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Host Interface Manual Cobas t511

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0% found this document useful (0 votes)
282 views138 pages

Host Interface Manual Cobas t511

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 138

cobas t 511 coagulation analyzer

Host interface manual version 5.0


Software version 2.2
2

Publication information

Publication version Software version Revision date Change description


1.0 1.0 February 2017 First version
2.0 2.0 January 2018 Software update with the following changes to the host
interface:
o Introduction of additional workflows and HL7 messages
o Update of alarm codes
o Introduction of new curve types
o Update of example result messages
u What is new in publication version 2.0 (19)
3.0 2.1 November 2019 Software update with changes to the host interface
u What is new in publication version 3.0 (17)
4.0 2.1.1 November 2020 IVDR Compliance to the Regulation (EU) 2017/746
Software update with the following changes to the host
interface:
o Corrected field length of SPM-4 and SPM-11
o Set MSH-12 to fixed value “2.5.1”
o TCD-8 usage setting for LIS -> Analyzer
o Delimiter in SPM-2 field
u What is new in publication version 4.0 (16)
5.0 2.2 December 2021 Software update with changes to the host interface:
o Update usage description for the X-term
o New LIS secure communication chapter
o Update data alarm code list
o Update OUL^R23 message table
o Information about different date and time formats added
o Information about allowed and not supported characters
on sample barcode labels added
u What is new in publication version 5.0 (15)
y Revision history

Edition notice Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.

All LIS Host configuration steps listed in this document


should be considered as suggestions. The laboratory
administrator should be aware of, understand, and accept
any configuration change done on LIS Host side. The
laboratory administrator also accepts the impact it might
have on security level before any step is performed.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
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Where to find information The User Assistance installed onto the control unit of
the analyzer contains all information about the product,
including the following:
• LIS secure
• Background information

Privacy notice
When you use User Assistance online, viewing events
(topics viewed and searches performed) and IP addresses
are logged.
The data collected is for Roche internal use only and is
never forwarded to third parties. It is anonymized, and
after one year it is automatically deleted.
Viewing events are analyzed to improve User Assistance
content and search functionality. IP addresses are used to
classify regional behavior.

The Host Interface Manual contains a description of


the protocols used in the host interface, and details of the
data items supported in messages to and from the host.

The intended audience for this manual is host interface


programmers and the Roche field engineers supporting
the system.

! 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.

! Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.

Training Do not carry out operation tasks or maintenance 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 and hardware images 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.

Roche Diagnostics
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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.

Copyright © 2017-2022, F. Hoffmann-La Roche Ltd. All rights


reserved.

License information The cobas t 511 coagulation analyzer software is


protected by contract law, copyright law, and
international treaties. The cobas t 511 coagulation
analyzer software 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 The cobas t 511 coagulation analyzer software 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
the cobas t 511 coagulation analyzer software, refer to
the electronic distribution included with this product.

This open source and commercial software and the


cobas t 511 coagulation analyzer software 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 the cobas t 511
coagulation analyzer software.

Trademarks The following trademarks are acknowledged:

COBAS and COBAS T 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.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
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Approvals The cobas t 511 coagulation analyzer meets the


requirements laid down in:

Regulation (EU) 2017/746 of the European Parliament and


of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU.

Directive 2011/65/EU of the European Parliament and of


the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.

Directive (EU) 2015/863 of 31 March 2015 amending


Annex II to Directive 2011/65/EU of the European
Parliament and of the Council as regards the list of
restricted substances.

Compliance is provided by means of the Declaration of


Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU


regulations.

R
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.

Issued by CSA Group for Canada and the US.


C US

Roche Diagnostics
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Contact addresses

Roche Diagnostics GmbH


Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland

Roche affiliates A list of all Roche affiliates can be found at:

www.roche.com/about/business/roche_worldwide.htm

eLabDoc Electronic user documentation can be downloaded using


the eLabDoc e-service on Roche DiaLog:

www.dialog.roche.com

For more information, contact your local affiliate or Roche


Service representative.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
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Safety information

Safety classifications The following safety information applies to the system


and is listed in accordance with ANSI Z535.6-2006. 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.

! CAUTION
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 Indicates additional information on correct use or


useful tips.

Roche Diagnostics
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Laboratory workflows

Failure to observe the following safety information may


result in incorrect results, data corruption, or data losses.

! WARNING
Incorrect results due to incorrect entry
r Ensure that manually entered data is correct.

! CAUTION
Unreliable validation due to unauthorized changes
to the validation and calculation rules.
r The manufacturer shall not be liable for any
consequences whatsoever resulting from subsequent,
unauthorized modifications to accepted medical
validation and calculation rules included in the system
upon customer request.
r Test all rule configuration thoroughly before using
rules in a live environment.

System safety

Failure to observe the following safety information may


result in incorrect results, data corruption, data losses, or
breaches of data security.

! 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.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
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! CAUTION
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 Use appropriate network encryption.

! CAUTION
The data is not encrypted
r Your infrastructure must ensure that access to the
data storage and backup files is permitted only to
authorized entities.

! WARNING
Disclosure of confidential data
Unauthorized users can view confidential data in an HL7
message when entered as unencrypted (plain) text.
r Do not enter any confidential data as plain text.
r Restrict physical access to the system.
r Read the respective safety information on data
security provided along with this product.

! CAUTION
Monitor system for suspicious activity
r Monitor the system regularly for suspicion activity.
Report any suspected compromise to your local Roche
contact.

! CAUTION
Data loss
r Back up your data at regular intervals (ideally every
day).

! CAUTION
Data loss or damage to the system due to power
failure.
r Ensure regular maintenance of the uninterruptible
power supply.

Roche Diagnostics
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Roche Diagnostics
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Table of contents 11

Table of contents

Publication information 2 4 Field definitions


Contact addresses 6 Message segments 59
Safety information 7 MSH: Message Header segment 63
Laboratory workflows 8 SPM: Specimen segment 66
System safety 8 SAC: Specimen Container Detail segment 68
Table of contents 11 INV: Inventory Detail segment 69
Preface 13 ORC: Common Order segment 73
Intended use 13 OBR: Observation Request segment 75
Symbols and abbreviations 13 TQ1: Timing/Quantity segment 76
What is new in publication version 5.0 15 OBX: Observation/Result segment 77
What is new in publication version 4.0 16 TCD: Test Code Detail segment 87
What is new in publication version 3.0 17 NTE: Notes and Comments segment (test
What is new in publication version 2.0 19 result) 89
QPD: Query Definition segment 90
RCP: Response Control Parameter segment 91
Interface specification QAK: Query Acknowledge segment 92
MSA: Message Acknowledge Segment 93
1 HL7 protocol ERR: Error segment 94
About HL7 27 EQU: Equipment Identification segment 95
Supported HL7 version 28
Minimal Lower Layer Protocol 29
Example messages
2 Supported workflows
Overview 33 5 Example messages
Work order download 34 Work order query (LAB-27) 101
Work order query 34 Work order download (LAB-28) 102
Patient sample result upload 34 Patient sample result upload (Lab 29) 103
Calibration result upload 34 Calibration result upload 104
Equipment status request 35 Equipment status request (ROC-01) 106
Equipment status update 35 Equipment status update (ROC-02) 107
Equipment inventory request 35 Equipment inventory request (ROC-03) 108
Equipment inventory update 35 Equipment inventory update (ROC-04) 109

3 Message structure
HL7 message mapping 39
LIS secure
OML^O33 WOS message 41
ORL^O34 acknowledgment message 43 6 Setup secure LIS communication
QBP^Q11 query message 44 Disclaimer 115
RSP^K11 acknowledgment message 45 Technical specifications 116
OUL^R22 result message 46 Communication use cases 118
OUL^R23 message 48 Certificate validation 125
ACK^R22 and ACK^R23 message 49 Troubleshooting 129
ESR^U02 message 50 References 131
INR^U14 message 51
ACK^U02 and ACK^U14 message 52
ESU^U01 message 53
Part index
INU^U05 message 54 Index 135
ACK^U01 and ACK^U05 message 55

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Roche Diagnostics
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Preface

This document provides a basis for the development of


communication between the cobas t 511 coagulation
analyzer system and Laboratory Information Systems
(LIS) using the HL7 communication protocol.

This document covers the generic structure of the


communication between the system and the LIS.
Customer-supported Laboratory Information Systems are
not part of the instrument package.

This document describes only the segments and segment


fields which are used in communication between the
system and the LIS. All other HL7 segments and segment
fields are still valid but are not used by the instrument.

Intended use

The cobas t 511 coagulation analyzer is a fully


automated, discrete coagulation analyzer intended for the
in-vitro qualitative and quantitative determination of
coagulation analytes in human citrated plasma, the
results of which aid in the diagnosis of coagulation
abnormalities and in monitoring anticoagulant therapy.
The cobas t 511 coagulation analyzer is a standalone
instrument.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the
following product names and abbreviations are used:

Product name Abbreviation


cobas t 511 coagulation analyzer Analyzer
y Product names

Symbols The following symbols are used:

Symbol Explanation
u Related topics containing further information
Tip. Extra information on correct use or useful
q
hints.
u Topic. Used in cross-references to topics.
Figure. Used in figure titles and cross-
w
references to figures.
y Symbols used in the publication

Roche Diagnostics
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Symbol Explanation
Table. Used in table titles and cross-references
y
to tables.
Code example. Used in code titles and cross-
k
references to codes.
y Symbols used in the publication

Symbols used on product


Symbol Explanation

For in vitro diagnostic use.

Global Trade Item Number

Catalog number

Unique device identifier.

Complies with the provisions of the applicable


EU regulations.
Manufacturer

Date of manufacture

y Symbols used on product

Abbreviations The following abbreviations are used:

Abbreviation Description
ANSI American National Standards Institute
AWOS Analytical Work Order Step (IHE LAW profile
definition)
CE Coded Element (HL7)
Ct Cycle threshold
EC European Community
EN European standard
HL7 Health Level Seven
Host Defined by IHE LAW as Analyzer Manager
referring to LIS Laboratory information
systems (LIS) or middleware systems
IEC International Electrotechnical Commission
IHE Integrating the Healthcare Enterprise,
www.ihe.net - a standardization organization
tightening existing standards and
consolidating their use in conformance
profiles.
IVD In vitro diagnostic
LAW Laboratory Analytical Workflow. An IHE
integration profile meant to improve
interoperability between IVD testing systems
and health informatics systems.
y Abbreviations

Roche Diagnostics
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Abbreviation Description
LIS Laboratory Information System
n/a not applicable
OSI Open Systems Interconnection (OSI) Model
(ISO/IEC 7498-1)
ROC Proprietary Roche extension
UL Underwriters Laboratories Inc.
VID Version Identifier (HL7)
WOS Work Order Step (order for tests, according to
IHE definition)
y Abbreviations

What is new in publication version 5.0

Software version 2.2 introduces the following changes to


the HL7 interface:

Data alarm code list NoClot data alarm replaced with the Clot.? data alarm.
• No-,early-, or slow clotting.

negAbs data alarm implemented


• Negative absorbance value detected.
u List of data alarm codes (85)

OUL^R23 message Table aligned according to the HL7 specification


document.
u OUL^R23 message (48)

Message segments Information about the date and time formatting added.
u Date and time formatting (59)
Analyzer -> LIS date and time formatting (60)
LIS -> Analyzer date and time formatting (60)

Information about allowed sample ID characters for


different barcode types added.
u Allowed characters for sample ID (61)

(X)-term usage • Update of the (X)-term usage description.

Target behavior aligned over the entire document


• Host -> Analyzer: Ignored
• Analyzer -> Host: Not sent
u HL7 message mapping (39)

Secure LIS communication New chapter about how to set up a secure


communication between the analyzer and the LIS Host.
u Setup secure LIS communication (113)

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What is new in publication version 4.0

Software version 2.1.1 introduces the following changes


to the HL7 interface:

IVDR Alignment to new European IVD regulations

SPM segment • SPM-4: The field supports now up to 250 characters


instead of (4).
• SPM-11: The field supports now up to 250 characters
instead of (1).
u SPM: Specimen segment (66)

MSH segment • MSH-12: Set to value 2.5.1 when data received from
host.
u MSH: Message Header segment (63)

Delimiter in SPM-2 field • All SPM-2 delimiter aligned to "&"


u Work order download (LAB-28) (102)

TCD-8 usage Usage setting for LIS -> Analyzer changed from "M" to
"CE".
u TCD: Test Code Detail segment (87)

Roche Diagnostics
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What is new in publication version 3.0

Software version 2.1 introduces the following changes to


the HL7 interface:

MSH segment • MSH-3: The field supports now only 1 component


instead of 3.
• MSH-9: For LAB-28 transactions, the value
ORL^O34^ORL_042 is sent instead of
ORL^O34^ORL_034.
• MSH-15: The field now supports the fixed value NE
instead of RE.
• MSH-21: For the messages OUL^R23 and ACK^R23,
the value LAB29C^Roche is sent.
u MSH: Message Header segment (63)

SPM segment • SPM-4.1: For calibration and QC results, the analyzer


sends the value ORH.
u SPM: Specimen segment (66)

INV segment • INV-2: For the CONTAINER group of QC and


calibration results, the analyzer sends the fixed value
OK^^HL70383.
u INV: Inventory Detail segment (69)

OBR segment • OBR-11: The field is empty if not a reflex test.


u OBR: Observation Request segment (75)

TCD segment • TCD-8: For calibration result messages (OUL^R23),


the field is not supported.
u TCD: Test Code Detail segment (87)

NTE segment • NTE-2: The field is now supported.


u NTE: Notes and Comments segment (test result) (89)

ERR segment • ERR-3: The field now supports 3 components instead


of 1.
u ERR: Error segment (94)

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OBX segment • OBX-2: For preliminary measurement failed results,


the value ST (string) is supported.
• OBX-4: The field now supports 3 components instead
of 1.
• OBX-5: For the OUL^R22 message, the fixed value
******* has been added for preliminary
measurement failed results. For the OUL^R23
message, the values RCM4 and RCM5 have been
added.
• OBX-8: For the OUL^R23 message, if no data alarm
applies, the value is set to NULL ( "" ) .
• OBX-17: The field now supports only 1 component
instead of 3. For the OUL^R23 message, the values
RCM4 and RCM5 have been added.
• OBX-29: For the OUL^R23 message, the field is not
supported. For the OUL^R22 message, the analyzer
sends the fixed value RLST.
u OBX in OUL^R22 message (77)
u OBX in OUL^R23 message (81)

QPD segment • QPD-4: Change of usage from (R) to (M).


u QPD: Query Definition segment (90)

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What is new in publication version 2.0

The following changes have been introduced.

Deviation from IHE LAW profile The analyzer sends the rack ID and the tube position in
the rack as WOS instead of WOS_BY_RACK.
u Overview (33)

Workflows The following workflows have been added.


u Calibration result upload (34)
u Equipment status request (35)
u Equipment status update (35)
u Equipment inventory request (35)
u Equipment inventory update (35)

HL7 messages The following messages have been added.


u Calibration result
OUL^R23 message (48)
u Acknowledgment to OUL^R23
ACK^R22 and ACK^R23 message (49)
u Equipment status update
ESR^U02 message (50)
u Equipment inventory request
INR^U14 message (51)
u Acknowledgment to ESR^U02 and INR^U14
ACK^U02 and ACK^U14 message (52)
u Equipment status update
ESU^U01 message (53)
u Equipment inventory update
INU^U05 message (54)
u Acknowledgment to ESU^01 and INU^05
ACK^U01 and ACK^U05 message (55)

HL7 segments The Equipment Identification segment (EQU) has been


added.
u ERR: Error segment (94)

Roche Diagnostics
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HL7 fields The following fields have been added.

Field Link
INV segment u INV: Inventory Detail segment (69)
o INV-15
o INV-21
o INV-22
OBX segment u OBX in OUL^R22 message (77)
o OBX-17
QPD segment u QPD: Query Definition segment (90)
o QPD-4
o QPD-5
y New fields

The definitions of the following fields have changed.

Field Link
MSH segment u MSH: Message Header segment (63)
o MSH-9
o MSH-21
SPM segment u SPM: Specimen segment (66)
o SPM-2
o SPM-4
o SPM-17
INV segment u INV: Inventory Detail segment (69)
o INV-1
o INV-2
o INV-4
o INV-16
ORC segment u ORC: Common Order segment (73)
o ORC-1
OBX segment u OBX in OUL^R22 message (77)
o OBX-2
o OBX-4
o OBX-5
o OBX-6
o OBX-8
o OBX-11
y Changed field definitions

Curve type The following 2 curve types have been added.


• RCM4: Rodbard function with 5 parameters
• RCM5: Sigmoid function with 4 parameters
u See field definition of OBX-5 and OBX-17.2 in
OBX in OUL^R22 message (77)

Alarm codes The list of supported data alarm codes has been updated.
u Data alarm codes (85)

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Example messages Additional example messages are provided for the new
workflows.
u Negative query response (OML^O33) (102)
u Equipment status update (ROC-02) (107)
u Equipment inventory request (ROC-03) (108)
u Equipment inventory update (ROC-04) (109)

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Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Interface specification

1 HL7 protocol............................................................................................................. 25
2 Supported workflows ............................................................................................ 31
3 Message structure ................................................................................................. 37
4 Field definitions....................................................................................................... 57

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Table of contents

HL7 protocol 1

This chapter describes the HL7 protocol supported by the


cobas t 511 coagulation analyzer, and explains the data
framing taking place at the lower layers of the protocol.

In this chapter 1
About HL7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Supported HL7 version . . . . . . . . . . . . . . . . . . . . . . . . . 28
Minimal Lower Layer Protocol . . . . . . . . . . . . . . . . . . . 29

1 HL7 protocol

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Table of contents
1 HL7 protocol

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
About HL7 27

About HL7
HL7 is an ANSI accredited organization dedicated to
developing standards for the exchange of electronic
health information. The organization’s mission is to
improve the interoperability of software applications used
by the health care industry.

In regular meetings called HL7 Work Group, HL7


members discuss and document how healthcare-related
information should be exchanged between disparate
healthcare applications.
u For more detailed information about HL7 standards,
refer to www.hl7.org.

OSI model In the OSI model of the ISO, the functions of both
communication software and hardware are separated
into 7 layers, or levels.

The "7" in HL7 refers to the seventh, or application, layer


of the OSI model. The application layer serves as the work
area for users to access network services. It includes
commonly needed functions including:
• Remote file access
• Supply sharing
• Network management
• Directory services
• Remote printer access
• Electronic messaging (e.g. email)
• Network virtual terminals

HL7 provides definitions for the data to be exchanged, the


timing of the data exchanges, and the communication of
application-specific errors between applications.

Limitations HL7 does not provide or support the following


functionality.
• Security - HL7 does not provide for the enforcement of
the user's security policies and does not specify a
1 HL7 protocol

specific encryption method.


• Confidentiality - HL7 does not address this issue and
makes no assumption about the use of the data at the
source or destination of a message.
• Accountability - HL7 does not define transaction
processing features needed in the user's environment.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
28 Supported HL7 version

Supported HL7 version


The host interface of the cobas t 511 coagulation
analyzer is based on HL7 version 2.5.1.

The cobas t 511 coagulation analyzer supports only a


subset of this protocol, dealing with tests and results, and
the management of the analyzer.
1 HL7 protocol

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Minimal Lower Layer Protocol 29

Minimal Lower Layer Protocol


Data framing is done according to the Minimal Lower
Layer protocol (MLLP, also known as MLP). The MLLP is
defined in the HL7 Implementation Guide, which you can
find on www.hl7.org.

For an overview on MLLP, also see:


www.hl7.org/documentcenter/public_temp_297F29C8-1C
23-BA17-0C2531D31DAD8828/wg/inm/mllp_transport_s
pecification.PDF

HL7 messages are enclosed by special characters to form


a block. The format is as follows:

<start_block>data<end_block><CR>

<start_block> Start Block character (1 byte)


ASCII <VT>, in other words, <0x0B>. This
should not be confused with the ASCII
characters SOH or STX.

data Data (variable number of bytes)


This is the HL7 data content of the block.
The data can contain any displayable ASCII
characters and the carriage return
character, <CR>.

<end_block> End Block character (1 byte)


ASCII <FS>, in other words, <0x1C>. This
should not be confused with the ASCII
characters ETX or EOT.

<CR> Carriage Return (1 byte)


The ASCII carriage return character, in
other words, <0x0D>.

The values used are <VT> for the start block and <FS>
for the end block.

97 +/GDWD )6 &5
1 HL7 protocol

w The HL7 data framed according to the HL7 standard

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1 HL7 protocol Minimal Lower Layer Protocol

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31
Table of contents

Supported workflows 2

The cobas t 511 coagulation analyzer LIS interface


supports a subset of HL7 messages in the workflows
described here. The supported transactions and message
structure follow the IHE LAW profile.

In this chapter 2
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Work order download . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Work order query . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Patient sample result upload. . . . . . . . . . . . . . . . . . . . . 34
Calibration result upload . . . . . . . . . . . . . . . . . . . . . . . . 34
Equipment status request . . . . . . . . . . . . . . . . . . . . . . . 35
Equipment status update. . . . . . . . . . . . . . . . . . . . . . . . 35
Equipment inventory request . . . . . . . . . . . . . . . . . . . . 35
Equipment inventory update . . . . . . . . . . . . . . . . . . . . . 35
2 Supported workflows

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Table of contents
2 Supported workflows

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Overview 33

Overview
The supported transactions and message structure follow
the IHE specifications described in the following
document:
IHE Pathology and Laboratory Medicine Technical
Framework Supplement - Laboratory Analytical Workflow
(LAW) (2016)

Acknowledgment mode Acknowledgment messages are expected for the


supported workflows. Also see IHE LAW [5] Section W.2.9
Error Handling.

Batch order download The analyzer accepts an unsolicited test order from the
host without previously sending a query for that order
(LAB-28).

q The analyzer can handle up to 600 messages within


300 seconds.

Host query mode The analyzer queries the host every time a sample is
loaded.

QC and patient results The analyzer automatically uploads QC results and


validated patient results to the host.

Deviations from IHE LAW profile • The IHE LAW profile requires 2 network connections,
but the analyzer uses a single, persistent network
connection. The analyzer can be configured as TCP
client or TCP server.
• The analyzer sends the rack ID (QPD-4) and the tube
position in the rack (QPD-5) together with the code
WOS (QPD-1.1). When sending the rack ID and tube
position, the IHE LAW standard requires
WOS_BY_RACK in QPD-1.1.
2 Supported workflows

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
34 Work order download

Work order download


Direction HL7 Message IHE Transaction Notes
LIS f Analyzer OML^O33 The LAB-28 workflow enables the LIS to add a new Work
LIS g Analyzer ORL^O34 LAB-28 Order Step (WOS), modify, or cancel an existing WOS
previously sent to the analyzer.
y Work order download (WOS)

Work order query


Direction HL7 Message IHE Transaction Notes
LIS g Analyzer QBP^Q11 The LAB-27 workflow is used by the analyzer to get the
LIS f Analyzer RSP^K11 WOS to perform for each specimen by querying the LIS
after specimen recognition.
According to the LAW profile for querying WOS from the
LAB-27
analyzer, the Analyzer Manager is expected to first send an
RSP^K11 message to acknowledge the reception of the
query and then initiate a LAB-28 transaction to send the
test orders.
y Work order query

Patient sample result upload


Direction HL7 Message IHE Transaction Notes
LIS g Analyzer OUL^R22 Patient results and QC results can be uploaded to the LIS.
LAB-29 Optionally, sample raw data can be sent to the LIS.
LIS f Analyzer ACK^R22
y Patient sample result upload
2 Supported workflows

Calibration result upload


By default, this workflow is disabled. If you wish to enable
it, talk to your supervisor or Roche Service representative.

Direction HL7 Message IHE Transaction Notes


LIS g Analyzer OUL^R23
LAB-29C Calibration results are uploaded to the LIS.
LIS f Analyzer ACK^R23
y Calibration result upload

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Equipment status request 35

Equipment status request


Direction HL7 Message IHE Transaction Notes
LIS f Analyzer ESR^U02 The LIS requests an instrument status update from the
ROC-01
LIS g Analyzer ACK^U02 analyzer.

y Equipment status request

Equipment status update


Direction HL7 Message IHE Transaction Notes
LIS g Analyzer ESU^U01 In the following scenarios, the analyzer sends the
LIS f Analyzer ACK^U01 instrument status to the LIS.
o When requested by an ESR^U02 message (ROC-01
ROC-02 workflow)
o After a status change of the analyzer (when the
Automatically send instrument status and test
availability to LIS option is enabled)
y Equipment status update

Equipment inventory request


Direction HL7 Message IHE Transaction Notes
LIS f Analyzer INR^U14 The LIS requests an inventory status update from the
LIS g Analyzer ACK^U14 analyzer.
ROC-03
Equipment inventory information only includes the test
availability.
y Equipment inventory request
2 Supported workflows

Equipment inventory update


Direction HL7 Message IHE Transaction Notes
LIS g Analyzer INU^U05 Equipment inventory information is limited to the test
LIS f Analyzer ACK^U05 availability.
In the following scenarios, the analyzer sends the test
availability to the LIS.
ROC-04 o When requested by an INR^U14 message (ROC-03
workflow)
o After a status change of the analyzer (when the
Automatically send instrument status and test
availability to LIS option is enabled)
y Equipment inventory update

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36
2 Supported workflows Equipment inventory update

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37
Table of contents

Message structure 3

The cobas t 511 coagulation analyzer and the LIS use the
HL7 protocol to communicate. The message structure is
described here, including the types of message and the
HL7 segments.

In this chapter 3
HL7 message mapping . . . . . . . . . . . . . . . . . . . . . . . . . 39
OML^O33 WOS message . . . . . . . . . . . . . . . . . . . . . . . 41
ORL^O34 acknowledgment message. . . . . . . . . . . . . 43
QBP^Q11 query message. . . . . . . . . . . . . . . . . . . . . . . 44
RSP^K11 acknowledgment message . . . . . . . . . . . . . 45
OUL^R22 result message . . . . . . . . . . . . . . . . . . . . . . . 46
OUL^R23 message . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
ACK^R22 and ACK^R23 message . . . . . . . . . . . . . . . 49
ESR^U02 message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
INR^U14 message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
3 Message structure
ACK^U02 and ACK^U14 message . . . . . . . . . . . . . . . 52
ESU^U01 message . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
INU^U05 message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
ACK^U01 and ACK^U05 message . . . . . . . . . . . . . . . 55

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Table of contents
3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
HL7 message mapping 39

HL7 message mapping


For each of the supported messages, the following
information is provided in a table.

Segment Description Usage Cardinality Mapping


HL7 segment identifier Purpose of the segment Code defining how a Number of instances a Reference to the
segment is used in the segment can appear in paragraph where the
message. a message. segment is described.
u Usage (39) u Cardinality (40)
y Message structure table

Usage A single-character code defining the circumstances


under which an HL7 element (segment-group, segment,
field) appears in a message. Some elements must always
be present, others may never be present, and others may
only be present under certain circumstances. The
following codes are used to define the usage of an
element.

Code Definition Description


M Mandatory o The sender must provide a
mandatory element.
o If a mandatory element is absent,
the receiver raises an error
(“AE”).
R Required o The sender must populate all “R”
elements with a non-empty
value.
o The receiver shall not raise an
error due to the presence of an
“R” element, but may raise an
error due to its absence.
RE Required if Enhanced information provided only
Available when data is available.
o If such information is available,
the sender must send the
respective “RE” element. If an
“RE” element is not supported, 3 Message structure
the receiver ignores it.
o If an “RE” element is absent, the
receiver does not raise an
exception.
C Conditional The usage of the elements depends
(a/b) on whether a condition is fulfilled.
o If the condition is fulfilled, the
usage follows rule “a”.
Otherwise, rule “b” applies.Rules
“a” and ”b” can be one of the
following values: M, R, RE, or X.
X Not sent or o The analyzer does not send “X”
ignored elements.
o The analyzer ignores "X"
elements that are sent from the
host.
y Usage

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40 HL7 message mapping

In addition, square and curly brackets are used to


indicate appearance and repetition of segments and
segment groups in a HL7 message.

Value Description
[..] 0 or 1 occurrence
{..} 1 or multiple occurrences
[{..}] 0 or multiple occurrences

Cardinality Cardinality identifies the minimum and maximum number


of repetitions for a particular HL7 element. Cardinalities
are expressed as a minimum-maximum pair of non-
negative integers.

Value Description
[0..1] Element may be omitted and can have at most 1
occurrence.
[1..1] Element must have exactly 1 occurrence.
[0..*] Element may be omitted or repeat for a non-
specified number of times.
[1..*] Element must appear at least once, and may repeat
for a non-specified number of times.
y Cardinality
3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OML^O33 WOS message 41

OML^O33 WOS message


The LIS sends a Work Order Step (WOS) message, with
details of the tests to be done on the sample. This is also
called a download of new Test Orders (Unsolicited New
Work Order Step Download).

Order number The analyzer uniquely identifies test orders by the Placer
Order Number (AWOS ID), specified in OBR-2.

The analyzer handles the Placer Order Number as follows.


• The LIS sends the following.
- Same test order
- Same sample
- Same Placer Order Number
The analyzer considers this a re-transmission of the
test order, and ignores it. The analyzer attempts to
perform any other tests in the order.
• The LIS sends the following.
- Same test order
- Same sample
- Different Placer Order Number
The analyzer considers this as a new order, and adds
it to the sample.
• This LIS sends the following.
- Same or different test order
- Different sample
- Same Placer Order Number
The analyzer rejects the order. It is not possible to
reuse Placer Order Numbers.

q Limitations of the OML^O33 WOS message 3 Message structure


o Results cannot be downloaded with the order. The
analyzer ignores any result segments.
o Only one SPM segment (specimen information) is
supported.
o Patient data is not supported. The analyzer ignores
any PID segment.

The following segments are supported by the LIS


interface.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
42 OML^O33 WOS message

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
{ ---SPECIMEN begin R [1..1] Only one specimen per message
SPM Specimen information M [1..1] u SPM: Specimen segment (66)
SAC Container information M [1..1] u SAC: Specimen Container Detail
segment (68)
{ ---ORDER begin M [1..*]
ORC Common Order (for one battery) M [1..1] u ORC: Common Order segment (73)
TQ1 Timing/Quantity RE [0..1] u TQ1: Timing/Quantity segment (76)
{ --- OBSERVATION REQUEST begin RE/X (2) [0..1]
OBR Observation Request M [1..1] u OBR: Observation Request segment (75)
TCD Test Code Detail M [1..1] u TCD: Test Code Detail segment (87)
} ---OBSERVATION REQUEST end
} ---ORDER end
} ---SPECIMEN end
y OML^O33 message
(1) M = Mandatory, R = Required, RE = Required if available, X = Ignored
(2) If it is a Negative Query Response, the host does not send the Observation Request group. In all other cases, the analyzer expects the
Observation Request. For details, see IHE PaLM-TF LAW [5], paragraf 4050.

u Related topics
• Work order download (34)
3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
ORL^O34 acknowledgment message 43

ORL^O34 acknowledgment message


The analyzer sends an ORL^O34 message to
acknowledge the receipt of an OML^O33 WOS message.

The analyzer accepts or rejects each AWOS test request


individually.
• MSA-1 is set to indicate whether the OML^O33
message was accepted or rejected.
• ORC-1 (Order Control Field) is set to indicate if each
AWOS test request has been accepted or rejected.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
MSA Message Acknowledgment M [1..1] u MSA: Message Acknowledge Segment (93)
ERR Error C (R/X) (2) [0..*] u ERR: Error segment (94)
[ ---RESPONSE begin C (X/RE)(3) [0..1]
{ ---SPECIMEN begin M [1..*]
SPM Specimen information M [1..1] u SPM: Specimen segment (66)
SAC Specimen Container M [1..1] u SAC: Specimen Container Detail segment (68)
{ ---ORDER begin M [1..*]
ORC Common Order M [1..1] u ORC: Common Order segment (73)
} ---ORDER end
} ---SPECIMEN end
] ---RESPONSE end
y ORL^O34 message
(1) C = Conditional, M = Mandatory, R = Required, RE = Required if available, X = Not sent
(2) An error segment is required if MSA-1 is not equal to AA. There may be multiple repetitions when multiple errors have been detected.
Otherwise, usage is not supported.
(3) No RESPONSE group if there is an ERR segment. Present in other cases if there is data available.

u Related topics
• Work order download (34)
3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
44 QBP^Q11 query message

QBP^Q11 query message


The analyzer sends a query message for the Work Order
Step (WOS).

The analyzer initiates a work order download (or Work


Order Step - WOS) with a QBP^Q11 query message.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
QPD Query Parameter Definition M [1..1] u QPD: Query Definition segment (90)
RCP Response Control Parameter M [1..1] u RCP: Response Control Parameter
segment (91)
y QBP^Q11 message
(1) M = Mandatory

Negative query response If the LIS has no test orders to send in response to a LAB-
27 QBP^Q11 message, it sends a negative query
response.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
{ ---SPECIMEN begin R [1..1] Only one specimen per message
SPM Specimen information M [1..1] u SPM: Specimen segment (66)
SAC Container information M [1..1] u SAC: Specimen Container Detail segment (68)
{ ---ORDER begin M [1..*]
ORC Common Order M [1..1] u ORC: Common Order segment (73)
} ---ORDER end
} ---SPECIMEN end
y Negative query response message
(1) M = Mandatory

If the LIS sends a negative query response, it contains the


following values.
3 Message structure

q If it is a negative query response, the host does not


send the Observation Request group in the OML^O33
WOS message.

SPM segment SAC segment ORC segment


SPM-4 = Null value ("") SAC-3 = Container identifier received in ORC-1 = DC (Discontinue request)
SPM-11 = U (Unknown) QPD-3 of the original query message ORC-9 is set to current date/time
y

u Related topics
• Work order query (34)
• OML^O33 WOS message (41)

Roche Diagnostics
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RSP^K11 acknowledgment message 45

RSP^K11 acknowledgment message


The LIS sends an RSP^K11 message to acknowledge
receipt of a WOS query from the analyzer.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
MSA Message Acknowledgment M [1..1] u MSA: Message Acknowledge Segment (93)
[ERR] Error C (R/X)(2) [0..1] u ERR: Error segment (94)
QAK Query Acknowledgment M [1..1] u QAK: Query Acknowledge segment (92)
QPD Query Parameter Definition M [1..1] u QPD: Query Definition segment (90)
y RSP^K11 message
(1) C = Conditional, M = Mandatory, R = Required, X = Ignored
(2) An error segment is required if MSA-1 is not equal to AA. There may be multiple repetitions when multiple errors have been detected.
Otherwise, usage is not supported.

u Related topics
• Work order query (34)

3 Message structure

Roche Diagnostics
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46 OUL^R22 result message

OUL^R22 result message


The analyzer sends test results in an OUL^R22 message.

Empty results If a measurement has failed, the analyzer sends an empty


result.
• OBX-5 is empty
• OBX-11 = X (Measurement failed)

Unvalidated results If the LIS result passthrough option is enabled, the


analyzer sends unvalidated results with the following
values:
• OBX-11 = R (Entered, not verified)

Validated results For validated results, OBX-11 = F (Final). Validated


results can only be changed with a corrected result.

Reruns If the LIS result passthrough option is enabled, the


analyzer automatically sends first-run results to the host
with the following values.
• OBX-11 = P (Preliminary)
• ORC-5 = IP (In Process)

If the LIS result passthrough option is disabled, the


analyzer sends first-run results only under the following 2
conditions.
• The first-run result is validated.
• The user manually forces an upload.

In these cases, the analyzer sends the first-run results


with the following values.
• OBX-11 = F or P (according to validation status)
• ORC-5 = CM

If the analyzer executes a rerun of a QC test order, only


3 Message structure

the second-run result is sent.

q The first and second run results both use the same
AWOS ID (Order Placer Number).

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
{ ---SPECIMEN begin M [1..*]
SPM Specimen information M [1..1] u SPM: Specimen segment (66)
[{ ---CONTAINER begin M [1..1]
SAC Container information M [1..1] u SAC: Specimen Container Detail
segment (68)
y OUL^R22 message

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OUL^R22 result message 47

Segment Description Usage(1) Cardinality Mapping


[INV] Detailed Substance information C (R/X)(2) [0..1] u INV: Inventory Detail segment (69)
(e.g. id, lot, manufacturer) of QC
specimen
}] ---CONTAINER end
{ ---ORDER begin M [1..*]
OBR Observation Order M [1..1] u OBR: Observation Request
segment (75)
ORC Common Order M [1..1] u ORC: Common Order segment (73)
[TQ1] Timing/Quantity R [1..1] u TQ1: Timing/Quantity segment (76)
{ ---RESULT begin M [1..*]
OBX Observation Result (3) M [1..1] u OBX in OUL^R22 message (77)
[TCD] Test Code Detail C/R/RE [0..1] u TCD: Test Code Detail segment (87)
[{INV}] Detailed Substance information RE (4) [0..*] u INV: Inventory Detail segment (69)
(e.g., reagents used for testing)
[{NTE}] Notes and comments RE(5) [0..*] u NTE: Notes and Comments segment
(test result) (89)
} ---RESULT end
{ ---RESULT begin
OBX Observation Result for raw data C (RE/X)(6) [0..*] u OBX in OUL^R22 message (77)
} ---RESULT end
} ---ORDER end
} ---SPECIMEN end
y OUL^R22 message
(1) C = Conditional, M = Mandatory, R = Required, RE = Required if available, X = Not sent
(2) Required if SPM-11 = Q. Otherwise empty.
(3) The OBX segment contains information for both observation results and observation results for raw data. This segment is placed in 2 separate
RESULT segment groups.
(4) Sent if information available.
(5) Sent if information available (for example, if entered by operator).
(6) Sent if configured in analyzer

Reflex test result A reflex test is a test order based on the evaluation of one
or more observation results for one or more AWOS.
• OBR-2 (Placer Order Number) is set to NULL (""), as 3 Message structure
the reflex test is initiated at the analyzer, and there is
no AWOS ID.
• OBR-11 (Specimen Action Code) =G, meaning a
reflex test.
• ORC-8 (Parent) is set to the AWOS ID(s) of the tests
that triggered the reflex. The field is repeated if there
are multiple parent test results that triggered the test.

u Related topics
• Patient sample result upload (34)

Roche Diagnostics
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48 OUL^R23 message

OUL^R23 message
The analyzer sends calibration results in an OUL^R23
message.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
{ ---SPECIMEN begin M [1..*]
SPM Specimen information M [1..1] u SPM: Specimen segment (66)
OBX Curve parameters M [1..1] u OBX in OUL^R23 message (81)
{ ---CONTAINER begin M [1..*]
SAC Container information M [1..1] u SAC: Specimen Container Detail
segment (68)
[INV] Detailed substance information R(2) [1..1] u INV: Inventory Detail segment (69)
of calibrator (for example: ID,
lot, manufacturer)
{ ---ORDER begin M [1..*]
OBR Observation Order M [1..1] u OBR: Observation Request
segment (75)
ORC Common Order M [1..1] u ORC: Common Order segment (73)
[{ ---RESULT begin RE [0..*]
OBX Observation Result(3) M [1..1] u OBX in OUL^R23 message (81)
[{OBX} ] Observation Result for raw data C (RE/X)(4) [0..*] u OBX in OUL^R22 message (77)
[{INV}] Substance information (for RE [0..*] u INV: Inventory Detail segment (69)
example: reagents used for
testing)
If more than one reagent /
substance is used for testing,
more than one segment is
sent.It is possible that the
requested information is not
sent/available (for example:
aborted test)
[{NTE}] Notes and comments RE [0..*] u NTE: Notes and Comments segment
(test result) (89)
}] ---RESULT end
3 Message structure

} ---ORDER end
} ---CONTAINER end
} ---SPECIMEN end
y OUL^R23 message
(1) C = Conditional, M = Mandatory, R = Required, RE = Required if available, X = Not sent
(2) For calibration results, SPM-11 is set to “C”.
(3) The OBX segment contains information for both observation results and observation results for raw data. This segment is placed in 2 separate
RESULT segment groups.
(4) Sent if configured in analyzer

u Related topics
• Calibration result upload (34)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
ACK^R22 and ACK^R23 message 49

ACK^R22 and ACK^R23 message


The LIS returns an acknowledgment to an OUL^R22 or
OUL^R23 message.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
MSA Message Acknowledgment M [1..1] u MSA: Message Acknowledge Segment (93)
[{ERR}] Error C (R/X)(2) [0..*] u ERR: Error segment (94)
The ERR segment is used for
negative acknowledgment (if
MSA-1 = AR or AE). It adds
error information to
acknowledgment messages.
y ACK^R22 and ACK^R23 message
(1) C = Conditional, M = Mandatory, R = Required, X = Ignored
(2) Required when MSA-1 is not equal to AA. Multiple ERR segments are sent for multiple errors.

u Related topics
• Patient sample result upload (34)
• Calibration result upload (34)

3 Message structure

Roche Diagnostics
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50 ESR^U02 message

ESR^U02 message
The LIS sends an ESR^U02 message to the analyzer to
request an instrument status update.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
EQU Equipment Identification M [1..1] u EQU: Equipment Identification segment (95)
y ESR^U02 message
(1) M = Mandatory

u Related topics
• Equipment status request (35)
3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
INR^U14 message 51

INR^U14 message
The LIS sends an INR^U14 message to the analyzer to
request an inventory status update. The analyzer only
returns the test availability. No other inventory
information is provided.

Filtering inventory information The analyzer does not support requests to filter inventory
information. The analyzer ignores the filtering request
from the LIS in the respective INV segments of the
INR^U14 message.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
EQU Equipment Identification M [1..1] u EQU: Equipment Identification segment (95)
INV Inventory Detail RE [0..*] u INV: Inventory Detail segment (69)
y INR^U14 message
(1) M = Mandatory, RE = Required if available

u Related topics
• Equipment inventory request (35)

3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
52 ACK^U02 and ACK^U14 message

ACK^U02 and ACK^U14 message


The analyzer returns an acknowledgment to an ESR^U02
or INR^U14 message.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
MSA Message Acknowledgment M [1..1] u MSA: Message Acknowledge Segment (93)
[{ERR}] Error C (R/X)(2) [0..*] u ERR: Error segment (94)
The ERR segment is used for
negative acknowledgment (if
MSA-1 = AR or AE). It adds
error information to
acknowledgment messages.
y ACK^U02 and ACK^U14 message
(1) C = Conditional, M = Mandatory, R = Required, X = Not sent
(2) Required when MSA-1 is not equal to AA. Multiple ERR segments are sent for multiple errors.

u Related topics
• Equipment status request (35)
• Equipment inventory request (35)
3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
ESU^U01 message 53

ESU^U01 message
The analyzer sends the instrument status to the LIS in an
ESU^U01 message.

The analyzer sends the instrument status under the


following 2 conditions:
• A LIS request (ESR^U02) was received.
• The analyzer state has changed, and the
Automatically send instrument status and test
availability to LIS option is enabled.

Field EQU-3.1 defines the analyzer state.


u Analyzer states (95)

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
EQU Equipment Identification M [1..1] u EQU: Equipment Identification segment (95)
y ESU^U01 message
(1) M = Mandatory

u Related topics
• Equipment status update (35)

3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
54 INU^U05 message

INU^U05 message
The analyzer sends the inventory status to the LIS in an
INU^U05 message. The analyzer only sends the test
availability.

The analyzer sends the inventory status under the


following 2 conditions:
• A LIS request (INR^U14) was received.
• A change in the test masking status occurred, and the
Automatically send instrument status and test
availability to LIS option is enabled.

The analyzer sends a separate INV segment for each


installed test with the following information:
• INV-1: NONE (fixed value)
• INV-2: OK^^HL70383 (fixed valued)
• INV-3: empty
• INV-15: test identifier
• INV-21: TA^^HL70942 (fixed value)
• INV-22: test availability: 0% for masked tests, 100%
for unmasked tests.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
EQU Equipment Identification M [1..1] u EQU: Equipment Identification segment (95)
INV Inventory Detail M [1..*] u INV: Inventory Detail segment (69)
y INU^U05 message
(1) M = Mandatory, RE = Required if available

u Related topics
• Equipment inventory update (35)
3 Message structure

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
ACK^U01 and ACK^U05 message 55

ACK^U01 and ACK^U05 message


The LIS returns an acknowledgment to an ESU^U01 or
INU^U05 message.

Segment Description Usage(1) Cardinality Mapping


MSH Message Header M [1..1] u MSH: Message Header segment (63)
MSA Message Acknowledgment M [1..1] u MSA: Message Acknowledge Segment (93)
[{ERR}] Error C (R/X)(2) [0..*] u ERR: Error segment (94)
The ERR segment is used for
negative acknowledgment (if
MSA-1 = AR or AE). It adds
error information to
acknowledgment messages.
y ACK^U01 and ACK^U05 message
(1) C = Conditional, M = Mandatory, R = Required, X = Ignored
(2) Required when MSA-1 is not equal to AA. Multiple ERR segments are sent for multiple errors.

u Related topics
• Equipment status update (35)
• Equipment inventory update (35)

3 Message structure

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56
3 Message structure ACK^U01 and ACK^U05 message

Roche Diagnostics
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57
Table of contents

Field definitions 4

This section gives the definition of the segments and


fields used by the analyzer’s host interface.

In this chapter 4
Message segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
MSH: Message Header segment . . . . . . . . . . . . . . . . . 63
SPM: Specimen segment . . . . . . . . . . . . . . . . . . . . . . . 66
SAC: Specimen Container Detail segment . . . . . . . . . 68
INV: Inventory Detail segment . . . . . . . . . . . . . . . . . . . 69
ORC: Common Order segment . . . . . . . . . . . . . . . . . . . 73
OBR: Observation Request segment . . . . . . . . . . . . . . 75
TQ1: Timing/Quantity segment. . . . . . . . . . . . . . . . . . . 76
OBX: Observation/Result segment. . . . . . . . . . . . . . . . 77
OBX in OUL^R22 message. . . . . . . . . . . . . . . . . . . 77
OBX in OUL^R23 message. . . . . . . . . . . . . . . . . . . 81
List of data alarm codes . . . . . . . . . . . . . . . . . . . . . 85
TCD: Test Code Detail segment . . . . . . . . . . . . . . . . . . 87
4 Field definitions

NTE: Notes and Comments segment (test result) . . . 89


QPD: Query Definition segment . . . . . . . . . . . . . . . . . . 90
RCP: Response Control Parameter segment. . . . . . . . 91
QAK: Query Acknowledge segment . . . . . . . . . . . . . . 92
MSA: Message Acknowledge Segment . . . . . . . . . . . 93
ERR: Error segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
EQU: Equipment Identification segment . . . . . . . . . . . 95

Roche Diagnostics
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58
Table of contents
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Message segments 59

Message segments
Omitted fields Omitted fields (e.g. MSH-8) should be left empty by the
LIS Interface when sending to the analyzer. The analyzer
ignores the content of these fields when receiving
messages.

For the field description, the following format is applied:

Text format Meaning


Bold HL7 field name
Courier New Example values and literal
fixed values
Quotation Marks “” fixed literal values sent by the
analyzer or expected
from LIS

q Quotation marks are not


part of the string sent or
expected by the analyzer.

Angle Brackets <parameter> Parameterized values known


depending on specific
configurations or run-time
environments / conditions
y Text formats in field descriptions

q HL7 NULL values are represented a double


quotation mark: “”. This is the only case in this
specification where quotation marks are actually sent or
received as part of the field value.

Date and time formatting The date time value represents dates and times with
values ranging from 00:00:00 (midnight), January 1, 0001
Anno Domini (Common Era) through 11:59:59 P.M.,
December 31, 9999 A.D. (C.E.) in the Gregorian calendar.

The following date and time formats are allowed(1):


4 Field definitions

• yyyyMMddHHmmsszzzz
• yyyyMMddHHmmss

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
60 Message segments

Analyzer -> LIS date and time formatting The format of dates and times, that are sent from the
analyzer must be the same in each applicable field of the
message. This output format is configurable in the
analyzer software under the Process Settings section.

The following three formats are provided:


• UTC (Coordinated Universal Time)
• Local time (without time zone)
• Local time with time zone

The following table describes the format for each


configuration with the corresponding example:

UTC Local time Local time with time zone


Format yyyyMMddHHmmsszzzz yyyyMMddHHmmss yyyyMMddHHmmsszzzz
Example 20211001211007+0000 20211001231007 20211001231007+0200
y Analyzer -> LIS date and time formatting

LIS -> Analyzer date and time formatting The format of dates and times, that the analyzer receives
from the LIS must be the same in each applicable field of
the message.

This input format can be:


• Date and time with time zone:
When time zone is available, date time is resolved as
local time with the specified time zone in the field or
resolved as UTC if the time zone offset is +0000.
• Date time without time zone:
This option is read as UTC
4 Field definitions

(1) yyyy: Represents the year as a number ranging from 0000 through
9999.
MM: Represents the month as a number with a leading zero ranging
from 01 through 12.
dd: Represents the day of the month as a number with a leading zero
ranging from 01 through 31.
HH; Represents the 24-hour clock hour with a leading zero ranging
from 00 through 23.
mm; Represents the minute as a number with a leading zero ranging
from 00 through 59.
ss; Represents the second as a number with a leading zero ranging
from 00 through 59.
zzzz: Represents the time zone information (without any delimiter)
of a date time value, measured in hours and minutes, e.g. +0500.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Message segments 61

Allowed characters for sample ID According to analyzer Data Concept [1], sample
information is contained in a one-dimensional sample
barcode label attached to a sample tube.

The 4 sample barcode types allow the following


characters with the cobas t 511/711 analyzer only:
• ITF:
0 to 9
• NW-7 / Codabar:
0 to 9, “-“, “/”, “.”, “$”, “:”, “+”
• Code 39:
0 to 9, A to Z, “-“, “/”, “.”, “+”, [space], “$”, “%”
• Code 128:
The following tables shows the allowed characters
with the cobas t 511/711 analyzer

DEC Char DEC Char DEC Char DEC Char


32 [Space] 65 A 82 R 105 i
36 $ 66 B 83 S 106 j
37 % 67 C 84 T 107 k
43 + 68 D 85 U 108 l
45 - 69 E 86 V 109 m
46 . 70 F 87 W 110 n
47 / 71 G 88 X 111 o
48 0 72 H 89 Y 112 p
49 1 73 I 90 Z 113 q
50 2 74 J 97 a 114 r
51 3 75 K 98 b 115 s
52 4 76 L 99 c 116 t
53 5 77 M 100 d 117 u
54 6 78 N 101 e 118 v
55 7 79 O 102 f 119 w
56 8 80 P 103 g 120 x
57 9 81 Q 104 h 121 y
122 z
y Allowed code 128 characters with the cobas t 511/711 analyzer
4 Field definitions

The following table shows characters that can be part of a


code 128 but not used with a cobas t 511/711 analyzer.

DEC Char DEC Char DEC Char DEC Char


33 ! 42 * 63 ? 96 ‘
34 " 44 , 64 @ 123 {
35 # 58 : 91 [ 124 |
38 & 59 ; 92 \ 125 }
39 ’ 60 < 93 ] 126 ~
40 ( 61 = 94 ^
41 ) 62 > 95 _
y Code 128 characters that are NOT supported with the cobas t 511/711 analyzer

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
62 Message segments

Field usage
Code Definition Description
M Mandatory o The sender must provide a
mandatory element.
o If a mandatory element is absent,
the receiver raises an error
(“AE”).
R Required o The sender must populate all “R”
elements with a non-empty
value.
o The receiver shall not raise an
error due to the presence of an
“R” element, but may raise an
error due to its absence.
RE Required if Enhanced information provided only
Available when data is available.
o If such information is available,
the sender must send the
respective “RE” element. If an
“RE” element is not supported,
the receiver ignores it.
o If an “RE” element is absent, the
receiver does not raise an
exception.
C Conditional The usage of the elements depends
(a/b) on whether a condition is fulfilled.
o If the condition is fulfilled, the
usage follows rule “a”.
Otherwise, rule “b” applies.Rules
“a” and ”b” can be one of the
following values: M, R, RE, or X.
X Not sent or o The analyzer does not send “X”
ignored elements.
o The analyzer ignores (X)
elements that are sent from the
host.
y Usage

u Related topics
• Usage (39)
• Cardinality (40)
4 Field definitions

Roche Diagnostics
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MSH: Message Header segment 63

MSH: Message Header segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

MSH-1 Field Delimiter | Ignored, i.e. the LIS cannot


(1) define other delimiters.
MSH-2 o Component delimiter ^~\& Ignored, i.e. the LIS cannot
(4) o Repetition delimiter define other delimiters.
o Escape delimiter
o Subcomponent
delimiter
(in exactly this order)
MSH-3 Sending application M String format RE
(227) MSH-3 consists of a single
component. The value
contains the following
information:
o Analyzer type
o Analyzer serial number
o String constant = M.
Example
o t511_19283747238_M
MSH-4 Sending Facility M String format RE
(227) Null value ("")
MSH-5 Receiving Application M String format RE
(227) Null value ("")
MSH-6 Receiving Facility M String format RE
(227) Null value ("")
MSH-7 Date/Time of Message M Date format M Date format
(24) Time zone information is u Date and time u Date and time
mandatory for this field (and
formatting (59) formatting (59)
only this field). All other
timestamps in the message Examples: Examples:
are assumed to be in the yyyyMMddHHmmsszzzz yyyyMMddHHmmsszzzz
same time zone as specified yyyyMMddHHmmss yyyyMMddHHmmss
in this field
u Analyzer -> LIS date u LIS -> Analyzer date
and time formatting (60) and time formatting (60)
4 Field definitions

Example UTC: Example UTC:


20211001211007+0000 20211001211007+0000
Example local time: Example local time:
20211001231007 20211001231007
Example local time with time Example local time with time
zone: zone:
20211001231007+0200 20211001231007+0200
y MSH - message header segment

Roche Diagnostics
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64 MSH: Message Header segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

MSH-9 Message Type M String M String


(15) u Supported Supported values: Supported values:
o LAB-27: o LAB-27:
workflows (31)
QBP^Q11^QBP_Q11 RSP^K11^RSP_K11
u Message structure (37) o LAB-28: o LAB-28:
ORL^O34^ORL_042 OML^O33^OML_033
o LAB-29: o LAB-29:
OUL^R22^OUL_R22 ACK^R22^ACK
o LAB-29C: o LAB-29C
OUL^R23^OUL_R23 ACK^R23^ACK
o ROC-01: o ROC-01:
ACK^U02^ACK ESR^U02^ESR_U02
o ROC-02 o ROC-02
ESU^U01^ESU_U01 ACK^U01^ACK
o ROC-03 o ROC-03:
ACK^U14^ACK INR^U14^INR_U14
o ROC-04: o ROC-04:
INU^U05^INU_U05 ACK^U05^ACK
MSH-9.1 Message code
MSH-9.2 Trigger event
MSH-9.3 Message structure
MSH-10 Message Control ID M String. Example: M String. Example:
(50) Used to track 25892e17-80f6-415f- 8789754421
acknowledgement 9c65-7395632f0223
messages.
MSH-11 Processing Mode M String constant: M String constant:
(3) (Priority) P = Production (fixed value) P = Production (fixed value)

MSH-12 HL7 Version ID M String constant: = HL7 M String constant:


(60) version Expected values:
2.5.1 o 2.5.1
MSH-15 Accept Acknowledgment C o Empty for response C o Empty for response
Type (M/X) messages (M/X) messages
o NE (fixed value) for all o NE (fixed value) for all
other messages other messages
MSH-16 Application C o Empty for C o Empty for
Acknowledgment Type (M/X) acknowledgment (M/X) acknowledgment
messages messages
4 Field definitions

o AL (fixed value) for all o AL (fixed value) for all


other messages other messages
MSH-18 Character Set M String M String
(16) Character encoding used Fixed value = UNICODE Fixed value = UNICODE
for the whole message. UTF-8 UTF-8
The LIS Interface always The analyzer always sends The analyzer always sends
sends messages in messages in UNICODE UTF- messages in UNICODE UTF-
UNICODE UTF-8 encoding. 8 encoding. 8 encoding.
y MSH - message header segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
MSH: Message Header segment 65

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

MSH-21 Message Profile M Complex value M Complex value


Identifier Constant values required by Constant values required by
IHE LAW profile, dependent IHE LAW profile, dependent
on message type: on message type:
o OUL^R22: o OML^O33:
LAB-29^IHE LAB-28^IHE
o OUL^R23 o RSP^K11:
LAB-29C^ROCHE LAB-27^IHE
o ORL^O34: o ACK^R22:
LAB-28^IHE LAB^29^ROCHE
o QBP^Q11: o ACK^R23:
LAB-27^IHE LAB^29C^ROCHE
o ACK^U02: o ESR^U02:
ROC-01^ROCHE ROC-01^ROCHE
o ESU^U01: o ACK^U01:
ROC-02^ROCHE ROC-02^ROCHE
o ACK^U14: o INR^U14:
ROC-03^ROCHE ROC-03^ROCHE
o INU^U05: o ACK^U05:
ROC-04^ROCHE ROC-04^ROCHE
MSH- IHE transaction number Supported values:
21.1 o LAB-27
o LAB-28
o LAB-29
o LAB-29C
o ROC-01
o ROC-02
o ROC-03
o ROC-04
MSH- Namespace ID Supported values:
21.2 o IHE
o ROCHE
y MSH - message header segment

u Related topics
• Messages using MSH
- OML^O33 WOS message (41)
- ORL^O34 acknowledgment message (43)
4 Field definitions

- QBP^Q11 query message (44)


- RSP^K11 acknowledgment message (45)
- OUL^R22 result message (46)
- ESR^U02 message (50)
- INR^U14 message (51)
- ACK^U02 and ACK^U14 message (52)
- ESU^U01 message (53)
- INU^U05 message (54)
- ACK^U01 and ACK^U05 message (55)

Roche Diagnostics
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66 SPM: Specimen segment

SPM: Specimen segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

SPM-1 Set ID M Number M Number


(4) Fixed value: 1 Fixed value: 1
1 1
SPM-2 Specimen ID M Complex value M Complex value
(128) Examples: Examples:
SMP0001&ROCHE SMP0001&ROCHE
5000-1&ROCHE 5000-1&ROCHE
123456789&ROCHE 123456789&ROCHE
SPM-2.1.1 Identifier o For patient results: o For patient results:
sample ID sample ID
u Allowed characters for u Allowed characters for
sample ID (61) sample ID (61)
o For QC results: o For QC results:
control material code control material code
o For calibration tubes:
calibrator code
SPM-2.1.2 Namespace ID ROCHE (fixed value) ROCHE (fixed value)
SPM-4 Specimen Type (Code) M Complex value M Complex value
(250) Code identifying the o PLAS^^HL70487 for o PLAS^^HL70487
sample type. sample results o NULL ("") for negative
o ORH^^HL70487 for query response
calibration and QC results Other values are rejected.
SPM-4.1 Identifier Supported values Supported values
o PLAS: fixed valued for o PLAS: fixed valued for
sample results sample results
o ORH: fixed valued for o NULL (""): for
calibration and QC results negative query
response
SPM-4.2 [empty]
SPM-4.3 Name of coding system HL70487 HL70487
y SPM - specimen segment
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
SPM: Specimen segment 67

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

SPM-11 Specimen Role (Code) M String value M String value


(250) From HL7 table 0369 Examples: Examples:
P^^HL70369 P^^HL70369
Q^^HL70369 U^^HL70369
SPM-11.1 Identifier Q = QC sample P = patient sample
P = patient sample U = negative query
C = calibrator response
Other values are rejected.
SPM-11.2 [empty]
SPM-11.3 Name of coding system HL70369 HL70369
SPM-17 Specimen Collection C (RE/X) Date value RE Date value:
(14) Date/Time u Date and time u Date and time
formatting (59) formatting (59)
Examples: Examples:
yyyyMMddHHmmsszzzz yyyyMMddHHmmsszzzz
yyyyMMddHHmmss yyyyMMddHHmmss

u Analyzer -> LIS date and u LIS -> Analyzer date


time formatting (60) and time formatting (60)
Example UTC: Example UTC:
20211001211007+0000 20211001211007+0000
Example local time: Example local time:
20211001231007 20211001231007
Example local time with time Example local time with
zone: time zone:
20211001231007+0200 20211001231007+0200

If the sample was ordered


form the host (AWOS), the
analyzer enters the data and
time when provided by the
host (usage RE).
If the sample was not ordered
by the host, the field is not
sent.
The field is empty for the
following samples:
o QC samples
4 Field definitions

o Calibrator samples
o Samples entered manually
at the analyzer
y SPM - specimen segment

u Related topics
• Messages using SPM
- OML^O33 WOS message (41)
- ORL^O34 acknowledgment message (43)
- OUL^R22 result message (46)
- OUL^R23 message (48)

Roche Diagnostics
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68 SAC: Specimen Container Detail segment

SAC: Specimen Container Detail segment

Analyzer f LIS

LIS f Analyzer
Description
(Length)

Usage

Usage
Field

SAC-3 Container Identifier M String M String


(128) (i.e. Tube ID/Barcode) u Allowed characters for u Allowed characters for
Note: barcode contains Sample ID or
sample ID (61) sample ID (61)
Sample ID and Specimen Type in any order.
Note: the analyzer uses the Specimen ID in
SPM-2 to identify samples / tubes.
SAC-10 Carrier Identifier RE String X Ignored
(705) Visual rack ID (4 digits) Examples:
ID of the rack (carrier) where the container 0001
(tube) is located. M002
SAC-11 Position in Carrier RE Numeric value from 1 to 5 X Ignored
(8) Position of the tube in the rack. Examples:
3
5
y SAC - specimen container detail segment

u Related topics
• Messages using SAC
- OML^O33 WOS message (41)
- ORL^O34 acknowledgment message (43)
- OUL^R22 result message (46)
- OUL^R23 message (48)
- ACK^R22 and ACK^R23 message (49)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
INV: Inventory Detail segment 69

INV: Inventory Detail segment


The INV segment is used for the following.
• To identify control material used for QC results
• To identify calibrator material used for calibration
results
• To identify reagents and diluents used to produce a
result
• To send the available test status of the analyzer.

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

INV-1 Substance Identifier M Complex value X Ignored


(128) Unique identifier for the In INU^U05 message:
substance in inventory o NONE (fixed value)
In all other messages:
o Value depends on result
type
Example
PT2330021^^99ROC
INV-1.1 Identifier of the substance o For patient results:
reagent container code
o For QC results: QC
material code
o For calibration results:
calibrator code
INV-1.2 empty
INV-1.3 Name of coding system Fixed value:
Manufacturer code 99ROC
INV-2 Substance Status M Complex value X Ignored
(705) From HL7 table 0383. In INU^U05 message:
o OK^^HL70383 (fixed
value)
In the INV segment of the
CONTAINER group of QC
and calibration results:
o OK^^HL70383 (fixed
value)
4 Field definitions

In all other messages:


o NA^^HL70383 (fixed
value)
INV-2.1 Identifier of the substance Supported values
status o OK = OK status
o NA = not applicable
INV-2.2 empty
INV-2.3 Name of coding system HL70383 (fixed value)
y INV - inventory detail segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
70 INV: Inventory Detail segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

INV-3 Substance Type C (M/X) Complex value X Ignored


(705) Example:
RC^^HL70384
INV-3.1 Identifier Supported values:
Substance type code o SR = single-reagent
cassette
o DI = diluent
o RC = reagent calibrator
o CO = control
o MR = multi-reagent
cassette
The field is not supported
(empty) in the INU^U05
message.
INV-3.2 empty
INV-3.3 Name of coding system HL70384 (fixed value)
INV-4 Inventory Container C (R/X) Complex value X Ignored
(20) Identifier The field is empty in
Identifies the inventory INU^U05 messages.
container, e.g., unique Note: the bottle count
identifier of a specific number is included in the
package instance of a calibrator and QC Material
specific substance. barcodes.
INV-4.1 Identifier of container o For reagents and
diluents:
cassette serial number.
o For calibrators:
calibrator barcode,
consists of calibrator
code, bottle count
number, and lot
number.
o For QC:
field is empty
INV-4.2 empty
INV-4.3 Name of coding system 99ROC (fixed value)
y INV - inventory detail segment
4 Field definitions

Roche Diagnostics
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INV: Inventory Detail segment 71

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

INV-15 Test Identifier C (R/X) Complex value C (RE/X) Complex value


(250) The field contains a list of o Only used in INU^U05 The field is mandatory only
tests that apply to the message, otherwise this when the INV segment
substance defined in this field is empty. does not apply to all tests.
INV segment. o INV-15 is a repeating Example:
field. If the field is 1^PT^99ROC
empty, the inventory
item (a substance or an
equipment state
indicator) applies to all
tests.
Example:
1^PT^99ROC
INV-15.1 Test code Equal to the ACN Equal to the ACN
(Application Code Number) (Application Code
of the test performed by the Number) of the test
analyzer. performed by the analyzer.
INV-15.2 test name Name of the test performed Name of the test
by the analyzer performed by the analyzer
INV-15.3 Test of coding 99ROC (fixed value) 99ROC (fixed value)
INV-16 Manufacturer Lot C (M/X) String value X Ignored
(20) Number Examples:
The lot number assigned by 100544
the manufacturer during 890063341
production of the substance. o Empty in INU^05
message
o For reagents: reagent
lot number
o For calibrators:
calibrators lot number
o For QC: QC material lot
number
INV-21 Equipment State C (R/X) Complex value C(RE/X) Complex value.
(200) Indicator Type Code o This field is only used in Only alowed if INV-3 is
This field specifies the type the INU^U05 message, empty.
of equipment inventory otherwise it is empty.
status to be quantified in Example:
INV-22. TA^^HL70942
INV-21.1 State value
4 Field definitions
TA TA
INV-21.2 Empty
INV-21.3 Coding HL70942 HL70942
y INV - inventory detail segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
72 INV: Inventory Detail segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

INV-22 Equipment State C (R/X) Complex value X Ignored


(242) Indicator Value o This field is only used in
The lot number assigned by the INU^U05 message,
the manufacturer during otherwise it is empty.
production of the substance. Example:
100^%&&UCUM
INV-22.1 Quantity For masked tests: 0
For unmasked tests: 100
INV-22.2 Quantity units 3 subcomponents
o INV-22.2.1: % (fixed
value)
o INV-22.2.2: empty
o INV-22.2.3: UCUM
(fixed)
y INV - inventory detail segment

u Related topics
• Messages using the INV segment:
- OUL^R22 result message (46)
- OUL^R23 message (48)
- INR^U14 message (51)
- INU^U05 message (54)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
ORC: Common Order segment 73

ORC: Common Order segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

ORC-1 Order Control M Coded value M Coded value


(2) Code to identify the order In OUL^R22 and OUL^R23 o CA = cancel order/ service
action. message: request
From HL7 table 0119 o SC = result status change o DC = discontinue request, only
In ORL^O34 message: sent in negative query
o OK = accept on OML NW response
o UA = reject on OML NW o NW = creates a new order if
o CR = accept on OML CA order number does not exist
o UC = reject on OML CA yet.
u Order control codes (74) Otherwise:
o if sample ID matches, adds
new tests, and ignores
other tests.
o if sample ID does not
match, it rejects the new
order.
Note: if the LIS sends a new test
order for an existing sample, the
analyzer ignores it.
ORC-2 Placer Order Number C (M/X) String value X Ignored
(50) In transactions LAB-27 Empty in OUL^R22 message The LIS sends the Placer Order
LAB-28, LAB-29, it is a (OBR-2 is used for the placer Number in OBR-2.
number assigned to the order number).
WOS (Work Order Step) by Mandatory in ORL^O34
the LIS. message (since OBR is not
If set, must match the value used there)
of the required field OBR-2.
ORC-5 Order Status M Coded value (string) X Ignored
(2) HL7 table 0038 In OUL^R22 message:
Note: the analyzer does not o CM (completed)
support partial results. o IP (rerun in process,
completed result to be
sent later)
In ORL^O34 message:
o SC = accept
o CA = reject
4 Field definitions

ORC-8 Parent C (RE/X) String value X Ignored


When sending a reflex test Structure is similar to ORC-2.
result, this field contains the o Required if the analyzer
parent AWOS ID. sends a reflex text result in
If multiple parent AWOS IDs a OUL^R22 message
exist, the field is repeatable. (OBR-11 = G)
o If the reflex test was not
triggered by the LIS, this
field is empty.
o Not sent, otherwise
Example:
AWOS1234
y ORC - common order segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
74 ORC: Common Order segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

ORC-9 Creation Date/Time of X Not sent M Date value:


(24) Order u Date and time formatting (59)
o For new orders, date and
time when the order was Examples:
created on the LIS. yyyyMMddHHmmsszzzz
o For order cancellation, yyyyMMddHHmmss
date and type when the
cancellation was u LIS -> Analyzer date and time
requested on the LIS. formatting (60)
Example UTC:
20211001211007+0000
Example local time:
20211001231007
Example local time with time zone:
20211001231007+0200
y ORC - common order segment

Code Description
CA Cancel order or service
CR Canceled as requested
DC Discontinue request
NW New order
OK Notification or request accepted
SC Status change
UA Unable to accept order or service
UC Unable to cancel
y Order control codes

u Related topics
• Messages using the ORC segment
- OML^O33 WOS message (41)
- ORL^O34 acknowledgment message (43)
- OUL^R22 result message (46)
- OUL^R23 message (48)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OBR: Observation Request segment 75

OBR: Observation Request segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

OBR-2 Placer Order Number M String M String


(50) The LIS generates this ID, o The analyzer returns the o The value of the field must
which must uniquely identify value sent by the LIS. be unique across all
the order (unique AWOS ID) o For requests created on orders sent to the
the analyzer, the value is analyzer.
NULL (""). o If multiple orders have the
Example: same Order Placer
Order_1"" Number, the analyzer
treats them as the same
order.
OBR-4 Observation Identifier M Examples: M Examples:
(36) Unambiguously identifies a 1087060^CA^99ROC 1087060^CA^99ROC
test. 250^PT^99ROC 250^PT^99ROC
OBR-4.1 Identifier Equal to the ACN Test codes sent by LIS must
Test code (Application Code Number) match the ACN (Application
of the test performed by Code Number) of one of the
analyzer tests installed on the cobas t
511/711 analyzer.
OBR-4.2 Text
Test name
OBR-4.3 Name of coding system 99ROC = Roche (fixed value) 99ROC = Roche (fixed value)
OBR-11 Specimen Action Code C(M/X) String value (see length). X Ignored
(1) This field is used to identify Supported values:
reflex orders generated at o G: for reflex test orders
the analyzer. created by the analyzer
(HL7 table 0065) o Field is empty in all other
cases
y OBR - observation request segment

u Related topics
• Messages using the OBR segment:
- OML^O33 WOS message (41)
- OUL^R22 result message (46)
4 Field definitions

- OUL^R23 message (48)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
76 TQ1: Timing/Quantity segment

TQ1: Timing/Quantity segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

TQ1-9 Priority M Complex value R Complex value


(250) Only a subset of HL7 priority Example: Example:
codes is supported. See HL7 S^^HL70485 S^^HL70485
table 0485
TQ1-9.1 Identifier o S: STAT (high priority) o S: STAT (high priority)
Priority code o R: Routine (normal o R: Routine (normal
priority) priority)
Any other value is rejected. Any other value is rejected.
TQ1-9.2 [empty] [empty]
TQ1-9.3 Name of coding system HL70485 HL70485
y TQ1 - timing / quantity segment

u Related topics
• Messages using the TQ1 segment:
- OML^O33 WOS message (41)
- OUL^R22 result message (46)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OBX: Observation/Result segment 77

OBX: Observation/Result segment


In this section
OBX in OUL^R22 message (77)
OBX in OUL^R23 message (81)
List of data alarm codes (85)

OBX in OUL^R22 message


The OBX segment of OUL^R22 is only sent the analyzer
to the LIS.
Analyzer f LIS
Component

Description
(Length)

Usage
Field

OBX-1 Set ID M Numeric value from 1 to 9999.


(4) This counts each OBX 1 for the first OBX, 2 for the second, etc
segment within one OBR
segment.
OBX-2 Value Type C(M/X) Coded value
(3) When sending test results,
the LIS Interface generates If OBX-11 contains the value F, R, or P, this field is mandatory.
the values for the OUL^R22 Otherwise, the field is empty (X).
message. Supported values In OUL^R22 message:
(HL7 table 0125) o NA: Numeric array (only for raw data)
This field defines the format o NM: numeric result
of the result value in OBX-5. o ST: Alphanumeric result (for preliminary measurement
failed results)
y OBX - observation / result segment

4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
78 OBX: Observation/Result segment

Analyzer f LIS
Component

Description
(Length)

Usage
Field

OBX-3 Observation Identifier M Complex value


(36) This field uniquely identifies Example results:
a test. o 1087060^CA^99ROC
o 250^PT^99ROC
o 1097060^CA^99ROC^S_RAW^Raw
Supplemental^IHELAW
OBX-3.1 Identifier Test code is equal to the ACN (Application Code Number) of
Test code the test performed by the analyzer.
OBX-3.2 Text
Test name
OBX-3.3 Name of coding system Fixed value: 99ROC
Fixed value
OBX-3.4 Supplementary result Fixed value: S_RAW
code
Fixed value with raw data
results, otherwise empty
OBX-3.5 Supplementary result Fixed value: Raw Supplemental
name
Fixed value with raw data
results, otherwise empty
OBX-3.6 Alternate coding system Fixed value: IHELAW
Fixed value with raw data
results, otherwise empty
OBX-4 Observation Sub-ID M String
(20) Distinguishes multiple OBX The value sent by the analyzer depends on the test type and
segments with the same reporting configuration in the analyzer software.
Observation ID organized Note: if OBX-5 contains raw data, only the first component
under one OBR. (OBX-4.1) is sent.
Examples:
o 1^Calibrated_%^1
o 1^Calibrated_mg/dL^1
o 1^RawResult^1
o 1^FP_MeanAfterCorrection^1
o 1^Calculated result^1
OBX-4.1 Fixed value: 1
OBX-4.2 Observation Sub-ID Supported values for OUL^R22 message:
o Calibrated_UoM: calibrated results; the value depends
4 Field definitions

on the unit of measurement of the result value in OBX-5.


o RawResult: uncalibrated results
o INR:normalized ratio
o FP_MeanAfterCorrection: for factor parallelism test
orders, the individual aggregated dilution measurement
results (mean of single dilution measurements)
o FP_MeanOfMeans: for factor parallelism test orders, the
test result mean (the mean of all aggregated dilution
measurement results).
o Calculated result: for calculated results
OBX-4.3 Fixed value: 1
y OBX - observation / result segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OBX: Observation/Result segment 79

Analyzer f LIS
Component

Description
(Length)

Usage
Field

OBX-5 Observation Value C (M/X) Complex value


(var) Contains the actual Supported values for OUL^R22 message:
observation value (for o Quantitative results (float format)
example a test run result) Examples:
o If the result is a numeric o 100.00000
value ( OBX-2 = NM), o 22.569474
this field contains a o 0.0065871425
numeric value. o Preliminary measurement failed result (string format)
o If OBX-11 = X, this field o Fixed value: *******
is empty. o Raw data is sent in a numeric array (NA), according to the
o If the result is a definitions in the HL7 specifications (v.2.5.1, section
preliminary 2.A.1.45).
measurement failed By default, the option to send raw data is disabled.
result (OBX-2 = ST), Example: vector of 8 numbers
this fields contains a o |125^34^-22^-234^569^442^-212^6|
string value. Example: 3 x 3 arrays
o |1.2^-3.5^5.2~2.0^3.1^-6.2~3.5^7.8^-
1.3|
OBX-6 Units of Measurement C (M/X) Complex value
(50) (UOM) If OBX-2 contains the value NM, this field is mandatory.
Unit of measurement Otherwise, this field is not sent.
according to UCUM. Examples:
o %^^UCUM
o mg/dL^^UCUM
o s^^UCUM
OBX-6.1 Identifier Unit code according to UCUM
OBX-6.2 [empty]
OBX-6.3 Name of coding system Fixed value: UCUM
Fixed Value
OBX-8 Interpretation Flags M Complex (length applies to single flags, not to the entire field)
(var) o Multiple flags are Examples:
separated by repeat o Samp.S^^99ROC (1 flag)
delimiters. o 2Samp.S^^99ROC~>Rerun^^99ROC (2 flags)
o If no data alarm applies,
the value is set to NULL.
OBX-8.1 Data alarm u For supported values, see Supported data alarm codes (85)
OBX-8.2 [empty]
OBX-8.3 Supported values:
4 Field definitions

o 99ROC (for proprietary Roche flag codes)


OBX-11 Observation Result Status M String value
(1) The values mentioned are Supported values:
supported by the LIS o F: Final validated results: the result has been validated
Interface when sending a manually or automatically.
message. See HL7 table o R: Entered, not verified (the result has been sent manually
0123. or automatically). Only supported for sample results.
o P: Preliminary result. A first-run result, not validated. Not
supported for calibration results.
o X: Measurement failed: if OBX-11 = X, OBX-5 is left empty.
y OBX - observation / result segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
80 OBX: Observation/Result segment

Analyzer f LIS
Component

Description
(Length)

Usage
Field

OBX-16 Responsible Observer M String value.


(250) This field identifies the user Supported values.
that released/validated the o For manual release: user ID of user logged on when the
result. manual release performed.
o For automatic release: fixed value: system
o Not released: NULL ("").
OBX-18 Equipment Instance M This field is sent twice, separated by a repeat delimiter.
(250) Identifier Example:
t511^ROCHE~7800.0005.010^ROCHE
OBX-18.1 Entity identifier o First repetition:
Equipment instance (e.g. t511
analyzer, analyzer module, o Second repetition:
group of analyzers...) c302 module serial number
responsible for the
production of the
observation
OBX-18.2 Text Fixed value: ROCHE
Namespace ID, fixed value.
OBX-19 Date/Time of the Analysis M Date value:
(14) u Date and time formatting (59)
Examples: yyyyMMddHHmmsszzzz
yyyyMMddHHmmss

u Analyzer -> LIS date and time formatting (60)


Example UTC: 20211001211007+0000
Example local time: 20211001231007
Example local time with time zone: 20211001231007+0200
OBX-29 Observation Type M Fixed value: RLST (observation result)
(4) The field defines the
observation type of the
result
y OBX - observation / result segment
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OBX: Observation/Result segment 81

OBX in OUL^R23 message


The OBX segment of OUL^R23 is only sent the analyzer
to the LIS.

Analyzer f LIS
Component

Description
(Length)

Usage
Field

OBX-1 Set ID M Numeric value from 1 to 9999.


(4) This counts each OBX 1 for the first OBX, 2 for the second, etc
segment within one OBR
segment.
OBX-2 Value Type M Coded value
(3) When sending test results, Supported value in OUL^R23 message
the LIS Interface generates o NA: A list of numeric values
the values for the
OURL^R23 message.
(HL7 table 0125)
OBX-3 Observation Identifier M Complex value
(36) This field uniquely identifies Example results:
a test. o 1087060^CA^99ROC
o 250^PT^99ROC
o 1097060^CA^99ROC^S_RAW^Raw
Supplemental^IHELAW
OBX-3.1 Identifier Test code is equal to the ACN (Application Code Number) of
Test code the test performed by the analyzer.
OBX-3.2 Text
Test name
OBX-3.3 Name of coding system 99ROC
Fixed value
OBX-3.4 Supplementary result S_RAW
code
Fixed value with raw data
results, otherwise empty
OBX-3.5 Supplementary result Raw Supplemental
name
Fixed value with raw data
results, otherwise empty
OBX-3.6 Alternate coding system IHELAW
4 Field definitions
Fixed value with raw data
results, otherwise empty
y OBX - observation / result segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
82 OBX: Observation/Result segment

Analyzer f LIS
Component

Description
(Length)

Usage
Field

OBX-4 Observation Sub-ID M String


(20) Distinguishes multiple OBX The value sent by the analyzer depends on the test type and
segments with the same reporting configuration in the analyzer software.
Observation ID organized Supported values in OUL^R23 message:
under one OBR. o Curve: the OBX segment contains curve data (OBX-5) and
curve definitions (OBX-17).
o Signal: OBX-5 contains the absorbance.
o <Number>:up to 12 different raw data from the single
measurements that were performed for the calibration. The
raw data OBX segments are numbered starting from 1.
Examples:
o 1
o Curve
o Signal
OBX-5 Observation Value C (M/X) Complex value
(var) Contains the actual Supported values in OUL^R23 message:
observation value If OBX-5 contains curve data (OBX-4 = Curve), the values
o If OBX-11 = X, this field depend on the curve type (OBX-17)
is empty. o Curve type Linear (AbsS1^K)
o OBX-5.1: offset of linear curve
o OBX-5.2: slope of linear curve
o Curve type RCMx (P1^P2^P3^P4^P5)
o The components P1-P5 contain the numerical
parameters of the equation that defines the curve type.
o RCM defines 4 parameters.
o If RCM2 is defined as result type, 4 parameters are
provided for RCM2T1.
o If RCM2 is defined as result type, 3 parameters are
provided for RCM2T2.
o RCM4 (Rodbard) defines 5 parameters.
o RCM5 (Sigmoid) defines 4 parameters.
o Curve type Spline (P1^...^P24)
o A spline with up to 6 knots is defined.
o A group of 4 consecutive values represents the
parameters that define 1 polynomial piece of the spline.
o The number of values provided is a multiple of 4. The
number of parameters divided by 4 is the number of
knots of the spline.
o Curve type Line Graph
o A spline with up to 6 knots is defined.
4 Field definitions

o A group of 4 consecutive values represents the


parameters that define 1 polynomial piece of the spline.
o The number of values provided is a multiple of 4. The
number of parameters divided by 4 is the number of
knots of the spline.
o For each pair, the first value is the raw result, and the
second value is the target value.
y OBX - observation / result segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OBX: Observation/Result segment 83

Analyzer f LIS
Component

Description
(Length)

Usage
Field

If OBX-5 contains the absorbance (OBX-4 = Signal), the


following 4 components are used:
o OBX-5.1: mean of raw measurement value 1 and raw
measurement value 2
o OBX-5.2: raw measurement value 1
o OBX-5.3: raw measurement value 2
o OBX-5.4: target value
If OBX-5 contain raw data, the formatting is according to the
NA data type.
OBX-8 Interpretation Flags M Complex (length applies to single flags, not to the entire field).
(var) o Multiple flags are Examples:
separated by repeat o Samp.S^^99ROC (1 flag)
delimiters. o 2Samp.S^^99ROC~>Rerun^^99ROC (2 flags)
o If no data alarm applies,
the value is set to NULL
("") .
OBX-8.1 Data alarm u For supported values, see Supported data alarm codes (85)
OBX-8.2 [empty]
OBX-8.3 HL70078 for standard codes
99ROC for proprietary Roche flag codes
OBX-11 Observation Result Status M String value
(1) The values mentioned are Supported values:
supported by the LIS o F: Final validated results: the result has been validated
Interface when sending a manually or automatically.
message. See HL7 table o X: Measurement failed: if OBX-11 = X, OBX-5 is left empty.
0123.
OBX-17 Observation Method C (M/X) String value
(50) This field is mandatory for calibration results in an OUL^R23
message when sending curve data (OBX-4 = Curve).
Supported values for calibration method:
o Full
o 1Point-Diff
o 1Point-Slope
o 2-Point
Supported values for calibration type:
o Linear
o RCM
o RCM2
o RCM4
4 Field definitions

o RCM5
o Line Graph
o Spline
The values for calibration method and calibration type are
linked by the ampersand (&) character in a single component
Example:
Full&Linear
y OBX - observation / result segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
84 OBX: Observation/Result segment

Analyzer f LIS
Component

Description
(Length)

Usage
Field

OBX-18 Equipment Instance M This field is sent twice, separated by a repeat delimiter.
(250) Identifier Example:
t511^ROCHE~7800.0005.010^ROCHE
OBX-18.1 Entity identifier o First repetition:
Equipment instance (e.g. t511
analyzer, analyzer module, o Second repetition:
group of analyzers...) c302 module serial number
responsible for the
production of the
observation
OBX-18.2 Text Fixed value: ROCHE
Namespace ID, fixed value.
OBX-19 Date/Time of the Analysis M Date value:
(14) u Date and time formatting (59)
Examples: yyyyMMddHHmmsszzzz
yyyyMMddHHmmss

u Analyzer -> LIS date and time formatting (60)


Example UTC: 20211001211007+0000
Example local time: 20211001231007
Example local time with time zone: 20211001231007+0200
y OBX - observation / result segment
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
OBX: Observation/Result segment 85

List of data alarm codes


Data alarm codes
Alarm code Description
<Cal Value below calibrated range
<CtVal Clotting time is below lower limit.
<dAbs Delta absorbance is below lower limit.
<Ext The value exceeds the low extended technical
limits
<Rept Result is below lower repeat limit.
<Rerun Result is below lower rerun limit.
<Test This data alarm occurs in the following 2
situations:
o The value exceeds the low technical limits
o The value is outside of the calibration
domain
<Val Result is below lower limit of validation range.
>Abs Absorbance is above upper limit.
>Cal Value above calibrated range
>CtVal Clotting time is above upper limit.
>dAbs Delta absorbance is over higher limit.
>Ext The value exceeds the extended high technical
limits.
>I.H Hemolytic sample
>I.I Icteric sample
>I.L Lipemic sample
>Kin Kinetic unstable
Absorbance curve is unstable and therefore a
rerun test with decreased dilution was
triggered.
>Kin1 Kinetic unstable 1
Absorbance curve is unstable and therefore a
repeat test was triggered.
>Kin2 Kinetic unstable 2
Absorbance curve is unstable and therefore a
rerun test with increased dilution was
triggered.
>Kin3 Kinetic unstable 3
Absorbance curve is unstable.
4 Field definitions

>Lin Linearity abnormal


Rate of change in absorbance is out of range.
>React Reaction limit over
Absorbance values are out of range.
>Rept Result is above upper repeat limit.
>Rerun Result is above upper rerun limit.
>Test This data alarm occurs in the following 2
situations:
o The value exceeds the high technical limits
o The value is outside of the calibration
domain
>Val Result is above upper limit of validation range.
Cal.I Invalid calibration
y Supported data alarm codes

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
86 OBX: Observation/Result segment

Alarm code Description


Calc.? Calculation not possible.
CDC.O Cobas development channel order
Clot.E Unexpected clotting curve
Dup.E Duplicate error
ExM.T Extended measurement time
FP.E Insufficient data for factor parallelism analysis
FP.O Factor parallelism order
FPAM.E Additional measurement for factor parallelism
was aborted
HIL.E Invalid HIL
HTR HIL test required
HU Value with higher uncertainty
Inc.T Incubator temperature Incubator temperature
is out of range.
LLD.E Liquid level detection
No liquid was detected or a liquid level
detection error has occured.
Mono.E Non-monotonic calibration curve
negAbs Negative absorbance value detected.
na.HIL HIL results not available
Clot.? No-,early-, or slow clotting.
NoFP No factor parallelism
Prob.T Heated reagent probe temperature
Temperature of the heated reagent probe is out
of range.
QCErr QC error. The QC associated with this test
result is invalid.
QCFail Value outside QC range
S1A.E Unexpected value for standard 1
Samp.? Value is above calibration upper limit.
Samp.C Sample clot Clot was detected.
Samp.S Sample short?
Insufficient sample volume
Samp.U Tube pressure or underpressure was detected
in closed tube [Samp.U].
SD.E SD limit error
4 Field definitions

Sens.E Sensitivity error


Sys.E System errors
y Supported data alarm codes

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
TCD: Test Code Detail segment 87

TCD: Test Code Detail segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

TCD-1 Universal Service C (M/X) Complex format RE Complex format


(36) Identifier o This fields contains the o This field contains the
This field unambiguously same values as OBX-3. same values as OBR-4.
identifies a test. o This field is empty in o If this field is empty but
calibration result messages OBR-4 is populated, the
(OUL^R23) system raises no error.
Examples: Examples:
o 1087060^CA^99ROC o 1087060^CA^99ROC
o 250^PT^99ROC o 250^PT^99ROC
TCD-1.1 Test code Test code (similar to OBX-3.1) Test code (similar to OBR-4.1)
TCD-1.2 Test name Test name (similar to OBX-3.2) Test name (equal to OBR-4.2)
TCD-1.3 Test coding Test coding system (similar to Test coding system (Similar to
OBX-3.3) OBR-4.3)
o 99ROC = Roche o 99ROC = Roche
TCD-2 Auto-Dilution Factor C (M/X) Complex format RE For non-specific dilution
(36) Concentration change This field is empty in factors, the following
(dilution) to be applied by calibration result messages scenarios are supported:
the analyzer. (OUL^R23). o ^1^- f increased
For non-specific dilution sample concentration
factors, the following scenarios o ^1^+ f decreased
are supported: sample concentration
o ^1^- f increased sample o ^1^:^1 f normal
concentration sample concentration
o ^1^+ f decreased sample o Any other value f reject
concentration message
o ^1^:^1 f normal sample
concentration
TCD-2.1 [empty]
TCD-2.2 1
TCD-2.3 Possible values:
o +
o -
o :
TCD-2.4 Possible values
4 Field definitions

o 1
o [empty]
y TCD - test code detail segment

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
88 TCD: Test Code Detail segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

TCD-8 Analyte Repeat Status C (M/X) Complex value CE Complex value


(705) See HL7 table 0389. In calibration result messages Example:
(OUL^R23), this field is not D^^HL70389
supported.
Example:
D^^HL70389
TCD-8.1 Identifier Supported values: Supported values:
o O = Original (first run) o O = Original (first run)
o D = Rerun o Any other value is
o F = Reflex mapped to O.
o R = Repeat
TCD-8.2 Description [empty] [empty]
TCD-8.3 Name of coding system. Fixed value: HL70389 Fixed value: HL70389
Fixed value.
y TCD - test code detail segment

u Related topics
• Messages using the TCD segment:
- OML^O33 WOS message (41)
- OUL^R22 result message (46)
- OUL^R23 message (48)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
NTE: Notes and Comments segment (test result) 89

NTE: Notes and Comments segment (test


result)
This segment is only sent by the analyzer to the LIS.

Analyzer f LIS
Component

Description
(Length)

Usage
Field

NTE-1 Set ID M Numeric value from 1 to 9999


(4) Counts the NTE segments in Example:1459899
the message.
NTE-2 Source of comment M String value
(1) Fixed value: z (analyzer)
NTE-3 Comment M String value
(65536) Example:
Result value confirmed by user.
y NTE - notes and comments segment

u Related topics
• Messages using the NTE segment:
- OUL^R22 result message (46)
- OUL^R23 message (48)

4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
90 QPD: Query Definition segment

QPD: Query Definition segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

QPD-1 Message Query Name M Complex value M Complex value


(250) Fixed value WOS^Work Order Step^IHE
LAW
QPD-1.1 Identifier WOS WOS
Fixed value
QPD-1.2 Text Work Order Step Work Order Step
Fixed value
QPD-1.3 Name of coding system IHELAW IHELAW
Fixed value
QPD-2 Query Tag M String value M String value
A unique identifier for the query A unique identifier for the query
QPD-3 Container Identifier M String value M String value
(128) (i.e. Tube ID/Barcode) Examples: Examples:
Note: barcode contains SMP0001 SMP0001
Sample ID or Sample ID 123456789 123456789
and Specimen Type in any 20131122-00196 20131122-00196
order.
Note: the analyzer uses
the Specimen ID in SPM-2
to identify samples /
tubes.
QPD-4 Carrier Identifier M String value X Ignored
(705) Visual ID of the rack Examples:
where the tube is located. 0001
M002
QPD-5 Position in Carrier M Numeric value from 1 to 5 X Ignored
(8) Position of the tube in the Examples:
rack (1-5). 1
3
5
y QPD - query definition segment

u Related topics
4 Field definitions

• Messages using the QPD segment:


- QBP^Q11 query message (44)
- RSP^K11 acknowledgment message (45)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
RCP: Response Control Parameter segment 91

RCP: Response Control Parameter segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

RCP-1 Query Priority M String value X Ignored


(1) Constant Fixed value: I
RCP-3 Response Modality M String value X Ignored
(250) See HL7 table 0394 Fixed value in all components:
R^Real Time^HL70394
RCP-3.1 Identifier R
RCP-3.2 Text Real Time
RCP-3.3 Name of coding system HL70394
y RCP - response control parameter segment

u Related topics
• Message using the RCP segment:
- QBP^Q11 query message (44)

4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
92 QAK: Query Acknowledge segment

QAK: Query Acknowledge segment

LIS f Analyzer
Component

Description
(Length)

Usage
Field

QAK-1 Query Tag M Contains the query tag from QPD-2 of the query message.
(32)
QAK-2 Query Response Status M String value
(2) Status code defining Supported values:
whether a query has been o AE = Application Error
accepted or rejected by the o AR= reject
receiver. o OK = Accept
HL7 table 0208
QAK-3 Message Query Name M Complex value
Copy of QPD-1: WOS^Work Order Step^IHELAW
y QAK - query acknowledgment segment

u Related topics
• Message using the QAK segment:
- RSP^K11 acknowledgment message (45)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
MSA: Message Acknowledge Segment 93

MSA: Message Acknowledge Segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

MSA-1 Acknowledgment Code M String value M String value


(2) Code in acknowledgment Supported values: Supported values:
messages determining o AA = Accepted o AA = Accepted
whether a preceding o AE = Application Error o AE = Application Error
message has been accepted o AR = Rejected o AR = Rejected
or rejected.
MSA-2 Message Control Id M String value M String value
(50) Identifier of the original Example: Example:
message to which the to 897652584 25892e17-80f6-415f-
acknowledgment message 9c65-7395632f0223
refers.
y MSA - message acknowledgment segment

u Related topics
• Messages using the MSA segment:
- ORL^O34 acknowledgment message (43)
- ACK^R22 and ACK^R23 message (49)
- ACK^U02 and ACK^U14 message (52)
- ACK^U01 and ACK^U05 message (55)

4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
94 ERR: Error segment

ERR: Error segment


The ERR segment is used in a negative acknowledgment
(when MSA-1 = AR or AE). It adds error information to
acknowledgment messages.

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

ERR-2 Error location M String value RE String value


(18) Fixed value Fixed value: Any value expected.
LIS interface
ERR-3 HL7 Error code M Coded value from table W.3.1-3(1) M Coded value from table W.3.1-3
(704) Example: Example:
201^^HL70357 201^^HL70357
ERR-3.1 Identifier
ERR-3.2 Text [empty] [empty]
ERR-3.3 Name of coding Fixed value: HL70357 Fixed value: HL70357
ERR-4 Severity M Coded value M Coded value
(2) Fixed value Fixed value: E Fixed value: E
ERR-8 User Message RE String value RE String value
(250) Text of the error message Text of the error message
y ERR - message error segment
(1) For Table W.3.1-3, see "IHE Pathology and Laboratory Medicine Technical Framework Supplement"

u Related topics
• Messages using ERR
- ORL^O34 acknowledgment message (43)
- RSP^K11 acknowledgment message (45)
- ACK^R22 and ACK^R23 message (49)
- ACK^U02 and ACK^U14 message (52)
- ACK^U01 and ACK^U05 message (55)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
EQU: Equipment Identification segment 95

EQU: Equipment Identification segment

Analyzer f LIS

LIS f Analyzer
Component

Description
(Length)

Usage

Usage
Field

EQU-1 Equipment Instance M Complex value M Complex value


(250) Identifier This field is sent twice, separated This field is sent twice,
This field identifies the by a repeat delimiter. The second separated by a repeat
equipment instance (e.g. repetition is optional. delimiter. The second
analyzer, analyzer Example: repetition is optional.
module, group of t511^ROCHE~7800.0005.01 Example:
analyzers) for which the 0^ROCHE t511^ROCHE~7800.0005.
information is provided. 010^ROCHE
EQU-1.1 Entity identifier o First repetition o First repetition
t511: instrument code: t511: instrument code:
o Second repetition: o Second repetition:
instrument serial number instrument serial number
EQU-1.2 Namespace ID o First repetition o First repetition
ROCHE (fixed value) ROCHE (fixed value)
o Second repetition o Second repetition
ROCHE (fixed value) ROCHE (fixed value)
EQU-2 Event Date/Time M Date format: M Date format:
(24) Date/time when the event YYYYMMDDhhmmss YYYYMMDDhhmmss
occurred (e.g. state Example: Example:
transition, issuing of 20201116085849 20201116085849
command, finishing of
command execution).
EQU-3 Equipment State C(R/X) Required when MSH-9.2 X Ignored
(250) Instrument status contains the trigger event U01,
U03, or U05. Otherwise, the field
is empty.
EQU-3.1 State value u For supported values, see
Analyzer states (95)
EQU-3.2 [empty]
EQU-3.3 Coding Fixed value: HL70365
y EQU - equipment identification segment

Analyzer state EQU-3.1 (HL7 table 0365)


4 Field definitions

Instrument offline PU
Initializing IN
Standby ID
Processing/busy OP
Pausing PA
Paused PD
Maintenance MA
Diagnostic DI
Shutting down SD
y Analyzer states

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
96 EQU: Equipment Identification segment

Analyzer state EQU-3.1 (HL7 table 0365)


Error FL
Sampling stop PA
Warning PD
y Analyzer states

u Related topics
• Messages using ERR
- ESR^U02 message (50)
- INR^U14 message (51)
- ESU^U01 message (53)
- INU^U05 message (54)
4 Field definitions

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Example messages

5 Example messages ................................................................................................ 99

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
99
Table of contents

Example messages 5

In this chapter 5
Work order query (LAB-27). . . . . . . . . . . . . . . . . . . . . . 101
Work order download (LAB-28) . . . . . . . . . . . . . . . . . . 102
Patient sample result upload (Lab 29). . . . . . . . . . . . . 103
Calibration result upload . . . . . . . . . . . . . . . . . . . . . . . . 104
Equipment status request (ROC-01) . . . . . . . . . . . . . . 106
Equipment status update (ROC-02) . . . . . . . . . . . . . . . 107
Equipment inventory request (ROC-03) . . . . . . . . . . . 108
Equipment inventory update (ROC-04) . . . . . . . . . . . . 109

5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
100
Table of contents
5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Work order query (LAB-27) 101

Work order query (LAB-27)

Order query (QBP^Q11)

MSH|^~\&|t511_tx11_M|""|""|""|20211115133208+0100||QBP^Q11^QBP_Q11|e612ee39-fbcf-4c61-8038-
be9a75353048|P|2.5.1|||NE|AL||UNICODE UTF-8|||LAB-27^IHE
QPD|WOS^Work Order Step^IHELAW|e612ee39-fbcf-4c61-8038-be9a75353048|S1|0045|1
RCP|I||R^Real Time^HL70394
k Work order query (QBP^Q11)

Acknowledgment for order query (RSP^K11, LAB-27)

MSH|^~\&|host|""|t511|""|20211115133209+0100||RSP^K11^RSP_K11|db010394-1949-4857-bbc7-
0c74256ff26f|P|2.5.1||||||UNICODE UTF-8|||LAB-27^IHE
MSA|AA|e612ee39-fbcf-4c61-8038-be9a75353048
QAK|e612ee39-fbcf-4c61-8038-be9a75353048|OK|WOS^Work Order Step^IHELAW
QPD|WOS^Work Order Step^IHELAW|e612ee39-fbcf-4c61-8038-be9a75353048|S1|0045|1
k Acknowledgment of work order query (RSP^K11, LAB-27)

5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
102 Work order download (LAB-28)

Work order download (LAB-28)

Work order download (OML^O33)

Work Order Download message constructed as a


response to the Order Query Message (QBP^Q11)

MSH|^~\&|host|""|""|""|20211115133210+0100||OML^O33^OML_O33|8789754421||2.5.1|||NE|AL||UNICODE UTF-
8|||LAB-28^IHE
SPM|1|S1&ROCHE||PLAS^^HL70487|||||||P^^HL70369||||||20211115132742+0100
SAC|||S1
ORC|NW||||||||20211115132742+0100
TQ1|||||||||R^^HL70485
OBR||HOST_QUERY_010_AT||27030^ATx^99ROC
TCD|27030^ATx^99ROC|^1^:^1||||||O^^HL70389
k Work order download (OML^O33)

Acknowledgment for work order download (ORL^O34)

MSH|^~\&|t511_tx11_M|""|""|""|20211115133211+0100||ORL^O34^ORL_O42|5f87d173096f4d8e8e41|P|2.5.1|||||
|UNICODE UTF-8|||LAB-28^IHE
MSA|AA|8789754421
SPM|1|S1&ROCHE||PLAS^^HL70487|||||||P^^HL70369||||||20211115132742+0100
SAC|||S1|||||||0385|1
ORC|OK|HOST_QUERY_010_AT|||SC||||
k Acknowledgment of work order download (ORL^O34)

Negative query response (OML^O33)

Negative Query Response message constructed as a


response to the Order Query Message (QBP^Q11)

MSH|^~\&|host|""|t511|""|20211115134911+0100||OML^O33^OML_O33|51bf1bcd-a8bb-4486-a540-
d0333b7f91e2|P|2.5.1|||NE|AL||UNICODE UTF-8|||LAB-28^IHE
5 Example messages

SPM|1|S1&ROCHE||""|||||||U^^HL70369
SAC|||S1
ORC|DC||||||||20211115134910+0100
k Work order query (QBP^Q11)

Acknowledgment for negative query response (ORL^O34)

MSH|^~\&|t511_tx11_M|""|""|""|20211115133210+0100||ORL^O34^ORL_O42|5f87d173096f4d8e8e41|P|2.5.1|||||
|UNICODE UTF-8|||LAB-28^IHE
MSA|AA|51bf1bcd-a8bb-4486-a540-d0333b7f91e2
k Acknowledgment of negative query response (ORL^O34)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Patient sample result upload (Lab 29) 103

Patient sample result upload (Lab 29)

Patient sample result without raw data (OUL^R22)

MSH|^~\&|t511_tx11_M|""|""|""|20211115133734+0100||OUL^R22^OUL_R22|1e1874ec-27e6-4c86-b0ce-
35c0039434f7|P|2.5.1|||NE|AL||UNICODE UTF-8|||LAB-29^IHE
SPM|1|S1&ROCHE||PLAS^^HL70487|||||||P^^HL70369||||||20211115132742+0100
SAC|||S1|||||||0036|1||||
OBR||HOST_QUERY_011_AT||27030^ATx^99ROC|||||||
ORC|SC||||CM
TQ1|||||||||R^^HL70485
OBX|1|NM|27030^ATx^99ROC|1^Calibrated_%^1|109|%^^UCUM||""|||R|||||""||t511^ROCHE~tx11^ROCHE|20211115
133620+0100||||||||||RSLT
TCD|27030^ATx^99ROC|^1^:^1||||||O^^HL70389
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|1^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|1^^99ROC||||||||||||000008
NTE|1|Z|This is a comment
k OUL^R22

Acknowledgment for patient result (ACK^R22)

MSH|^~\&|host|""|t511|""|20211115133735+0100||ACK^R22^ACK|10040|P|2.5.1||||||UNICODE UTF-8|||LAB-
29^IHE
MSA|AA|1e1874ec-27e6-4c86-b0ce-35c0039434f7
k ACK^R22

5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
104 Calibration result upload

Calibration result upload

Calibration result (OUL^R23)

MSH|^~\&|t511_tx11_M|""|""|""|20211115120640+0100||OUL^R23^OUL_R23|a91a69fd-6c71-49f7-bd08-
03e8cf4ef1bd|P|2.5.1|||NE|AL||UNICODE UTF-8|||LAB-29C^ROCHE
SPM|1|1002&ROCHE||ORH^^HL70487|||||||C^^HL70369
OBX|1|NA|27030^ATx^99ROC|Curve|0.241^-
0.00097||||||F||||||Full&Linear|t511^ROCHE~tx11^ROCHE|20211115120100+0100
SAC|||1002|||||||C006|3
INV|1002^^99ROC|OK^^HL70383|RC^^HL70384|000001^^99ROC||||||||||||000001
OBR||""||27030^ATx^99ROC
ORC|SC||||CM
OBX|1|NA|27030^ATx^99ROC|Signal|0.107^0.108^0.107^140.3||||||F|||||||t511^ROCHE~tx11^ROCHE|202111151
20100+0100
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
OBX|2|NA|27030^ATx^99ROC^S_RAW^Raw
Supplemental^IHELAW|1|408^588^625^800^Params~0.1073211^0.0534057^0.0508373^0.0386964^156~0.1072802^0
.0529495^0.0501571^0.0381028||||||F|||||||t511^ROCHE~tx11^ROCHE|20211115120100+0100
OBX|3|NA|27030^ATx^99ROC^S_RAW^Raw
Supplemental^IHELAW|2|408^588^625^800^Params~0.1037641^0.053204^0.0502123^0.0349632^155~0.1039829^0.
0531263^0.0501913^0.0348156||||||F|||||||t511^ROCHE~tx11^ROCHE|20211115120100+0100
SPM|2|1001&ROCHE||ORH^^HL70487|||||||C^^HL70369
OBX|2|NA|27030^ATx^99ROC|Curve|0.241^-
0.00097||||||F||||||Full&Linear|t511^ROCHE~tx11^ROCHE|20211115120100+0100
SAC|||1001|||||||C006|1
INV|1001^^99ROC|OK^^HL70383|RC^^HL70384|000001^^99ROC||||||||||||000001
5 Example messages

OBR||""||27030^ATx^99ROC
ORC|SC||||CM
OBX|1|NA|27030^ATx^99ROC|Signal|0.146^0.145^0.146^93.5||||||F|||||||t511^ROCHE~tx11^ROCHE|2021111512
0100+0100
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Calibration result upload 105

OBX|2|NA|27030^ATx^99ROC^S_RAW^Raw
Supplemental^IHELAW|1|408^588^625^800^Params~0.0832029^0.0398992^0.0379524^0.0291265^154~0.0831914^0
.0394253^0.0374307^0.0287599||||||F|||||||t511^ROCHE~tx11^ROCHE|20211115120100+0100
OBX|3|NA|27030^ATx^99ROC^S_RAW^Raw
Supplemental^IHELAW|2|408^588^625^800^Params~0.0827662^0.0380534^0.0356998^0.0251287^153~0.0835209^0
.0381581^0.0357321^0.0250905||||||F|||||||t511^ROCHE~tx11^ROCHE|20211115120100+0100
SPM|3|1002&ROCHE||ORH^^HL70487|||||||C^^HL70369
OBX|3|NA|27030^ATx^99ROC|Curve|0.241^-
0.00097||||||F||||||Full&Linear|t511^ROCHE~tx11^ROCHE|20211115120100+0100
SAC|||1002|||||||C006|3
INV|1002^^99ROC|OK^^HL70383|RC^^HL70384|000001^^99ROC||||||||||||000001
OBR||""||27030^ATx^99ROC
ORC|SC||||CM
OBX|1|NA|27030^ATx^99ROC|Signal|0.233^0.231^0.234^10||||||F|||||||t511^ROCHE~tx11^ROCHE|202111151201
00+0100
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
INV|0795259^^99ROC|NA^^HL70383|MR^^HL70384|00001^^99ROC||||||||||||000008
OBX|2|NA|27030^ATx^99ROC^S_RAW^Raw
Supplemental^IHELAW|1|408^588^625^800^Params~0.0324056^0.0013593^0.0017632^0.003485^152~0.0330959^0.
0013506^0.0017242^0.0034012||||||F|||||||t511^ROCHE~tx11^ROCHE|20211115120100+0100
OBX|3|NA|27030^ATx^99ROC^S_RAW^Raw
Supplemental^IHELAW|2|408^588^625^800^Params~0.0312693^0.0016959^0.0019744^0.0032485^151~0.0319847^0
.0015956^0.0019703^0.0032766||||||F|||||||t511^ROCHE~tx11^ROCHE|20211115120100+0100
k OUL^R23

5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
106 Equipment status request (ROC-01)

Equipment status request (ROC-01)

Equipment status request (ESR^U02)

MSH|^~\&|host|""|""|""|20211115154303+0100||ESR^U02^ESR_U02|414|P|2.5.1|||NE|AL||UNICODE UTF-
8|||ROC-01^ROCHE
EQU|t511^Roche|20211115154253+0100
k ESR^U02

Acknowledgment of equipment status request (ACK^U02)

MSH|^~\&|t511_tx11_M|""|""|""|20211115154304+0100||ACK^U02^ACK|86896f63377a4f86a964|P|2.5.1||||||UNI
CODE UTF-8|||ROC-01^ROCHE
MSA|AA|414
k ACK^U02
5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Equipment status update (ROC-02) 107

Equipment status update (ROC-02)

Equipment status update (ESU^U01)

MSH|^~\&|t511_tx11_M|""|""|""|20211115154304+0100||ESU^U01^ESU_U01|35aec2fc-35f2-4972-a122-
5d6c23d2e6b0|P|2.5.1|||NE|AL||UNICODE UTF-8|||ROC-02^ROCHE
EQU|t511^ROCHE~tx11^ROCHE|20211115154304+0100|ID^^HL70365
k ESU^U01

Acknowledgment of equipment status update (ACK^U01)

MSH|^~\&|host||||20211115154304+0100||ACK^U01^ACK|10042|P|2.5.1||||||UNICODE UTF-8|||ROC-02^ROCHE
MSA|AA|35aec2fc-35f2-4972-a122-5d6c23d2e6b0
k ACK^U01

5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
108 Equipment inventory request (ROC-03)

Equipment inventory request (ROC-03)

Equipment inventory request (INR^U14)

MSH|^~\&|host|""|""|""|20211115154856+0100||INR^U14^INR_U14|416|P|2.5.1|||NE|AL||UNICODE UTF-
8|||ROC-03^ROCHE
EQU|t511^Roche|20211115154741+0100
k INR^U14

Acknowledgment of equipment inventory request (ACK^U14)

MSH|^~\&|t511_tx11_M|""|""|""|20211115154856+0100||ACK^U14^ACK|e98491de2ffd4e61a886|P|2.5.1||||||UNI
CODE UTF-8|||ROC-03^ROCHE
MSA|AA|416
k ACK^U14
5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Equipment inventory update (ROC-04) 109

Equipment inventory update (ROC-04)

Equipment inventory update (INU^U05)

MSH|^~\&|t511_tx11_M|""|""|""|20211115154856+0100||INU^U05^INU_U05|c175bba1-f309-400c-834e-
112f4070fbf2|P|2.5.1|||NE|AL||UNICODE UTF-8|||ROC-04^ROCHE
EQU|t511^ROCHE~tx11^ROCHE|20211115154856+0100|ID^^HL70365
INV|NONE|OK^^HL70383|||||||||||||27030^ATx^99ROC||||||TA^^HL70942|100^%&&UCUM
INV|NONE|OK^^HL70383|||||||||||||1^PTx^99ROC||||||TA^^HL70942|100^%&&UCUM
k INR^U05

Acknowledgment of equipment inventory update (ACK^U05)

MSH|^~\&|host||||20211115154857+0100||ACK^U05^ACK|10046|P|2.5.1||||||UNICODE UTF-8|||ROC-04^ROCHE
MSA|AA|c175bba1-f309-400c-834e-112f4070fbf2
k ACK^U05

5 Example messages

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
110
5 Example messages Equipment inventory update (ROC-04)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
LIS secure

6 Setup secure LIS communication .................................................................. 113

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
113
Table of contents

Setup secure LIS communication 6

In this chapter 6
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Technical specifications. . . . . . . . . . . . . . . . . . . . . . . . . 116
Communication use cases . . . . . . . . . . . . . . . . . . . . . . 118
LIS communication disabled. . . . . . . . . . . . . . . . . . 119
Encryption disabled . . . . . . . . . . . . . . . . . . . . . . . . . 120
Encryption enabled with analyzer as client. . . . . . 121

6 Setup secure LIS communication


Encryption enabled with analyzer as server . . . . . 123
Certificate validation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Certificate validation on analyzer side . . . . . . . . . . 125
Certificate validation on LIS Host side . . . . . . . . . . 127
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
114
Table of contents
6 Setup secure LIS communication

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Disclaimer 115

Disclaimer
All LIS Host configuration steps listed in this document
should be considered as suggestions.

The laboratory administrator should be aware of,


understand, and accept any configuration change done
on the LIS Host side. The laboratory administrator also
accepts the impact it might have on security level and on
laboratory performance before any step is performed.

6 Setup secure LIS communication

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
116 Technical specifications

Technical specifications
The cobas t 511 coagulation analyzer supports
encryption of the communication with the laboratory
information systems (LIS).

Transport Layer Security protocol is supported for secure


communication purposes.

Supported versions are:


• TLS 1.3
• TLS 1.2

Other secure communication protocols, such as lower


TLS versions, or SSL, are actively refused.

The cobas t 511 coagulation analyzer application


supports the following Cipher suites:
• TLS_AES_256_GCM_SHA384 (TLS 1.3)
• TLS_AES_128_GCM_SHA256 (TLS 1.3)
• TLS_AES_128_CCM_SHA256 (TLS 1.3)
• TLS_ECDHE_ECDSA_WITH_AES_256_GCM_SHA384
(TLS 1.2)
• TLS_ECDHE_ECDSA_WITH_AES_256_CCM (TLS 1.2)
• TLS_ECDHE_ECDSA_WITH_AES_128_GCM_SHA256
(TLS 1.2)
6 Setup secure LIS communication

• TLS_ECDHE_ECDSA_WITH_AES_128_CCM (TLS 1.2)


• TLS_ECDHE_RSA_WITH_AES_256_GCM_SHA384
(TLS 1.2)
• TLS_ECDHE_RSA_WITH_AES_128_GCM_SHA256
(TLS 1.2)
• TLS_DHE_RSA_WITH_AES_256_GCM_SHA384
(TLS 1.2)
• TLS_DHE_RSA_WITH_AES_256_CCM (TLS 1.2)
• TLS_DHE_RSA_WITH_AES_128_GCM_SHA256
(TLS 1.2)
• TLS_DHE_RSA_WITH_AES_128_CCM (TLS 1.2)

q Not listed Cipher suites are not supported.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Technical specifications 117

If you perform the certificate validation on the analyzer


side, the analyzer application may raise any of the
X509ChainStatusFlags (1) as part of the Server-Client
handshake, excluding:
• RevocationStatusUnknown (ignored)
• OfflineRevocation (ignored)
• UntrustedRoot (enabled by default, ignored only when
analyzer LIS settings have “AllowUntrustedRoot”
setting enabled).

6 Setup secure LIS communication

(1) https://docs.microsoft.com/en-
us/dotnet/api/system.security.cryptography.x509certificates.x509c
hainstatusflags?view=net-6.0

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
118 Communication use cases

Communication use cases


In the TLS protocol, Server and Client perform a
handshake before establishing a secure communication.
As part of the handshake, the Server presents a certificate
to the Client. Optionally, the Server may also request a
certificate from the Client.

2QHZD\DXWKHQWLFDWLRQ 7ZRZD\DXWKHQWLFDWLRQ

6HUYHU &OLHQW 6HUYHU &OLHQW

q One-way authentication: The Server presents a


certificate to the Client.
Two-way authentication: The Server and the Client
exchanging their certificates as per request of the Server.
6 Setup secure LIS communication

The handshake is completed after both Server and Client


applications have successfully completed their
corresponding security checks.

This check regards the following points:


• Protocol usage
• Cipher suite negotiation (at least one cipher suite in
common in both sides, which they agreed to use
during the negotiation)
• Certificate validation

After the successful handshake, the secure connection is


established. From then on, exchanged messages are
secured with the configuration negotiated between both
sides.

The cobas t 511 coagulation analyzer configuration is


relevant for the communication with the LIS. The cobas t
511 coagulation analyzer configuration can be found on
the analyzer application user interface in the
Administration > Settings > LIS Settings panel.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Communication use cases 119

On the analyzer application, in the LIS Setting panel, the


Connect to LIS option is set to No by default.
u Encryption enabled with analyzer as client (121)

q The default configuration on the cobas t 511


coagulation analyzer is as follow:
o Network type: Client
o Enable encryption: Yes (enabled)
o Allow untrusted root: No (disabled)
This default configuration provides the highest level of
communication security achievable by the analyzer.
To achieve an even higher security level, refer to the
corresponding LIS Host configuration to enable Two-
way authentication on the Server side. This way, the LIS
Host validates the analyzer (Client) certificate.

LIS communication disabled


This setting is the default configuration of the cobas t
511 coagulation analyzer. If the installed analyzer is not
expected to communicate with the LIS, make sure that
the connection to the LIS is disabled on the analyzer
side.

6 Setup secure LIS communication


q No communication can be established with the
cobas t 511 coagulation analyzer when LIS
&RPPXQLFDWLRQGLVDEOHG communication is disabled. This configuration reduces
the possibilities for a malicious attack.

How to achieve this configuration:


6HUYHU &OLHQW
• cobas t 511 coagulation analyzer application
configuration:
- Administration > Settings > LIS Settings
> Connect to LIS: No (disabled)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
120 Communication use cases

Encryption disabled
The communication is enabled. The cobas t 511
coagulation analyzer is not expecting any level of security
to be applied to the communication channel with the LIS
Host.

No TLS handshake is performed when establishing the


connection, and HL7 messages are exchanged as
plain-text through the communication channel.

q A non-secured communication is established


between Server and Client.
,QVHFXUHFRPPXQLFDWLRQ The data is exchanged as plain-text.

How to achieve this configuration:

6HUYHU &OLHQW • cobas t 511 coagulation analyzer application


Administration > Settings > LIS Settings panel:
- Network type: Client or Server
- Connect to LIS: Yes (enabled)
- Enable encryption: No (disabled)
• LIS Host configuration:
- Network: Server or Client (opposite of analyzer)
- Make sure encryption is also disabled.

q The certificate validation is disabled on both sides in


6 Setup secure LIS communication

this communication case.

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Communication use cases 121

Encryption enabled with analyzer as client


The cobas t 511 coagulation analyzer acts as Client. The
analyzer initiates a secure connection request to the LIS
Host, which acts as Server.

One-way authentication
• The LIS Host (Server) presents its certificate to the
analyzer (Client).

Two-way authentication
• Both sides exchange their certificates.

2QHZD\DXWKHQWLFDWLRQ 7ZRZD\DXWKHQWLFDWLRQ

/,6+RVW $QDO\]HU /,6+RVW $QDO\]HU


6HUYHU &OLHQW 6HUYHU &OLHQW

q The Server configuration (LIS Host in this connection

6 Setup secure LIS communication


case) determines whether the One-way authentication
or Two-way authentication method is used.

If the cobas t 511 coagulation analyzer works as a Client,


the analyzer has a Client certificate available at all time.

How to achieve this configuration:


• cobas t 511 coagulation analyzer application
Administration > Settings > LIS Settings panel:
- Network type: Client
- Connect to LIS: Yes (enabled)
- Enable encryption: Yes (enabled)
• LIS Host configuration:
- Network: Server
- Verify that encryption is also enabled on the LIS
Host side.
- Verify that the LIS Host supports TLS 1.3 or TLS 1.2.
- Verify that the LIS Host supports any of the cipher
suites supported by the cobas t 511 coagulation
analyzer.
u Technical specifications (116)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
122 Communication use cases

Certificate validation:
• The cobas t 511 coagulation analyzer (Client) always
validates the received LIS Host (Server) certificate,
independently whether the LIS Host is configured for
One-way authentication or Two-way
authentication.
u Certificate validation on analyzer side (125)
• If the LIS Host (Server) is configured as Two-way
authentication, the LIS Host (Server) requests and
validates the certificate from the cobas t 511
coagulation analyzer (Client).
u Certificate validation on LIS Host side (127)
6 Setup secure LIS communication

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Communication use cases 123

Encryption enabled with analyzer as server


The cobas t 511 coagulation analyzer acts as Server. The
analyzer opens a secure communication socket. The
analyzer starts listening for connection requests, sent
from the LIS Host which acts as Client.

The analyzer always presents its Server certificate to the


LIS Host (Client) during the handshake.

q In the cobas t 511 coagulation analyzer application,


Authentication type option is configured at/under
Administration > Settings > LIS Settings panel, when
the analyzer is configured as Server. When set to Two-
way authentication, the analyzer (Server) sends a
request for a Client certificate to the LIS Host (Client).

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$QDO\]HU /,6+RVW $QDO\]HU /,6+RVW


6HUYHU &OLHQW 6HUYHU &OLHQW

6 Setup secure LIS communication


q In these configuration cases, the analyzer (Server)
determines whether the One-way authentication or the
Two-way authentication method is used.

How to achieve this configuration:


• cobas t 511 coagulation analyzer application
Administration > Settings > LIS Settings panel:
- Network type: Server
- Connect to LIS: Yes (enabled)
- Enable encryption: Yes (enabled)
• LIS Host configuration:
- Network: Client
- Verify that encryption is also enabled on the LIS
Host side.
- Verify that the LIS Host supports TLS 1.3 or TLS 1.2.
- Verify that the LIS Host supports any of the cipher
suites supported by the cobas t 511 coagulation
analyzer
u Technical specifications (116)
Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
124 Communication use cases

Certificate validation:
• The LIS Host (Client) application validates the
received Server certificate. This validation is
independent of the cobas t 511 coagulation analyzer
configuration for One-way authentication or Two-
way authentication.
u Certificate validation on LIS Host side (127)

• If the analyzer (Server) is configured as Two-way


authentication, a Client certificate request is sent to
the LIS host (Client). The analyzer (Server) validates
the provided Client certificate from the LIS Host
(Client).
u Certificate validation on analyzer side (125)
6 Setup secure LIS communication

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Certificate validation 125

Certificate validation
If the encryption option is enabled, the certificate
validation is performed on one or both sides of the
connection. The certificate validation depends on the
configuration of each side.

Certificate validation on analyzer side


If encryption is enabled on the cobas t 511 coagulation
analyzer, and the analyzer is configured as:
• Client or,
• Server in Two-way authentication

then the analyzer requests the LIS Host to present a


certificate during the handshake, and validates it.

The cobas t 511 coagulation analyzer application may


raise an UntrustedRoot X509 error flag (1) and rejects the
connection.

Since the analyzer is not recognizing the LIS Host


certificate, the laboratory administrator should choose
one of the following options:

6 Setup secure LIS communication


• Obtain and import a valid signed certificate for the LIS
Host.
• Disable the UntrustedRoot validation on the analyzer
side and continue using an unsigned certificate (or
signed by unknown certification authority).
Signed certificate (recommended)
- The Roche Service Representative can request a
Roche-signed certificate for the customer LIS Host
(for the appropriate LIS Host usage: Server or
Client) and imports it on the LIS Host application.
- If the LIS Host presents a Roche-signed certificate,
the analyzer does not raise the UntrustedRoot flag
and connection is accepted.
Unsigned certificate (not recommended)
- In the analyzer application Administration
> Settings > LIS Settings panel, set the Allow
untrusted root option to Yes (enabled). The
analyzer ignores now this flag during certificate
validation.

(1) https://docs.microsoft.com/en-
us/dotnet/api/system.security.cryptography.x509certificates.x509c
hainstatusflags?view=net-6.0

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
126 Certificate validation

q The unsigned certificate option is not recommended.


This option should only be enabled to ignore the error
flag as a last resort since it opens the possibility to man-
in-the-middle attacks.

If the analyzer is configured as Client, a


CtlNotValidForUsage X509 error flag (1) may raise and
reject the connection. Make sure that the analyzer LIS
Settings field Certificate name has the same value as
the Common Name (CN) of the LIS Host’s server
certificate.
6 Setup secure LIS communication

(1) https://docs.microsoft.com/en-
us/dotnet/api/system.security.cryptography.x509certificates.x509c
hainstatusflags?view=net-6.0

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Certificate validation 127

Certificate validation on LIS Host side


If encryption is enabled on the LIS Host side, and the LIS
Host is configured as:
• Client or,
• Server in Two-way authentication

then the LIS Hosts requests the cobas t 511 coagulation


analyzer to present a certificate during the handshake,
and validates it.

The cobas t 511 coagulation analyzer (Client/Server)


certificate is self-signed. This self-signature means, it is
not signed from a certification authority recognized by the
LIS Host. As such, the LIS Host may raise an
UntrustedRoot X509 error flag (1) and rejects the
connection.
• Since the LIS Host is not recognizing the analyzer
certificate, the laboratory administrator should choose
one of the following options:
Import the public key of the analyzer certificate
in the LIS Host application (recommended)
- In order to do so, on the analyzer application
Administration > Settings > LIS Settings
panel, configure a public key target and choose on
the Export public key button.

6 Setup secure LIS communication


- With the exported public key (stored on a
removable storage device), follow the manual of
the LIS Host application in order to import the
public certificate onto the LIS Host certificate
storage.
Disable the signed certificate validation (not
recommended):
- If the LIS Host application supports this case, it
might be possible to ignore the UntrustedRoot
error flag on LIS Host side.

! WARNING
Data security
Disabling this check can have an impact on security
when connecting, not only to the cobas t 511
coagulation analyzer, but any other equipment as well.
r Always secure the communication between the LIS
Host and the analyzer.

(1) https://docs.microsoft.com/en-
us/dotnet/api/system.security.cryptography.x509certificates.x509c
hainstatusflags?view=net-6.0

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
128 Certificate validation

q The latest option is not recommended.


This flag should only be ignored as a last resort. And only
if it does not affect the connection from the LIS Host to
other applications/analyzers.
The laboratory administrator may consider TLS with a
self-signed certificate is better than no security at all.

Other X509 error flags (1) may raise during the LIS Host
certificate validation.
6 Setup secure LIS communication

(1) https://docs.microsoft.com/en-
us/dotnet/api/system.security.cryptography.x509certificates.x509c
hainstatusflags?view=net-6.0

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Troubleshooting 129

Troubleshooting
If the connection rejection reason is unknown, the
following steps can help to trace the issue.

r To troubleshoot connection rejection

1 Verify that the IP address and port on analyzer and LIS


Host application are correct.
• Verify and correct cobas t 511 coagulation
analyzer Control Unit IP address (from Windows
Control Panel).
Verify as well that this IP address is not assigned to
other Roche devices under the same fortigate,
causing an IP conflict.
• Verify and correct analyzer configurations:
Connection to LIS
IP address
Port number
Network type
• Verify and correct LIS Host configuration
• Verify network topology
The cobas t 511 coagulation analyzer, FortiGate
and LIS Host ethernet cables are properly
connected.
I If the cobas® link is properly connected to the

6 Setup secure LIS communication


Fortigate and the Control Unit, the cobas® link
system icon on the user interface should appear as
connected.

2 Verify LIS Host is compatible with TLS 1.3 or TLS 1.2


(in documentation or by inspection).
• If not, LIS Host application is not compatible with
cobas t 511 coagulation analyzer secure LIS
communication.
The laboratory administrator can choose to revert
the configuration to a non secure communication
(with the associated impact on
communication security).

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
130 Troubleshooting

3 Verify LIS Host supported ciphersuites list has any


entry in common with the cobas t 511 coagulation
analyzer supported ciphersuites list (in documentation
or by inspection).
• If not, we suggest expanding the LIS Host
ciphersuite list with at least one compatible
ciphersuite which is considered secure by the
laboratory administrator.
• Otherwise, LIS Host system is not compatible
with cobas t 511 coagulation analyzer secure LIS
communication.
The laboratory administrator can choose to revert
the configuration to a non secure communication
(with the associated impact on
communication security).

4 At this stage, if connection is not established, it is


probably caused by certificate validation.
Taking into account which side of the connection is
performing certificate validation and which is not:
• Verify which side is rejecting the connection.
• If the analyzer is rejecting the connection, or it is
not clear which side is rejecting the connection,
refer to the certificate validation on the analyzer
side section.
• If the LIS Host is rejecting the connection, refer to
the certificate validation on the LIS Host side
section.
6 Setup secure LIS communication

q Verify which side is rejecting the connection.


u Certificate validation (125)

5 Certificate validation on LIS Host side.


• On the analyzer application Administration
> Settings > LIS Settings panel, choose the
Recertify button and retry the connection.
• If connection is not established, LIS Host might be
rejecting the analyzer certificate because it is self-
signed.

q Refer to section for instructions on how to deploy


the public key of the analyzer certificate onto the LIS
Host.
u Certificate validation on LIS Host side (127)

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
References 131

6 WARNING! Encryption disabled:


When connection is established, any result pending to
be uploaded will be sent over an unencrypted
communication channel.
6 As a last resort, temporarily disable encryption on both
sides and verify if connection is established (always
remember to enable encryption again).
If connection is not established verify the following
parts again.
• IP address
• Port number
• Physical connection on both sides
I Remember to enable encryption again after this
step.

u Related topics
• Certificate validation (125)
• Certificate validation on analyzer side (125)
• Certificate validation on LIS Host side (127)

References
[1]

6 Setup secure LIS communication


u https://docs.microsoft.com/en-
us/dotnet/api/system.security.cryptography.x509certifi
cates.x509c hainstatusflags?view=net-6.0

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
132
6 Setup secure LIS communication References

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Part index

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Index 135

Index

A D

Abbreviations, 14 Data alarms, 85


Abnormal flags (interpretation flags), 79, 83 Date and time of analysis, 80, 84
Accept acknowledgment, 64 Date and time of message, 63
Acknowledgment Date and time of specimen collection, 67
– accept acknowledgment, 64 DC, 73
– acknowledgment code, 93 Delimiters, 63
– application acknowledgment, 64 Dilution
Acknowledgment mode, 33 – auto-dilution factor, 87
Action code, 75
Analysis, date / time, 80, 84
Analyte repeat status, 88
E
Analyzer ID, 80, 84
Empty results, 46
Analyzer states, 95
End block, HL7, 29
Auto-dilution factor, 87
Equipment instance identifier, 80, 84
Equipment state, 95
B Equipment state indicator type code, 71
Equipment state indicator value, 72
Barcode Error code, 94
– container identifer in QPD query, 90 Error message, 94
– rack or carrier identifier, 68 Escape delimiter, 63
– tube or container identifier, 68
F
C
Feedback, 4
CA, 73 Frames in HL7, 29
Cardinality, 40 Framing, 29
Carrier FS, HL7 framing, 29
– position of tube in carrier, 68
– See also Carrier identifier
Carrier identifier, 90
H
– SAC, 68
HL7
Character set, 64
– limitations, 27
Code
HL7 standards, 27
– error, 94
HL7 table 0038, 73
Component delimiter, 63
HL7 table 0078, 79, 83
Container identifier
HL7 table 0125, 77, 81
– in QPD query, 90
HL7 table 0208, 92
– SAC, 68
HL7 table 0369, 67
Control code, 73
HL7 table 0383, 69
Control ID
HL7 table 0384, 70
– MSA-2, 93
HL7 table 0389, 88
– MSH-10, 64
HL7 table 0394, 91
Conventions used in this publication
HL7 table 0485, 76
– abbreviations, 14
HL7 table 0487, 66
– product names, 13
HL7 version, 28, 64
Index

– symbols, 13
Host Query, 33
Copyright, 4
CR
– HL7 framing, 29 I
– ORC-1, 73
IHE LAW deviations, 33
Instrument approvals, 5

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
136 Index

Instrument ID, 80, 84 – status, 73


Instrument status, 95 – see also Order number
Intended use, 13 Order number
Interpretation flags, 79, 83 – OBR-2, 75
Inventory container identifier, 70 – ORC-2, for OUL^R34, 73
OSI model, 27
L
P
LAB-27, 34
LAB-28, 34 Position in carrier, 90
LAB-29, 34 Position of tube in rack (carrier)
LIS secure – SAC, 68
– certificate validation, 125 Priority, 76
– certificate validation on analyzer side, 125 Processing mode, 64
– certificate validation on LIS Host side, 127 Product names, 13
– communication use cases, 118
– encryption disabled, 120
– encryption enabled with analyzer as client, 121
Q
– encryption enabled with analyzer as server, 123
Qualitative result, 79
– LIS communication disabled, 119
Quantitative result, 79, 82
– references, 131
Query response status, 92
– technical specifications, 116
Query tag, 90
– troubleshooting, 129
Location
– error code, 94 R
Lot number, 71
Rack
– position of tube in rack, SAC, 68
M Rack ID, 90
– SAC, 68
Measurement units, 79
Receiving application, 63
Message
Receiving facility, 63
– date and time, 63
Reflet test result, 47
– error, 94
Reflex
– message control ID, MSA-2, 93
– repeat, rerun, reflex code, 88
– message control ID, MSH-10, 64
Repeat
– message profile identifier, 65
– repeat, rerun, reflex code, 88
– type, 64
Repeat delimiter, 63
Minimal Layer Protocol (MLP), 29
Rerun
Minimal Lower Layer Protocol (MLLP), 29
– repeat, rerun, reflex code, 88
Mode (processing mode), 64
Reruns, 46
Response modality, 91
N Result
– abnormal flags, 79, 83
Negative query response, 44 – interpretation flags, 79, 83
NW, 73 – qualitative result, 79
– quantitative result, 79, 82
– status, 79, 83
O – test result, 79, 82
– value type, 77, 81
Observation identifier, 75, 78, 81
ROC, 34
Observation method, 83
Index

ROC-01, 35
Observation value, 79, 82
ROC-02, 35
OK, 73
ROC-03, 35
Order
ROC-04, 35
– accept status, 73
Routine order code, 76
– codes for cancel, replace, create, 73
– creation date / time, 74
– reject status, 73

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
Index 137

S Usage, 39
User, release result, 80
Safety information
– classifications, 7
SC, 73
V
Screenshot disclaimer, 3
Version of HL7, 64
Security
VT, HL7 framing, 29
– confidentiality, 9
Sending application, 63
Sending facility, 63 W
Serial number, inventory container identifier, 70
Severity Warranty, 4
– error, 94
Specimen
– collection date / time, 67
– role, 67
– specimen ID, 66
– specimen type code, 66
Start block, HL7, 29
STAT order code, 76
Status
– order status, 73
– result status, 79, 83
– substance status, 69
Subcomponent delimiter, 63
Substance
– identifier, 69
– status, 69
– type, 70
Symbols
– safety, 7
Symbols used in this publication, 13

Test
– date / time of test, 80, 84
– repeat, rerun, reflex code, 88
– test ID (observation identifier - OBX-3), 78, 81
– test ID (observation identifier) in OBR-4, 75
– test ID in TCD, 87
– test result, 79, 82
Test identifier, 71
Trademarks, 4
Tube
– position in rack, SAC, 68
– tube ID,SAC, 68
Tube position, 90
Type of message, 64

U
Index

UA, 73
UC, 73
UCUM, 79
Units of measurement, 79
Universal service identifier, 87
Unvalidated results, 46

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0
138
Index Index

Roche Diagnostics
cobas t 511 coagulation analyzer · 2.2 · Host interface manual · 5.0

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