Reference Manual

LIS Implementation Guide and Interface Specification

for Kaluza Analysis and Kaluza C Software

C17197AB
July 2018

Beckman Coulter, Inc.

250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.
LIS Implementation Guide and Interface Specification
for Kaluza Analysis and Kaluza C Software
PN C17197AB (July 2018)

© 2018 Beckman Coulter, Inc.

All rights reserved.
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Original Instructions
 Revision History
Initial Issue, 12/17
Kaluza Analysis Software, version 2.0
Kaluza C Software, version 1.0

Issue AB, 07/18

Kaluza Analysis Software, version 2.0
Kaluza C Software, version 1.0
Changes or additions were made in the following: added Safety Notice; LIS Implementation Guide for
Kaluza Analysis and Kaluza C*(footnote); CHAPTER 1, Exporting Data to the LIS- Figure 1.5; NOTE;
added CHAPTER 2, LIS Interface Specification; added APPENDIX A, Messages.

Note: Changes that are part of the most recent revision are indicated in text by a bar in the left margin of
the amended page.

This document applies to the latest software listed and higher versions. When a subsequent software
version affects the information in this document, a new issue will be released to the Beckman Coulter
website. For labeling updates, go to www.beckman.com and download the latest version of the manual or
system help for your instrument.

C17197AB iii
 Revision History

iv C17197AB
 Safety Notice
Read all product manuals and consult with Beckman Coulter-trained personnel before attempting
to use this product. Do not attempt to perform any procedure before carefully reading all
instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as
to how to proceed in any situation, contact Beckman Coulter.

Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards
such as the use of barrier protection. This may include, but is not limited to, protective eyewear,
gloves, and suitable laboratory attire when operating or maintaining this or any other automated
laboratory analyzer.

Alerts for Warning, Caution, Important, and Note

WARNING
WARNING indicates a potentially hazardous situation which, if not avoided, could
result in death or serious injury.

CAUTION
CAUTION indicates a potentially hazardous situation, which, if not avoided, may
result in minor or moderate injury. It may also be used to alert against unsafe
practices.

IMPORTANT IMPORTANT is used for comments that add value to the step or procedure being performed.
Following the advice in the Important adds benefit to the performance of a piece of equipment or to a
process.

NOTE NOTE is used to call attention to notable information that should be followed during installation, use,
or servicing of this equipment.

C17197AB v
 Safety Notice
Product Alerts

Product Alerts

WARNING
This computer program is protected by international copyright and patent laws.
Unauthorized copying, use, distribution, transfer, or sale is a violation of those
laws that may result in civil or criminal penalties. This computer program may also
be subject to additional restrictions contained in a license granted by Beckman
Coulter, Inc. to the authorized user of this computer program or to the authorized
owner or other authorized user of the system onto which this computer program
is installed. Any violation of the license provisions may result in additional civil
penalties, including an injunction and damages. Please refer to the computer
program or system agreement or to the computer program or system
documentation for the terms and conditions of that license.

CAUTION
If you purchased this product from anyone other than Beckman Coulter or an
authorized Beckman Coulter distributor, and it is not presently under a Beckman
Coulter service maintenance agreement, Beckman Coulter cannot guarantee that
the product is fitted with the most current mandatory engineering revisions or
that you will receive the most current information bulletins concerning the
product. If you purchased this product from a third party and would like further
information concerning this topic, contact us.

vi C17197AB
 Contents

Revision History, iii

Safety Notice, v
Alerts for Warning, Caution, Important, and Note, v
Product Alerts, vi

LIS Implementation Guide

for Kaluza Analysis and Kaluza C, 1-1
Connecting Kaluza Software to the LIS System, 1-1
ASTM TCP/IP Interface, 1-1
ASTM Serial Port Interface, 1-3
HL7 Interface, 1-4
Exporting Data to the LIS, 1-5
Using the View Log Feature, 1-12

LIS Interface Specification, 2-1

Purpose, 2-1
Overview, 2-1
References, 2-1
Definitions, Acronyms, and Abbreviations, 2-1
Communication Transport, 2-2
Supported Transports, 2-2
Serial Configuration Options, 2-2
TCP/IP Configuration Options, 2-2
Unidirectional Communication, 2-3
ASTM Protocol, 2-3
Overview, 2-3
Conventions, 2-3
Supported Character Encodings, 2-3
UTF-8 , 2-3
ASTM Record Format, 2-4
Delimiters, 2-4
Record Format Definitions, 2-4
Sequence Column (SEQ), 2-5
Cardinality (CARD), 2-5
Max Len Column (LEN), 2-5
Data Type Column (DT), 2-5

vii
 Contents

Send/Receive Column (SEND/RECV), 2-6

Sequence Number, 2-6
Common ASTM Record Definitions, 2-7
H – Header Record, 2-7
P – Patient Information Record, 2-8
O – Test Order Record, 2-9
R – Result Record, 2-10
C – Comment Record, 2-12
L – Message Terminator Record, 2-12
Transmission Phases, 2-12
Establishment Phase, 2-12
Transfer Phase, 2-13
Termination Phase (Release Link), 2-14
ASTM Application Layer Messages, 2-14
Message Format Definitions, 2-14
Result Message, 2-14
HL7 Protocol, 2-20
Overview, 2-20
Conventions, 2-20
Supported Character Encodings, 2-21
Data Format, 2-21
Message, 2-22
ORU^R01 Message, 2-22
ACK^R01, 2-23
Segment, 2-23
MSH , 2-23
PID, 2-24
OBR, 2-24
OBX, 2-25
MSA, 2-26
ERR, 2-27
Examples, 2-27
Upload Results, 2-27
Upload Images, 2-28

Messages, A-1
Troubleshooting, A-1

Beckman Coulter, Inc.

Customer End User License Agreement
Related Documents

viii
 Illustrations

Illustrations

1.1 ASTM TCP/IP Options, 1-2

1.2 ASTM Serial Port Options, 1-3
1.3 HL7 Options, 1-4
1.4 LIS Preview — Plots Section, 1-6
1.5 LIS Preview Window — Values Section, 1-7
1.6 Selected Statistics Window, 1-8
1.7 Selected Keywords Window, 1-9
1.8 LIS Preview Window in Kaluza Software — Before
Exporting, 1-10
1.9 Data in an Example LIS System, 1-11
1.10 Plots in an Example LIS System, 1-11
1.11 LIS Log Window, 1-12

ix
 Illustrations

x
 CHAPTER 1
LIS Implementation Guide
for Kaluza Analysis* and Kaluza C

Kaluza C and Kaluza Analysis provide an interface that enables the transmission of plots, statistics,
and keywords to a Laboratory Information System (LIS). This guide covers instructions for using the
Export to LIS feature, including the following topics:

• Connecting Kaluza Software to the LIS System

• Exporting Data to the LIS
• Using the View Log Feature

Connecting Kaluza Software to the LIS System

To export data to a LIS system, first you must connect Kaluza Software to the LIS system.
Configuring this connection is specific to the type of connection interface that is being used in your
laboratory. Options include:

• ASTM TCP/IP Interface

• ASTM Serial Port Interface
• HL7 Interface

ASTM TCP/IP Interface

To connect to LIS using an ASTM TCP/IP Connection:

1 Click (Application button) > Export > Export to LIS. The LIS Preview window opens.

* Kaluza Analysis and the plots and statistics produced by it are For Research Use Only. Not for use in diagnostic
procedures.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Connecting Kaluza Software to the LIS System

2 In the upper right corner, click Options. The LIS Option Window appears (Figure 1.2).

Figure 1.1 ASTM TCP/IP Options

3 For the LIS Connection type choose ASTM TCP/IP.

4 In the LIS Server Address field, enter the TCP/IP address of the LIS server.

5 In the LIS Server Port field, enter the TCP/IP port location for the LIS server.

6 Click Apply.

7 Click to close the window.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Connecting Kaluza Software to the LIS System 1

ASTM Serial Port Interface

NOTE When exporting images to a LIS, using a serial port connection may not be a suitable option, due to
the speed limitations related to this connection type.

To connect to LIS using an ASTM Serial Port:

1 Click (Application button) > Export > Export to LIS. The LIS Preview window opens.

2 In the upper right corner, click Options. The LIS Option Window appears (Figure 1.2).

Figure 1.2 ASTM Serial Port Options

3 For the LIS Connection type choose ASTM Serial Port.

4 In Com, select the communications port type from the drop-down.

5 In BaudRate, select the rate at which information is transferred in bits per second from the
drop-down.

6 For StopBits, select the number of bits to indicate the end of transmission for one byte.

7 In Parity, select the type of parity to apply to strings of binary code. Parity is a simple way of
detecting errors. If Parity is set to None, checking is not performed. If Parity is set to Odd or Even,
the number of mark bits is counted for the string, and, if necessary, a bit is added to ensure the
count is paired as specified.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Connecting Kaluza Software to the LIS System

8 In DataBits, choose the number of bits to represent one character of data.

9 Choose the Enable RTS (Request to Send) check box if you wish to reduce frame collisions
caused by the wireless node problem.

10 Choose the Use CRC check box if you use an error-detecting code that detects accidental
changes to raw data.

11 Click Apply.

12 Click to close the window.

HL7 Interface
To connect to LIS using an HL7 interface:

1 Click (Application button) > Export > Export to LIS. The LIS Preview window opens.

2 In the upper right corner, click Options. The LIS Option Window appears (Figure 1.3).

Figure 1.3 HL7 Options

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Exporting Data to the LIS 1

3 For the LIS Connection type, choose HL7.

4 In the Timeout field, enter the amount of time (in seconds) to allow for the system to attempt a
connection with the LIS.

5 In the LIS Server Address field, enter the address for the LIS server.

6 In the LIS Server Port field, enter the port location for HL7.

7 Click Apply.

8 Click to close the window.

Exporting Data to the LIS

To export Kaluza Software data to the LIS:

1 Click (Application button) > Export > Export to LIS. The LIS Preview window opens.

2 If necessary, deselect the From FCS Keyword check box, and manually enter the sample ID in the
Sample ID field.

NOTE By default, the From FCS Keyword check box is selected. This option automatically completes
the field based on the acquisition data Sample ID keyword, if the data is present in the raw data file.

3 If desired, enter a test ID in the Test ID field, and then click the Update button in the lower right
corner (Figure 1.5).

4 In Kaluza Software, locate a plot(s) you wish to include in the LIS export. (You may need to
temporarily move the LIS Preview window to find the plot).

NOTE All plots in the LIS Preview window must originate from the same Analysis. If you attempt to add
plots from a different Analysis, a new LIS Preview window opens for items related to any
subsequent Data Sets.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Exporting Data to the LIS

5 For each plot that you wish to export, click and drag it into the confines of the LIS Preview
window and release the mouse button.

6 In the Plots section of the LIS Preview window (Figure 1.4), if desired, enter channel information
for each plot in the Channel field. When completed, click the Update button in the lower right
corner of the LIS Preview screen (shown in Figure 1.5).

Figure 1.4 LIS Preview — Plots Section

1. Channel field
2. Delete: Click this icon to delete the plot from the LIS export.

NOTE The Description field is not editable; content is derived from the
Description for each parameter and the input gate from the source plot.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Exporting Data to the LIS 1

7 Next, you will complete the Values section of the LIS Preview window. Review Figure 1.5 to
understand the options that are available in this section. Instructions for completing editable
fields are provided in steps 8 to 10.

Figure 1.5 LIS Preview Window — Values Section

1. Add Statistic: Clicking this button opens the Select Statistics window, where you can configure and
select the statistics to include in the LIS export.
2. Channel: Entry field for LIS test code.
3. Add Keyword: Clicking this button opens the Select Keywords window, which allows you to choose
the desired keywords to include in the LIS export.
4. Description: This field is not editable; content is derived from the Description for each parameter and
the input gate from the source plot.
5. Value: This field is not editable; content shows the value of the selected keyword or statistic.
6. Type: Identifies the data type for the listed value.
7. Delete: To delete a specific row, click the Delete icon on that row.
8. Update: Click the Update button to apply changes made to the Test ID or Channel field.
9. Export to LIS: Clicking this button initiates the LIS export of all content in the LIS Preview window.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Exporting Data to the LIS

8 To include statistics with the LIS export:

a. Click the Add Statistic button. The Select Statistics window appears (Figure 1.6).
b. If desired, in the Gate drop-down, choose a gate for the statistics.
c. In Scale, choose the scale type for the statistics.
d. Choose the desired statistics for the selected Gate and Scale by clicking the desired check
boxes.
e. Click the Add to LIS button to include the selected statistics in the LIS export.
f. Repeat steps a. to e. for each desired Gate/Scale combination.
g. Click to close the window.

Figure 1.6 Selected Statistics Window

1. Gate: Allows you to choose a gate to which the selected statistics apply.
2. Scale: Allows you to choose a scale to which the selected statistics apply.
3. Statistics: Click the check box for each desired statistic for the currently selected Gate and Scale
type.
4. Uncheck All: Deselects all currently selected statistics.
5. Add to LIS: Adds the selected statistics to the LIS Preview window.

1-8 C17197AB
 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Exporting Data to the LIS 1

9 To include keywords with the LIS export:

a. Click the Add Keyword button. The Select Keywords window appears (Figure 1.7).
b. Choose the desired keywords to include in the LIS export by clicking the desired
check boxes.
OR
Click the Check All button to include all keywords for the Data Set.
c. Click the Add to LIS button.
d. Repeat steps a. to e. for each desired Gate/Scale combination.
e. Click to close the window.

Figure 1.7 Selected Keywords Window

1. Selection check boxes: Click the check box for each desired keyword to include in the LIS export.
2. Key Description: The name of the keyword.
3. Keyword Value: The value associated with the keyword.
4. Uncheck All: Deselects all selected keywords.
5. Check All: Selects all keywords.
6. Add to LIS: Adds the selected keyword to the LIS Preview window.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Exporting Data to the LIS

10 If desired, enter channel information for each statistic and keyword in the Channel field; when
completed, click the Update button in the lower right corner of the LIS Preview screen (shown
in Figure 1.5).

11 Click Export to LIS to upload all current contents in the LIS Preview window into the your LIS
system.Figure 1.8 shows an example of LIS Preview data in Kaluza Software prior to being
exported to a LIS system. Figure 1.9 and Figure 1.10 show the same data after it is exported to
an example LIS system.

12 Click to close the window

Figure 1.8 LIS Preview Window in Kaluza Software — Before Exporting

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Exporting Data to the LIS 1

Figure 1.9 Data in an Example LIS System

Figure 1.10 Plots in an Example LIS System

NOTE The selections made for plots, statistic values and key words to be transmitted can be transferred to
new data files as part of the protocol.

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Using the View Log Feature

Using the View Log Feature

The View Log feature allows you to view transmission details and errors related to exporting data
to a LIS.

To view records in the LIS Log Window:

1 Click (Application button) > Export > Export to LIS. The LIS Preview window opens.

2 Click the View Log button in the upper left corner of the LIS Preview window. The LIS Log
Window appears (Figure 1.11).

Figure 1.11 LIS Log Window

1. Information tab (shown): This tab provides the details of all attempted LIS export transmissions
(since it was last cleared).
2. Error tab: Shows any errors received during the LIS export transmission, as well as details
surrounding the error for the selected error.
3. Clear: Completely clears the contents of the LIS Log Window.

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Using the View Log Feature 1

3 Click the desired tab to view its contents.

4 If desired, click the Clear button to clear the contents included on both tabs.

5 Click to close the window

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 LIS Implementation Guide for Kaluza Analysis and Kaluza C
Using the View Log Feature

1-14 C17197AB
 CHAPTER 2
LIS Interface Specification

Purpose

This document establishes the basis for the design and implementation of an LIS interface by Kaluza
2.0 and Kaluza C (hereafter referred to as “Kaluza software”). This document is intended to be used
as a guide to diagnosing and troubleshooting LIS communication problems. This document
describes a generic interface that is implemented by Kaluza software.

Overview

The primary purpose of the LIS interface is to allow the Kaluza software to transmit results to an
LIS. Kaluza software does not support receiving sampling programming from LIS.

References

• Specification for Low-Level Protocol to Transfer Messages between Clinical Laboratory

Instruments and Computer Systems; Approved Standard - Second Edition. (CLSI LIS01-A2
Vol. 28 No. 13. This is a revision of the former ASTM Designation E 1381-02)
• Specification for Transferring Information between Clinical Laboratory Instruments and
Information Systems; Approved Standard - Second Edition. (CLSI LIS02-A2 Vol.24 No. 33. This is
a revision of the former ASTM Designation E 1394-97)
• Specification for the Version 2.8 of the Health Level Seven (HL7) Standard

Definitions, Acronyms, and Abbreviations

Accept The interface successfully received the message and will update the system’s persistent
storage with the information.
ASTM American Society for Testing and Material (communication protocol)
Device General term used to refer to the analyzer or automation system that communicates to a
host using the protocol defined in this document.
Frame From CLSI LIS01-A2. A subdivision of a message and part of a record. If message size is
more than the frame size, the record will be divided into several frames to allow periodic
error checking and acknowledgements.
HL7 Health Level Seven (HL7) Standard

C17197AB 2-1
 LIS Interface Specification
Communication Transport

Host General term used to refer to the middleware or laboratory information system that is
communicating with the device.
LIS Laboratory Information System
Message A collection of information passed from one software component or device to another.
Record From CLSI LIS02-A2. A collection of fields that represent one part of a complete message.
Reject The interface did not successfully receive a message or the system’s persistent storage
could not be updated with information from the message.
Segment From HL7. A collection of fields that represent one part of a complete message

Communication Transport

Supported Transports
The following transport layers are supported by the interface:

• Serial – serial parameters are configurable

• TCP/IP – IP Address and port are configurable

Serial Configuration Options

The interface allows the following configuration options for serial data transport:

Configuration Item Options Default

Port All available ports First available port
Baud Rate 4800, 9600, 14400, 19200, 38400, 57600 9600
Data Bits 8 8
Stop Bits 1 1
Parity Even, Odd, None None

TCP/IP Configuration Options

The interface allows the following configuration options for TCP/IP data transport. Kaluza (client)
will connect to LIS (server) only when the export button is pressed, and only for the duration
necessary to transmit results. It will then disconnect.

Configuration Item Options Default

Port Number User-entered port: 1 to 65535 12001
IP Address of Server User-entered IP Address Blank

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 LIS Interface Specification
ASTM Protocol 2

Unidirectional Communication
The interface supports only one channel of communication with the LIS. All data will travel over a
single serial cable or one TCP port between the LIS and the device.
The Kaluza software does not support bidirectional communication with LIS. For ASTM Protocol the
Kaluza software will ignore all the messages from LIS except the ACK, ENQ, NAK and other flow
control characters. For HL7 the Kaluza software only accept ACK Message from LIS.

ASTM Protocol

Overview
The low-level protocol is supported as specified by CLSI LIS01-A2. The high-level protocol is
supported as specified by CLSI LIS2-2A. The data transmission rate for an LIS using TCP/IP shall
conform to IEEE 802.3 and operate at least 10 MB/second (LIS01-A2–7.2.3.1). Kaluza supports a
frame sizes 247 bytes for serial communication (including frame overhead) and 64000 bytes for
TCP/IP (including frame overhead).

When there is line contention (both systems are bidding at the same time), Kaluza software behaves
as an Instrument (LIS01-A2, 6.2.7.1). The Kaluza software tries 3 times to establish a connection with
LIS when line contention occurs before raising a loss of communication alert. The interval of each
try is one second.

Conventions
The manufacturer records M are used to transmit an image encoded as a base64 with jpeg format.
Formatted as below:
“M|Record number|^^^Image name^^^Base64 encoded binary data of image||||||Result Status
|Completed time|”.

Supported Character Encodings

The interface supports transmitting and receiving data encoded as UTF-8.

UTF-8
UTF-8 is a variable-width encoding which can represent all characters in the Unicode character set.
The messages used by the interface are encoded as UTF-8. Streams of bytes are not prefixed with a
byte order mark (BOM).

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 LIS Interface Specification
ASTM Protocol

ASTM Record Format

The data record formats for all transmissions to and from Kaluza software are:

<STX>FN text <ETB><CS><CR><LF> (intermediate frame)

<STX>FN text <CR><ETX><CS><CR><LF> (end frame)

Format Description
<STX> The start of message character (Hexadecimal ASCII CODE: 0x02)
FN Frame number (Integer Value: 0 to 7)
The frame number is an ASCII digit ranging from 0 to 7. The frame number begins
at 1 with the first frame of the Transfer phase. The frame number is incremented
by one for every new frame transmitted. After 7, the frame number rolls over to
0, and continues in this fashion.
text Data – the message
<CR> Data always terminated by a carriage return (Hexadecimal ASCII CODE: 0x0D)

NOTE <CR> is only present when ETX is present.

<ETB> End of frame – required when record is too big (beyond 247 bytes for ASTM by
serial port or beyond 64000 bytes for ASTM over TCP/IP) for a frame (Hexadecimal
ASCII CODE: 0x17)
<ETX> End of frame (Hexadecimal ASCII CODE: 0x03)
<CS > Checksum – follows exactly LIS01-A2 6.3.3.
<CR> Carriage Return ASCII character (Hexadecimal ASCII CODE: 0x0D)
<LF> Line Feed ASCII character (Hexadecimal ASCII CODE: 0x0A)

Delimiters
The interface will use the delimiters listed below.

Delimiter Type Delimiter Description

Field | Vertical bar (|) ASCII (124)
Repeat \ Backslash (\) ASCII (92)
Component ^ Caret (^) ASCII (94)
Escape & Ampersand (&)ASCII (38)

Record Format Definitions

The following sections define the column specifications for the LIS record formats.

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 LIS Interface Specification
ASTM Protocol 2

Sequence Column (SEQ)

The number in the sequence column represents the order in which the field or component is
present in the record. In cases where a sequential value is missing this indicates the field is not used
and will be ignored. When a field is omitted delimiters must still be present in the record.

Cardinality (CARD)
The value in the cardinality column represents the number of repetitions that are allowed or
required for each field and component.

Max Len Column (LEN)

The maximum length specified for this field in characters. If this field is blank, the interface shall
not validate the length of this field. Note that the number of bytes transmitted could be up to four
times the listed value for each field because the interface uses variable length character encodings.

Data Type Column (DT)

Possible values used in the Format column are specified as follows:

Format Identifier Description

N Numeric, 0-9
F Floating point – see Send/Receive Column (SEND/RECV) below
FS Floating point including ‘<’ and ‘>’
C Printable characters
C-X C-Exact, the value must match one of the available choices provided in the
specification for the particular field or component. Unless otherwise specified, if
an exact match is not found, the message will be rejected
D Date – YYYMMDD
DT Date and time – YYYMMDDHHMMSS
24 hour format in UTC time unless otherwise specified.
T Time – HHMMSS
24 hour format in UTC time unless otherwise specified.

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 LIS Interface Specification
ASTM Protocol

Send/Receive Column (SEND/RECV)

Each record definition has a SEND and RECV column. The SEND column describes which fields the
analyzer will send to the host. The RECV column describes which fields the analyzer expects when
receiving a message from the host. Possible values used in the receive column are specified as
follows:

SEND/RECV Description
Req • This field must be sent by the sender
• When receiving this field, the interface will validate format of this field. This field must
be well-formed or the message will be rejected.
Yes • Sending this field is optional or conditional. Refer to the description of the field for
detailed usage.
• When receiving this field, the interface will validate format of this field. This field must
be well-formed or the message will be rejected.
No • This field is not sent and will be ignored if received by the interface.
• The interface will not validate the length or format of the field.

Sequence Number
All records except for the header record contain a sequence number field as the second field in the
record. This field shall be used as described in section 5.6.7 of LIS02-A2.

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ASTM Protocol 2

Common ASTM Record Definitions

The following sections describe the details of each record that has a common definition between
multiple messages. The tables define the format and usage of each component and field. For records
that are only used in one message the record definition will be listed with the message definition.

H – Header Record
The Header Record is always the first record of each message sent. The second field in this record
contains the delimiters that will be used for all records in that message.

The Header record is formatted as specified in the table below.

SEQ Element Name CARD LEN DT SEND /RECV Comments

1 Record Identifier (H) [1..1] 1 C-X Req Always “H”
2 Delimiters [1..1] - - -
2.1 Field delimiter [1..1] 1 C Req Vertical bar (|) ASCII (124)
2.2 Repeat delimiter [1..1] 1 C Req Backslash (\) ASCII (92)
2.3 Component delimiter [1..1] 1 C Req Caret (^) ASCII (94)
2.4 Escape delimiter [1..1] 1 C Req Ampersand (&) ASCII (38)
5 Sender Name or ID [0..1] - - -
5.1 Sender Name [0..1] 128 C Yes User-definable from LIS
configuration
5.2 Sender ID [0..1] 128 C Yes User-definable from LIS
configuration
5.3 Software Revision [0..1] 128 C Yes E.g. “DxI 4.5.9”
13 Version Number [0..1] 128 C-X Yes Always “LIS2-A2”
14 Date and Time of [0..1] 14 DT Yes E.g. “20131120164321”
Message

C17197AB 2-7
 LIS Interface Specification
ASTM Protocol

P – Patient Information Record

The patient record is used as defined by the LIS2-A2 protocol. The Patient Information Record is
formatted as specified in the table below.

SEQ Element Name CARD LEN DT SEND /RECV Comments

1 Record Identifier (P) [1..1] 1 C-X Req Always “P”
2 Sequence Number [1..1] 5 N Req See Sequence Number
4 Laboratory- assigned [0..1] 128 C Yes Patient identifier. This field
Patient ID is required if any other
field in the record is
populated.
6 Patient Name [0..1] - - -
6.1 Last Name [0.1] 128 C Yes Patient last name.
6.2 First Name [0..1] 128 C Yes Patient first name.
6.3 Middle Name [0..1] 128 C Yes Patient middle name or
initial.
8 Birth Date [0..1] 8 D Yes E.g. “19501120”
9 Patient Sex [0..1] 1 C Yes M = Male
F = Female
U = Unknown or
undefined.
(If blank or non-listed
value, will assume ‘U’)
14 Attending Physician [0..1] - - -
14.1 ID [0..1] 128 C Yes E.g “86443947”
14.2 Last Name [0..1] 128 C Yes E.g “Jones”
14.3 First Name [0..1] 128 C Yes E.g. “Mark”
14.4 Middle Initial or Name [0..1] 128 C Yes E.g. “G”
14.5 Suffix [0..1] 128 C Yes E.g “Sr.”
14.6 Title [0..1] 128 C Yes E.g. “Dr.”
26 Patient Location [0..1] 128 C Yes E.g. “Room 421”

NOTE The Kaluza software doesn’t contain the patient information so the P record is always like this: P|1.

2-8 C17197AB
 LIS Interface Specification
ASTM Protocol 2

O – Test Order Record

The Test Order Record contains all specimen information, including test requests. The test order
record is formatted as specified in the table below.

SEQ Element Name CARD LEN DT SEND RECV Comments

1 Record Identifier (O) [1..1] 1 C-X Req Req Always “O”
2 Sequence Number [1..1] 5 N Req Req See Sequence Number
3 Specimen ID [1..1] 128 C Req Req E.g. “SAMPLE001”
5 Universal Test ID [0..*] - - - -
5.1 Test ID [0..1] 128 C Yes Yes LOINC test code
5.2 Test Name [0..1] 128 C Yes Yes LOINC test name
5.3 Test ID Type [0..1] 128 C-X Yes Yes If populated, always
“LOINC”
5.4 Local Code [0..1] 128 C Yes Yes Locally defined test
code specified in the
system test
configuration
6 Priority [0..1] 1 C-X Yes Yes S = STAT
R = Routine
(If blank or unlisted
value, R is assumed)
8 Specimen Collection [0..1] 14 DT No Yes E.g
Date and Time “20091005120000”
12 Action Code [0..1] 1 C Yes Yes See
Action Code (O–12)
16 Specimen Type [1..1] 128 C-X Yes Yes See
Specimen Type (0-16)
17 Ordering Physician [0..1] - - - -
17.1 ID [0..1] 128 C Yes Yes E.g “DR5963”
17.2 Last Name [0..1] 128 C Yes Yes E.g. “Doe”
17.3 First Name [0..1] 128 C Yes Yes E.g “Jane”
17.4 Middle Initial or Name [0..1] 128 C Yes Yes E.g. “G”
17.5 Suffix [0..1] 128 C Yes Yes E.g “Sr.”
17.6 Title [0..1] 128 C Yes Yes E.g. “Dr.”
21 Requested Analyzer [0..*] - - - -

21.1 Analyzer Name [0..1] 128 C No Yes E.g. “DxI123”

21.2 Sub-module Name [0..1] 128 C No Yes E.g. “Pipettor-1”
26 Report Type [0..1] 1 C-X Yes Yes See
Report Type (O-26)

C17197AB 2-9
 LIS Interface Specification
ASTM Protocol

Universal Test ID (O–5)

The repeat delimiter may be used to request multiple tests from a single order record. This is the
recommended method for ordering multiple tests for a single sample. This field is required when
placing orders for a sample. Kaluza software doesn’t support ordering for samples from LIS.

Action Code (O–12)

This field describes what action should be taken by the recipient of the message.

When sending messages to the host the system uses the following codes:

Code Description
Q The associated sample should be treated as a QC
sample.
Blank / No Value / A If the field is empty then the associated sample
should be treated as a patient sample.

Specimen Type (0-16)

This field is always blank for Kaluza software.

Report Type (O-26)

This field describe the possible values in the report type field.

When receiving messages from the host the following codes are used:

Code Description
Y, Z The message represents a response to a host query.
There are no order for this sample.
O The message represents a request to run the
specified tests on the associated sample.
Blank / No Value The system will interpret no value as “O.”

When sending messages to the host the system uses the following codes:

Code Description
X The specified tests could not be completed or were
cancelled.
F Final results for the sample are being reported.

R – Result Record
The Result Record contains the result of a single analytical determination. This record is only sent
from the device to the host. The result record is formatted as described in the table below.

SEQ Element Name CARD LEN DT SEND Comments

1 Record Identifier (R) [1..1] 1 C-X Req Always “R”
2 Sequence Number [1..1] 5 N Req See Sequence Number

2-10 C17197AB
 LIS Interface Specification
ASTM Protocol 2

SEQ Element Name CARD LEN DT SEND Comments

3 Universal Test ID [1..*] - - Req
3.1 Test ID [0..1] 128 C Yes LOINC test code
3.2 Test Name [0..1] 128 C Yes LOINC test name
3.3 Test ID Type [0..1] 128 CX Yes If populated, always “LOINC”
3.4 Local Code [1..1] 128 C Req E.g. “01A” or “X-RDWR-SD”
4 Value [1..1] - - Req
5 Units [1..1] 128 C Yes E.g “mg/ml”
6 Reference Range [0..1] 128 C Yes E.g. “3.6 to 10.2”
9 Result Status [1..1] 1 C-X Req R = Re-transmitted final result
F = Final result
13 Date/Time test completed [1..1] 14 DT Req “20100103150423”
14 Instrument Identification [1..1] - - Yes
14.1 Serial Number [1..1] 128 C Yes The serial number of the
instrument that produced the
result.
14.2 Instrument Model [1..1] 128 C Yes The model of the instrument that
produced the result.
14.3 Manufacturer [1..1] 128 C-X Yes Always “Beckman Coulter”

Universal Test ID (R-3)

This field contains the channel identifier defined by LIS side. The Kaluza software use the format as
below:

^^^Channel Number^^^.

Data or Measurement Value (R–4)

This field contains details of a single result for an ordered test. This field may be empty if the order
could not be completed or a result could not be obtained.

NOTE A result of >x indicates a result whose value is some number greater than x. Similarly, a result of <y
indicates a result whose value is less than y.

Primary Result
This field may contain a qualitative or a quantitative result, depending on which is selected as the
primary in the device configuration. This component may be empty.

Value
If a quantitative result is available it will be located in this component. This component may be
empty.
Interpretation
If a qualitative result is available it will be located in this component. This component may be
empty.

For Kaluza software the Primary Result and Interpretation is presented. Only the value is presented.

C17197AB 2-11
 LIS Interface Specification
ASTM Protocol

C – Comment Record
The comment record is used for patient, sample, and result comments.

Result Comment

• Sent after a result record if there are any flags or operator entered conditions associated with
the result.

The messages sent by Kaluza software will not contain the comment record.

L – Message Terminator Record

This record signifies the last record in a message. There must be one terminator record for every
header record sent by either system. The terminator record is formatted as specified in the table
below.

SEQ Element Name CARD LEN DT SEND/RECV Comments

1 Record Identifier (L) [1..1] 1 C-X Req Always “L”
2 Sequence Number [1..1] 5 N Req Always 1
3 Terminator Code [0..1] 1 C-X Yes Always “N” (normal
termination)

Transmission Phases
There are three phases involved in the transmission message frames between Kaluza software and
LIS described as below:

• Establishment Phase (or Link Connection): This phase determines the direction of information
flow and prepares the receiver to accept information.
• Transfer Phase: During this phase the sender transmits messages to receiver by frames.
• Termination Phase: When come to this phase the link between sender and receiver is released
and the sender notifies the receiver all the messages are sent.

Establishment Phase
This phase determines the direction of information flow and prepares the receiver to accept
information.

The system with information available (Kaluza software) initiates the establishment phase to notify
the receiver (LIS) that the information is available.

The sequence is as below:

1 The sender (Kaluza software) determines the data link is in neutral state.

2-12 C17197AB
 LIS Interface Specification
ASTM Protocol 2

2 The sender (Kaluza software) send <ENQ> transmission control character to receiver (LIS). The
sender will ignore all response except the <ACK>, <NAK>, <ENQ>.

3 After the sender sends the <ENQ>, there will be there cases:
a. If the receiver is ready to receive data, it gives the response to the sender with the <ACK>
transmission control character. The link connection is established and the Transfer Phase
is entered.
b. If the receiver is not ready to receive data, it responds with the <NAK> characters. The
sender (Kaluza software) will wait 10 seconds to send another <ENQ>. The sender will try to
send an <ENQ> every 10 seconds up to 3 times until the <ACK> is responded or a time out
message is alerted.
c. If the receiver and the sender send the <ENQ> at same time, the Kaluza software as the
sender has the priority to send another <ENQ> after 1 second and the receiver (LIS) must
stop trying to send the <ENQ> to Kaluza software and prepare to receive data from the
Kaluza software.

Transfer Phase
During the Transfer Phase the sender will transmit messages until all the messages are sent.

The message is divided into frames by bytes to be sent from sender to receiver. For ASTM over
TCP/IP the frame size is 64000 bytes (including frame overhead). For serial port the frame size is
247 bytes (including frame overhead). For details see ASTM Record Format.

If the receiver receive the frames it will respond the characters as below:

1. <ACK>

If the frame is accept by the receiver and it prepares to receive next frame it responds with the
<ACK>. If the <ACK> is received the sender will send the next frame or send a <EOT> to notify
the receiver it has completed the message.
2. <NAK>
If the frame is not accept by the receiver it will respond the <NAK> to the sender. The sender
will retry to send the frame 6 times till the frame is accept by the receiver or alert a failed
message.
3. <EOT>
During the transfer phase, if the receiver responds to a frame with an <EOT> in place of the
usual <ACK>, the sender must interpret this reply as a receiver interrupt request. The <EOT> is
a positive acknowledgment of the end frame, signifies the receiver is prepared to receive next
frame, and is a request to the sender to stop transmitting.
The sender does not have to stop transmitting after receiving the receiver interrupt request. If
the sender chooses to ignore the <EOT>, the receiver must re-request the interrupt for the
request to remain valid

NOTE The Kaluza software will ignore the <EOT> until the messages is completed.

C17197AB 2-13
 LIS Interface Specification
ASTM Protocol

Termination Phase (Release Link)

The Termination Phase returns the data link to the Neutral State. The sender initiates the
Termination Phase by transmitting the <EOT> character and then regards the link to be in the
Neutral State. After receiving the <EOT>, the receiver also considers the link to be in the Neutral
State.

ASTM Application Layer Messages

This section describes the application layer messages that may be transmitted between a device and
the host.

Message Format Definitions

Each message is described by a table containing 3 columns: Records, Description, and Cardinality.

Records
The Records column defines the structure of the message. It defines logical grouping of records and
shows how they are arranged and uses symbols to denote their cardinality and whether or not they
are required. A grouping or record enclosed in braces ([…]) is optional and brackets ({…}) identifies
repeatable items.

Description
The Description column provides a brief description of the record or grouping in that column.

Cardinality
The Cardinality column specifies the number of records or groups that are permitted in each part
of the message.

Result Message
Sent By: Kaluza software

Purpose: Sent when a result has been produced by the Kaluza software

LIS Configuration: Send reagent information with results.

Device Sending Value Results

The result message is sent by the device to report patient or QC results to the host.

Example
H|\^&|||Kaluza^Kaluza||||||||LIS2-A2|20170512161813<CR>
P|1<CR>
O|1|SAMPLE001|||R||20170512161532||||A||||||||||||||F<CR>
R|1|^^^L^^^|1023|||||F||||20170512161532|<CR>R|2|^^^L^^^|200|||||F||||20170512161532|<CR>
R|3|^^^M^^^|100|||||F||||20170512161532|<CR>
R|4|^^^N^^^|10000|||||F||||20170512161532|<CR>
L|1|N<CR>

2-14 C17197AB
 LIS Interface Specification
ASTM Protocol 2

The device is reporting results for SAMPLE001. Results for tests L, M and N are being reported.

Device Sending Image Results

The image is sent by the device to the host with M record.

The format is as follows:

M|1|^^^name of the iamge|base64 encoded binary data of a jpeg image||||||F||||20170505105232

Example

H|\^&|||Kaluza^Kaluza||||||||LIS2-A2|20170512161813<CR>
P|1<CR>
O|1|SAMPLE001|||R||20170512161532||||A||||||||||||||F<CR>
M|1|^^^L+Image^^^|/9j/4AAQSkZJRgABAQEAYABgAAD/2wBDAAMCAgMCAgMDAwMEAwMEBQgF
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8q/4ST43/wDRPPh//wCF5ff/ACmo/wCEk+N//RPPh/8A+F5ff/KavVaKAPKv+Ek+N/8A0Tz4f/8AheX

C17197AB 2-15
 LIS Interface Specification
ASTM Protocol

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2-16 C17197AB
 LIS Interface Specification
ASTM Protocol 2

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C17197AB 2-17
 LIS Interface Specification
ASTM Protocol

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2-18 C17197AB
 LIS Interface Specification
ASTM Protocol 2

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+qwajaf2ooiTYImt1jLB7g/OxUKBsP1xpfxM8H654uv/CuneK9D1DxRp6GS80S11GGW9tlBUFpIFYugB
deSB94eorpaAPkq8/Zv+JX/AAsDxf8AEmzg8Ir4v8a6be6Nqulzavd/YtOt5ILKC2khnFruuHQWRd0aKE
MZyodQgZvpjwL4Tg8B+B/D3hm1lee10XTrfTopZBhnSGJY1Y+5Cit2igAooooAp6zaXOoaPfWtneHT7
uaCSOG7VA5gcqQsgUkZ2kg474r478H/ALI/xF8L3Wk6/BF4R0/WtFudJ1E6TbaveS2fiHUreO6gu9Ru7
h7USW9xNDdHJWOcs8YMjPwV+0KKAPjm1/Y/8a2dv46sBN4cks/ifLDd+K5/t9ysmmTf2jdXUy2SeQR
cr5d15KmRoCDEHIO4oPsaiigAooooA8++KXw+1Hxt4m+GWo2M1rFB4Y8SnWbxbh2VpIf7PvbbbHhTl
99zGcEqNobnIAPztdfse+OLzR/BWmvN4ajT4Z3Ut/4TuRf3LHU5v7UtryEXsfkD7MoitjC3ltOS028Y2b
W+yqKAPkSb9mD4jW3ibxp4ysV8KHxL4+sNU03W7CbVLoWumJcLaxW8tvMLUtcmOO1yyNHBvaTh
0C8/Ung/w1b+DPCOieH7R3ktdJsYLCF5PvMkUaopPvhRWvRQAUUUUAFFFFABRRRQAUUUUAFFFF
ABRRRQAUUUUAFFFFABRRRQAUUUUAFFFFAHyb+yjqPjaHxn8Z7fSvD+gXnhd/ijq3/2vUrzXZ7e9hJ
EG/wAu1WzkSTC7SMzpkkg7cZPU/sc/6746/wDZUta/9At69n8G/D3QPh+2unQLD7Adc1SbWtQ/fSSe
feTBRJL87HbnYvyrhRjgCuLj/Zi8CWuvavq9iPE+kXerajJq19HpPjHWLG3nu5CC8rQQ3axZbaM/LggAY
wMUAeefHTTYPDvx0+BM99p1t4f8HW3iS4Sw1DRVVrmfV7y3uALeeLCeTBKWldpE84yPgOsQ/eH6Z
rznTf2evAek+LbTxHb6PcG+sriS7srWfVLubT7GeTdvltrJ5TbwSHe/zxxq3zvz8zZ9GoAKKKKACiiigAo
oooAKKKKACiiigAooooAKKKKACiiigD//2Q==|||||F||||20170505105232<CR>
L|1|N<CR>

Analyze the message above and decode the image data with base64 will result in the image as below:

C17197AB 2-19
 LIS Interface Specification
HL7 Protocol

Message Format
The results message is formatted as specified in the following table.

Records Description Cardinality

H Message header [1..1]
--PATIENT begin [1..1]
P Patient record [1..1]
[{C}] Patient comment [0..*]
-- PATIENT end
{ -- ORDER begin [1..*]
O Test order record [1..1]
[{C}] Order/ sample comment [0..*]
{ -- RESULT begin [0..*]
{R} Result record [1..*]
[{M}] M|119 Reagent Information [0..*]
[{C}] Result comment [0..*]
} -- RESULT end
} -- ORDER end
L Message terminator [1..1]

HL7 Protocol

Overview
The Kaluza software use the protocol described in the specification for the Version 2.8 of the Health
Level Seven (HL7) Standard.

Conventions
The Kaluza software doesn’t support bidirectional communication with LIS.

It ignores the messages from LIS except ACK messages.

After the Kaluza completed its messages it will disconnect from LIS system.

The Kaluza software works as a client when transmitting results to LIS system by TCP/IP.

2-20 C17197AB
 LIS Interface Specification
HL7 Protocol 2

Supported Character Encodings

UTF-8 is a variable-width encoding which can represent all characters in the Unicode character set.
The messages used by the interface are encoded as UTF-8. Streams of bytes are not prefixed with a
byte order mark (BOM).

Data Format
In HL7 the data is transmitted as the Messages String.

The HL7 message is composed of several segments. The segment is composed of several fields. Each
segment in a message is separated from another by the ‘<CR>’. Each field in a segment is separated
from another by the ‘|’.

The data format in HL7 for transmission is as follows:

The first byte is the Start Block Character refer to the ASCII code 0x0B to indicate the start of a
message. The next n bytes are the message data string. The last two bytes are the End Block
Character 0x1C and Carriage Return Character 0x0D to indicate the end of a message.

The details are shown as the image below.

C17197AB 2-21
 LIS Interface Specification
HL7 Protocol

Message
There are many kinds of messages with various segments for different purpose in HL7 such as the
QRY^Q02 is used to download samples from LIS and ORU^R01 is used to transmit results to LIS.

The Kaluza software only use the ORU^R01 to transmit the unsolicited results to LIS system. And the
LIS system shall send the ACK^R01 as the response to Kaluza software.

ORU^R01 Message
The ORU^R01 Message contains the many segments but some of them are optional. The Kaluza
software only use some necessary segments in ORU^R01 Message. The below is the structure of
ORU^R01 message used in Kaluza. The segment encompassed by the bracket means it is optional.
The segment encompassed by brace means it will be repeated. The segment encompassed by both
brace and bracket means it will not be presented or repeated. Multiple segments encompassed by
brace or bracket is called a group.

Segments Description Cardinality

MSH Message header [1..1]
{ -- Group begin [1..*]
[PID] Patient Identification [0..1]
OBR Observations Report Identifier [1..1]
{ --Group begin [1..1]
OBX Observations/Result [1..*]
} -- Group end [1..*]
} --Group end [1..*]

• MSH: The MSH segment is the message header, it indicates the message purpose containing the
information of message type, character encodings and so on.

• PID: The PID segment contains the information of patients. This segment is optional. For Kaluza
software the segment is always not presented.
• OBR: The OBR segment is intend to transmit the information related on the report. It contains
the sample id, collection time and so on.
• OBX: The OBX segment is intend to transmit the observation items and the results of the items.

2-22 C17197AB
 LIS Interface Specification
HL7 Protocol 2

ACK^R01
The ACK^R01 message is sent by LIS system as the response of the ORU^R01 message.

Segments Description Cardinality

MSH Message header [1..1]
[{ SFT }] Software segment [0..1]
[UAC] User Authentication Credential [1..1]
MSA Message acknowledgment [1..1]
[{ ERR }] Error [1..*]

• MSH: Message header

• SFT: The Kaluza software will ignore this segment.

• UAC: The Kaluza software will ignore this segment.
• MSA: Message acknowledgment. It contains the acknowledgement code and message control
identifier. The Kaluza software will analyze the segment.
• ERR: Contains the details of the error. For Kaluza software this segment is not necessary in
ACK^R01 message as response from LIS to Kaluza software.

Segment
The segment is composed of several fields.

MSH
All the HL7 messages begin with MSH segment. It indicates the message type and character
encodings and so on. The details is as below:

Length Required/OptIonal
No. Field Name (byte) (R/O) Description
1 Field Separator 1 R Field delimiter, For Kaluza
software it is always ‘|’.
2 Encoding Characters 4 R Component delimiter, repeat
delimiter, Escaping delimiter,
Sub-component delimiter (^~\&)
3 Sending Application 180 O Always Kaluza
4 Sending Facility 180 O Kaluza
5 Receiving Application 180 O Blank
6 Receiving Facility 180 O Blank
7 Date/Time Of Message 26 O Current system time.
8 Security 40 O Blank
9 Message Type 7 R Message type. ORU^R01

C17197AB 2-23
 LIS Interface Specification
HL7 Protocol

Length Required/OptIonal
No. Field Name (byte) (R/O) Description
10 Message Control ID 1..199 R GUID
11 Processing ID 3 R Always P
12 Version ID 60 R 2.8.0
13 Sequence Number 15 O Blank
14 Continuation Pointer 180 O Blank
15 Accept Acknowledgment 2 O Blank
Type
16 Application 2 O Blank
Acknowledgment Type
17 Country Code 2 O Blank
18 Character Set 16 O UTF-8
19 Principal Language Of 60 O Blank
Message
20 Alternate Character Set 20 O Blank
Handling Scheme

PID
The PID segment is not used in Kaluza software.

OBR
The OBR segment contains 54 fields but Kaluza software only use some of the fields as below the
others are blank. The details of OBR segment is shown as below.

Length Required/OptIonal
No. Field Name (byte) (R/O) Description
1 Set ID 1 R For the first order transmitted, the
sequence number shall be 1; for
the second order, it shall be 2; and
so on. For Kaluza software it will be
always 1 because there is only 1
OBR segment is ORU^R01
message sent by Kaluza software
2 Placer order number 4 O Always blank
3 Fill order number 180 R Use as the sample id defined in LIS
system.
4 Universal Service 180 O Type of Test
Identifier
5 Priority 180 O Blank
6 Requested Date/Time 180 O Blank

2-24 C17197AB
 LIS Interface Specification
HL7 Protocol 2

Length Required/OptIonal
No. Field Name (byte) (R/O) Description
7 Observation Date/Time # 26 O Current system time. The format
is ‘YYMMDDHHSSmm’
8 Observation End 40 O Current system time. The format
Date/Time# is ‘YYMMDDHHSSmm’

OBX
The OBX segment contains the observation/result refer to sample id define in the OBR segment.

Multiple OBX segment may refer to one sample id define in the OBR segment.

The details of the OBX segment is shown as below. The fields not listed in the table below are always
blank.

Length Required/OptIonal
No. Field Name (byte) (R/O) Description
1 Set ID 1 R This field contains the sequence
number of the OBX segment
2 Value Type 4 R ‘ST’ refers to text result.
‘NM’ refers to numerical result.
‘ED’ refers to the image encoded
by base64
3 Observation Identifier 180 R The channel number negotiated
with LIS. The format is as below.
^M^L. The M is the channel
number.
For image the M is the image
name.
4 Observation Sub ID 180 O The one observation has multiple
results this field is filled. And value
is the sequence number of the
observation value.
5 Observation Value 180 R The test results
6 Unit 180 O The unit of the test result
7 References Range 26 O Always blank
8 Interpretation Codes 40 O Always blank
9 Probability O Always blank
10 Nature of abnormal test O Always blank
11 Observation Result R Always F
Status

C17197AB 2-25
 LIS Interface Specification
HL7 Protocol

MSA
MSA is the message acknowledgement segment. The details are shown as below:

Length Required/OptIonal
No. Field Name (byte) (R/O) Description
1 Acknowledgment Code 1 R When LIS send response to Kaluza
software this field must not be
blank. The code is as below.
AA: Accept the results
AE: There is an error in the
message sent by Kaluza software
AR: Reject the results transmitted
by Kaluza software
2 Message Control ID 1..199 R This field contains the message
control ID of the message sent by
the sending system. It allows the
sending system to associate this
response with the message for
which it is intended.
3 Text Message O Kaluza software ignore this field
4 Expected Sequence O Kaluza software ignore this field
Number
5 Delayed 180 O Kaluza software ignore this field
Acknowledgment Type
6 Error Condition 180 O Kaluza software ignore this field
7 Message Waiting Number 26 O Kaluza software ignore this field
8 Message Waiting Priority 40 O Kaluza software ignore this field

2-26 C17197AB
 LIS Interface Specification
HL7 Protocol 2

ERR
The ERR segment is necessary for Kaluza software. If presented the details are shown as below:

Length Required/OptIonal
No. Field Name (byte) (R/O) Description
1 Error Code and Location 1 O Kaluza software ignore this field.
2 Error Location 1..199 O Identifies the location in a
message related to the identified
error, warning or message. If
multiple repetitions are present,
the error results from the values in
a combination of places.
3 HL7 Error Code O Identifies the HL7
(communications) error code.
Refer to specification for version
2.8 of HL7 section 2.14.5.3.
4 Severity O Kaluza software ignore this field.

Examples

Upload Results
The example below transmits the 3 results refer to the sample with id ‘PI second’. The M, C, D is the
channel defined in LIS system.

The result value of the channel M is 60.0752.

The result value of the channel C is 29.4027.

The result value of the channel D is 499.5054.

MSH|^~\&#|Kaluza|Kaluza|||20170615163920||ORU^R01|48ed0d4e-768d-421f-848c-5e8967395f3d|P|2
.8.1||||||UNICODE UTF-8||||||||<CR>
OBR|1||PI second||||20170615163647|20170615163647|||||||||||||||||||||||||||||||||||||||||||||||<CR>
OBX|0|NM|^M^L|1|60.0752||||||F|||||||||||||||||||<CR> OBX|1|NM|^C^L|1|29.4027||||||F|||||||||||||||||||<CR>
OBX|2|NM|^D^L|1|499.5054||||||F|||||||||||||||||||<CR>

C17197AB 2-27
 LIS Interface Specification
HL7 Protocol

If LIS accept this transmission, it shall give the response to Kaluza software as below:

MSH|^~\\&|||||2017-06-15 16:52:43||ACK^R01|01a7e3e3-e1a7-4564-87b7-
85bb33799e1a|P|2.3.1|||||||||<CR>
MSA|AA|48ed0d4e-768d-421f-848c-5e8967395f3d|Message accepted|||0|<CR>

NOTE The message control id in the second field of MSA segment must be same as the message control id
send by Kaluza software.

Upload Images
The example below transmits an image:

MSH|^~\&#|Kaluza|Kaluza|||20170615172307||ORU^R01|51044159-6e85-4282-afe6-
990ff0798446|P|2.8.1||||||UNICODE UTF-8||||||||<CR>
OBR|1||12||||20170615163647|20170615163647|||||||||||||||||||||||||||||||||||||||||||||||<CR>
OBX|0|ED|^Scatter^L|1|^image^jpg^Base64^/9j/4AAQSkZJRgABAQEAYABgAAD/2wBDAAMCAgMC
AgMDAwMEAwMEBQgFBQQEBQoHBwYIDAoMDAsKCwsNDhIQDQ4RDgsLEBYQERMUFRUVDA8XGB
YUGBIUFRT/2wBDAQMEBAUEBQkFBQkUDQsNFBQUFBQUFBQUFBQUFBQUFBQUFBQUFBQUFBQUF
BQUFBQUFBQUFBQUFBQUFBQUFBQUFBT/wAARCAEuATIDASIAAhEBAxEB/8QAHwAAAQUBAQEB
AQEAAAAAAAAAAAECAwQFBgcICQoL/8QAtRAAAgEDAwIEAwUFBAQAAAF9AQIDAAQRBRIhMUEG
E1FhByJxFDKBkaEII0KxwRVS0fAkM2JyggkKFhcYGRolJicoKSo0NTY3ODk6Q0RFRkdISUpTVFVWV1
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Gx8jJytLT1NXW19jZ2uHi4+Tl5ufo6erx8vP09fb3+Pn6/8QAHwEAAwEBAQEBAQEBAQAAAAAAAAECA
wQFBgcICQoL/8QAtREAAgECBAQDBAcFBAQAAQJ3AAECAxEEBSExBhJBUQdhcRMiMoEIFEKRobHB
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1rUNPmuyksdzbxoDEs8OUKTPuQlWDAcjBU+V/EL9nn4ga5/wuL7DoHn/ANv/ABF8P67pv+m26+fZ

2-28 C17197AB
 LIS Interface Specification
HL7 Protocol 2

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C17197AB 2-29
 LIS Interface Specification
HL7 Protocol

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2-30 C17197AB
 LIS Interface Specification
HL7 Protocol 2

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C17197AB 2-31
 LIS Interface Specification
HL7 Protocol

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2-32 C17197AB
 LIS Interface Specification
HL7 Protocol 2

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C17197AB 2-33
 LIS Interface Specification
HL7 Protocol

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2-34 C17197AB
 LIS Interface Specification
HL7 Protocol 2

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C17197AB 2-35
 LIS Interface Specification
HL7 Protocol

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2-36 C17197AB
 LIS Interface Specification
HL7 Protocol 2

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||||||||<CR>

NOTE When upload the image to LIS system the OBX-2 is ED, the OBX-3 is like this ‘^Scatter^L’. The scatter
is the image name. The OBX-5 is the image data encoded by Base64. The OBX-5 format is
like^image^jpg^base64^image data encoded by base64. If analyze the message above and decoded
the base64 image data it will result the image below:

The Kaluza software will send Base64 encoded images (M records) and standard statistic and
keyword results (R records) in same transmission if both record types are present . The Kaluza
software may transmit multiple Base64 encoded images (M records) in one ORU^R01 message.

C17197AB 2-37
 LIS Interface Specification
HL7 Protocol

2-38 C17197AB
 APPENDIX A
Messages

Troubleshooting

Error Message Comment Solution

LIS Export Result When this error appears, an error will be 1. Remove plot images from LIS preview
Failed to receive correct logged in the View Log section in the LIS window and try to transmit results again. If
response from LIS. Please preview window. The failed ASTM or HL7 the transmission succeeds, this error was
contact your LIS message will be recorded in the Error tab caused by rejection of your LIS
administrator. of the View Log section. transmission. Configure LIS server to
accept the Base64 encoded plot images.
2. For ASTM or HL7 TCP/IP connections, this
error indicates a connection was
established with the LIS server but there is
a problem with the LIS server configuration
or compatibility. Verify the LIS option
configured (ASTM or HL7) matches the LIS
server configuration.
3. For Serial connections, this error is caused
by a mismatch in settings between Kaluza
client and LIS server. Verify that the
configuration details in the ASTM Serial
Port LIS options screen match the serial
configuration of the LIS server.
4. If the above troubleshooting steps do not
resolve the export issue, the issue may be
caused by an incompatible LIS server
configuration. Provide local LIS support
team the Kaluza LIS specifications
document and the complete error
message in the View Log > Error screen for
troubleshooting.
5. Contact us for additional assistance.

C17197AB A-1
 Messages
Troubleshooting

Error Message Comment Solution

LIS Connection Status When this error appears, an error will be 1. Verify LIS Server Address and LIS Server
Failed to connect to the LIS, logged in the View Log section in the LIS Port values entered in the LIS option
please contact your LIS preview window. The failed ASTM or HL7 windows are correct.
administrator. message will be recorded in the Error tab 2. Verify LIS Server is switched on and is
of the View Log section. available for incoming client connections.
This message only applies to ASTM or HL7 3. Verify Kaluza workstation has network
connections of TCP/IP. connectivity and is able to communicate
with (i.e ping) LIS server address.
4. Contact us for additional assistance.
LIS Export Result This message indicates successful If results are not visible in LIS, verify that the
The export is accepted by transmission of results by Kaluza client and sample ID entered at the top of the LIS preview
LIS. acceptance of the results by LIS server. No window is the ID needed by the LIS to file the
data will be logged in the View Log section results. If the sample ID is not the one needed
in the LIS preview window. The by the LIS, adjust your workflow to enter the
successfully transmitted ASTM or HL7 proper ID in the cytometer software before
message will not be recorded. acquisition, overwrite the sample ID within
Kaluza, or adjust the LIS server configuration
to accept the ID provided.

A-2 C17197AB
 Beckman Coulter, Inc.
Customer End User License Agreement
This Product contains software that is owned by Beckman Coulter, Inc. or its suppliers and is protected by
United States and international copyright laws and international trade provisions. You must treat the
software contained in this Product like any other copyrighted material. This license and your right to use the
Product terminate automatically if you violate any part of this agreement.

This is a license agreement and not an agreement for sale. Beckman Coulter hereby licenses this Software to
you under the following terms and conditions:

You May:
1. Use this software in the computer supplied to you by Beckman Coulter;
2. Maintain one copy of this software for backup purposes (the backup copy shall be supplied by Beckman
Coulter);
3. After written notification to Beckman Coulter, transfer the entire Product to another person or entity,
provided you retain no copies of the Product software and the transferee agrees to the terms of this
license agreement.

You May Not:

1. Use, copy or transfer copies of this Software except as provided in this license agreement;
2. Alter, merge, modify or adapt this Software in any way including disassembling or decompiling;
3. Loan, rent, lease, or sublicense this Software or any copy.

Limited Warranty
Beckman Coulter warrants that the software will substantially conform to the published specifications for the
Product in which it is contained, provided that it is used on the computer hardware and in the operating
system environment for which it was designed. Should the media on which your software arrives prove
defective, Beckman Coulter will replace said media free of charge within 90 days of delivery of the Product.
This is your sole remedy for any breach of warranty for this software.

Except as specifically noted above, Beckman Coulter makes no warranty or representation, either expressed
or implied, with respect to this software or its documentation including quality, performance,
merchantability, or fitness for a particular purpose.

No Liability for Consequential Damages

In no event shall Beckman Coulter or its suppliers be liable for any damages whatsoever (including, without
limitation, damages for loss of profits, business interruption, loss of information, or other pecuniary loss)
arising out of the use of or inability to use the Beckman Coulter Product software. Because some states do not
allow the exclusion or limitation of liability for consequential damages, the above limitation might not apply
to you.

General
This agreement constitutes the entire agreement between you and Beckman Coulter and supersedes any
prior agreement concerning this Product software. It shall not be modified except by written agreement
dated subsequent to the date of this agreement signed by an authorized Beckman Coulter representative.
Beckman Coulter is not bound by any provision of any purchase order, receipt, acceptance, confirmation,
correspondence, or otherwise, unless Beckman Coulter specifically agrees to the provision in writing. This
agreement is governed by the laws of the State of California.

C17197AB Warranty-1
 Beckman Coulter, Inc. Customer End User License Agreement

Warranty-2 C17197AB
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