cobas IT middleware

Roche cobas IT middleware User manual

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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.
Copyright © 2012-2018, F. Hoffmann-La Roche Ltd. All rights reserved.
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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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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cobas IT middleware
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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cobas IT middleware
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
Table of contents
/