of backup files.

CAUTION

Monitor system for suspicious activity

r Monitor the system regularly for suspicious activity. Report any suspected compromise

to your local Roche contact.

CAUTION

Incorrect or corrupt data due to unauthorized access

Data security is breached if unauthorized users have access to your user ID and password.

r Always enter your password unobserved.

r Do not write down your password.

r Never write down the password in a contact form, in the address book, or in a file on

the computer.

r Do not disclose your password to anyone.

r Roche will never ask you for your password.

r If you ever disclose your password to anyone, change it immediately after.

r If you think anyone else might have access to your account, then contact your local

Roche affiliate.

r Do not use the same credentials on multiple instruments.

r Do not share your user accounts with any other person.

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NOTICE

The host interface does not support secure data transmission

When using host communication, your infrastructure must ensure that transported data is

protected appropriately. It is your responsibility that access to the network is restricted only

to authorized entities and/or the communication protocol is secured.

r This can be achieved by using system level tunneling protocols like TLS or other means

of network encryption.

NOTICE

Internet Explorer

Ensure that you use the 32 bit Internet Explorer.

r 64-bit Internet Explorer is not supported.

CAUTION

Sample quality measurement is only indicative

The sample quality measurement in the condition is taken by camera. This is only

indicative. It is not enough to ensure the patient results are reliable.

The accuracy of the optical configuration on the instrument varies significantly depending

on the configuring user. The decision to use sample quality measurements, and the

consequences of using them, are solely the responsibility of the laboratory administrator.

r To get a reliable measurement of sample quality, use serum indices tests. To implement

serum indices tests, talk to your Roche Service representative.

NOTICE

Unknown data alarm flags

An instrument may send data alarm flags that are not recognized by cobas

IT middleware.

Such flags can be misinterpreted or ignored, leading to delays or unintentional release of

results.

r Ensure that installed instrument drivers are up-to-date.

r Instrument drivers might not support all flags sent by the instrument. Check for any

unknown flags on the instrument.

NOTICE

Manufacturer’s liability

The manufacturer shall not be liable for any consequences whatsoever resulting from

subsequent, unauthorized modifications.

r Do not make unauthorized modifications of the system.

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Introduction

1 System overview ............................................................................................................................... 19

2 Understanding the user interface .................................................................................................... 37

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cobas IT middleware 1 System overview

Table of contents

System overview 1

In this chapter you can find information about accessing the system, filtering options,

column configuration, and the opened tasks and actions that you need to address.

In this chapter

Chapter

1

About cobas IT middlewarecobas IT middleware...........................................................21

Logging into the system ................................................................................................21

Changing the password .................................................................................................21

Filtering options .............................................................................................................22

Filtering samples ......................................................................................................22

Filtering QC..............................................................................................................22

Filtering multi-rules.................................................................................................23

Filtering profiles.......................................................................................................23

Filtering patients ......................................................................................................23

Filtering test results..................................................................................................24

Filtering the list of racks..........................................................................................24

Filtering the error log list ........................................................................................24

Filtering the list of consumption reports ..............................................................25

Filtering the late samples list ..................................................................................25

Creating/deleting filters.......................................................................................................26

Configuring the columns ....................................................................................................28

Reviewing the error log files ...............................................................................................29

Viewing the details of an error log.....................................................................................30

Task overview........................................................................................................................31

Displaying pending tasks ..............................................................................................32

Configuring missing sample results ............................................................................32

Disconnecting and reconnecting instruments...........................................................33

About the instrument state ...........................................................................................33

Viewing the state of instrument modules ...................................................................34

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1 System overview cobas IT middleware

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