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10913821 Rev. B, 2015-02

© 2015 Siemens Healthcare Diagnostics. All rights reserved.
No part of this operator’s guide or the products it describes may be
reproduced by any means or in any form without prior consent in
writing from Siemens Healthcare Diagnostics.
IMMULITE and VersaCell are trademarks of
Siemens Healthcare Diagnostics.

The information in this operator’s guide was correct at the time of

printing. However, Siemens Healthcare Diagnostics continues to
improve products and reserves the right to change specifications,
equipment, and maintenance procedures at any time without notice.
If the system is used in a manner differently than specified by
Siemens Healthcare Diagnostics, the protection provided by the
equipment may be impaired. See warning and hazard statements.
1 Introduction

Using this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

How this Manual Is Organized. . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
Conventions Used in this Manual . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Basic LIS Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
LIS Configuration Screen Terms . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
LIS Worklist Screen Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
What Is an LIS? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
How Does an LIS Work?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
General Schematic of an LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
Summary of LIS Workflow Steps . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Order Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Sample Receiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Results Entry/Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Example Patient Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
How Do Instruments Communicate with an LIS?. . . . . . . 1-12
Cable Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14
Lab Automation Configuration . . . . . . . . . . . . . . . . . . . . . 1-14
Communication Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
ASTM Handshaking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
IMMULITE/LIS Messaging . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Basic Message Hierarchy (Lower number has higher priority) . . 1-16
Hierarchy Example of LIS to IMMULITE Systems Transfer . . . . . 1-16
Hierarchy Example of IMMULITE to LIS Transfer . . . . . . . . . . . . 1-17
Hierarchy Example of IMMULITE 2000/XPi to LIS Transfer
(Immunoassay) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Hierarchy Example of IMMULITE 2000/XPi to
LIS Transfer (Allergy) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Hierarchy Example of Query to LIS . . . . . . . . . . . . . . . . . . . . . . 1-19
Hierarchy Example of Response to Query . . . . . . . . . . . . . . . . . 1-20
Basic Format of a Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Header Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Patient Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Order Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Interface Specifications page 1-i

Introduction

Result Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22

Maximum Values for Database Fields Across
Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Transfer Examples of Bi-Directional and Uni-Directional,
IMMULITE 2000/XPi to LIS . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Host Query Example, Query to LIS . . . . . . . . . . . . . . . . . . 1-27

page 1-ii Interface Specifications

Introduction

Using this Manual

The IMMULITE® Systems Interface Specifications manual is written
primarily for software developers who are familiar with implementing
layered communications protocols. This manual contains information for
customers using the IMMULITE systems.

How this Manual Is Organized

The following table provides an overview of the manual and explains the
contents of each section:

If you want to… Refer to…

read an overview of how an instrument Section 3, IMMULITE 1000 / LIS
interfaces with an LIS or LAS. Configurations.
determine the IMMULITE installation and Section 4,
configuration settings for both bi-directional or IMMULITE 2000/XPi / LIS
unidirectional settings, the LAS, or look up error Configurations.
messages.
determine the IMMULITE 1000 installation and Appendix A, Protecting Yourself
configuration settings for both bi-directional or from Biohazards.
unidirectional settings, or look up error
messages.
determine the IMMULITE 2000/XPi installation Appendix B, Service and
and configuration settings for both bi-directional Warranty Information.
or unidirectional settings, or look up error
messages.
review biohazard guidelines. Section 3, IMMULITE 1000 / LIS
Configurations.
contact Siemens Healthcare Diagnostics. Section 4,
IMMULITE 2000/XPi / LIS
Configurations.

Interface Specifications page 1 - 1

Introduction

Conventions Used in this Manual

The IMMULITE Interface Specifications manual uses the following text and
symbol conventions:

Convention Description
Bold Bold type indicates the following:
text on the user interface
For example, if the word save appears as Save, it refers to
the Save button on the user interface.
a key on the keyboard or a system key on the front of the
system
For example, when the word enter appears as Enter, it refers
to the Enter key on the keyboard.
Italics Italics type refers to the title of a document or a section title
in this manual.
For example, IMMULITE 1000 / LIS Configurations refers to
Section 2 of this manual.
Caution statements alert you to conditions that may cause
CAUTION product damage or loss of data. On the system, this symbol
indicates that you should refer to the manuals for more
information.
Note Note statements alert you to important information that
requires your attention.

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 Introduction

Basic LIS Terms

Term Description
ACK Acknowledge
Response to sender message was properly received.
ASTM American Society for Testing and Materials, the agency
previously involved in setting standards for electronic
communications. This activity has been taken over by the
Clinical and Laboratory Standards Institute (formerly NCCLS).
Channel codes An interchangeable term with test code
Checksum Error checking calculation performed on each message to
insure all characters are properly received.
Data Stream The data stream is the coded message that is transmitted
back and forth between the LIS and the instruments
attached to it. This message contains items such as the
instrument’s ID, the sample ID, assay test code and test
result.
ENQ Enquiry
First character sent in a transaction, initiates communication
session.
EOT End Transmit
Indicates the sender is done sending and is entering "idle"
mode. Terminates a communication session.
ETX End of Text
Indicates end of text for a specific message.
Field An item within a record
For example, Patient Name in a patient message is a field.
Frame Number The first character sent in a message.
The value increments by one every message until number 7.
It is then reset to number 0 (0-7). The header message (first
message sent) always begins with number one.
H message Header Message
First message sent in any transaction, contains system
information such as sender ID, receiver ID, address, etc.
HL7 A communication protocol designed to standardize the
abbreviations and names used for laboratory tests, test
codes, medical diagnoses, and so forth.
The HL7 allows all healthcare information systems to use the
same terms for the same tests and facilitate communications
between the various information systems.
Interface An application that translates what the instrument sends
into symbols that the LIS can use and translates what the LIS
sends into symbols that the instrument can use.

Interface Specifications page 1 - 3

Introduction

Term Description
L message Terminator Message
Last message sent in a transaction, contains termination
codes.
Line Noise Unintended voltage.
This may cause LIS 30 second timeout errors on the
IMMULITE systems and occurs for many reasons, some of
which are:
• Insecure connections
• Cable problems
Interference from power sources
Middleware An intermediate device used between instruments and the
connection to the host system that include specialized
interface workstations to provide additional data
management capability.
NAK Negative Acknowledge
Response to sender message was not properly received.
O message Order Message
Defines which test, such as TSH or HCG, should be
performed on the patient sample for a particular accession
number.
P message Patient Message
Contains patient information, patient ID, name.
Password A password defined by the LIS software company.
This field may be left blank if desired.
Panel A predefined set of tests.
Panel names may be sent to the instrument. All tests within a
panel are run if the panel is configured on the instrument.
Results are then sent from the instrument to the LIS as
individual test codes.
Note Panel names should be unique. Do not name a panel
the same as a test code.
Pipe Sign ( | ) A vertical bar that separates fields within a record.
Port A port is an access point allowing connection from an
instrument or computer into the LIS network.
An example of a port can be as simple as the wall plug for
your telephone.
Q message Query Message
A request to the LIS for patient information and test orders.
Contains the primary tube accession number.

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 Introduction

Term Description
R message Result Message
Contains test results and additional information, such as test
code and the units in which the results are delivered. This
message is sent to the LIS.
Receiver ID The identity of the system receiving a message.
For example, If the IMMULITE system is receiving a message
the receiver ID may be IMMULITE, if the LIS is receiving a
message the receiver ID may be LIS. The data in this field is
defined by the LIS software company.
Record Also known as a message, contains all information for a
particular item.
All information in a patient message.
Rocket Card A computer board used on IMMULITE 2000 systems to
provide the serial ports used for LIS communications.
Sender ID The identity of the system sending a message.
For example, If the IMMULITE system is sending a message
the sender ID may be IMMULITE, if the LIS is sending a
message the sender ID may be LIS. The data in this field is
defined by the LIS software company.
Sequence Number Each message type has its own sequence number.
This number increments by one after each record is sent. A
record sent of a higher hierarchy (see message hierarchy)
resets this value to zero.
STX Start of Text
Indicates start of text for a specific message.
Test Codes Upload and download codes that can be found in package
inserts.
Note Entering test codes into the LIS for allergy assays can
be time consuming because customers may run hundreds
of allergy tests. Using common naming conventions like
HL7 makes this less tedious because the LIS will already
recognize the standard codes.
Workstation An LIS terminal or PC that allows the operator to work with
the LIS software.

Interface Specifications page 1 - 5

Introduction

LIS Configuration Screen Terms

Screen Term Description
Auto Send Control The instrument sends QC results automatically to the
Results LIS when complete.
Auto-Send Invalid If selected, the instrument auto sends patient results
Adjustment flagged with an ADJ flag.
Auto-Send Invalid If selected, the instrument auto sends patient results if
Control the controls for an assay do not meet criteria configured
as single rule or multi rule in the QC Data Entry screen.
Auto-Send Invalid Range If selected, the instrument auto sends patient results
that are > or < the review range.
Auto Send Patient Patient results are sent to the LIS automatically without
Results operator intervention.
Exceptions to this may include the following:
Failed or overdue adjustment
Failed QC and single or multi-rules is active
Result is outside of Review Range
Invalid result, such as Calc Error
Baud Rate A field in the LIS Parameters screen that defines the
maximum allowable speed of LIS communication.
This information should be supplied by the LIS vendor.
Bi-Directional Orders are manually transmitted from the LIS to the
instrument and data is automatically transmitted from
the instrument to the LIS.
Bi-Directional Query Same as bi-directional but orders from the LIS are sent
automatically after sample tube barcodes are read by
the instrument.
COM Parameters A field in the LIS Parameters screen.
The IMMULITE systems support N81.
COM Port Another term commonly used to identify a serial port
on the system.
Diagnostics A field in the LIS Parameters screen that allows for a
communication log to be generated between the
instrument and the LIS for troubleshooting purposes.
On the IMMULITE 2000/XPi, replace the 0 in the
Diagnostics field with a 1 to activate the log. The log
should not be active during normal operation and
should only be changed at the direction of Technical
Service.
Display Controls on LIS QC orders and results will appear on the LIS Worklist
Screen screen.

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 Introduction

Screen Term Description

Hide Sent Defaults the Hide Sent/Show Sent button on the LIS
Worklist screen to Hide Sent.
Results sent to the LIS are removed from the LIS
Worklist screen.
Network Connection A port designed to use the RJ45 standard network cable
rather than the older DB9 serial port connector.
Network connections are typically not serial
communications.
No Re-query If an accession number is found in the instrument
database (pending or completed tests), the accession
number will not be re-queried to an LIS.
Password A password defined by the LIS software company.
This field may be left blank if desired.
Query Controls The instrument will request QC orders from the LIS
when a QC barcode is read on the Sample Carousel.
Receiver ID The identity of the system receiving a message.
For example, if IMMULITE is receiving a message, the
receiver ID may be displayed as IMMULITE.
If the LIS is receiving a message, the receiver ID may be
displayed as LIS. The data in this field is defined by the
LIS software company.
Re-query All Accession numbers are always requeried and duplicate
test orders are run.
Re-query New Orders Accession numbers are always requeried and duplicate
test orders are not run if that test is currently in
progress.
Sender ID The identity of the system sending a message; for
example, if the IMMULITE system is sending a message,
the sender ID may be displayed as IMMULITE.
If the LIS is sending a message, the sender ID may be
displayed as LIS.
The data in this field is defined by the LIS software
company.
Serial Port A field in the LIS Parameters screen that identifies which
serial port on the back of the user-side computer is
being used to transmit to and from the LIS via the
attached cable.
The LIS cable must be connected to the same numbered
port on the back of the instrument as the port number
configured on the LIS configuration screen.
Unidirectional Data is transmitted from the instrument to the LIS only.

Interface Specifications page 1 - 7

Introduction

LIS Worklist Screen Terms

LIS Screen Terms Description
Clear Permanently deletes selected records from the
instrument’s database. There is no way to recover the
lost data.
Note Never use this feature.
Hide Sent/Show Sent Hide Sent only displays un-sent results.
To view sent results, touch Hide Sent to toggle to the
button to Show Sent.
LIS Active/LIS Paused Toggles the LIS interface on or off.
When paused, no LIS communication occurs. When LIS
Active is chosen, any held LIS data is transmitted (if
Auto Send is configured).
Print List Prints all records listed in the order displayed.
Choose the Sort By button to change the display order.
Re-Send Re-transmits previously sent tagged records to the LIS.
Records that have been previously sent are gray and
have a status of Sent.
Send (Auto-Send) Transmits tagged records to the LIS if not previously
sent.
If Auto Send Patient Results is selected in
Configurations, this button is labeled Auto Send.
Sort By Displays options for sorting records that appear on the
screen.
Options include: All, Prior 24 Hr and Choose Date. The
order of display can also be chosen here.
Note Sorting is done by date and time the record is
created.
Tag All Tags (selects) all valid results (results without errors).
Button toggles to Un-Tag All when selected.

What Is an LIS?
A Laboratory Information System (LIS) is software that receives, processes,
and stores information generated by laboratory procedures. This system
often interfaces with instruments, and other information systems such as
hospital information systems (HIS).

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 Introduction

The three primary functions of an LIS system are test ordering, result
management and reporting, and billing. An LIS is comprised of complex
software applications that are customized to each laboratory’s current
policies and standard operating procedures. The laboratory provides the
information used to build the necessary tables and definitions, which are
first validated and then maintained.
An LIS has modular components, so that the laboratory can select the
appropriate modules. There are basic test ordering and billing modules,
and modules designed for specific lab disciplines, such as microbiology,
blood banking, and genetics testing. Some vendors offer all components;
others specialize in specific modules.
Sometimes you may see an LIS listed as a Laboratory Information
Management System (LIMS). A LIMS and an (LIS) perform similar functions.
The term LIMS is used to describe systems targeted toward environmental,
research or commercial analysis; such as pharmaceutical or petrochemical,
and the term LIS is used to describe systems targeted toward the clinical
market (hospitals and other clinical labs).
Laboratory Information Systems have impacted the way lab testing is
performed. Prior to an LIS, laboratory technologists were responsible for
writing down each test result, or keeping track of little slips of paper from
each instrument. Instruments directly interfaced with the LIS offer an
efficient method for accurate reporting of patient result data.

How Does an LIS Work?

The LIS is typically a centralized computer, but systems using a local area
network (LAN) of personal computers are common in smaller labs. The LIS
manages the basic information steps in laboratory operation. It provides
the functionality to order tests; enter test results, report the results, and bill
for the testing.
In its most basic form, an LIS is a big data collator. An LIS works just like any
other computer: data is entered as input and reports are generated as easy
to read output.

General Schematic of an LIS

A generic schematic of an LIS installation in a typical lab assumes multiple
technologists are operating instruments from several of the workstations.
A workstation is an LIS terminal or PC allowing the operator to work with
the LIS software.

Interface Specifications page 1 - 9

Introduction

Larger facility may use other configurations. For these facilities, fewer
workstations are used and the technologist would then accept results from
multiple instruments. Often, in larger more complex operations, the LIS
connects multiple sections within the lab. These could also be connected
to the internet and could also connect multiple off-site locations.

Summary of LIS Workflow Steps

This section provides how the LIS handles the workflow.

Order Entry
The order entered into the system contains the list of tests to be
performed. An almost universal requirement for using an LIS is to have a
unique accession number for each patient sample. A patient may have
multiple accession numbers, so you need a unique identifier for each
patient, as well. The unique identifier is usually called a medical record
number, patient ID (PID), or patient record number.
In addition, the LIS prints bar-coded labels, displaying the unique accession
number, for the draw tubes. In some cases, more advanced LIS products
provide a separate and unique identifier for each patient sample. This
provides the ability to track, at the sample level, the chain of custody from
the point it is taken from the patient to the point that it is discarded. The
sample-accession-patient hierarchy is linked in a tree-like numeric
structure.
The following steps illustrate how the LIS handles work orders:
1. The LIS creates work orders for patients or they may be transferred
from the HIS.
2. The LIS performs the following actions:
• Assigns accession numbers to patient samples
• Produces barcode labels
• Produces collection lists to facilitate sample collection
3. Work orders are downloaded to instruments.

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 Introduction

Sample Receiving
You can configure most LIS systems to download patient sample data to an
instrument either after the order is placed, or when a patient sample is
verified as received in the lab. When the bar-coded sample tube is read by
the instrument, the unique ID is read off the sample tube label and the
instrument matches it with the order.
1. If the instruments are configured for Uni-Directional communication,
the operator must input the order on the instrument.
Results are then sent to the LIS.
2. If configured for Bi-Directional batch communication, the operator
must request that the LIS send test orders to the instrument.
This is usually scheduled as a batch download.
3. If configured for Bi-Directional Query, the operator places the bar-
coded sample tubes onto the instrument.
When the instrument scans the sample tube barcodes, it sends a
message to the LIS asking for test orders for that accession number.
This is also called Host Query.
4. Patient samples are processed and results are uploaded from the
instruments to the LIS.

Results Entry/Verification
When results of lab tests are available, they are entered into the LIS
manually or automatically uploaded from an instrument if it is interfaced.
Results must be reviewed prior to their release. Typically, this review is
performed by a laboratory professional who verifies each result.
More recently, software has been developed that can verify results in the
same manner as a lab technologist would. This is done by constructing a
series of rules that are used to verify each test result. This software-based
approach is called autoverification and recent applications can use very
complex rule sets that incorporate patient information (age, sex,
diagnosis), as well as lab results. Once these results are double-checked or
verified, they are then released to the medical record.
Released results are often compiled and printed on patient-specific lab
reports and LIS patient records are updated with the result information.

Interface Specifications page 1 - 11

Introduction

Example Patient Report

As you can see from the example below, this patient had laboratory work
done on 3 consecutive dates with multiple tests run on 2 of these dates.
On February 2, she had 2 of the same tests run at different times. Each had
a different accession number.

St. CEC Hospital Laboratory Medical Dir: Dr. Robert Smith

Patient Name: Doe, Jane Medical Record Number: 2564786

Date Time Accession No. Tests Ordered

Jan. 31, 2006 08:00 T2456 CBC
Feb. 1, 2006 08:05 W3507 CBC
Feb. 1, 2006 10:00 W3515 Urinalysis
Feb. 1, 2006 08:05 W3524 Chem7
Feb. 2, 2006 07:00 H6546 CBC
Feb. 2, 2006 16:35 H6551 CBC-STAT
Feb. 3, 2006 07:00 F4496 H&H

Report Printed: Feb. 3, 2006 @23

How Do Instruments Communicate with an LIS?

Most laboratory instruments have the capacity to communicate with an
LIS. Just like a group of computers interconnected in a network,
instruments are networked or interfaced with an LIS. To create this
network, you must create an interface so the instrument’s computer can
interact with the LIS’ computer.
The interface is usually provided by the LIS vendor and comes at a cost to
the lab. The interface allows data to move back and forth between the LIS
and the instruments, carrying test orders for patient samples to the
instruments (linked to the accession number), and results from those test
orders back to the LIS (again, linked to the accession number).
Occasionally an LIS is not connected via a communications cable with any
instrument in a lab and, in this case, results would be entered manually.
Most are connected to every instrument and every lab department. LIS
terminals are commonly found on every bench top and near every
instrument.

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 Introduction

The interface can have several components:

• Physical
– Instrument has an active input/output port.
– The host computer (LIS) must have a corresponding I/O port
available.
– A connection cable is required from the instrument to the host
system.
• Hardware
– The instrument usually has a data management system.
– Sometimes intermediate devices are used between the instrument
and the connection to the host system.
These devices may include specialized interface workstations that
provide additional data management capability, commonly referred
to as middleware.
• Software
The main categories of system software used by all three components
(host LIS, the intermediate device, and the instrument) are operating
software and application software.
– Operating software controls basic machine functions; such as
interaction with the I/O devices, memory management, disk access,
and creating the application software environment.
– Application software provides all of the user-interface features and
functionality.
For the interface to perform smoothly, all of these elements must be
working in conjunction with each other. There can be issues with the
interface language used in communication. However, when problems
occur it is advisable to start with the most obvious possibility: the cable
connection.

Cable Specifications
The LIS vendor or the laboratory is responsible for the cable. The cable is
commonly an RS232 null modem cable with a DB9 (9-Pin) female
connector at the IMMULITE port or a network cable that is connected to the
the IMMULITE system with an RJ45-DB9 converter. More recently, standard
RJ45 network cables or USB-based cable connections are becoming more
widely used.

Interface Specifications page 1 - 13

Introduction

You can purchase the cable at an electronics store. Because

troubleshooting LIS errors may involve testing the cable, you should have
an extra cable available.
When using a serial (RS232) connection, the IMMULITE systems use these
connections:
• send on pin 3
• receive on pin 2
• use pin 5 as the ground

Figure 1: Serial RS232 Connection

1 Pin 5
2 Pin 3
3 Pin 2

Some common LIS communication errors may occur. The Troubleshooting

Section of this booklet describes these errors and actions that should be
taken to help troubleshoot the issue.

References
www.medtechnet.com/public_pdf/mtc16pdf.pdf
en.wikipedia.org/wiki/Laboratory_information_system

Lab Automation Configuration

Lab automation enables multiple instruments to send results using the
same data cable, and all of those results enter a single COM port in the LIS.
Therefore, since a single COM port receives results from multiple
instruments, the port number alone can no longer be used to uniquely
identify a specific instrument.

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 Introduction

The new method of instrument identification uses the actual data stream
itself to identify the instrument. Every time an IMMULITE system
communicates with the LIS, it sends a bulk of information other than just
the accession number and the result.
One of the data fields sent is the Instrument ID. This field has not been
used often in the past because both instrument and LIS vendors relied on
port numbers to identify the instrument.

Communication Protocol
To properly troubleshoot communication problems, it is important to know
what basic communication protocol is being used.

Protocol Description
Uni-Directional In this mode, the worklist is generated on the instrument, the
samples are run, and the results are uploaded to the LIS when
completed.
Patient data is only sent in one direction from the instrument to
the LIS. Refer to Chapter 4 for more information on the
operation of this software with uni-directional configurations.
Bi-Directional This mode provides bi-directional data transfer between the LIS
and the instrument.
A worklist is generated on the LIS and then batch downloaded
to the instrument. Samples are run and results are uploaded
from the instrument to the LIS when completed. Refer to
Chapter 5 for more information on the operation of this
software with bi-directional configurations.
Bi-Directional This mode also provides bi-directional data transfer between the
Query LIS and the instrument. Bar-coded samples are placed on the
instrument and interrogated. The instrument then sends a
query to the LIS to find out which tests are to be run. The
required test orders are then sent from the LIS to the
instrument. Samples are run and results are uploaded from the
instrument to the LIS when completed.

ASTM Handshaking
The IMMULITE systems are set-up to communicate with LIS systems via a
standard ASTM Handshaking protocol. Even with uni-directional
communication where data only travels from the instrument to the LIS,
ASTM handshaking is required. This protocol requires all data transactions
to include a query (to send) and an acknowledgement (to receive).

Interface Specifications page 1 - 15

Introduction

IMMULITE/LIS Messaging
Basic Message Hierarchy (Lower number has higher
priority)
Priority Message
1 Header
2 Patient
3 Order
4 Result

Hierarchy Example of LIS to IMMULITE Systems

Transfer

<ENQ>
Header
Patient 1
Order 1
Patient 2
Order 1
Order 2
Order 3
Patient 3
Order 1
Terminator
<EOT>

page 1 - 16 Interface Specifications

 Introduction

Hierarchy Example of IMMULITE to LIS Transfer

<ENQ>
Header
Patient 1
Order 1
Result 1
Patient 2
Order 1
Result 1
Order 2
Result 1
Order 3
Result 1
Patient 3
Order 1
Result 1
Terminator
<EOT>

Interface Specifications page 1 - 17

Introduction

Hierarchy Example of IMMULITE 2000/XPi to LIS

Transfer (Immunoassay)
<ENQ>
Header
Patient 1
Order 1
Result 1
Patient 2
Order 1
Result 1
Patient 3
Order 1
Result 1
Patient 4
Order 1
Result 1
Patient 5
Order 1
Result 1
Terminator
<EOT>

page 1 - 18 Interface Specifications

 Introduction

Hierarchy Example of IMMULITE 2000/XPi to

LIS Transfer (Allergy)
<ENQ>
Header
Patient 1
Order 1
Result 1
Result 2
Patient 2
Order 1
Result 1
Result 2
Patient 3
Order 1
Result 1
Result 2
Terminator
<EOT>

Hierarchy Example of Query to LIS

<ENQ>
Header
Query
Terminator
<EOT>

Interface Specifications page 1 - 19

Introduction

Hierarchy Example of Response to Query

<ENQ>
Header
Patient 1
Order 1
Order 2
Order 3
Terminator
<EOT>

Basic Format of a Message

[Start of Text <STX>][Frame Number][Message Type]
[Message][Carriage Return <CR>][End of Text <ETX>][CHECKSUM]
[Carriage Return <CR>][Line Feed <LF>]

Header Message
[Record Type (H)] [Delimiter Def.] [Message Control ID]
[Password] [Sending systems company name] [Sending Systems
address] [Reserved] [Senders Phone#] [Communication
parameters] [Receiver ID] [Comments/special instructions]
[Processing ID] [Version#] [Message Date + Time]
1H|\^&||PASSWORD|DPC||Flanders^New^Jersey^07836||973-927-
2828|N81|Your System||P|1|19940407120613<CR><ETX>[51
Checksum] <CR><LF>

page 1 - 20 Interface Specifications

 Introduction

Patient Message
[Record Type (P)][Sequence #][Practice Assigned Patient
ID][Laboratory Assigned Patient ID][Patient ID][Patient
Name][Mother's Maiden Name][BirthDate][Patient
Sex][Patient Race][Patient Address][Reserved][Patient
Phone #][Attending Physician ID][Special Field
1][Special Field 2][Patient Height][Patient
Weight][Patients Known or Suspected Diagnosis] [Patient
active medications][Patients Diet][Practice Field
#1][Practice Field #2][Admission and Discharge
Dates][Admission Status][Location][Nature of
Alternative Diagnostic Code and
Classification][Alternative Diagnostic Code and
Classification][Patient Religion][Marital
Status][Isolation Status][Language][Hospital
Service][Hospital Institution][Dosage Category]
2P|1|101|||Riker^Al||19611102|F|||||Bashere<CR><ETX>[2ACheck
Sum] <CR><LF>

Order Message
[Record Type (O)][Sequence#][Specimen ID
(Accession#)][Instrument Specimen ID][Universal Test
ID][Priority][Order Date/Time][Collection Date/
Time][Collection End Time][Collection
Volume][Collector ID][Action Code][Danger
Code][Relevant Clinical Info][Date/Time Specimen
Received][Specimen Descriptor,Specimen Type,Specimen
Source][Ordering Physician][Physician's Telephone
Number][User Field No.1][User Field No.2][Lab Field
No.1][Lab Field No.2][Date/Time results reported or
last modified][Instrument Charge to Computer
System][Instrument Section ID][Report Types][Reserved
Field][Location or ward of Specimen
Collection][Nosocomial Infection Flag][Specimen
Service][Specimen Institution]
3O|1|1550623||^^^LH|R|19931011091233|19931011091233
<CR><ETX>[6C Checksum] <CR><LF>

Interface Specifications page 1 - 21

Introduction

Result Message
[Record Type (R)][Sequence #][Universal Test ID][Data
(result)][Units][ReferenceRanges] [Result abnormal
flags][Nature of Abnormality Testing][Result
Status][Date of change in instruments normal values or
units][Operator ID][Date\Time Test Started][Date\Time
Test Completed][Instrument ID]
4R|1|^^^LH|8.2|mIU/
mL|.7\.7^400\400|N|N|F||test|19931011091233|1993101109
1233|DPC<CR><ETX>[8FCheckSum] <CR><LF>

Maximum Values for Database Fields Across

Instruments
IMMULITE
Record Type Field One 1000 2000 / XPi
Header LIS Password 15 15 10
LIS Receiver ID 15 15 10
LIS Sender ID 20 20 10
Patient Patient Last Name 20 30 Last & 30 Last &
First First
Patient First Name 15 n/a n/a
Patient Birth Date 8 8 8
Patient Sex 1 1 1
Physician Name 20 30 30
Patient ID 15 20 20
Order Specimen ID 20 20 20
(Accession #)
Test Type 6 6 6
Allergen Code n/a n/a n/a
Priority 1 1 1
Order Date/Time 14 14 14
Collection Date/ 14 14 14
Time

page 1 - 22 Interface Specifications

 Introduction

Transfer Examples of Bi-Directional and Uni-Directional,

IMMULITE 2000/XPi to LIS
Example 1
1H|\^&||DPC|IMMU01R|111 Canfield
Road^Randolph^NJ^07869||(201)927-
2828|N81|IMMU01S||P|1|20001108161627
E2
2P|1||||||||||||
0F
3O|1|00052111||^^^BMG|R|||||||||||||||||||E0872
45
4R|1|^^^BMG|>500|ng/
mL|0.30\0.30^500\500|>|N|F|||20001102140412|2000110
2144054|E0872
A7
5P|2|66412558|||||||||||
B8
6O|1|66412558||^^^HCG|||200011081530||||||Normal|||
||||||||E0872
CB
7R|1|^^^HCG|>5000|mIU/
mL|1.00\1.00^5000\5000|>|N|F|||20001108153251|20001
108160934|E0872
7E
0P|3||||||||||||
0F
1O|1|68031236||^^^TXQ|R|||||||||||||||||||E0872
7D
2R|1|^^^TXQ|<5.00|IU/
mL|5.00\5.00^250\250|<|N|F|||20001108112235|2000110
8123235|E0872
D3
3L|1
3C

Interface Specifications page 1 - 23

Introduction

Example 2
1H|\^&||DPC|IMMU01R|111 Canfield
Road^Randolph^NJ^07869||(201)927-
2828|N81|IMMU01S||P|1|20001107160944
E2
2P|1||||||||||||
0F
3O|1|09861081||^^^fPS|R|||||||||||||||||||E0872
8F
4R|1|^^^fPS|0.26|ng/
mL|0.05\0.05^25.0\25.0|N|N|F|||20001107051521|20001
107062514|E0872
4D
5P|2||||||||||||
13
6O|1|09861081||^^^PSA|R|||||||||||||||||||E0872
6D
7R|1|^^^PSA|0.28|ng/
mL|0.04\0.04^150\150|N|N|F|||20001104035557|2000110
4043253|E0872
D1
0P|3||||||||||||
0F
1O|1|09861081||^^^TSH|R|||||||||||||||||||E0872
73
2R|1|^^^TSH|0.602|uIU/
mL|0.400\0.002^4.00\75.0|N|N|F|||20001103035444|200
01103050438|E0872
FD
3L|1
3C

page 1 - 24 Interface Specifications

 Introduction

Example 3
1H|\^&||DPC|IMMU01R|111 Canfield
Road^Randolph^NJ^07869||(201)927-
2828|N81|IMMU01S||P|1|20001107162353
DE
2P|1||||||||||||
0F
3O|1|68552470||^^^DHS|R|||||||||||||||||||E0872
69
4R|1|^^^DHS|178|ug/
dL|30.0\30.0^1000\1000|N|N|F|||20001107115846|20001
107123532|E0872
F8
5L|1
3E
Example 4 (Allergy)
1H|\^&||DPC|IMMU01R|111 Canfield
Road^Randolph^NJ^07869||(201)927-
2828|N81|IMMU01S||P|1|20001107162353
A2
2P|1||||||||||||
0F
3O|1|Z00058364||^^^SPE E1|R|||||||||||||||||||F1420
4E
4R|1|^^^SPE E1|3.23|KU/
L|0.0\0.10^0.0\100|H|N|F|||20010619084600|200106190
95655|
F1420
85
5R|2|^^^SPE
E1|II|SCLASS||H|N|F|||20010619084600|20010619095655
|
F1420
F9

Interface Specifications page 1 - 25

Introduction

Example 4
[New Receive Session]
3/21/05 2:29:21 PM 52161.91
[R] <ENQ>
3/21/05 2:29:21 PM 52161.91
[S] <ACK>
3/21/05 2:29:22 PM 52162.04
[R] _1H|\^&||MARY|MISYS|||||PATH||P|1
_B5
3/21/05 2:29:22 PM 52162.04
[S] <ACK>
3/21/05 2:29:22 PM 52162.22
[R] _2P|1|E05002027|E05002027||Doe^Jane
_25
3/21/05 2:29:22 PM 52162.22
[S] <ACK>
3/21/05 2:29:22 PM 52162.34
[R] _3O|1|E05002027||^^^sPS|R
_86
3/21/05 2:29:22 PM 52162.39
[S] <ACK>
3/21/05 2:29:22 PM 52162.48
[R] _4L|1|F
_FF
3/21/05 2:29:22 PM 52162.48
[S] <ACK>
3/21/05 2:29:22 PM 52162.54
[R] <EOT>
[New Send Session]
3/21/05 2:29:22 PM 52162.55
[S] <ENQ>
3/21/05 2:29:22 PM 52162.63
[R] <ACK>
3/21/05 2:29:22 PM 52162.63

page 1 - 26 Interface Specifications

 Introduction

[S] _1H|\^&||MARY|PATH|111 Canfield

Ave^Randolph^NJ^07869||(201)927-
2828|N81|MISYS||P|1|20050321142922
_2D
3/21/05 2:29:22 PM 52162.8
[R] <ACK>
3/21/05 2:29:22 PM 52162.8
[S] _2Q|1|^E05002038||ALL||||||||O
_F1
3/21/05 2:29:22 PM 52162.86
[R] <ACK>
3/21/05 2:29:22 PM 52162.86
[S] _3L|1
_3C
3/21/05 2:29:22 PM 52162.95
[R] <ACK>
3/21/05 2:29:22 PM 52162.95
[S] <EOT>

Host Query Example, Query to LIS

1H|\^&||PASSWORD|DPC||Randolph^New^Jersey^07869||(2
01)927-2828|N81|Your System||P|1|19940407120613
51
2Q|1|^123ABC||ALL||||||||O
76
3L|1
3C

Interface Specifications page 1 - 27

Introduction

page 1 - 28 Interface Specifications

 IMMULITE Interface to LIS

2 IMMULITE Interface to LIS

2IMMULITE Interface to LIS

Configuring the IMMULITE System . . . . . . . . . . . . . . . . . . . 2-1
Required Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Qualitative Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Upload/Download Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
IMMULITE Bi-Directional LIS Specification ASTM E1394 . . 2-3
Bi-Directional Transfer Example, IMMULITE System
to LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Header Record Definition (7.1–7.1.14). . . . . . . . . . . . . . . . . . . . .2-6
Sample Header Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
(7.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
(7.1.2) Delimiter Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
(7.1.3) Message Control ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
(7.1.4) Access Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
(7.1.5) Sender Name or ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
(7.1.6) Sender Street Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.7) Reserved Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.8) Senders Telephone Number. . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.9) Characteristics of Sender . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.10) Receiver ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.11) Comments/ Special Instructions. . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.12) Processing ID Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.13) Version Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
(7.1.14) Date + Time of Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Patient Information Record Definition (8.1–8.1.35). . . . . . . . . . .2-8
Sample Patient Information Record . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
(8.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
(8.1.2) Sequence # Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
(8.1.3) Practice Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
(8.1.4) Laboratory Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . .2-8
(8.1.5) Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
(8.1.6) Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
(8.1.7) Mother's Maiden Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
(8.1.8) Birthdate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
(8.1.9) Patient's Sex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
(8.1.10) Patient Race-Ethnic Origin . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
(8.1.11) Patient's Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
(8.1.12) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Interface Specifications page 2-i

IMMULITE Interface to LIS

(8.1.13) Patient's Phone# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

(8.1.14) Attending Physician ID (Last Name Only) . . . . . . . . . . . . . . 2-9
(8.1.15) Special Field 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
(8.1.16) Special Field 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
(8.1.17) Patient Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
(8.1.18) Patient Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
(8.1.19) Known or Suspected Diagnosis . . . . . . . . . . . . . . . . . . . . . . . 2-9
(8.1.20) Active Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.21) Patient's Diet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.22) Practice Field 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.23) Practice Field 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.24) Admission and Discharge Dates . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.25) Admission Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.26) Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.27) Nature of Alt. Diag. Code. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.28) Alt. Diag. Code and Classifications . . . . . . . . . . . . . . . . . . . 2-10
(8.1.29) Patient Religion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.30) Marital Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.31) Isolation Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.32) Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
(8.1.33) Hospital Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
(8.1.34) Hospital Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
(8.1.35) Dosage Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Order Record Definition (9.4.1–9.4.31) . . . . . . . . . . . . . . . . . . 2-11
Sample Test Order Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
(9.4.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
(9.4.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
(9.4.3) Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
(9.4.4) Instrument Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.5) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.7) Requested/Ordered Date and Time . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.8) Specimen Collection Date and Time . . . . . . . . . . . . . . . . . . . 2-12
(9.4.9) Collection End Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.10) Collection Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.11) Collector ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.12) Action Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.13) Danger Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
(9.4.14) Relevant Clinical Information . . . . . . . . . . . . . . . . . . . . . . . 2-13
(9.4.15) Date/Time Specimen Received . . . . . . . . . . . . . . . . . . . . . . 2-13
(9.4.16) Specimen Descriptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
(9.4.16.1) Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
(9.4.17) Ordering Physician. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
(9.4.18) Physician's Telephone Number . . . . . . . . . . . . . . . . . . . . . . 2-13

page 2-ii Interface Specifications

 IMMULITE Interface to LIS

(9.4.19) Users Field No. 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

(9.4.20) Users Field No. 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
(9.4.21) Lab Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
(9.4.22) Lab Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
(9.4.23) Date/Time Results Reported . . . . . . . . . . . . . . . . . . . . . . . . .2-13
(9.4.24) Instrument Charge to Computer Sys. . . . . . . . . . . . . . . . . .2-13
(9.4.25) Instrument Section ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
(9.4.26) Report Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
(9.4.27) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
(9.4.28) Location of Specimen Collection . . . . . . . . . . . . . . . . . . . . .2-14
(9.4.29) Nosocomial Infection Flag . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
(9.4.30) Specimen Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
(9.4.31) Specimen Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Result Record Definition (10.1–10.1.14) . . . . . . . . . . . . . . . . . .2-14
Sample Result Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
(10.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
(10.1.2) Sequence #. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
(10.1.3) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
(10.1.4) Data or Measurement Value (Result) . . . . . . . . . . . . . . . . . .2-15
(10.1.5) Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
(10.1.6) Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
(10.1.7) Result Abnormal Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
(10.1.8) Nature of Abnormality Testing . . . . . . . . . . . . . . . . . . . . . .2-16
(10.1.9) Results Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
(10.1.10) Date Systems Values/Units Changed . . . . . . . . . . . . . . . . .2-17
(10.1.11) Operator Name/ID# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
(10.1.12) Date+Time Test Started . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
(10.1.13) Date+Time Test Completed . . . . . . . . . . . . . . . . . . . . . . . .2-17
(10.1.14) Instrument ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
Request Information Record Definition (Host Query)
(12.1–12.1.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
Example Request Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
(12.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
(12.1.2) Sequence Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17
(12.1.3) Starting Range ID Number . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.4) Ending Range ID Number. . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.5) Universal Test ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.6) Request Time Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.7) Beginning Request Results . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.8) Ending Request Results . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.9) Physician Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.10) Physician Phone # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
(12.1.11) User field #1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Interface Specifications page 2-iii

IMMULITE Interface to LIS

(12.1.12) User field #2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

(12.1.13) Request Information Status Codes . . . . . . . . . . . . . . . . . . 2-19
Message Terminator Record Definition (13.1–13.1.3) . . . . . . . 2-19
(13.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
(13.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
(13.1.3) Termination Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
IMMULITE Uni-Directional LIS Specification
ASTM E1394. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Uni-Directional Transfer Example, IMMULITE System
to LIS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Header Record Definition (7.1–7.1.14) . . . . . . . . . . . . . . . . . 2-22
Sample Header Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
(7.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
(7.1.2) Delimiter Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
(7.1.3) Message Control ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
(7.1.4) Access Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
(7.1.5) Sender Name or ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
(7.1.6) Sender Street Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
(7.1.7) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
(7.1.8) Senders Telephone Number . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
(7.1.9) Characteristics of Sender . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
(7.1.10) Receiver ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
(7.1.11) Comments/Special Instructions . . . . . . . . . . . . . . . . . . . . . . 2-23
(7.1.12) Processing ID Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
(7.1.13) Version Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
(7.1.14) Date+Time of Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Patient Information Record Definition (8.1–8.1.35) . . . . . . . . . 2-24
Sample Patient Information Record. . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
(8.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
(8.1.2) Sequence # Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
(8.1.3) Practice Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
(8.1.4) Laboratory Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . 2-24
(8.1.5) Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
(8.1.6) Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
(8.1.7) Mother's Maiden Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.8) Birthdate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.9) Patient's Sex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.10) Patient Race-Ethnic Origin . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.11) Patient's Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.12) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.13) Patient's Phone# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.14) Attending Physician ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
(8.1.15) Special Field 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

page 2-iv Interface Specifications

 IMMULITE Interface to LIS

(8.1.16) Special Field 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25

(8.1.17) Patient Height. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25
(8.1.18) Patient Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25
(8.1.19) Known or Suspected Diagnosis . . . . . . . . . . . . . . . . . . . . . .2-25
(8.1.20) Active Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.21) Patient's Diet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.22) Practice Field 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.23) Practice Field 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.24) Admission and Discharge Dates. . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.25) Admission Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.26) Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.27) Nature of Alt. Diag. Code . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.28) Alt. Diag. Code and Classifications. . . . . . . . . . . . . . . . . . . .2-26
(8.1.29) Patient Religion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.30) Marital Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.31) Isolation Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.32) Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26
(8.1.33) Hospital Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27
(8.1.34) Hospital Institution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27
(8.1.35) Dosage Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27
Order Record Definition (9.4.1–9.4.31) . . . . . . . . . . . . . . . . . . .2-27
Sample Test Order Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27
(9.4.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27
(9.4.2)Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27
(9.4.3) Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27
(9.4.4) Instrument Specimen ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.5) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.6) Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.7) Requested/Ordered Date and Time . . . . . . . . . . . . . . . . . . . .2-28
(9.4.8) Specimen Collection Date and Time . . . . . . . . . . . . . . . . . . .2-28
(9.4.9) Collection End Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.10) Collection Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.11) Collector ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.12) Action Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.13) Danger Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.14) Relevant Clinical Information . . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.15) Date/Time Specimen Received . . . . . . . . . . . . . . . . . . . . . . .2-28
(9.4.16) Specimen Descriptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29
(9.4.16.1) Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29
(9.4.17) Ordering Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29
(9.4.18) Physician's Telephone Number . . . . . . . . . . . . . . . . . . . . . .2-29
(9.4.19) Users Field No. 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29
(9.4.20) Users Field No. 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29

Interface Specifications page 2-v

IMMULITE Interface to LIS

(9.4.21) Lab Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

(9.4.22) Lab Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
(9.4.23) Date/Time Results Reported. . . . . . . . . . . . . . . . . . . . . . . . . 2-29
(9.4.24) Instrument Charge to Computer Sys . . . . . . . . . . . . . . . . . . 2-29
(9.4.25) Instrument Section ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
(9.4.26) Report Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
(9.4.27) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
(9.4.28) Location of Specimen Collection . . . . . . . . . . . . . . . . . . . . . 2-30
(9.4.29) Nosococmial Infection Flag . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
(9.4.30) Specimen Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
(9.4.31) Specimen Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
Result Record Definition (10.1–10.1.14) . . . . . . . . . . . . . . . . . 2-30
Sample Result Message: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
(10.1.1) Record Types Definition- . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
(10.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
(10.1.3) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
(10.1.4) Data or Measurement Value (Result) . . . . . . . . . . . . . . . . . 2-31
(10.1.5) Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
(10.1.6) Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
(10.1.7) Result Abnormal Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
(10.1.8) Nature of Abnormality Testing . . . . . . . . . . . . . . . . . . . . . . 2-32
(10.1.9) Results Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
(10.1.10) Date Systems Values/Units Changed. . . . . . . . . . . . . . . . . 2-33
(10.1.11) Operator Name/ID# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
(10.1.12) Date+Time Test Started . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
(10.1.13) Date+Time Test Completed . . . . . . . . . . . . . . . . . . . . . . . . 2-33
(10.1.14) Instrument ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Request Information Record (12.1–12.1.13) . . . . . . . . . . . . . . 2-33
Message Terminator Record Definition (13.1–13.1.3) . . . . . . . 2-33
Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
(13.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
(13.1.3) Termination Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
IMMULITE LIS Error Message Definitions . . . . . . . . . . . . . 2-34

page 2-vi Interface Specifications

IMMULITE Interface to LIS

Configuring the IMMULITE System

The IMMULITE systemhas the following limitations when communicating
with an LIS:
• Cannot auto-send results.
• Cannot re-send a sent result.
Results are cleared from the LIS screen after sending them to an LIS.
To set up a connection between the IMMULITE system and an LIS, follow
these steps:
1. Connect the Cable.
Refer to Cable Specifications, page 1-13. The LIS cable is connected to
serial port 2 of the IMMULITE computer.
Use COM Port 2 on the back of the user-side computer.
2. Configure LIS Parameters:
a. At the Start screen, select LIS Parms.
The LIS Params screen password is CONNECT.
b. Select Yes for either Unidirectional or Host Query, but not both.
Do not select Yes for Unidirectional if you select Yes for Host Query
or the LIS will send test orders. If you select No for both Uni-
directional and Host Query, communication will be batch bi-
directional. Refer to Sample Receiving, page 1-11.

Field Details
Activate LIS Y or N, select Y(es) to activate
Activate Host Query Y or N, select Y(es) to activate
Activate Uni-Directional Y or N, select Y(es) to send results only
Password LIS Vendor to provide
Sender ID LIS Vendor to provide
Receiver ID LIS Vendor to provide
Baud Rate LIS Vendor to provide, usually 9600

3. Test the Communication:

a. Run sample tube(s) after activating the LIS feature.
b. Tag and send results from the LIS Data Management screen.
• IMMULITE system cannot auto-send results to the LIS.
Interface Specifications page 2 - 1
IMMULITE Interface to LIS

• Results can be sent to the LIS only once (no re-send option is
available).
• Results are successfully sent to the LIS if no errors occur and the
results are removed from the LIS Data Management screen.
4. Test IMMULITE Host Query (if applicable):
a. Enter sample cup number.
b. Use hand-held scanner to scan in accession number.
If you have entered the patient name, it should populate the
screen.
c. Load patient sample in specified cup number and run.
d. Results display in the LIS Data Management screen.
If any LIS errors display, contact Technical Service.
5. Manage Results:
a. Results must be tagged and sent to the LIS (no auto-send option is
present on the IMMULITE system).
b. Results are cleared from the LIS screen after sending to the LIS and
cannot be re-sent.
c. Results are sent using floating decimals as follows:

Result # Decimal Places Sent Example

less than 1.00* 2 0.45
1.00–9.99 2 1.23
10.0–99.9 1 10.2
100 and above None 102
* Results for some assays (including third generation such as TSH and RTH) are
reported with three decimal places if the result is less than 1.00.

Required Flags
Required flags include > and <. H, L, and N flags are supported but not
required. You must use the pipe ( | ) character if H, L, and N flags are not
included. Refer to (10.1.7) Result Abnormal Flags, page 2-32.
Greater than (>) and less than (<) calibration range results are sent as
follows:
0R|1|^^^TSH|75.0|uIU/
mL|.4\.002^4\75|>|N|F||test|19940407085044|19940407
085148|Siemens
• 75.0 is the Assay Max
• > is the Result Flag

page 2 - 2 Interface Specifications

 IMMULITE Interface to LIS

Qualitative Tests
Qualitative tests result as Reactive, Non-Reactive or Indeterminate, and are
sent to the LIS as follows:

Result Sent to LIS as

Non-reactive 0
Reactive 1
Indeterminate 2

Upload/Download Codes
Siemens Test Codes are used for upload and download codes and can be
found in Assay package inserts. This is a 2–3-digit test code found on the
package insert.

IMMULITE Bi-Directional LIS Specification ASTM E1394

Bi-Directional Transfer Example, IMMULITE System
to LIS
1H|\^&||PASSWORD|SenderID|Randolph^New^Jersey^07869
||(201)927-2828|8N1|ReceiverID||P|1|19950522092817
6F
2P|1|119813;TGH|||Last 1^First 1|||F|||||
46
3O|1|130000445||^^^TT4|||19950118085700
B4
4R|1|^^^TT4|10.3|ug/
dL|4.5\.4^12.5\24|N|N|F||test|19950119084508|199501
19092826|SenderID
0B
5O|2|130000445||^^^TU|||19950118085700
84
6R|1|^^^TU|26.6|Percnt|23\10^35\70|N|N|F||test|1995
0119084508|19950119092756|SenderID
07
7P|2|325031;AH|||Last 2^First 2|||F|||||
EB
0O|1|130000617||^^^FER|||19950118103000
A3

Interface Specifications page 2 - 3

IMMULITE Interface to LIS

1R|1|^^^FER|173.|ng/
mL|.5\.5^1500\1500|N|N|F||test|19950119084641|19950
119092858|SenderID
42
2P|3|326829;AH|||Last 3^First 3|||F|||||
F9
3O|1|130000722||^^^FER|||19950118102000
A2
4R|1|^^^FER|490.|ng/
mL|.5\.5^1500\1500|N|N|F||test|19950119084741|19950
119092928|SenderID
46
5P|4|124462;TGH|||Last 4^First 4|||F|||||
4E
6O|1|130000724||^^^E2|||19950118122000
43
7R|1|^^^E2|25.3|pg/
mL|12\12^2000\2000|N|N|F||test|19950119084815|19950
119100049|SenderID
CC
0O|2|130000724||^^^FSH|||19950118122000
A8
1R|1|^^^FSH|60.6|mIU/
mL|.1\.1^170\170|N|N|F||test|19950119084815|1995011
9093030|SenderID
0B
2O|3|130000724||^^^LH|||19950118122000
5E
3R|1|^^^LH|24.4|mIU/
mL|.7\.7^400\400|N|N|F||test|19950119084815|1995011
9093101|SenderID
C1
4P|5|556395;AH|||Last 5^First 5|||M|||||
0B
5O|1|130000741||^^^FER|||19950118115500
AE
6R|1|^^^FER|238.|ng/
mL|.5\.5^1500\1500|N|N|F||test|19950119084949|19950
119093132|SenderID

page 2 - 4 Interface Specifications

 IMMULITE Interface to LIS

46
7P|6|556357;MB|||Last 6^First 6|||M|||||
15
0O|1|130000790||^^^IGE|||19950118120000
9C
1R|1|^^^IGE|517.|IU/
mL|.01\.01^600\600|N|N|F||test|19950119085018|19950
119093202|SenderID
EC
2P|7|141053;TGH|||Last 7^First 7|||F|||||
4F
3O|1|130000805||^^^FER|||19950118120000
A4
4R|1|^^^FER|21.0|ng/
mL|.5\.5^1500\1500|N|N|F||test|19950119085049|19950
119093233|SenderID
34
5P|8|320439;TGH|||Last 8^First 8|||F|||||
5C
6O|1|130000890||^^^FER|||19950118130000
AC
7R|1|^^^FER|12.9|ng/
mL|.5\.5^1500\1500|N|N|F||test|19950119085254|19950
119093609|SenderID
45
0P|9||||Last 9^First 9||||||||
C1
1O|1|130000911||^^^E2
01
2R|1|^^^E2|71.3|pg/
mL|12\12^2000\2000|N|N|F||test|19950119085423|19950
119100800|SenderID
BF
3P|10|358069;TGH|||Last 10^First 10|||F|||||
DF
4O|1|130000929||^^^FER|||19950118123000
AF

Interface Specifications page 2 - 5

IMMULITE Interface to LIS

5R|1|^^^FER|219.|ng/
mL|.5\.5^1500\1500|N|N|F||test|19950119085628|19950
119093843|SenderID
48
6L|1
3A

Header Record Definition (7.1–7.1.14)

[Record Type (H)] [Delimiter Def.] [Message Control
ID] [Password] [Sending systems company name]
[Sending Systems address] [Reserved] [Senders
Phone#] [Communication parameters] [Receiver ID]
[Comments/special instructions] [Processing ID]
[Version#] [Message Date + Time]

Sample Header Message

<STX>[FrameNumber]H|\^&||Password|Siemens|Randolph^
New^Jersey^07869||(201)927-
2828|8N1|YourSystem||P|1|19940323082858
<CR><ETX>[CheckSum]<CR><LF>

(7.1.1) Record Types Definition

Letter Record Type Status

H Header Record REQUIRED

(7.1.2) Delimiter Definition

Symbol Record Type Status

¦ Field Delimiter REQUIRED
\ Repeat Delimiter REQUIRED
^ Component Delimiter REQUIRED
& Escape Delimiter DEFINED, NOT SUPPORTED

(7.1.3) Message Control ID

NOT SUPPORTED

(7.1.4) Access Password

REQUIRED (Configurable in LIS Param screen; Maximum of 15 characters)

(7.1.5) Sender Name or ID

REQUIRED (Configurable in LIS Param screen; Maximum of 20 characters)

page 2 - 6 Interface Specifications

 IMMULITE Interface to LIS

(7.1.6) Sender Street Address

SUPPORTED

(7.1.7) Reserved Field

NOT SUPPORTED

(7.1.8) Senders Telephone Number

SUPPORTED

(7.1.9) Characteristics of Sender

SUPPORTED (8 bits No Parity 1 Stop Bit)

(7.1.10) Receiver ID
REQUIRED (Configurable in LIS Param screen; Maximum of 15 characters)

(7.1.11) Comments/ Special Instructions

NOT SUPPORTED

(7.1.12) Processing ID Definition

Letter Record Type Status

P Normal production/running message SUPPORTED
T Training message NOT SUPPORTED
D Debugging, used to debug a program(s). NOT SUPPORTED
Q Message is for QC/regulatory purposes. NOT SUPPORTED

(7.1.13) Version Number

SUPPORTED (Currently 1)

(7.1.14) Date + Time of Message

SUPPORTED (YYYYMMDDHHMMSS)

Interface Specifications page 2 - 7

IMMULITE Interface to LIS

Patient Information Record Definition (8.1–8.1.35)

[Record Type (P)][Sequence #][Practice Assigned
Patient ID][Laboratory Assigned Patient ID][Patient
ID][Patient Name][Mother's Maiden
Name][BirthDate][Patient Sex][Patient Race][Patient
Address][Reserved][Patient Phone #][Attending
Physician ID][Special Field 1][Special Field
2][Patient Height][Patient Weight][Patients Known
or Suspected Diagnosis] [Patient active
medications][Patients Diet][Practice Field
#1][Practice Field #2][Admission and Discharge
Dates][Admission Status][Location][Nature of
Alternative Diagnostic Code and
Classification][Alternative Diagnostic Code and
Classification][Patient Religion][Marital
Status][Isolation Status][Language][Hospital
Service][Hospital Institution][Dosage Category]

Sample Patient Information Record

<STX>[FrameNumber]P|1|101|||Riker^Al||19611102|F|||
||Bashere<CR><ETX>[CheckSum]<CR><LF>

(8.1.1) Record Types Definition

Letter Record Type Status

P Patient Identity Record REQUIRED

(8.1.2) Sequence # Definition

REQUIRED

(8.1.3) Practice Assigned Patient ID

REQUIRED (maximum of 15 characters)

(8.1.4) Laboratory Assigned Patient ID

NOT SUPPORTED

(8.1.5) Patient ID
NOT SUPPORTED

(8.1.6) Patient Name

SUPPORTED (Last^First^Initial; Maximum of 20 characters for Last Name;
Maximum of 15 characters for First Name)

page 2 - 8 Interface Specifications

 IMMULITE Interface to LIS

(8.1.7) Mother's Maiden Name

NOT SUPPORTED

(8.1.8) Birthdate
SUPPORTED (YYYYMMDD; Maximum of 8 characters)

(8.1.9) Patient's Sex

SUPPORTED (M or F; maximum of 1 character)

(8.1.10) Patient Race-Ethnic Origin

NOT SUPPORTED

(8.1.11) Patient's Address

NOT SUPPORTED

(8.1.12) Reserved Field

NOT SUPPORTED

(8.1.13) Patient's Phone#

NOT SUPPORTED

(8.1.14) Attending Physician ID (Last Name Only)

SUPPORTED (Maximum of 20 characters)

(8.1.15) Special Field 1

NOT SUPPORTED

(8.1.16) Special Field 2

NOT SUPPORTED

(8.1.17) Patient Height

NOT SUPPORTED

(8.1.18) Patient Weight

NOT SUPPORTED

(8.1.19) Known or Suspected Diagnosis

NOT SUPPORTED

Interface Specifications page 2 - 9

IMMULITE Interface to LIS

(8.1.20) Active Medications

NOT SUPPORTED

(8.1.21) Patient's Diet

NOT SUPPORTED

(8.1.22) Practice Field 1

NOT SUPPORTED

(8.1.23) Practice Field 2

NOT SUPPORTED

(8.1.24) Admission and Discharge Dates

NOT SUPPORTED

(8.1.25) Admission Status

NOT SUPPORTED

(8.1.26) Location
NOT SUPPORTED

(8.1.27) Nature of Alt. Diag. Code

NOT SUPPORTED

(8.1.28) Alt. Diag. Code and Classifications

NOT SUPPORTED

(8.1.29) Patient Religion

NOT SUPPORTED

(8.1.30) Marital Status

NOT SUPPORTED

(8.1.31) Isolation Status

NOT SUPPORTED

(8.1.32) Language
NOT SUPPORTED

page 2 - 10 Interface Specifications

 IMMULITE Interface to LIS

(8.1.33) Hospital Service

NOT SUPPORTED

(8.1.34) Hospital Institution

NOT SUPPORTED

(8.1.35) Dosage Category

NOT SUPPORTED

Order Record Definition (9.4.1–9.4.31)

[Record Type (O)][Sequence#][Specimen ID
(Accession#)][Instrument Specimen ID][Universal
Test ID][Priority][Order Date/Time][Collection
Date/Time][Collection End Time][Collection
Volume][Collector ID][Action Code][Danger
Code][Relevant Clinical Info][Date/Time Specimen
Received][Specimen Descriptor,Specimen
Type,Specimen Source][Ordering
Physician][Physician's Telephone Number][User Field
No.1][User Field No.2][Lab Field No.1][Lab Field
No.2][Date/Time results reported or last
modified][Instrument Charge to Computer
System][Instrument Section ID][Report
Types][Reserved Field][Location or ward of Specimen
Collection][Nosocomial Infection Flag][Specimen
Service][Specimen Institution]

Sample Test Order Message

<STX>[FrameNumber]O|1|1550623||^^^LH|R|199310110912
33|19931011091233<CR><ETX>[CheckSum]<CR><LF>

(9.4.1) Record Types Definition

Letter Record Type Status

O Test Order Record REQUIRED

(9.4.2) Sequence #
REQUIRED

(9.4.3) Specimen ID
REQUIRED (accession # on primary tube; Maximum of 20 characters)

Interface Specifications page 2 - 11

IMMULITE Interface to LIS

(9.4.4) Instrument Specimen ID

NOT SUPPORTED

(9.4.5) Universal Test ID

REQUIRED
(Maximum of 6 characters)
(^^^[Test Code])
Example Test Codes:
TSH, LH, FSH, DGX, T4, HCG, TU, RTH, T3, FER, PSA, PAP

(9.4.6) Priority SUPPORTED

(Maximum of 1 character)
S Stat
A As soon as possible
R Routine
C Callback
P Preoperative

(9.4.7) Requested/Ordered Date and Time

SUPPORTED (YYYYMMDDHHMMSS; Maximum of 14 characters)

(9.4.8) Specimen Collection Date and Time

SUPPORTED (Maximum of 14 characters)

(9.4.9) Collection End Time

NOT SUPPORTED

(9.4.10) Collection Volume

NOT SUPPORTED

(9.4.11) Collector ID
NOT SUPPORTED

(9.4.12) Action Code

NOT SUPPORTED

(9.4.13) Danger Code

NOT SUPPORTED

page 2 - 12 Interface Specifications

 IMMULITE Interface to LIS

(9.4.14) Relevant Clinical Information

NOT SUPPORTED

(9.4.15) Date/Time Specimen Received

NOT SUPPORTED

(9.4.16) Specimen Descriptor

NOT SUPPORTED

(9.4.16.1) Specimen Type

NOT SUPPORTED

(9.4.17) Ordering Physician

NOT SUPPORTED

(9.4.18) Physician's Telephone Number

NOT SUPPORTED

(9.4.19) Users Field No. 1

NOT SUPPORTED

(9.4.20) Users Field No. 2

NOT SUPPORTED

(9.4.21) Lab Field No. 1

NOT SUPPORTED

(9.4.22) Lab Field No. 2

NOT SUPPORTED

(9.4.23) Date/Time Results Reported

NOT SUPPORTED

(9.4.24) Instrument Charge to Computer Sys.

NOT SUPPORTED

(9.4.25) Instrument Section ID

NOT SUPPORTED

Interface Specifications page 2 - 13

IMMULITE Interface to LIS

(9.4.26) Report Types

NOT SUPPORTED

(9.4.27) Reserved Field

NOT SUPPORTED

(9.4.28) Location of Specimen Collection

NOT SUPPORTED

(9.4.29) Nosocomial Infection Flag

NOT SUPPORTED

(9.4.30) Specimen Service

NOT SUPPORTED

(9.4.31) Specimen Institution

NOT SUPPORTED

Result Record Definition (10.1–10.1.14)

[Record Type (R)][Sequence #][Universal Test
ID][Data (result)][Units][ReferenceRanges] [Result
abnormal flags][Nature of Abnormality
Testing][Result Status][Date of change in
instruments normal values or units][Operator
ID][Date\Time Test Started][Date\Time Test
Completed][Instrument ID]

Sample Result Message

<STX>[FrameNumber]R|1|^^^LH|8.2|mIU/
mL|.7\.7^400\400|N|N|F||test|19931011091233|1993101
1091233|Siemens<CR><ETX>[CheckSum]<CR><LF>

(10.1.1) Record Types Definition

Letter Record Type Status

R Result Record REQUIRED

(10.1.2) Sequence #
REQUIRED

page 2 - 14 Interface Specifications

 IMMULITE Interface to LIS

(10.1.3) Universal Test ID

Note For Universal Test ID, only the Record Types Definition status reads
as Partially Supported or Required. Under Order Types Definition, Universal
Test ID status is Required.
PARTIALLY SUPPORTED / REQUIRED (^^^[Test Code])
Example Test Codes:
TSH, LH, FSH, DGX, T4, HCG, TU, RTH, T3, FER, PSA, PAP

(10.1.4) Data or Measurement Value (Result)

REQUIRED

(10.1.5) Units
REQUIRED Current Siemens Units of Measure: ng/mL, ng/dL, µg/dL, µIu/mL,
mIU/mL, pg/mL, nmol/L, pmol/L, mIU/L, µg/L, IU/mL, IU/L

(10.1.6) Reference Ranges

SUPPORTED ([Low]\[Panic\Low]^[High]\[Panic High])

Interface Specifications page 2 - 15

IMMULITE Interface to LIS

(10.1.7) Result Abnormal Flags

Letter Record Type Status

L Below Normal SUPPORTED
H Above Normal SUPPORTED
LL Below Panic NOT SUPPORTED
HH Above Panic NOT SUPPORTED
< Below readable limit REQUIRED
> Above readable limit REQUIRED
N Normal SUPPORTED
A Abnormal NOT SUPPORTED
U Significant change UP NOT SUPPORTED
D Significant change DOWN NOT SUPPORTED
B Better NOT SUPPORTED
W Worse NOT SUPPORTED

(10.1.8) Nature of Abnormality Testing

Letter Record Type Status

A Age population tested NOT SUPPORTED
S Sex based Population NOT SUPPORTED
R Race based Population NOT SUPPORTED
N Normal generic range SUPPORTED

(10.1.9) Results Status

Letter Record Type Status

C Correction of previously sent results NOT SUPPORTED
P Preliminary Results NOT SUPPORTED
F Final Results SUPPORTED
X Results cannot be done. NOT SUPPORTED
For example, Calculation Error
I In instrument, results pending NOT SUPPORTED
S Partial Results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED
R This result was previously transmitted SUPPORTED
N This result record contains necessary NOT SUPPORTED
information to run a new order.

page 2 - 16 Interface Specifications

 IMMULITE Interface to LIS

(10.1.10) Date Systems Values/Units Changed

NOT SUPPORTED

(10.1.11) Operator Name/ID#

SUPPORTED

(10.1.12) Date+Time Test Started

SUPPORTED
(YYYYMMDDHHMMSS)

(10.1.13) Date+Time Test Completed

SUPPORTED
(YYYYMMDDHHMMSS)

(10.1.14) Instrument ID
SUPPORTED
(Configurable From Siemens 'KIT' Program)

Request Information Record Definition (Host Query)

(12.1–12.1.13)
[Record Type ID (Q)][Sequence #][Starting
Range][Ending Range][Test ID][Request Time
Limits][Beginning request results date and
time][Ending request results date and
time][Physician name][Physician Phone Number][User
Field 1]User Field 2][Status Codes]

Example Request Record

<STX>[FrameNumber]Q|1|^1234ABC||ALL|||||||O<CR>
<ETX> [CheckSum]<CR><LF>

(12.1.1) Record Types Definition

Letter Record Type Status

Q Request Information Record. SUPPORTED
(UPLOAD ONLY)

(12.1.2) Sequence Number

SUPPORTED

Interface Specifications page 2 - 17

IMMULITE Interface to LIS

(12.1.3) Starting Range ID Number

REQUIRED

(12.1.4) Ending Range ID Number

NOT SUPPORTED

(12.1.5) Universal Test ID

REQUIRED

(12.1.6) Request Time Limits

NOT SUPPORTED

(12.1.7) Beginning Request Results

NOT SUPPORTED

(12.1.8) Ending Request Results

NOT SUPPORTED

(12.1.9) Physician Name

NOT SUPPORTED

(12.1.10) Physician Phone #

NOT SUPPORTED

(12.1.11) User field #1

NOT SUPPORTED

(12.1.12) User field #2

NOT SUPPORTED

page 2 - 18 Interface Specifications

 IMMULITE Interface to LIS

(12.1.13) Request Information Status Codes

Letter Record Type Status

C Correction of previous results NOT SUPPORTED
P Preliminary Results NOT SUPPORTED
F Final Results NOT SUPPORTED
X Results cannot be done, cancel. NOT SUPPORTED
I Request Results Pending NOT SUPPORTED
S Request partial results NOT SUPPORTED
M Result is a MIC level. NOT SUPPORTED
R Result previously transmitted. NOT SUPPORTED
A Abort/cancel last request REQUIRED
N Requesting new results only NOT SUPPORTED
O Requesting orders and demographics REQUIRED
D Requesting demographics only NOT SUPPORTED

Message Terminator Record Definition (13.1–13.1.3)

[Record Type ID (L)][Sequence Number][Termination
Code]
Example Termination Record:
<STX>[FrameNumber]L|1|N<CR><ETX>[CheckSum]<CR><LF>

(13.1.1) Record Types Definition

Letter Record Type Status

L Terminator Record SUPPORTED

(13.1.2) Sequence #
REQUIRED

Interface Specifications page 2 - 19

IMMULITE Interface to LIS

(13.1.3) Termination Code

Letter Record Type Status

N Normal termination SUPPORTED
T Sender aborted NOT SUPPORTED
R Receiver abort NOT SUPPORTED
E Unknown system error NOT SUPPORTED
Q Error in last request for information REQUIRED WITH QUERY
I No information available from last REQUIRED WITH QUERY
query
F Last request for information REQUIRED WITH QUERY
processed

IMMULITE Uni-Directional LIS Specification

ASTM E1394
Uni-Directional Transfer Example, IMMULITE System
to LIS
1H|\^&||PASSWORD|Siemens|Randolph^New^Jersey^07869|
|(201)927-2828|8N1|Your System||P|1|19940407085426
1
2P|1||||Smith^||||||||
72
3O|1|123ABC||^^^TSH
18
4R|1|^^^TSH|2.09|uIU/
mL|.4\.002^4\75|N|N|F||test|19940407084325|19940407
084457|Siemens
DF
5O|2|123ABC||^^^T4
B4
6R|1|^^^T4|3.7|ug/
dL|4.5\.4^12.5\24|L|N|F||test|19940407084325|199404
07084556|Siemens
6A
7O|3|123ABC||^^^T3
B6

page 2 - 20 Interface Specifications

 IMMULITE Interface to LIS

0R|1|^^^T3|35|ng/
dL|82\35^179\600|<|N|F||test|19940407084325|1994040
7084630|Siemens
F9
1O|4|123ABC||^^^TU
D3
2R|1|^^^TU|10|Percnt|23\10^35\70|<|N|F||test|199404
07084325|19940407084645|Siemens
60
3P|2||||^||||||||
6F
4O|1|789XYZ||^^^TSH
70
5R|1|^^^TSH|4.2|uIU/
mL|.4\.002^4\75|H|N|F||test|19940407084907|19940407
084923|Siemens
A9
6P|3||||Jones^||||||||
72
7O|1|HIJ456||^^^TSH
3A
0R|1|^^^TSH|6.19|uIU/
mL|.4\.002^4\75|H|N|F||test|19940407085044|19940407
085148|Siemens
D7
1P|4||||Riker^William||19601111|M|||||Doctor
87
2O|1|LMN141||^^^TSH
38
3R|1|^^^TSH|5.5|uIU/
mL|.4\.002^4\75|H|N|F||test|19940407085234|19940407
085352|Siemens
A2
4L|1
3D

Interface Specifications page 2 - 21

IMMULITE Interface to LIS

Header Record Definition (7.1–7.1.14)

[Record Type (H)] [Delimiter Def.] [Message Control
ID] [Password] [Sending systems company name]
[Sending Systems address] [Reserved] [Senders
Phone#] [Communication parameters] [Receiver ID]
[Comments/special instructions] [Processing ID]
[Version#] [Message Date + Time]

Sample Header Message

<STX>[FrameNumber]H|\^&||Password|Siemens|Randolph^
New^Jersey^07869||(201)927-
2828|8N1|Receiver||P|1|19920521132100
<CR><ETX>[CheckSum]<CR><LF>

(7.1.1) Record Types Definition

Letter Record Type Status

H Header Record REQUIRED

(7.1.2) Delimiter Definition

Letter Record Type Status

¦ Field Delimiter REQUIRED
\ Repeat Delimiter REQUIRED
^ Component Delimiter REQUIRED
& Escape Delimiter DEFINED, NOT SUPPORTED

(7.1.3) Message Control ID

NOT SUPPORTED

(7.1.4) Access Password

REQUIRED (Configurable in LIS PARAMETERS window; Maximum of 15
characters)

(7.1.5) Sender Name or ID

REQUIRED (Configurable in LIS PARAMETERS window; Maximum of 20
characters)

(7.1.6) Sender Street Address

SUPPORTED

page 2 - 22 Interface Specifications

 IMMULITE Interface to LIS

(7.1.7) Reserved Field

NOT SUPPORTED

(7.1.8) Senders Telephone Number

SUPPORTED

(7.1.9) Characteristics of Sender

SUPPORTED (8 bits No Parity 1 Stop Bit)

(7.1.10) Receiver ID
REQUIRED (Configurable in the LIS PARAMETERS window; Maximum of 15
characters)

(7.1.11) Comments/Special Instructions

NOT SUPPORTED

(7.1.12) Processing ID Definition

Letter Record Type Status

P Normal production/running message SUPPORTED
T Training message NOT SUPPORTED
D Debugging, used to debug a NOT SUPPORTED
program(s)
Q Message is for QC/regulatory NOT SUPPORTED
purposes

(7.1.13) Version Number

SUPPORTED (Currently 1)

(7.1.14) Date+Time of Message

SUPPORTED (YYYYMMDDHHMMSS)

Interface Specifications page 2 - 23

IMMULITE Interface to LIS

Patient Information Record Definition (8.1–8.1.35)

[Record Type (P)][Sequence #][Practice Assigned
Patient ID][Laboratory Assigned Patient ID][Patient
ID][Patient Name][Mother's Maiden
Name][BirthDate][Patient Sex][Patient Race][Patient
Address][Reserved][Patient Phone #][Attending
Physician ID][Special Field 1][Special Field
2][Patient Height][Patient Weight][Patients Known
or Suspected Diagnosis] [Patient active
medications][Patients Diet][Practice Field
#1][Practice Field #2][Admission and Discharge
Dates][Admission Status][Location][Nature of
Alternative Diagnostic Code and
Classification][Alternative Diagnostic Code and
Classification][Patient Religion][Marital
Status][Isolation Status][Language][Hospital
Service][Hospital Institution][Dosage Category]

Sample Patient Information Record

<STX>[FrameNumber]P|1||||Jones^Jane^L||19640804|F||
|||Doctor<CR><ETX>[CheckSum]<CR><LF>

(8.1.1) Record Types Definition

Letter Record Type Status

P Patient Identity Record REQUIRED

(8.1.2) Sequence # Definition

REQUIRED

(8.1.3) Practice Assigned Patient ID

NOT SUPPORTED

(8.1.4) Laboratory Assigned Patient ID

NOT SUPPORTED

(8.1.5) Patient ID
NOT SUPPORTED

(8.1.6) Patient Name

SUPPORTED (Last^First^Initial; maximum of 20 characters for Last Name;
maximum of 15 characters for First Name)

page 2 - 24 Interface Specifications

 IMMULITE Interface to LIS

(8.1.7) Mother's Maiden Name

NOT SUPPORTED

(8.1.8) Birthdate
SUPPORTED (YYYYMMDD; maximum of 8 characters)

(8.1.9) Patient's Sex

SUPPORTED (M or F; maximum of 1 character)

(8.1.10) Patient Race-Ethnic Origin

NOT SUPPORTED

(8.1.11) Patient's Address

NOT SUPPORTED

(8.1.12) Reserved Field

NOT SUPPORTED

(8.1.13) Patient's Phone#

NOT SUPPORTED

(8.1.14) Attending Physician ID

SUPPORTED (Last Name Only; maximum of 20 characters)

(8.1.15) Special Field 1

NOT SUPPORTED

(8.1.16) Special Field 2

NOT SUPPORTED

(8.1.17) Patient Height

NOT SUPPORTED

(8.1.18) Patient Weight

NOT SUPPORTED

(8.1.19) Known or Suspected Diagnosis

NOT SUPPORTED

Interface Specifications page 2 - 25

IMMULITE Interface to LIS

(8.1.20) Active Medications

NOT SUPPORTED

(8.1.21) Patient's Diet

NOT SUPPORTED

(8.1.22) Practice Field 1

NOT SUPPORTED

(8.1.23) Practice Field 2

NOT SUPPORTED

(8.1.24) Admission and Discharge Dates

NOT SUPPORTED

(8.1.25) Admission Status

NOT SUPPORTED

(8.1.26) Location
NOT SUPPORTED

(8.1.27) Nature of Alt. Diag. Code

NOT SUPPORTED

(8.1.28) Alt. Diag. Code and Classifications

NOT SUPPORTED

(8.1.29) Patient Religion

NOT SUPPORTED

(8.1.30) Marital Status

NOT SUPPORTED

(8.1.31) Isolation Status

NOT SUPPORTED

(8.1.32) Language
NOT SUPPORTED

page 2 - 26 Interface Specifications

 IMMULITE Interface to LIS

(8.1.33) Hospital Service

NOT SUPPORTED

(8.1.34) Hospital Institution

NOT SUPPORTED

(8.1.35) Dosage Category

NOT SUPPORTED

Order Record Definition (9.4.1–9.4.31)

[Record Type (O)][Sequence#][Specimen ID
(Accession#)] [Instrument Specimen ID][Universal
Test ID][Priority][Order Date/Time][Collection
Date/Time] [Collection End Time][Collection Volume]
[Collector ID][Action Code][Danger Code][Relevant
Clinical Info][Date/Time Specimen
Received][Specimen Descriptor,Specimen
Type,Specimen Source][Ordering
Physician][Physician's Telephone Number][User Field
No.1][User Field No.2][Lab Field No.1][Lab Field
No.2][Date/Time results reported or last modified]
[Instrument Charge to Computer System][Instrument
Section ID][Report Types][Reserved Field][Location
or ward of Specimen Collection][Nosocomial
Infection Flag][Specimen Service][Specimen
Institution]

Sample Test Order Message

<STX>[FrameNumber]O|1|123456||^^^TSH<CR><ETX>[Check
Sum] <CR><LF>

(9.4.1) Record Types Definition

Letter Record Type Status

O Test Order Record REQUIRED

(9.4.2)Sequence #
REQUIRED

(9.4.3) Specimen ID
REQUIRED (ACCESSION # ON PRIMARY TUBE; maximum of 20 characters)

Interface Specifications page 2 - 27

IMMULITE Interface to LIS

(9.4.4) Instrument Specimen ID

NOT SUPPORTED

(9.4.5) Universal Test ID

REQUIRED (maximum of 6 characters)
(^^^[Test Code]) Example Test Codes: TSH, LH, FSH, DGX, TT4, HCG, TU,
RTH, T3, FER, PSA, PAP

(9.4.6) Priority
NOT SUPPORTED (maximum of 1 character)

(9.4.7) Requested/Ordered Date and Time

NOT SUPPORTED (maximum of 14 characters)

(9.4.8) Specimen Collection Date and Time

NOT SUPPORTED (maximum of 14 characters)

(9.4.9) Collection End Time

NOT SUPPORTED

(9.4.10) Collection Volume

NOT SUPPORTED

(9.4.11) Collector ID
NOT SUPPORTED

(9.4.12) Action Code

NOT SUPPORTED

(9.4.13) Danger Code

NOT SUPPORTED

(9.4.14) Relevant Clinical Information

NOT SUPPORTED

(9.4.15) Date/Time Specimen Received

NOT SUPPORTED

page 2 - 28 Interface Specifications

 IMMULITE Interface to LIS

(9.4.16) Specimen Descriptor

NOT SUPPORTED

(9.4.16.1) Specimen Type

NOT SUPPORTED

(9.4.17) Ordering Physician

NOT SUPPORTED

(9.4.18) Physician's Telephone Number

NOT SUPPORTED

(9.4.19) Users Field No. 1

NOT SUPPORTED

(9.4.20) Users Field No. 2

NOT SUPPORTED

(9.4.21) Lab Field No. 1

NOT SUPPORTED

(9.4.22) Lab Field No. 2

NOT SUPPORTED

(9.4.23) Date/Time Results Reported

NOT SUPPORTED

(9.4.24) Instrument Charge to Computer Sys

NOT SUPPORTED

(9.4.25) Instrument Section ID

NOT SUPPORTED

(9.4.26) Report Types

NOT SUPPORTED

(9.4.27) Reserved Field

NOT SUPPORTED

Interface Specifications page 2 - 29

IMMULITE Interface to LIS

(9.4.28) Location of Specimen Collection

NOT SUPPORTED

(9.4.29) Nosococmial Infection Flag

NOT SUPPORTED

(9.4.30) Specimen Service

NOT SUPPORTED

(9.4.31) Specimen Institution

NOT SUPPORTED

Result Record Definition (10.1–10.1.14)

[Record Type (R)][Sequence #][Universal Test
ID][Data (result)][Units][ReferenceRanges] [Result
abnormal flags][Nature of Abnormality
Testing][Result Status][Date of change in
instruments normal values or units][Operator
ID][Date\Time Test Started][Date\Time Test
Completed][Instrument ID]

Sample Result Message:

<STX>[FrameNumber]R|1|^^^TSH|8.19|uIU/
mL|.4\.002^4\75|H|N|F||test|1994032810834|199205261
10500|Siemens<CR><ETX>[CheckSum]<CR><LF>

(10.1.1) Record Types Definition-

Letter Record Type Status

R Result Record REQUIRED

(10.1.2) Sequence #
REQUIRED

(10.1.3) Universal Test ID

Note For Universal Test ID, only the Record Types Definition status reads
as Partially Supported or Required. Under Order Types Definition, Universal
Test ID status is Required.
PARTIALLY SUPPORTED / REQUIRED (^^^[Test Code])
Example Test Codes: TSH, LH, FSH, DGX, TT4, HCG, TU, RTH, T3, FER, PSA,
PAP

page 2 - 30 Interface Specifications

 IMMULITE Interface to LIS

(10.1.4) Data or Measurement Value (Result)

REQUIRED Current

(10.1.5) Units
REQUIRED
Current Siemens Units of Measure: ng/mL, ng/dL, µg/dL, µIu/mL, mIU/mL,
pg/mL, nmol/L, pmol/L, mIU/L, µg/L, IU/mL, IU/L

(10.1.6) Reference Ranges

SUPPORTED
([Low]\[Panic\Low]^[High]\[Panic High])

Interface Specifications page 2 - 31

IMMULITE Interface to LIS

(10.1.7) Result Abnormal Flags

Letter Record Type Status

L Below Normal SUPPORTED
H Above Normal SUPPORTED
LL Below Panic NOT SUPPORTED
HH Above Panic NOT SUPPORTED
< Below readable limit REQUIRED
> Above readable limit REQUIRED
N Normal SUPPORTED
A Abnormal NOT SUPPORTED
U Significant change UP NOT SUPPORTED
D Significant change DOWN NOT SUPPORTED
B Better NOT SUPPORTED
W Worse NOT SUPPORTED

(10.1.8) Nature of Abnormality Testing

Letter Record Type Status

A Age population tested NOT SUPPORTED
S Sex based Population NOT SUPPORTED
R Race based Population NOT SUPPORTED
N Normal generic range SUPPORTED

(10.1.9) Results Status

Letter Record Type Status

C Correction of previously sent results NOT SUPPORTED
P Preliminary Results NOT SUPPORTED
F Final Results SUPPORTED
X Results cannot be done . NOT SUPPORTED
(For example, Calculation Error)
I In instrument, results pending NOT SUPPORTED
S Partial Results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED
R This result was previously NOT SUPPORTED
transmitted.
N This result record contains necessary NOT SUPPORTED
information to run a new order.

page 2 - 32 Interface Specifications

 IMMULITE Interface to LIS

(10.1.10) Date Systems Values/Units Changed

NOT SUPPORTED

(10.1.11) Operator Name/ID#

SUPPORTED

(10.1.12) Date+Time Test Started

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.13) Date+Time Test Completed

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.14) Instrument ID
SUPPORTED (Configurable From Siemens 'KIT' Program)

Request Information Record (12.1–12.1.13)

NOT SUPPORTED IN UNI DIRECTIONAL MODE

Message Terminator Record Definition (13.1–13.1.3)

[Record Type ID (L)][Sequence Number][Termination
Code]

Example Termination Record:

<STX>[FrameNumber]L|1|N<CR><ETX>[CheckSum]<CR><LF>

Record Types Definition

Letter Record Type Status

L Terminator record SUPPORTED

(13.1.2) Sequence #
REQUIRED

Interface Specifications page 2 - 33

IMMULITE Interface to LIS

(13.1.3) Termination Code

Letter Record Type Status

N Normal termination SUPPORTED
T Sender aborted NOT SUPPORTED
R Receiver abort NOT SUPPORTED
E Unknown system error NOT SUPPORTED
O Error in last request for information NOT SUPPORTED
I No information available from last NOT SUPPORTED
query
F Last request for information NOT SUPPORTED
processed

IMMULITE LIS Error Message Definitions

Message Definition
Invalid ID This is the #1 question asked by LIS customers. The
Sender ID and \ or Receiver ID is incorrect in the header
message. These items need to be switched by the LIS
when sending messages to the IMMULITE system.
Example:
Sender ID is set to Siemens
Receiver ID is set to HOSPITAL
• IMMULITE Sending
Sender ID Field = Siemens
Receiver ID Field = HOSPITAL
• LIS Sending
Sender ID Field = HOSPITAL
Receiver ID Field = Siemens
Invalid Password The password is incorrect in the header message. Correct
by entering the proper password in the LIS PARAMETER
section from the START menu. Siemens does not know
this password, this is set by the software company.
SUNQUEST does not use a password. This field should be
left blank for SUNQUEST systems.
Bad or Missing The frame number in the message is not proper. Usually
Frame Number indicates a programming bug in the LIS software, but
may be a bad message (for example, line noise). See
ASTM 1394 Logical layer section 6.3.2 for further detail.

page 2 - 34 Interface Specifications

 IMMULITE Interface to LIS

Message Definition
Invalid Sequence The sequence number in the message is not proper.
Number Usually indicates a programming bug in the LIS software,
but may be a bad message (for example, line noise). See
ASTM 1394 section 6.6.7 for further detail.
Message Too Short Data within the message was dropped or not sent.
Usually indicates a programming bug in the LIS software,
but may be a bad message (for example, line noise).
LIS Timeout The LIS is not responding to the IMMULITE system.
Causes can be a cabling problem, communication
problem (hardware related), or programming bug in the
LIS software.
<CR> or <LF> Usually indicates a programming bug in the LIS software,
Missing in LIS but may be a bad message (E.G. line noise).
Transmission
Error in last request This is a response FROM the LIS stating the LIS
encountered an error to the system’s request for
information.
No info on this # A response from the LIS to a Query message. The LIS has
no information for the sample (accession#).

Interface Specifications page 2 - 35

IMMULITE Interface to LIS

page 2 - 36 Interface Specifications

3 Configuring the IMMULITE 1000

Setting Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Test the Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Test IMMULITE 1000 Host Query (If Applicable) . . . . . . . . . . . . . .3-2
Manage Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Required Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Qualitative Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Upload/Download Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
IMMULITE 1000 Bi-Directional LIS Specification
ASTM E1394 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
HEADER RECORD DEFINITION (7.1–7.1.14) . . . . . . . . . . . . . . . . .3-4
Sample Header Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
(7.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
(7.1.2) Delimiter Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
(7.1.3) Message Control ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
(7.1.4) Access Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.5) Sender Name or ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.6) Sender Street Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.7) Reserved Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.8) Senders Telephone Number. . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.9) Characteristics of Sender . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.10) Receiver ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.11) Comments/Special Instructions . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.12) Processing ID Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.13) Version Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
(7.1.14) Date + Time of Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Patient Information Record Definition (8.1–8.1.35). . . . . . . . . . .3-6
Sample Patient Information Record . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
(8.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
(8.1.2) Sequence # Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
(8.1.3) Practice Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
(8.1.4) Laboratory Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . .3-6
(8.1.5) Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
(8.1.6) Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
For patient sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
For Control Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
For adjustor sample (SUPPORTED INTERNAL TO Siemens) . . . . . . . . .3-8
For verifier sample (SUPPORTED INTERNAL TO Siemens) . . . . . . . . . .3-8
(8.1.7) Mother's Maiden Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

Interface Specifications page 3-i

Configuring the IMMULITE 1000

(8.1.8) Birthdate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

(8.1.9) Patient's Sex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.10) Patient Race-Ethnic Origin . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.11) Patient's Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.12) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.13) Patient's Phone# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.14) Attending Physician ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.15) Special Field 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.16) Special Field 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.17) Patient Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.18) Patient Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.19) Known or Suspected Diagnosis . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.20) Active Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.21) Patient's Diet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
(8.1.22) Practice Field 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.23) Practice Field 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.24) Admission and Discharge Dates . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.25) Admission Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.26) Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.27) Nature of Alt. Diag. Code. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.28) Alt. Diag. Code and Classifications . . . . . . . . . . . . . . . . . . . 3-10
(8.1.29) Patient Religion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.30) Marital Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.31) Isolation Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.32) Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.33) Hospital Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.34) Hospital Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
(8.1.35) Dosage Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Order Record Definition (9.4.1-9.4.31) . . . . . . . . . . . . . . . . . . . 3-11
Sample Test Order Message: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
(9.4.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
(9.4.2)Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
(9.4.3) Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
For patient sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
For control sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
For adjustor sample (SUPPORTED INTERNAL TO Siemens) . . . . . . . . 3-12
For verifier sample (SUPPORTED INTERNAL TO Siemens) . . . . . . . . . 3-12
(9.4.4) Instrument Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
(9.4.5) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
(9.4.6) Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
(9.4.7) Requested/Ordered Date and Time . . . . . . . . . . . . . . . . . . . . 3-13
(9.4.8) Specimen Collection Date and Time . . . . . . . . . . . . . . . . . . . 3-13
(9.4.9) Collection End Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
(9.4.10) Collection Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

page 3-ii Interface Specifications

Configuring the IMMULITE 1000

(9.4.11) Collector ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

(9.4.12) Action Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
(9.4.13) Danger Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
(9.4.14) Relevant Clinical Information . . . . . . . . . . . . . . . . . . . . . . . .3-13
(9.4.15) Date/Time Specimen Received . . . . . . . . . . . . . . . . . . . . . . .3-13
(9.4.16) Specimen Descriptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
(9.4.16.1) Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.17) Ordering Physician (Last Name Only) . . . . . . . . . . . . . . . . .3-14
(9.4.18) Physician's Telephone Number . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.19) Users Field No. 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.20) Users Field No. 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.21) Lab Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.22) Lab Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.23) Date/Time Results Reported . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.24) Instrument Charge to Computer Sys . . . . . . . . . . . . . . . . . .3-14
(9.4.25) Instrument Section ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.26) Report Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.27) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.28) Location of Specimen Collection . . . . . . . . . . . . . . . . . . . . .3-14
(9.4.29) Nosocomial Infection Flag . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
(9.4.30) Specimen Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
(9.4.31) Specimen Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
Result Record Definition (10.1 - 10.1.14) . . . . . . . . . . . . . . . . . .3-15
Sample Result Message: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
(10.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
(10.1.2) Sequence #. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
(10.1.3) Universal Test ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
(10.1.4) Data or Measurement Value (Result) . . . . . . . . . . . . . . . . . .3-15
(10.1.5) Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
(10.1.6) Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16
(10.1.7) Result Abnormal Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16
(10.1.8) Nature of Abnormality Testing. . . . . . . . . . . . . . . . . . . . . . .3-16
(10.1.9) Results Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
(10.1.10) Date systems values/units changed . . . . . . . . . . . . . . . . . .3-17
(10.1.11) Operator Name/ID# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
(10.1.12) Date+Time Test Started . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
(10.1.13) Date+Time Test Completed . . . . . . . . . . . . . . . . . . . . . . . .3-17
(10.1.14) Instrument ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
Request Information Record Definition (Host Query)
(12.1 - 12.1.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
Example Request Record: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
(12.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
(12.1.2) Sequence Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

Interface Specifications page 3-iii

 Configuring the IMMULITE 1000

(12.1.3) Starting Range ID Number. . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

(12.1.4) Ending Range ID Number . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.5) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.6) Request Time Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.7) Beginning Request Results . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.8) Ending Request Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.9) Physician Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.10) Physician Phone # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.11) User field #1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
(12.1.12) User field #2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
(12.1.13) Request information status codes. . . . . . . . . . . . . . . . . . . 3-19
Message Terminator Record Definition (13.1 - 13.1.3) . . . . . . 3-19
Example Termination Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
(13.1.1) Record Types Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
(13.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
(13.1.3) Termination Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
IMMULITE 1000 Uni-Directional Lis Specification
ASTM E1394. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Header Record Definition (7.1 - 7.1.14) . . . . . . . . . . . . . . . . . . 3-20
Sample Header Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
(7.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.2) Delimiter Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.3) Message Control ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.4) Access Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.5) Sender Name or ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.6) Sender Street Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.7) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.8) Senders Telephone Number . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.9) Characteristics of Sender . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.10) Receiver ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
(7.1.11) Comments/Special Instructions . . . . . . . . . . . . . . . . . . . . . . 3-22
(7.1.12) Processing ID Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
(7.1.13) Version Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
(7.1.14) Date+Time of Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Patient Information Record Definition (8.1 - 8.1.35) . . . . . . . . 3-22
Sample Patient Information Record: . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
(8.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
(8.1.2) Sequence # Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
(8.1.3) Practice Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
(8.1.4) Laboratory Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . 3-23
(8.1.5) Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
(8.1.6) Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
(8.1.7) Mother's Maiden Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

page 3-iv Interface Specifications

Configuring the IMMULITE 1000

(8.1.8) Birthdate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

(8.1.9) Patient's Sex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
(8.1.10) Patient Race-Ethnic Origin . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
(8.1.11) Patient's Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
(8.1.12) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
(8.1.13) Patient's Phone#. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
(8.1.14) Attending Physician ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.15) Special Field 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.16) Special Field 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.17) Patient Height. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.18) Patient Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.19) Known or Suspected Diagnosis . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.20) Active Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.21) Patient's Diet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.22) Practice Field 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.23) Practice Field 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.24) Admission and Discharge Dates. . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.25) Admission Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.26) Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
(8.1.27) Nature of Alt. Diag. Code . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
(8.1.28) Alt. Diag. Code and Classifications. . . . . . . . . . . . . . . . . . . .3-25
(8.1.29) Patient Religion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
(8.1.30) Marital Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
(8.1.31) Isolation Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
(8.1.32) Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
(8.1.33) Hospital Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
(8.1.34) Hospital Institution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
(8.1.35) Dosage Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Order Record Definition (9.4.1-9.4.31) . . . . . . . . . . . . . . . . . . . .3-26
Sample Test Order Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
(9.4.1) Record types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
(9.4.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
(9.4.3) Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
(9.4.4) Instrument Specimen ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
(9.4.5) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
(9.4.6) Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
(9.4.7) Requested/Ordered Date and Time . . . . . . . . . . . . . . . . . . . .3-27
(9.4.8) Specimen Collection Date and Time . . . . . . . . . . . . . . . . . . .3-27
(9.4.9) Collection End Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
(9.4.10) Collection Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
(9.4.11) Collector ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
(9.4.12) Action Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
(9.4.13) Danger Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27

Interface Specifications page 3-v

 Configuring the IMMULITE 1000

(9.4.14) Relevant Clinical Information . . . . . . . . . . . . . . . . . . . . . . . 3-27

(9.4.15) Date/Time Specimen Received . . . . . . . . . . . . . . . . . . . . . . 3-27
(9.4.16) Specimen Descriptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
(9.4.16.1) Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
(9.4.17) Ordering Physician. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
(9.4.18) Physician's Telephone Number . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.19) Users Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.20) Users Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.21) Lab Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.22) Lab Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.23) Date/Time Results Reported. . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.24) Instrument Charge to Computer Sys. . . . . . . . . . . . . . . . . . 3-28
(9.4.25) Instrument Section ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.26) Report Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.27) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.28) Location of Specimen Collection . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.29) Nosococmial Infection Flag . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
(9.4.30) Specimen Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
(9.4.31) Specimen Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Result Record Definition (10.1 - 10.1.14) . . . . . . . . . . . . . . . . . 3-29
Sample Result Message: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
(10.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
(10.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
(10.1.3) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
(10.1.4) Data or Measurement Value (Result) . . . . . . . . . . . . . . . . . 3-29
(10.1.5) Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
(10.1.6) Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
(10.1.7) Result Abnormal Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
(10.1.8)Nature of Abnormality Testing . . . . . . . . . . . . . . . . . . . . . . . 3-31
(10.1.9) Results Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
(10.1.10) Date systems values/units changed . . . . . . . . . . . . . . . . . 3-32
(10.1.11) Operator Name/ID# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
(10.1.12) Date+Time Test Started . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
(10.1.13) Date+Time Test Completed . . . . . . . . . . . . . . . . . . . . . . . . 3-32
(10.1.14) Instrument ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Request Information Record (12.1 - 12.1.13) . . . . . . . . . . . . . . 3-32
Message Terminator Record Definition (13.1 - 13.1.3) . . . . . . 3-32
Example Termination Record: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
(13.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
(13.1.3) Termination Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
IMMULITE LIS Error Message Definitions . . . . . . . . . . . . . . 3-33

page 3-vi Interface Specifications

Configuring the IMMULITE 1000 System

The IMMULITE 1000 LIS interface has the following features:

• Ability to autosend results.
• Ability to re-send results.
• Ability to receive test orders for Control samples.
• Ability to send (autosend) Control sample results if the control test
order was sent by the LIS.
• The IMMULITE 1000 system can be configured for European numbers
such as 1.200,34.
If configured for European numbers, the concentration in the result
record for the IMMULITE 1000 system is in European number
configuration. The IMMULITE system did not have the capability to be
configured for European numbers.

Setting Up
To set up a connection between the IMMULITE 1000 system and an LIS,
follow the steps below:
1. Connect the Cable.
Refer to Cable Specifications, page 13. Use COM Port 4 on the back of
the user-side computer.
2. Configure LIS Parameters:
Note All configurations require log off to activate changes.
a. Select Tools > Configurations > LIS Parameters.
For IMMULITE 2000 and IMMULITE 2000 XPi systems,
select Menu > Configuration > LIS.
The LIS Parameters screen password is CONNECT.
b. Select the appropriate LIS Host Query Mode:
• Password, Receiver ID, and Sender ID should be provided by LIS
Vendor.
• COM Parameters must be N81 in LIS Configurations and if sent
in Header Record from LIS.
• The LIS serial port is labeled “4” on the back of the instrument.
3. To enable a log of the communication between the IMMULITE 1000
system and the LIS for troubleshooting, select Diagnostics.
The LIS log should be disabled during normal operation.
Interface Specifications page 3 - 1
Configuring the IMMULITE 1000

4. Select Display Patients.

5. If the LIS sends test orders for control samples to the IMMULITE 1000
system, select Display Controls.
6. To hide sent results from view on the LIS screen, select Hide Sent.
7. To automatically send each completed result to the LIS, select Auto-
Send Patient Results.
Completed results are not collated per accession number prior to
sending.
Auto-Send out-of-control QC.
8. To automatically send patient results flagged ADJ on review screens,
select Auto-Send Invalid Adjustment.
Select Auto-Send Control Results only if the LIS sends test orders for
control samples.
9. Select how to Report and Display Qualitative Infectious Disease Assay
Results.

Test the Communication

You must run patient sample(s) after the LIS feature is activated.
Results are successfully sent to the LIS if no errors occur and the results are
managed as follows depending on what is showing on the Hide Sent/Show
Sent button.
• Show Sent
Results display the status of Sent.
• Hide Sent
Results disappear from the LIS Data Management screen.

Test IMMULITE 1000 Host Query (If Applicable)

1. At the instrument window, select WORKLIST.
2. Select Patient.
3. Enter sample cup number.
4. Type or use hand-held scanner to enter accession number; the name
populates the appropriate field if the LIS sends it.
The Name field is Not Required so it will only populate if the
information was entered at the LIS.

page 3 - 2 Interface Specifications

 Configuring the IMMULITE 1000

5. Load patient sample in specified cup number and run.

Results display in the LIS Data Management screen.
If any LIS errors display, contact Technical Service.

Manage Results
Results (including semi-quantitative ratio results) are sent using floating
decimals as follows:

Result # Decimal Places Sent Example

less than 1.00 * 2 0.45
1.00–9.99 2 1.23
10.0–99.9 1 10.2
100 and above None 102
* Results for some assays (including third generation such as TSH, RTH)
are reported with three decimal places if the result is less than 1.00.

Required Flags
Required flags include H, L, N, < and >.
Greater than (>) and Less than (<) calibration range results are sent as
follows:
0R|1|^^^TSH|75.0|uIU/
mL|.4\.002^4\75|>|N|F||test|19940407085044|19940407
085148|Siemens
• 75.0 is the Assay Max
• > is the Result Flag

Qualitative Test Results

Qualitative tests result either as a qualitative interpretation for Reactive,
Non-Reactive or Indeterminate or as a semi-quantitative ratio (patient CPS/
Cutoff CPS), either of which is sent to the LIS (not both).
The qualitative interpretation is sent to the LIS as follows:

Result Sent to LIS as

Non-reactive 0
Reactive 1
Indeterminate 2

Interface Specifications page 3- 3

Configuring the IMMULITE 1000

See assay package inserts for interpretation of qualitative assay ratio

results.

Upload/Download Codes
IMMULITE Test Codes are used for upload and download codes and can be
found in IMMULITE Assay package inserts.

IMMULITE 1000 Bi-Directional LIS Specification

ASTM E1394
HEADER RECORD DEFINITION (7.1–7.1.14)
[Record Type (H)] [Delimiter Def.] [Message Control
ID] [Password] [Sending systems company name]
[Sending Systems address] [Reserved] [Senders
Phone#] [Communication parameters] [Receiver ID]
[Comments/special instructions] [Processing ID]
[Version#] [Message Date + Time]

Sample Header Message

<STX>[FrameNumber]H|\^&||Password|Siemens|Flanders^
New^Jersey^07836||973-927-
2828|N81|YourSystem||P|1|19940323082858
<CR><ETX>[CheckSum]<CR><LF>

(7.1.1) Record Types Definition

Letter Record Type Status

H Header record REQUIRED

(7.1.2) Delimiter Definition

Letter Record Type Status

¦ Field Delimiter REQUIRED
\ Repeat Delimiter REQUIRED
^ Component Delimiter REQUIRED
& Escape Delimiter DEFINED, NOT SUPPORTED

(7.1.3) Message Control ID

NOT SUPPORTED

page 3 - 4 Interface Specifications

 Configuring the IMMULITE 1000

(7.1.4) Access Password

REQUIRED (Configurable in LIS Parameters screen; Maximum of 15
characters)

(7.1.5) Sender Name or ID

REQUIRED (Configurable in LIS Parameters screen; Maximum of 20
characters)

(7.1.6) Sender Street Address

SUPPORTED

(7.1.7) Reserved Field

NOT SUPPORTED

(7.1.8) Senders Telephone Number

SUPPORTED

(7.1.9) Characteristics of Sender

SUPPORTED (No Parity 8 bits 1 Stop Bit)

(7.1.10) Receiver ID
REQUIRED (Configurable in LIS Parameters screen; Maximum of 15
characters)

(7.1.11) Comments/Special Instructions

NOT SUPPORTED

(7.1.12) Processing ID Definition

Letter Record Type Status

P Normal production/running SUPPORTED
message
T Training message NOT SUPPORTED
D Debugging, used to debug a NOT SUPPORTED
program(s)
Q Message is for QC/regulatory NOT SUPPORTED
purposes

(7.1.13) Version Number

SUPPORTED (Currently 1)

Interface Specifications page 3- 5

Configuring the IMMULITE 1000

(7.1.14) Date + Time of Message

SUPPORTED (YYYYMMDDHHMMSS)

Patient Information Record Definition (8.1–8.1.35)

[Record Type (P)][Sequence #][Practice Assigned
Patient ID][Laboratory Assigned Patient ID][Patient
ID][Patient Name][Mother's Maiden
Name][BirthDate][Patient Sex][Patient Race][Patient
Address][Reserved][Patient Phone #][Attending
Physician ID][Special Field 1][Special Field
2][Patient Height][Patient Weight][Patients Known
or Suspected Diagnosis] [Patient active
medications][Patients Diet][Practice Field
#1][Practice Field #2][Admission and Discharge
Dates][Admission Status][Location][Nature of
Alternative Diagnostic Code and
Classification][Alternative Diagnostic Code and
Classification][Patient Religion][Marital
Status][Isolation Status][Language][Hospital
Service][Hospital Institution][Dosage Category]

Sample Patient Information Record

<STX>[FrameNumber]P|1|101|||Riker^Al||19611102|F|||
||Bashere<CR><ETX>[CheckSum]<CR><LF>

(8.1.1) Record Types Definition

Letter Record Type Status

P Patient Identity Record REQUIRED

(8.1.2) Sequence # Definition

REQUIRED

(8.1.3) Practice Assigned Patient ID

REQUIRED (maximum of 20 characters)

(8.1.4) Laboratory Assigned Patient ID

NOT SUPPORTED

(8.1.5) Patient ID
NOT SUPPORTED

page 3 - 6 Interface Specifications

 Configuring the IMMULITE 1000

(8.1.6) Patient Name

SUPPORTED

For patient sample

Last^First^Initial

Maximum of 30 characters for Last & First name

Interface Specifications page 3- 7

Configuring the IMMULITE 1000

For Control Sample

Position Description
First 2 characters ~C (use uppercase letter)
Next 6 characters Control Name (if fewer than 6 characters, right-
padded with spaces; should not be empty)
Next 3 characters Control Lot (use 3 numeric digits; should not be
empty)
Next 6 characters Expiration Date (use YYYYMM format; should not be
empty)
Last 1 character Control Level (should not be empty)

For adjustor sample (SUPPORTED INTERNAL TO Siemens)

Position Description
First 2 characters ~A (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Kit Lot (use 3 numeric digits; should not be empty)
Next 3 characters Adjustor Lot (use 3 numeric digits; should not be
empty)
Last 2 character Level (use 2 numeric digits; should not be empty)

For verifier sample (SUPPORTED INTERNAL TO Siemens)

Position Description
First 2 characters ~V (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Verifier Lot (should not be empty)
Next 1 characters Level (numeric values should not be empty)
Next 4 characters Range low (numeric value; should not be empty)
Last 4 character Range high (numeric value; should not be empty)

(8.1.7) Mother's Maiden Name

NOT SUPPORTED

(8.1.8) Birthdate
SUPPORTED (YYYYMMDD Maximum of 8 characters)

page 3 - 8 Interface Specifications

 Configuring the IMMULITE 1000

(8.1.9) Patient's Sex

SUPPORTED (M or F; maximum of 1 character)

(8.1.10) Patient Race-Ethnic Origin

NOT SUPPORTED

(8.1.11) Patient's Address

NOT SUPPORTED

(8.1.12) Reserved Field

NOT SUPPORTED

(8.1.13) Patient's Phone#

NOT SUPPORTED

(8.1.14) Attending Physician ID

NOT SUPPORTED

(8.1.15) Special Field 1

NOT SUPPORTED (supported internal to Siemens) (Siemens Field 1)

(8.1.16) Special Field 2

NOT SUPPORTED

(8.1.17) Patient Height

NOT SUPPORTED

(8.1.18) Patient Weight

NOT SUPPORTED

(8.1.19) Known or Suspected Diagnosis

NOT SUPPORTED

(8.1.20) Active Medications

NOT SUPPORTED

(8.1.21) Patient's Diet

NOT SUPPORTED

Interface Specifications page 3- 9

Configuring the IMMULITE 1000

(8.1.22) Practice Field 1

NOT SUPPORTED

(8.1.23) Practice Field 2

NOT SUPPORTED

(8.1.24) Admission and Discharge Dates

NOT SUPPORTED

(8.1.25) Admission Status

NOT SUPPORTED

(8.1.26) Location
NOT SUPPORTED

(8.1.27) Nature of Alt. Diag. Code

NOT SUPPORTED

(8.1.28) Alt. Diag. Code and Classifications

NOT SUPPORTED

(8.1.29) Patient Religion

NOT SUPPORTED

(8.1.30) Marital Status

NOT SUPPORTED

(8.1.31) Isolation Status

NOT SUPPORTED

(8.1.32) Language
NOT SUPPORTED

(8.1.33) Hospital Service

NOT SUPPORTED

(8.1.34) Hospital Institution

NOT SUPPORTED

page 3 - 10 Interface Specifications

 Configuring the IMMULITE 1000

(8.1.35) Dosage Category

NOT SUPPORTED

Order Record Definition (9.4.1-9.4.31)

[Record Type (O)][Sequence#][Specimen ID
(Accession#)][Instrument Specimen ID][Universal
Test ID][Priority][Order Date/Time][Collection
Date/Time][Collection End Time][Collection
Volume][Collector ID][Action Code][Danger
Code][Relevant Clinical Info][Date/Time Specimen
Received][Specimen Descriptor,Specimen
Type,Specimen Source][Ordering
Physician][Physician's Telephone Number][User Field
No.1][User Field No.2][Lab Field No.1][Lab Field
No.2][Date/Time results reported or last
modified][Instrument Charge to Computer
System][Instrument Section ID][Report
Types][Reserved Field][Location or ward of Specimen
Collection][Nosocomial Infection Flag][Specimen
Service][Specimen Institution]

Sample Test Order Message:

<STX>[FrameNumber]O|1|1550623||^^^LH|R|199310110912
33|19931011091233<CR><ETX>[CheckSum]<CR><LF>

(9.4.1) Record Types Definition

Letter Record Type Status

O Test Order Record REQUIRED

(9.4.2)Sequence #
REQUIRED

(9.4.3) Specimen ID
REQUIRED (maximum of 30 characters)

For patient sample

Accession number on primary tube

Interface Specifications page 3- 11

Configuring the IMMULITE 1000

For control sample

Position Description
First 2 characters ~C (use uppercase letter)
Next 6 characters Control Name (if fewer than 6 characters, right-
padded with spaces; should not be empty)
Next 3 characters Control Lot (use 3 numeric digits; should not be
empty)
Next 6 characters Expiration Date (use YYYYMM format; should not be
empty)
Last 1 character Control Level (should not be empty)

For adjustor sample (SUPPORTED INTERNAL TO Siemens)

Position Description
First 2 characters ~A (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Kit Lot (use 3 numeric digits; should not be empty)
Next 3 characters Adjustor Lot (use 3 numeric digits; should not be
empty)
Last 2 character Level (use 2 numeric digits; should not be empty)

For verifier sample (SUPPORTED INTERNAL TO Siemens)

Position Description
First 2 characters ~V (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Verifier Lot (should not be empty)
Next 1 characters Level (numeric values should not be empty)
Next 4 characters Range low (numeric value; should not be empty)
Last 4 character Range high (numeric value; should not be empty)

(9.4.4) Instrument Specimen ID

NOT SUPPORTED SUPPORTED INTERNAL TO Siemens (Sample Cup #)

(9.4.5) Universal Test ID

REQUIRED (^^^[Test Code]) (Maximum of 6 characters)
Example Test Codes: TSH, LH, FSH, DGX, T4, HCG, TU, RTH, T3, FER, PSA,
PAP

page 3 - 12 Interface Specifications

 Configuring the IMMULITE 1000

(9.4.6) Priority
SUPPORTED (Maximum of 1 character)

S Stat
A As soon as possible
R Routine
C Callback
P Preoperative

(9.4.7) Requested/Ordered Date and Time

SUPPORTED (YYYYMMDDHHMMSS Maximum of 14 characters)

(9.4.8) Specimen Collection Date and Time

SUPPORTED (Maximum of 14 characters)

(9.4.9) Collection End Time

NOT SUPPORTED

(9.4.10) Collection Volume

NOT SUPPORTED

(9.4.11) Collector ID
NOT SUPPORTED

(9.4.12) Action Code

NOT SUPPORTED

(9.4.13) Danger Code

NOT SUPPORTED

(9.4.14) Relevant Clinical Information

NOT SUPPORTED

(9.4.15) Date/Time Specimen Received

NOT SUPPORTED

(9.4.16) Specimen Descriptor

NOT SUPPORTED

Interface Specifications page 3- 13

Configuring the IMMULITE 1000

(9.4.16.1) Specimen Type

NOT SUPPORTED

(9.4.17) Ordering Physician (Last Name Only)

NOT SUPPORTED

(9.4.18) Physician's Telephone Number

NOT SUPPORTED

(9.4.19) Users Field No. 1

NOT SUPPORTED SUPPORTED INTERNAL TO Siemens (Siemens Field 2)

(9.4.20) Users Field No. 2

NOT SUPPORTED

(9.4.21) Lab Field No. 1

NOT SUPPORTED SUPPORTED INTERNAL TO Siemens (CPS)

(9.4.22) Lab Field No. 2

NOT SUPPORTED SUPPORTED INTERNAL TO Siemens (Kit Lot)

(9.4.23) Date/Time Results Reported

NOT SUPPORTED

(9.4.24) Instrument Charge to Computer Sys

NOT SUPPORTED

(9.4.25) Instrument Section ID

NOT SUPPORTED

(9.4.26) Report Types

NOT SUPPORTED

(9.4.27) Reserved Field

NOT SUPPORTED

(9.4.28) Location of Specimen Collection

NOT SUPPORTED

page 3 - 14 Interface Specifications

 Configuring the IMMULITE 1000

(9.4.29) Nosocomial Infection Flag

NOT SUPPORTED

(9.4.30) Specimen Service

NOT SUPPORTED

(9.4.31) Specimen Institution

NOT SUPPORTED

Result Record Definition (10.1 - 10.1.14)

[Record Type (R)][Sequence #][Universal Test
ID][Data (result)][Units][ReferenceRanges] [Result
abnormal flags][Nature of Abnormality
Testing][Result Status][Date of change in
instruments normal values or units][Operator
ID][Date\Time Test Started][Date\Time Test
Completed][Instrument ID]

Sample Result Message:

<STX>[FrameNumber]R|1|^^^LH|8.2|mIU/
mL|.7\.7^400\400|N|N|F||test|19931011091233|1993101
1091233|Siemens<CR><ETX> [CheckSum]<CR><LF>

(10.1.1) Record Types Definition

Letter Record Type Status

R Result Record REQUIRED

(10.1.2) Sequence #
REQUIRED

(10.1.3) Universal Test ID

PARTIALLY SUPPORTED \ REQUIRED (^^^[Test Code])
Example Test Codes: TSH, LH, FSH, DGX, T4, HCG, TU, RTH, T3, FER, PSA,
PAP

(10.1.4) Data or Measurement Value (Result)

REQUIRED

(10.1.5) Units
REQUIRED

Interface Specifications page 3- 15

Configuring the IMMULITE 1000

Current Siemens Units of Measure: ng/mL, ng/dL, ug/dL, uIu/mL, mIU/mL,

pg/mL, nmol/L, pmol/L, mIU/L, ug/L, IU/mL, IU/L

(10.1.6) Reference Ranges

SUPPORTED ([Low]\[Panic\Low]^[High]\[Panic High])

(10.1.7) Result Abnormal Flags

Letter Record Type Status

L Below Normal SUPPORTED
H Above Normal SUPPORTED
LL Below Panic NOT SUPPORTED
HH Above Panic NOT SUPPORTED
< Below readable limit REQUIRED
> Above readable limit REQUIRED
N Normal SUPPORTED
A Abnormal NOT SUPPORTED
U Significant change UP NOT SUPPORTED
D Significant change DOWN NOT SUPPORTED
B Better NOT SUPPORTED
W Worse NOT SUPPORTED

(10.1.8) Nature of Abnormality Testing

Letter Record Type Status

A Age population tested NOT SUPPORTED
S Sex based Population NOT SUPPORTED
R Race based Population NOT SUPPORTED
N Normal generic range SUPPORTED

page 3 - 16 Interface Specifications

 Configuring the IMMULITE 1000

(10.1.9) Results Status

Letter Record Type Status

C Correction of previously sent results NOT SUPPORTED
P Preliminary Results NOT SUPPORTED
F Final Results SUPPORTED
X Results cannot be done NOT SUPPORTED
For example, Calculation Error
I In instrument, results pending NOT SUPPORTED
S Partial Results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED
R This result was previously SUPPORTED
transmitted
N This result record contains NOT SUPPORTED
necessary information to run a new
order

(10.1.10) Date systems values/units changed

NOT SUPPORTED

(10.1.11) Operator Name/ID#

SUPPORTED

(10.1.12) Date+Time Test Started

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.13) Date+Time Test Completed

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.14) Instrument ID
SUPPORTED (Configurable From Siemens 'KIT' Program)

Request Information Record Definition (Host Query)

(12.1 - 12.1.13)
[Record Type ID (Q)][Sequence #][Starting
Range][Ending Range][Test ID][Request Time
Limits][Beginning request results date and
time][Ending request results date and
time][Physician name][Physician Phone Number][User
Field 1]User Field 2][Status Codes]

Interface Specifications page 3- 17

Configuring the IMMULITE 1000

Example Request Record:

<STX>[FrameNumber]Q|1|^1234ABC||ALL|||||||O<CR>
<ETX>[CheckSum] <CR><LF>

(12.1.1) Record Types Definition

Letter Record Type Status

Q Request information SUPPORTED (UPLOAD ONLY)
Record

(12.1.2) Sequence Number

SUPPORTED

(12.1.3) Starting Range ID Number

REQUIRED

(12.1.4) Ending Range ID Number

NOT SUPPORTED

(12.1.5) Universal Test ID

REQUIRED

(12.1.6) Request Time Limits

NOT SUPPORTED

(12.1.7) Beginning Request Results

NOT SUPPORTED

(12.1.8) Ending Request Results

SUPPORTED

(12.1.9) Physician Name

NOT SUPPORTED

(12.1.10) Physician Phone #

NOT SUPPORTED

(12.1.11) User field #1

NOT SUPPORTED

page 3 - 18 Interface Specifications

 Configuring the IMMULITE 1000

(12.1.12) User field #2

NOT SUPPORTED

(12.1.13) Request information status codes

Letter Record Type Status

C Correction of previous results NOT SUPPORTED
P Preliminary Results NOT SUPPORTED
F Final Results NOT SUPPORTED
X Results cannot be done, cancel NOT SUPPORTED
I Request Results Pending NOT SUPPORTED
S Request partial results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED
R Result previously transmitted NOT SUPPORTED
A Abort/cancel last request REQUIRED
N Requesting new results only NOT SUPPORTED
O Requesting orders and demographics REQUIRED
D Requesting demographics only NOT SUPPORTED

Message Terminator Record Definition (13.1 - 13.1.3)

[Record Type ID (L)][Sequence Number][Temination
Code]

Example Termination Record

<STX>[FrameNumber]L|1|N<CR><ETX>[CheckSum]<CR><LF>

(13.1.1) Record Types Definition

Letter Record Type Status

L Terminator record SUPPORTED

(13.1.2) Sequence #
REQUIRED

Interface Specifications page 3- 19

Configuring the IMMULITE 1000

(13.1.3) Termination Code

Letter Record Type Status

N Normal termination SUPPORTED
T Sender Aborted NOT SUPPORTED
R Receiver Abort NOT SUPPORTED
E Unknown system error NOT SUPPORTED
Q Error in last request for information REQUIRED WITH QUERY
I No information available from last REQUIRED WITH QUERY
query
F Last request for information REQUIRED WITH QUERY
Processed

IMMULITE 1000 Uni-Directional Lis Specification

ASTM E1394
Header Record Definition (7.1 - 7.1.14)
[Record Type (H)] [Delimiter Def.] [Message Control
ID] [Password] [Sending systems company name]
[Sending Systems address] [Reserved] [Senders
Phone#] [Communication parameters] [Receiver ID]
[Comments/special instructions] [Processing ID]
[Version#] [Message Date + Time]

Sample Header Message

<STX>[FrameNumber]H|\^&||Password|Siemens|Flanders^
New^Jersey^07836|| 973-927-
2828|N81|Receiver||P|1|19920521132100
<CR><ETX>[CheckSum]<CR><LF>

page 3 - 20 Interface Specifications

 Configuring the IMMULITE 1000

(7.1.1) Record Types Definition

Letter Record Type Status

H Header record REQUIRED

(7.1.2) Delimiter Definition

Symbol Record Type Status

¦ Field Delimiter REQUIRED
\ Repeat Delimiter REQUIRED
^ Component Delimiter REQUIRED
& Escape Delimiter DEFINED, NOT SUPPORTED

(7.1.3) Message Control ID

NOT SUPPORTED

(7.1.4) Access Password

REQUIRED (Configurable in LIS Parameters window; Maximum of 15
characters)

(7.1.5) Sender Name or ID

REQUIRED (Configurable in LIS Parameters window; Maximum of 20
characters)

(7.1.6) Sender Street Address

SUPPORTED

(7.1.7) Reserved Field

NOT SUPPORTED

(7.1.8) Senders Telephone Number

SUPPORTED

(7.1.9) Characteristics of Sender

SUPPORTED (8 bits No Parity 1 Stop Bit)

(7.1.10) Receiver ID
REQUIRED (Configurable in the LIS Parameters window; Maximum of 15
characters)

Interface Specifications page 3- 21

Configuring the IMMULITE 1000

(7.1.11) Comments/Special Instructions

NOT SUPPORTED

(7.1.12) Processing ID Definition

Letter Record Type Status

P Normal production/running SUPPORTED
message
T Training message NOT SUPPORTED
D Debugging, used to debug a NOT SUPPORTED
program(s)
Q Message is for QC/regulatory NOT SUPPORTED
purposes

(7.1.13) Version Number

SUPPORTED (Currently 1)

(7.1.14) Date+Time of Message

SUPPORTED (YYYYMMDDHHMMSS)

Patient Information Record Definition (8.1 - 8.1.35)

[Record Type (P)][Sequence #][Practice Assigned
Patient ID][Laboratory Assigned Patient ID][Patient
ID][Patient Name][Mother's Maiden
Name][BirthDate][Patient Sex][Patient Race][Patient
Address][Reserved][Patient Phone #][Attending
Physician ID][Special Field 1][Special Field
2][Patient Height][Patient Weight][Patients Known
or Suspected Diagnosis] [Patient active
medications][Patients Diet][Practice Field
#1][Practice Field #2][Admission and Discharge
Dates][Admission Status][Location][Nature of
Alternative Diagnostic Code and
Classification][Alternative Diagnostic Code and
Classification][Patient Religion][Marital
Status][Isolation Status][Language][Hospital
Service][Hospital Institution][Dosage Category]

Sample Patient Information Record:

<STX>[FrameNumber]P|1||||Jones^Jane^L||19640804|F||
|||Doctor<CR><ETX>[CheckSum]<CR><LF>

page 3 - 22 Interface Specifications

 Configuring the IMMULITE 1000

(8.1.1) Record Types Definition

Letter Record Type Status
P Patient Identity Record REQUIRED

(8.1.2) Sequence # Definition

REQUIRED

(8.1.3) Practice Assigned Patient ID

NOT SUPPORTED

(8.1.4) Laboratory Assigned Patient ID

NOT SUPPORTED

(8.1.5) Patient ID
NOT SUPPORTED

(8.1.6) Patient Name

SUPPORTED (Last^First^Initial; maximum of 20 characters for Last Name,
maximum of 15 characters for First Name)

(8.1.7) Mother's Maiden Name

NOT SUPPORTED

(8.1.8) Birthdate
SUPPORTED (YYYYMMDD; maximum of 8 characters)

(8.1.9) Patient's Sex

SUPPORTED (M or F; maximum of 1 character)

(8.1.10) Patient Race-Ethnic Origin

NOT SUPPORTED

(8.1.11) Patient's Address

NOT SUPPORTED

(8.1.12) Reserved Field

NOT SUPPORTED

(8.1.13) Patient's Phone#

NOT SUPPORTED

Interface Specifications page 3- 23

Configuring the IMMULITE 1000

(8.1.14) Attending Physician ID

SUPPORTED (Last Name Only; maximum of 20 characters)

(8.1.15) Special Field 1

NOT SUPPORTED

(8.1.16) Special Field 2

NOT SUPPORTED

(8.1.17) Patient Height

NOT SUPPORTED

(8.1.18) Patient Weight

NOT SUPPORTED

(8.1.19) Known or Suspected Diagnosis

NOT SUPPORTED

(8.1.20) Active Medications

NOT SUPPORTED

(8.1.21) Patient's Diet

NOT SUPPORTED

(8.1.22) Practice Field 1

NOT SUPPORTED

(8.1.23) Practice Field 2

NOT SUPPORTED

(8.1.24) Admission and Discharge Dates

NOT SUPPORTED

(8.1.25) Admission Status

NOT SUPPORTED

(8.1.26) Location
NOT SUPPORTED

page 3 - 24 Interface Specifications

 Configuring the IMMULITE 1000

(8.1.27) Nature of Alt. Diag. Code

NOT SUPPORTED

(8.1.28) Alt. Diag. Code and Classifications

NOT SUPPORTED

(8.1.29) Patient Religion

NOT SUPPORTED

(8.1.30) Marital Status

NOT SUPPORTED

(8.1.31) Isolation Status

NOT SUPPORTED

(8.1.32) Language
NOT SUPPORTED

(8.1.33) Hospital Service

NOT SUPPORTED

(8.1.34) Hospital Institution

NOT SUPPORTED

(8.1.35) Dosage Category

NOT SUPPORTED

Interface Specifications page 3- 25

Configuring the IMMULITE 1000

Order Record Definition (9.4.1-9.4.31)

[Record Type (O)][Sequence#][Specimen ID
(Accession#)][Instrument Specimen ID][Universal
Test ID][Priority][Order Date/Time][Collection
Date/Time][Collection End Time][Collection
Volume][Collector ID][Action Code][Danger
Code][Relevant Clinical Info][Date/Time Specimen
Received][Specimen Descriptor,Specimen
Type,Specimen Source][Ordering
Physician][Physician's Telephone Number][User Field
No.1][User Field No.2][Lab Field No.1][Lab Field
No.2][Date/Time results reported or last
modified][Instrument Charge to Computer
System][Instrument Section ID][Report
Types][Reserved Field][Location or ward of Specimen
Collection][Nosocomial Infection Flag][Specimen
Service][Specimen Institution]

Sample Test Order Message

<STX>[FrameNumber]O|1|123456||^^^TSH<CR><ETX>[Check
Sum]<CR> <LF>

(9.4.1) Record types Definition

Letter Record Type Status

O Test Order Record REQUIRED

(9.4.2) Sequence #
REQUIRED

(9.4.3) Specimen ID
REQUIRED (ACCESSION # ON PRIMARY TUBE; maximum of 20 characters)

(9.4.4) Instrument Specimen ID

NOT SUPPORTED (SUPPORTED INTERNAL TO Siemens)
Sample Cup #

(9.4.5) Universal Test ID

REQUIRED (^^^[Test Code])
Example Test Codes: TSH, LH, FSH, DGX, TT4, HCG, TU, RTH, T3, FER, PSA,
PAP (maximum of 6 characters)

page 3 - 26 Interface Specifications

 Configuring the IMMULITE 1000

(9.4.6) Priority
NOT SUPPORTED (maximum of 1 character)

(9.4.7) Requested/Ordered Date and Time

NOT SUPPORTED (maximum of 14 characters)

(9.4.8) Specimen Collection Date and Time

NOT SUPPORTED (maximum of 14 characters)

(9.4.9) Collection End Time

NOT SUPPORTED

(9.4.10) Collection Volume

NOT SUPPORTED

(9.4.11) Collector ID
NOT SUPPORTED

(9.4.12) Action Code

NOT SUPPORTED

(9.4.13) Danger Code

NOT SUPPORTED

(9.4.14) Relevant Clinical Information

NOT SUPPORTED

(9.4.15) Date/Time Specimen Received

NOT SUPPORTED

(9.4.16) Specimen Descriptor

NOT SUPPORTED

(9.4.16.1) Specimen Type

NOT SUPPORTED

(9.4.17) Ordering Physician

NOT SUPPORTED

Interface Specifications page 3- 27

Configuring the IMMULITE 1000

(9.4.18) Physician's Telephone Number

NOT SUPPORTED

(9.4.19) Users Field No. 1

NOT SUPPORTED

(9.4.20) Users Field No. 2

NOT SUPPORTED

(9.4.21) Lab Field No. 1

NOT SUPPORTED SUPPORTED (INTERNAL TO Siemens)
(CPS)

(9.4.22) Lab Field No. 2

NOT SUPPORTED SUPPORTED (INTERNAL TO Siemens)
(Kit Lot)

(9.4.23) Date/Time Results Reported

NOT SUPPORTED

(9.4.24) Instrument Charge to Computer Sys.

NOT SUPPORTED

(9.4.25) Instrument Section ID

NOT SUPPORTED

(9.4.26) Report Types

NOT SUPPORTED

(9.4.27) Reserved Field

NOT SUPPORTED

(9.4.28) Location of Specimen Collection

NOT SUPPORTED

(9.4.29) Nosococmial Infection Flag

NOT SUPPORTED

page 3 - 28 Interface Specifications

 Configuring the IMMULITE 1000

(9.4.30) Specimen Service

NOT SUPPORTED

(9.4.31) Specimen Institution

NOT SUPPORTED

Result Record Definition (10.1 - 10.1.14)

[Record Type (R)][Sequence #][Universal Test
ID][Data (result)][Units][ReferenceRanges] [Result
abnormal flags][Nature of Abnormality
Testing][Result Status][Date of change in
instruments normal values or units][Operator
ID][Date\Time Test Started][Date\Time Test
Completed][Instrument ID]

Sample Result Message:

<STX>[FrameNumber]R|1|^^^TSH|8.19|uIU/
mL|.4\.002^4\75|H|N|F||test|1994032810834|199205261
10500|Siemens<CR><ETX>[CheckSum]<CR><LF>

(10.1.1) Record Types Definition

Letter Record Type Status

R Result Record REQUIRED

(10.1.2) Sequence #
REQUIRED

(10.1.3) Universal Test ID

PARTIALLY SUPPORTED \ REQUIRED (^^^[Test Code])
Example Test Codes: TSH, LH, FSH, DGX, TT4, HCG, TU, RTH, T3, FER, PSA,
PAP

(10.1.4) Data or Measurement Value (Result)

REQUIRED
Current

(10.1.5) Units
REQUIRED
Current Siemens Units of Measure: ng/mL, ng/dL, µg/dL, µIu/mL, mIU/mL,
pg/mL, nmol/L, pmol/L, mIU/L, µg/L, IU/mL, IU/L

Interface Specifications page 3- 29

Configuring the IMMULITE 1000

(10.1.6) Reference Ranges

SUPPORTED ([Low]\[Panic\Low]^[High]\[Panic High])

page 3 - 30 Interface Specifications

 Configuring the IMMULITE 1000

(10.1.7) Result Abnormal Flags

Letter Record Type Status

L Below Normal SUPPORTED
H Above Normal SUPPORTED
LL Below Panic NOT SUPPORTED
HH Above Panic NOT SUPPORTED
< Below readable limit REQUIRED
> Above readable limit REQUIRED
N Normal SUPPORTED
A Abnormal NOT SUPPORTED
U Significant change UP NOT SUPPORTED
D Significant change DOWN NOT SUPPORTED
B Better NOT SUPPORTED
W Worse NOT SUPPORTED

(10.1.8)Nature of Abnormality Testing

Letter Record Type Status

A Age population tested NOT SUPPORTED
S Sex based Population NOT SUPPORTED
R Race based Population NOT SUPPORTED
N Normal generic range SUPPORTED

(10.1.9) Results Status

Letter Record Type Status

C Correction of previously sent NOT SUPPORTED
results
P Preliminary Results NOT SUPPORTED
F Final Results SUPPORTED
X Results cannot be done NOT SUPPORTED
(For example, Calculation Error)
I In instrument, results pending NOT SUPPORTED
S Partial Results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED

Interface Specifications page 3- 31

Configuring the IMMULITE 1000

Letter Record Type Status

R This result was previously SUPPORTED
transmitted
N This result record contains NOT SUPPORTED
necessary information to run a
new order

(10.1.10) Date systems values/units changed

NOT SUPPORTED

(10.1.11) Operator Name/ID#

SUPPORTED

(10.1.12) Date+Time Test Started

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.13) Date+Time Test Completed

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.14) Instrument ID
SUPPORTED (Configurable From Siemens 'KIT' Program)

Request Information Record (12.1 - 12.1.13)

Not supported in uni-directional mode.

Message Terminator Record Definition (13.1 - 13.1.3)

[Record Type ID (L)][Sequence Number][Temination
Code]

Example Termination Record:

<STX>[FrameNumber]L|1|N<CR><ETX>[CheckSum]<CR><LF>

Record Types Definition

Letter Record Type Status

L Terminator record SUPPORTED

(13.1.2) Sequence #
REQUIRED

page 3 - 32 Interface Specifications

 Configuring the IMMULITE 1000

(13.1.3) Termination Code

Letter Record Type Status

N Normal termination SUPPORTED
T Sender Aborted NOT SUPPORTED
R Receiver Abort NOT SUPPORTED
E Unknown system error NOT SUPPORTED
Q Error in last request for NOT SUPPORTED
information
I No information available from last NOT SUPPORTED
query
F Last request for information NOT SUPPORTED
Processed

IMMULITE LIS Error Message Definitions

Error Message Definition
300 LIS Error Timeout During The LIS is not responding to the
Receive IMMULITE 1000 system. Causes
can be a cabling problem,
hardware communication problem
or a programming bug in the LIS
software.
301 LIS Error Invalid Frame The frame number in the message
Number is not proper. Usually indicates a
programming bug in the LIS
software, but may be a bad
message (for example, line noise).
See ASTM 1381 Logical layer
section 6.3.2.1 for further detail.
302 LIS Error Invalid Checksum Checksum did not match due to a
transmission error
303 LIS Error Missing Control Usually indicates a programming
Character bug in the LIS software, but may be
a bad message (for example, line
noise).

Interface Specifications page 3- 33

Configuring the IMMULITE 1000

Error Message Definition

304 LIS Error Invalid Message Data within the message was
Length dropped or not sent. Usually
indicates a programming bug in
the LIS software, but may be a bad
message (for example, line noise).
305 LIS Error Invalid Frame The sequence number in the
Sequence message is not proper. Usually
indicates a programming bug in
the LIS software, but may be a bad
message (for example, line noise).
See ASTM 1381 section 6.3.2.1 for
further detail.
306 LIS Error No There is no communication
Acknowledgement between the IMMULITE 1000
from LIS system and the LIS.
307 LIS Error Timeout During Send The LIS is not responding to
IMMULITE 1000 system. Causes
can be a cabling problem,
communication problem
(hardware related), or
programming bug in the LIS
software
308 LIS Error Excessive LIS errors There are numerous LIS errors
are occurring during a session.
309 LIS Error Log File Error There was an error while writing to
the Log File.
314 LIS Error Header Message Not The Header Password is incorrect
Received or there is no header message.
315 LIS Error Patient Message Not A record required for LIS
Received communications is not found.
316 LIS Error EOT received prior to An LIS message was received out
ENQ of sequence
317 LIS Error Invalid LIS Message An invalid message type code was
transmitted.
318 LIS Error Unexpected Communication Error.
Communication
from LIS
319 LIS Error Cannot Open The serial port is not configured
Communication Port properly or is not configured at all.

page 3 - 34 Interface Specifications

 Configuring the IMMULITE 1000

Error Message Definition

31421 LIS No Results Selected Tagged records are not found in
Error the database.
31422 LIS LIS Unavailable The LIS is not responding to the
Error IMMULITE 1000 system. The
causes can be a cabling problem, a
hardware communication problem
or a bug in the LIS software.
31423 LIS Terminator Code There is a terminator code error.
Error Error
31424 LIS LIS Terminator Code The terminator code is invalid.
Error Invalid
31425 LIS Password Error The password is incorrect in the
Error header message. Correct by
entering the proper password in
the LIS PARAMETER section from
the START menu. Siemens does not
know this password, this is set by
the software company. SUNQUEST
does not use a password. This field
should be left blank for SUNQUEST
systems.
31427 LIS Receiver ID Error This is the #1 question asked by LIS
Error customers. The Receiver ID is
incorrect in the header message.
These items need to be switched
by the LIS when sending messages
to IMMULITE 1000 system.
Example:
Receiver ID is set to “HOSPITAL” on
IMMULITE 1000 systems
IMMULITE Sending: Sender ID field = Siemens
Receiver ID Field = HOSPITAL
LIS Sending Sender ID Field = HOSPITAL
Receiver ID field = Siemens
31428 LIS Patient ID Missing The LIS is missing a patient ID.
Error
31429 LIS Patient ID exceeded The Patient ID has exceeded the
Error 20 characters allowable number of characters.

Interface Specifications page 3- 35

Configuring the IMMULITE 1000

Error Message Definition

31430 LIS Accession Number The accession number is missing.
Error Missing
31431 LIS Accession Number The accession number has
Error Exceeded 20 exceeded the allowable number of
Characters characters.
31433 LIS No Control Record Control information is not in the
Error Found database.
31435 LIS Invalid Control Data Control data is in an invalid format.
Error
31437 LIS LIS Unavailable in Occurs when an underlying
Error Test Mode hardware or configuration error
causes a software communication
error.
31439 LIS Call Technical Occurs when an underlying
Error Services hardware or configuration error
causes a software communication
issue.
31440 LIS Query Failure The LIS encountered an error when
Error processing the system’s request for
information.
31520 LIS Query The IMMULITE 1000 LIS software is
Error Communication not responding. The LIS
Error configuration parameters may
have changed.

page 3 - 36 Interface Specifications

4 IMMULITE 2000/XPi Interface to LIS

Results Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Required Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Qualitative Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
IMMULITE 2000/XPi LIS Configurations. . . . . . . . . . . . . . . . 4-2
Test Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
IMMULITE 2000/XPi Bi-Directional Lis Specification
ASTM E1394 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Header Record Definition (7.1 - 7.1.14) . . . . . . . . . . . . . . . . . . . .4-4
Sample Header Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.2) Delimiter Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.3) Message Control ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.4) Access Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.5) Sender Name or ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.6) Sender Street Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.7) Reserved Field. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.8) Senders Telephone Number. . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
(7.1.9) Characteristics of Sender . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
(7.1.10) Receiver ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
(7.1.11) Comments/Special Instructions . . . . . . . . . . . . . . . . . . . . . . .4-6
(7.1.12) Processing ID Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
(7.1.13) Version Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
(7.1.14) Date+Time of Message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
Patient Information Record Definition (8.1 - 8.1.35) . . . . . . . . . .4-7
Sample Patient Information Record: . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
(8.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
(8.1.2) Sequence # Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
(8.1.3) Practice Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
(8.1.4) Laboratory Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . .4-7
(8.1.5) Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
(8.1.6) Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
For Patient Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
For control sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
For Adjustor Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
For Verifier Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
(8.1.7) Mother's Maiden Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
(8.1.8) Birthdate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
(8.1.9) Patient's Sex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
(8.1.10) Patient Race-Ethnic Origin . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
Interface Specifications page 4-i
IMMULITE 2000/XPi Interface to LIS

(8.1.11) Patient's Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

(8.1.12) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
(8.1.13) Patient's Phone# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.14) Attending Physician ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.15) Special Field 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.16) Special Field 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.17) Patient Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.18) Patient Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.19) Known or Suspected Diagnosis . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.20) Active Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.21) Patient's Diet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.22) Practice Field 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.23) Practice Field 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.24) Admission and Discharge Dates . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.25) Admission Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
(8.1.26) Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.27) Nature of Alt. Diag. Code. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.28) Alt. Diag. Code and Classifications . . . . . . . . . . . . . . . . . . . 4-11
(8.1.29) Patient Religion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.30) Marital Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.31) Isolation Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.32) Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.33) Hospital Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.34) Hospital Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(8.1.35) Dosage Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Order Record Definition (9.4.1-9.4.31) . . . . . . . . . . . . . . . . . . . 4-12
Sample Test Order Message: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
(9.4.1) Record types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
(9.4.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
(9.4.3) Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
For Patient Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
For Control Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
For Adjustor Sample (Supported Internal to Siemens) . . . . . . . . . . . 4-14
For Verifier Sample (Supported Internal to Siemens) . . . . . . . . . . . . 4-14
(9.4.4) Instrument Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
(9.4.5) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
(9.4.6) Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
(9.4.7) Requested/Ordered Date and Time . . . . . . . . . . . . . . . . . . . . 4-15
(9.4.8) Specimen Collection Date and Time . . . . . . . . . . . . . . . . . . . 4-15
(9.4.9) Collection End Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
(9.4.10) Collection Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
(9.4.11) Collector ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
(9.4.12) Action Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
(9.4.13) Danger Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

page 4-ii Interface Specifications

IMMULITE 2000/XPi Interface to LIS

(9.4.14) Relevant Clinical Information . . . . . . . . . . . . . . . . . . . . . . . .4-16

(9.4.15) Date/Time Specimen Received . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.16) Specimen Descriptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.17) Ordering Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.18) Physician's Telephone Number . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.19) Users Field No. 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.20) Users Field No. 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.21) Lab Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.22) Lab Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.23) Date/Time Results Reported . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.24) Instrument Charge to Computer Sys . . . . . . . . . . . . . . . . . .4-16
(9.4.25) Instrument Section ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.26) Report Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
(9.4.27) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
(9.4.28) Location of Specimen Collection . . . . . . . . . . . . . . . . . . . . .4-17
(9.4.29) Nosococmial Infection Flag . . . . . . . . . . . . . . . . . . . . . . . . .4-17
(9.4.30) Specimen Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
(9.4.31) Specimen Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
Result Record Definition (10.1 - 10.1.14) . . . . . . . . . . . . . . . . . .4-17
Sample Result Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
(10.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
(10.1.2) Sequence #. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
(10.1.3) Universal Test ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
(10.1.4) Data or Measurement Value (Result) . . . . . . . . . . . . . . . . . .4-18
(10.1.5) Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18
(10.1.6) Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18
(10.1.7) Result Abnormal Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18
(10.1.8) Nature of Abnormality Testing. . . . . . . . . . . . . . . . . . . . . . .4-19
(10.1.9) Results Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19
(10.1.10) Date systems values/units changed . . . . . . . . . . . . . . . . . .4-19
(10.1.11) Operator Name/ID# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19
(10.1.12) Date+Time Test Started . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19
(10.1.13) Date+Time Test Completed . . . . . . . . . . . . . . . . . . . . . . . .4-19
(10.1.14) Instrument ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19
Request Information Record Definition (Host Query) (12.1 -
12.1.13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
Example Request Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
(12.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
(12.1.2) Sequence Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
(12.1.3) Starting Range ID Number . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
(12.1.4) Ending Range ID Number. . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
(12.1.5) Universal Test ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20
(12.1.6) Request Time Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

Interface Specifications page 4-iii

IMMULITE 2000/XPi Interface to LIS

(12.1.7) Beginning Request Results . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

(12.1.8) Ending Request Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
(12.1.9) Physician Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
(12.1.10) Physician Phone # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
(12.1.11) User field #1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
(12.1.12) User field #2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
(12.1.13) Request Information Status Codes . . . . . . . . . . . . . . . . . . 4-21
Message Terminator Record Definition (13.1 - 13.1.3) . . . . . . 4-21
Example Termination Record: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
(13.1.1) Record Types Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
(13.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
(13.1.3) Termination Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
IMMULITE 2000/XPi Uni-Directional LIS Specification
ASTM E1394. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Header Record Definition (7.1 - 7.1.14) . . . . . . . . . . . . . . . . . . 4-22
Sample Header Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
(7.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
(7.1.2) Delimiter Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.3) Message Control ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.4) Access Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.5) Sender Name or ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.6) Sender Street Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.7) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.8) Senders Telephone Number . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.9) Characteristics of Sender . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.10) Receiver ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.11) Comments/Special Instructions . . . . . . . . . . . . . . . . . . . . . . 4-23
(7.1.12) Processing ID Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
(7.1.13) Version Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
(7.1.14) Date+Time of Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Patient Information Record Definition (8.1 - 8.1.35) . . . . . . . . 4-24
Sample Patient Information Record. . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
(8.1.1) Record Types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
(8.1.2) Sequence # Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.3) Practice Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.4) Laboratory Assigned Patient ID . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.5) Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.6) Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.7) Mother's Maiden Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.8) Birthdate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.9) Patient's Sex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.10) Patient Race-Ethnic Origin . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
(8.1.11) Patient's Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

page 4-iv Interface Specifications

IMMULITE 2000/XPi Interface to LIS

(8.1.12) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

(8.1.13) Patient's Phone#. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25
(8.1.14) Attending Physician ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25
(8.1.15) Special Field 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.16) Special Field 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.17) Patient Height. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.18) Patient Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.19) Known or Suspected Diagnosis . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.20) Active Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.21) Patient's Diet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.22) Practice Field 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.23) Practice Field 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.24) Admission and Discharge Dates. . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.25) Admission Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.26) Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.27) Nature of Alt. Diag. Code . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
(8.1.28) Alt. Diag. Code and Classifications. . . . . . . . . . . . . . . . . . . .4-27
(8.1.29) Patient Religion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
(8.1.30) Marital Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
(8.1.31) Isolation Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
(8.1.32) Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
(8.1.33) Hospital Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
(8.1.34) Hospital Institution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
(8.1.35) Dosage Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
Order Record Definition (9.4.1-9.4.31) . . . . . . . . . . . . . . . . . . . .4-27
Sample Test Order Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
(9.4.1) Record types Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
(9.4.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
(9.4.3) Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
(9.4.4) Instrument Specimen ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
(9.4.5) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
(9.4.6) Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
(9.4.7) Requested/Ordered Date and Time . . . . . . . . . . . . . . . . . . . .4-28
(9.4.8) Specimen Collection Date and Time . . . . . . . . . . . . . . . . . . .4-28
(9.4.9) Collection End Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.10) Collection Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.11) Collector ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.12) Action Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.13) Danger Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.14) Relevant Clinical Information . . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.15) Date/Time Specimen Received . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.16) Specimen Descriptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
(9.4.16.1) Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29

Interface Specifications page 4-v

IMMULITE 2000/XPi Interface to LIS

(9.4.17) Ordering Physician. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

(9.4.18) Physician's Telephone Number . . . . . . . . . . . . . . . . . . . . . . 4-29
(9.4.19) Users Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
(9.4.20) Users Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
(9.4.21) Lab Field No. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.22) Lab Field No. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.23) Date/Time Results Reported. . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.24) Instrument Charge to Computer Sys . . . . . . . . . . . . . . . . . . 4-30
(9.4.25) Instrument Section ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.26) Report Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.27) Reserved Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.28) Location of Specimen Collection . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.29) Nosococmial Infection Flag . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.30) Specimen Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
(9.4.31) Specimen Institution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Result Record Definition (10.1 - 10.1.14) . . . . . . . . . . . . . . . . . 4-31
Sample Result Message: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
(10.1.1) Record Types Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
(10.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
(10.1.3) Universal Test ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
(10.1.4) Data or Measurement Value (Result) . . . . . . . . . . . . . . . . . 4-31
(10.1.5) Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
(10.1.6) Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
(10.1.7) Result Abnormal Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32
(10.1.8) Nature of Abnormality Testing . . . . . . . . . . . . . . . . . . . . . . 4-32
(10.1.9) Results Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
(10.1.10) Date systems values/units changed . . . . . . . . . . . . . . . . . 4-33
(10.1.11) Operator Name/ID# . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
(10.1.12) Date+Time Test Started . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
(10.1.13) Date+Time Test Completed . . . . . . . . . . . . . . . . . . . . . . . . 4-33
(10.1.14) Instrument ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Request Information Record (12.1 - 12.1.13) . . . . . . . . . . . . . . 4-33
Message Terminator Record Definition (13.1 - 13.1.3) . . . . . . 4-33
Example Termination Record: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
(13.1.1) Record Types Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
(13.1.2) Sequence # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
(13.1.3) Termination Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
IMMULITE 2000/XPi LIS Error Message Definitions . . . . . 4-34
IMMULITE 2000/XPi LIS Troubleshooting . . . . . . . . . . . . . 4-43
LIS 15-Second Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43
LIS 30-Second Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

page 4-vi Interface Specifications

IMMULITE 2000/XPi Interface to LIS

Results Handling
Results are sent using floating decimals as follows

Result # Decimal Places Sent Example

less than 1.00 * 3 *TSH, RTH 0.025
1.00–9.99 2 1.23
10.0–99.9 1 10.2
100 and above None 102

Required Flags
Required flags include H, L, N, < and >.
Greater than (>) and Less than (<) calibration range results are sent as
follows:
0R|1|^^^TSH|>75.0|uIU/
mL|.4\.002^4\75|>|N|F||test|19940407085044|19940407
085148|Siemens
• > or < flag included with the assay Min/Max
• > is the Result Flag

Qualitative Test Results

Qualitative tests result either as a qualitative interpretation for Reactive,
Non-Reactive or Indeterminate or as a semi-quantitative ratio (patient CPS/
Cutoff CPS), and can be sent to the LIS as either a qualitative interpretation
or as a ratio (not both).
The qualitative interpretation is sent to the LIS as follows:

Result Sent to LIS as

Non-reactive 0.0
Reactive 1.00
Indeterminate 2.00

See assay package inserts for interpretation of qualitative assay ratio

results.

Interface Specifications page4 - 1

IMMULITE 2000/XPi Interface to LIS

IMMULITE 2000/XPi LIS Configurations

To set up a connection between the IMMULITE 2000/XPi and an LIS, follow
the steps below:
1. Connect the Cable.
Refer to Cable Specifications, page 1-13. Use serial port 8 (labeled
“LIS”) in the I/O panel on the back of the System.
Note The IMMULITE 2000/XPi network ports cannot be used for LIS
communication.
2. Configure LIS Parameters.
Individual fields are defined in LIS Configuration Screen Terms, page 1-
6.
Note LIS messaging uses non-multi-byte characters only. Multi-byte
characters are used in languages such as Russian and Chinese.
3. At the instrument window, select Menu > Configure > LIS.
4. Select the appropriate LIS Host Query Mode.
Password, Receiver, and Sender ID’s should be supplied by the LIS
vendor.
Baud Rate should be supplied by the LIS vendor.
COM Parameters are N81.
Serial Port 8 is labeled LIS on the Instrument I/O panel.
5. To activate a log of the transmission between the instrument and the
LIS for troubleshooting, in the Diagnostics field replace 0 with 1.
The log should not be active during normal operation and should only
be changed at the direction of Technical Service.
6. To hide sent results from view on the LIS screen, select Hide Sent.
7. To automatically send results, select Auto-Send Patient Results.
8. To automatically send patient results flagged ADJ, select Auto-Send
Invalid Adjustment.
9. To automatically send patient results if the controls for an assay are
configured as single or multi-rule in the QC | Data Entry screen, select
Auto-Send Invalid Control Results.
10. To automatically send patient results that are greater than or less than
the calibration range, select Auto-Send Invalid Range.

page 4 - 2 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

11. To automatically send all results for control samples, select Auto Send
Control Results.
12. Select LIS Requery, as appropriate:
• No Requery – if an accession number is found in the Instrument
database (pending or completed tests), the accession number will
not be requeried to an LIS.
• Requery New Orders – Accession numbers are always requeried
and duplicate test orders are not run if that test is currently in
progress.
• Requery All – Accession numbers are always requeried and
duplicate test orders are run.
13. Select LIS Query for Controls.
• Exclude Controls – Control samples are not queried to an LIS.
• Include Controls – All control samples are queried to an LIS.
14. Report Qualitative Assay Results sent to the LIS:
• Qualitative Only
Results display on the LIS screen as follows:

Result Sent to LIS as…

Non-Reactive 0.0
Reactive 1.00
Indeterminate 2.00

• Ratio Only
Results sent as a ratio (Patient cps/cutoff cps).
15. Report Qualitative Assay Results display on LIS screen:
• Qualitative only
Results display on LIS screen as follows:

Reactive
Non-React
Indeterminate

• Qualitative and Ratio

Results display on LIS screen as numerical ratio plus NR, R, or I.

Interface Specifications page 4 - 3

IMMULITE 2000/XPi Interface to LIS

16. Configure the IMMULITE 2000 systems to use the Q action code to
indicate to the LIS that an order record contains a QC result: In the
Controls panel, select Send Action Code.
17. Configure the IMMULITE 2000 systems to send a 3 character or 5
character Bio-Rad lot to your LIS. The default is 3 characters. To
configure the IMMULITE 2000 systems to send a 5-character lot to your
LIS, perform the following steps:
a. Select MENU.
b. Select Configure.
c. Select LIS.
d. In the Controls panel, select Send 5 digit lot number.

Test Codes
IMMULITE 2000/XPi Test Codes are upload and download Test codes, and
can be found in IMMULITE 2000/XPi Assay Test Kit package inserts.
• If ^^^HCG^40 is downloaded, the Instrument dilutes HCG assay x40.
• The instrument sends the result with test code ^^^HCG (dilution not
included).
• Operators can create test panels on the instrument.
• Panel names can be sent to the Instrument.
All tests within a panel will be run.
• Individual test codes are sent with results.
The Panel name is not returned.
• Panel names should be unique.
Do not name a panel the same as an assay code.

IMMULITE 2000/XPi Bi-Directional Lis Specification

ASTM E1394
Header Record Definition (7.1 - 7.1.14)
[Record Type (H)] [Delimiter Def.] [Message Control
ID] [Password] [Sending systems company name]
[Sending Systems address] [Reserved] [Senders
Phone#] [Communication parameters] [Receiver ID]
[Comments/special instructions] [Processing ID]
[Version#] [Message Date + Time]

page 4 - 4 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

Sample Header Message

<STX>[FrameNumber]H|\^&||Password|Siemens|Randolph^
New^Jersey^07869||(973)927-
2828|8N1|YourSystem||P|1|19940323082858
<CR><ETX>[CheckSum]<CR><LF>

(7.1.1) Record Types Definition

Letter Record Type Status

H Header record REQUIRED

(7.1.2) Delimiter Definition

REQUIRED

Symbol Record Type Status

¦ Field Delimiter REQUIRED
\ Repeat Delimiter REQUIRED
^ Component Delimiter REQUIRED
& Escape Delimiter DEFINED, NOT SUPPORTED

(7.1.3) Message Control ID

NOT SUPPORTED

(7.1.4) Access Password

REQUIRED (Configurable by Siemens; Maximum of 10 characters)

(7.1.5) Sender Name or ID

REQUIRED (Configurable by Siemens; maximum of 10 characters)

(7.1.6) Sender Street Address

SUPPORTED

(7.1.7) Reserved Field

NOT SUPPORTED

(7.1.8) Senders Telephone Number

SUPPORTED

Interface Specifications page 4 - 5

IMMULITE 2000/XPi Interface to LIS

(7.1.9) Characteristics of Sender

SUPPORTED
(8 bits, No Parity, 1 Stop Bit)

(7.1.10) Receiver ID
REQUIRED (Configurable by Siemens; maximum of 10 characters)

(7.1.11) Comments/Special Instructions

NOT SUPPORTED

(7.1.12) Processing ID Definition

Letter Record Type Status

P Normal production/running SUPPORTED
message
T Training message NOT SUPPORTED
D Debugging, used to debug a NOT SUPPORTED
program(s)

(7.1.13) Version Number

SUPPORTED (Currently 1)

(7.1.14) Date+Time of Message

SUPPORTED (YYYYMMDDHHMMSS)

page 4 - 6 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

Patient Information Record Definition (8.1 - 8.1.35)

[Record Type (P)][Sequence #][Practice Assigned
Patient ID][Laboratory Assigned Patient ID][Patient
ID][Patient Name][Mother's Maiden
Name][BirthDate][Patient Sex][Patient Race][Patient
Address][Reserved][Patient Phone #][Attending
Physician ID][Special Field 1][Special Field
2][Patient Height][Patient Weight][Patients Known
or Suspected Diagnosis] [Patient active
medications][Patients Diet][Practice Field
#1][Practice Field #2][Admission and Discharge
Dates][Admission Status][Location][Nature of
Alternative Diagnostic Code and
Classification][Alternative Diagnostic Code and
Classification][Patient Religion][Marital
Status][Isolation Status][Language][Hospital
Service][Hospital Institution][Dosage Category]

Sample Patient Information Record:

<STX>[FrameNumber]P|1|101|||Riker^Al||19611102|F|||
||Bashere<CR><ETX>[CheckSum]<CR><LF>

(8.1.1) Record Types Definition

Letter Record Type Status

P Patient Identity Record REQUIRED

(8.1.2) Sequence # Definition

REQUIRED

(8.1.3) Practice Assigned Patient ID

REQUIRED (maximum of 20 characters)

(8.1.4) Laboratory Assigned Patient ID

NOT SUPPORTED

(8.1.5) Patient ID
NOT SUPPORTED

(8.1.6) Patient Name

SUPPORTED

Interface Specifications page 4 - 7

IMMULITE 2000/XPi Interface to LIS

For Patient Sample

Last^First^Initial
Maximum of 30 characters for both Last&First name

For control sample

Note Control accession numbers that begin with ‘~C’ follow the format in
Table 1 and Table 2. Control accession numbers do not need to follow this
convention. Alternatively, controls may be defined using any allowed
characters for a patient accession number.
Table 1: Non Bio-Rad Controls

Position Description
First 2 characters ~C (use uppercase letter)
Next 6 characters Control Name (if fewer than 6 characters, right-
padded with spaces; should not be empty)
Next 3 characters Control Lot (use 3 numeric digits; should not be
empty)
Next 6 characters Expiration Date (use YYYYMM format; should not be
empty)
Last 1 character Control Level (should not be empty)

Table 2: Bio-Rad Controls

Position Description
First 2 characters ~C (use uppercase letter)
Next 4 characters Bio-Rad Control Name (should not be empty)
Next 5 characters Control Lot (use 5 numeric digits; should not be
empty)
Next 6 characters Expiration Date (use YYYYMM format; should not be
empty)
Last 1 character Control Level (should not be empty)

Note Bio-Rad controls are configurable to send with a 3 character lot (the
same format as non Bio-Rad Controls) or 5 character lot. See step 17 on
page 4.

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 IMMULITE 2000/XPi Interface to LIS

For Adjustor Sample

Position Description
First 2 characters ~A (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Kit Lot (use 3 numeric digits; should not be empty)
Next 3 characters Adjustor Lot (use 3 numeric digits; should not be
empty)
Last 2 character Level (use 2 numeric digits; should not be empty)

For Verifier Sample

Position Description
First 2 characters ~V (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Verifier Lot (should not be empty)
Next 1 characters Level (numeric values should not be empty)
Next 4 characters Range low (numeric value; should not be empty)
Last 4 character Range high (numeric value; should not be empty)

(8.1.7) Mother's Maiden Name

NOT SUPPORTED

(8.1.8) Birthdate
SUPPORTED (YYYYMMDD; maximum of 8 characters)

(8.1.9) Patient's Sex

SUPPORTED (M or F; maximum of 1 character)

(8.1.10) Patient Race-Ethnic Origin

NOT SUPPORTED

(8.1.11) Patient's Address

NOT SUPPORTED

(8.1.12) Reserved Field

NOT SUPPORTED

Interface Specifications page 4 - 9

IMMULITE 2000/XPi Interface to LIS

(8.1.13) Patient's Phone#

NOT SUPPORTED

(8.1.14) Attending Physician ID

NOT SUPPORTED (Value is sent only from Instruments to LIS)

(8.1.15) Special Field 1

NOT SUPPORTED

(8.1.16) Special Field 2

NOT SUPPORTED

(8.1.17) Patient Height

NOT SUPPORTED

(8.1.18) Patient Weight

NOT SUPPORTED

(8.1.19) Known or Suspected Diagnosis

NOT SUPPORTED

(8.1.20) Active Medications

NOT SUPPORTED

(8.1.21) Patient's Diet

NOT SUPPORTED

(8.1.22) Practice Field 1

NOT SUPPORTED

(8.1.23) Practice Field 2

NOT SUPPORTED

(8.1.24) Admission and Discharge Dates

NOT SUPPORTED

(8.1.25) Admission Status

NOT SUPPORTED

page 4 - 10 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

(8.1.26) Location
NOT SUPPORTED

(8.1.27) Nature of Alt. Diag. Code

NOT SUPPORTED

(8.1.28) Alt. Diag. Code and Classifications

NOT SUPPORTED

(8.1.29) Patient Religion

NOT SUPPORTED

(8.1.30) Marital Status

NOT SUPPORTED

(8.1.31) Isolation Status

NOT SUPPORTED

(8.1.32) Language
NOT SUPPORTED

(8.1.33) Hospital Service

NOT SUPPORTED

(8.1.34) Hospital Institution

NOT SUPPORTED

(8.1.35) Dosage Category

NOT SUPPORTED

Interface Specifications page 4 - 11

IMMULITE 2000/XPi Interface to LIS

Order Record Definition (9.4.1-9.4.31)

[Record Type (O)][Sequence#][Specimen ID
(Accession#)][Instrument Specimen ID][Universal
Test ID][Priority][Order Date/Time][Collection
Date/Time][Collection End Time][Collection
Volume][Collector ID][Action Code][Danger
Code][Relevant Clinical Info][Date/Time Specimen
Received][Specimen Descriptor,Specimen
Type,Specimen Source][Ordering
Physician][Physician's Telephone Number][User Field
No.1][User Field No.2][Lab Field No.1][Lab Field
No.2][Date/Time results reported or last
modified][Instrument Charge to Computer
System][Instrument Section ID][Report
Types][Reserved Field][Location or ward of Specimen
Collection][Nosocomial Infection Flag][Specimen
Service][Specimen Institution]

Sample Test Order Message:

<STX>[FrameNumber]O|1|1550623||^^^LH|R|199310110912
33|19931011091233||||||Post
Menopausal<CR><ETX>[CheckSum]<CR><LF>

(9.4.1) Record types Definition

Letter Record Type Status

O Test Order Record REQUIRED

(9.4.2) Sequence #
REQUIRED

(9.4.3) Specimen ID
REQUIRED (maximum of 20 characters)

For Patient Sample

Accession number on primary tube.

page 4 - 12 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

For Control Sample

Note Control accession numbers that begin with ‘~C’ follow the format in
Table 3 and Table 4. Control accession numbers do not need to follow this
convention. Alternatively, controls may be defined using any allowed
characters for a patient accession number.
Table 3: Non Bio-Rad Controls

Position Description
First 2 characters ~C (use uppercase letter)
Next 6 characters Control Name (if fewer than 6 characters, right-
padded with spaces; should not be empty)
Next 3 characters Control Lot (use 3 numeric digits; should not be
empty)
Next 6 characters Expiration Date (use YYYYMM format; should not be
empty)
Last 1 character Control Level (should not be empty)

Table 4: Bio-Rad Controls

Position Description
First 2 characters ~C (use uppercase letter)
Next 4 characters Bio-Rad Control Name (should not be empty)
Next 5 characters Control Lot (use 5 numeric digits; should not be
empty)
Next 6 characters Expiration Date (use YYYYMM format; should not be
empty)
Last 1 character Control Level (should not be empty)

Note Bio-Rad controls are configurable to send with a 3 character lot (the
same format as non Bio-Rad Controls) or 5 character lot. See step 17 on
page 4.

Interface Specifications page 4 - 13

IMMULITE 2000/XPi Interface to LIS

For Adjustor Sample (Supported Internal to Siemens)

Position Description
First 2 characters ~A (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Kit Lot (use 3 numeric digits; should not be empty)
Next 3 characters Adjustor Lot (use 3 numeric digits; should not be
empty)
Last 2 character Level (use 2 numeric digits; should not be empty)

For Verifier Sample (Supported Internal to Siemens)

Position Description
First 2 characters ~V (use uppercase letter)
Next 6 characters Test Code (should not be empty)
Next 3 characters Verifier Lot (should not be empty)
Next 1 characters Level (numeric values should not be empty)
Next 4 characters Range low (numeric value; should not be empty)
Last 4 character Range high (numeric value; should not be empty)

(9.4.4) Instrument Specimen ID

NOT SUPPORTED

(9.4.5) Universal Test ID

REQUIRED (^^^[Test Code]) Test Code can be up to 10 characters.
Examples:
• Order for TSH
^^^TSH
• Order for multiple TSH tests
^^^TSH\^^^TSH
• Order for TSH with ten-fold dilution
^^^TSH^10
• Order for multiple TSH tests with dilutions
^^^TSH^10\^^^TSH^40
• Order for a panel of tests called PANEL1
^^^PANEL1

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 IMMULITE 2000/XPi Interface to LIS

• Order for allergy

^^^ SPE D120
A maximum of 3 characters for the Universal Reagent (SPE), a space, and a
maximum of 6 characters for the Allergen Code (D120).

(9.4.6) Priority
SUPPORTED (All maximum of 1 character)

S Stat
A As soon as possible
R Routine
C Callback
P Preoperative

(9.4.7) Requested/Ordered Date and Time

SUPPORTED (YYYYMMDDHHMMSS; maximum of 14 characters)

(9.4.8) Specimen Collection Date and Time

SUPPORTED (maximum of 14 characters)

(9.4.9) Collection End Time

NOT SUPPORTED

(9.4.10) Collection Volume

NOT SUPPORTED

(9.4.11) Collector ID
NOT SUPPORTED

(9.4.12) Action Code

Letter Record Type Status

Q Message is for QC/regulatory SUPPORTED
purposes (upload only)

(9.4.13) Danger Code

NOT SUPPORTED

Interface Specifications page 4 - 15

IMMULITE 2000/XPi Interface to LIS

(9.4.14) Relevant Clinical Information

SUPPORTED

(9.4.15) Date/Time Specimen Received

NOT SUPPORTED

(9.4.16) Specimen Descriptor

NOT SUPPORTED

(9.4.17) Ordering Physician

NOT SUPPORTED

(9.4.18) Physician's Telephone Number

NOT SUPPORTED

(9.4.19) Users Field No. 1

NOT SUPPORTED

(9.4.20) Users Field No. 2

NOT SUPPORTED

(9.4.21) Lab Field No. 1

NOT SUPPORTED

(9.4.22) Lab Field No. 2

NOT SUPPORTED

(9.4.23) Date/Time Results Reported

NOT SUPPORTED

(9.4.24) Instrument Charge to Computer Sys

NOT SUPPORTED

(9.4.25) Instrument Section ID

SUPPORTED

(9.4.26) Report Types

NOT SUPPORTED

page 4 - 16 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

(9.4.27) Reserved Field

NOT SUPPORTED

(9.4.28) Location of Specimen Collection

NOT SUPPORTED

(9.4.29) Nosococmial Infection Flag

NOT SUPPORTED

(9.4.30) Specimen Service

NOT SUPPORTED

(9.4.31) Specimen Institution

NOT SUPPORTED

Result Record Definition (10.1 - 10.1.14)

[Record Type (R)][Sequence #][Universal Test
ID][Data (result)][Units][ReferenceRanges] [Result
abnormal flags][Nature of Abnormality
Testing][Result Status][Date of change in
instruments normal values or units][Operator
ID][Date\Time Test Started][Date\Time Test
Completed][Instrument ID]

Sample Result Message

<STX>[FrameNumber]R|1|^^^LH|8.2|mIU/
mL|.7\.7^400\400|N|N|F||test|19931011091233|1993101
1091233|Siemens<CR><ETX>[CheckSum]<CR><LF>

(10.1.1) Record Types Definition

Letter Record Type Status

R Result Record REQUIRED

(10.1.2) Sequence #
REQUIRED

(10.1.3) Universal Test ID

REQUIRED (^^^[Test Code])
Example Test Codes: TSH, LH, FSH, DGX, T4, HCG, RTH, SPE D120

Interface Specifications page 4 - 17

IMMULITE 2000/XPi Interface to LIS

(10.1.4) Data or Measurement Value (Result)

REQUIRED

(10.1.5) Units
REQUIRED
Current Siemens Units of Measure: ng/mL, ng/dL, µg/dL, µIu/mL, mIU/mL,
pg/mL, nmol/L, pmol/L, mIU/L, µg/L, IU/mL, IU/L, KU/L, SClass

(10.1.6) Reference Ranges

SUPPORTED ([Low]\[Panic\Low]^[High]\[Panic High])

(10.1.7) Result Abnormal Flags

Letter Record Type Status

L Below Normal SUPPORTED
H Above Normal SUPPORTED
LL Below Panic NOT SUPPORTED
HH Above Panic NOT SUPPORTED
< Below readable limit REQUIRED
> Above readable limit REQUIRED
N Normal SUPPORTED
A Abnormal NOT SUPPORTED
U Significant change UP NOT SUPPORTED
D Significant change DOWN NOT SUPPORTED
B Better NOT SUPPORTED
W Worse NOT SUPPORTED

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 IMMULITE 2000/XPi Interface to LIS

(10.1.8) Nature of Abnormality Testing

Letter Record Type Status

A Age population tested NOT SUPPORTED
S Sex based Population NOT SUPPORTED
R Race based Population NOT SUPPORTED
N Normal generic range SUPPORTED

(10.1.9) Results Status

Letter Record Type Status

C Correction of previously sent results NOT SUPPORTED
P Preliminary Results NOT SUPPORTED
F Final Results SUPPORTED
X Results cannot be done NOT SUPPORTED
For example, Calculation Error
I In instrument, results pending NOT SUPPORTED
S Partial Results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED
R This result was previously SUPPORTED
transmitted
N This result record contains NOT SUPPORTED
necessary information to run a new
order

(10.1.10) Date systems values/units changed

NOT SUPPORTED

(10.1.11) Operator Name/ID#

SUPPORTED

(10.1.12) Date+Time Test Started

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.13) Date+Time Test Completed

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.14) Instrument ID
SUPPORTED (Configurable from Siemens)

Interface Specifications page 4 - 19

IMMULITE 2000/XPi Interface to LIS

Request Information Record Definition (Host Query)

(12.1 - 12.1.13)
[Record Type ID (Q)][Sequence #][Starting
Range][Ending Range][Test ID][Request Time
Limits][Beginning request results date and
time][Ending request results date and
time][Physician name][Physician Phone Number][User
Field 1]User Field 2][Status Codes]

Example Request Record

<STX>[FrameNumber]Q|1|^1234ABC||ALL|||||||O<CR>
<ETX>[CheckSum] <CR><LF>

(12.1.1) Record Types Definition

Letter Record Type Status
Q Request information SUPPORTED (upload only)
Record

(12.1.2) Sequence Number

SUPPORTED

(12.1.3) Starting Range ID Number

REQUIRED

(12.1.4) Ending Range ID Number

NOT SUPPORTED

(12.1.5) Universal Test ID

REQUIRED

(12.1.6) Request Time Limits

NOT SUPPORTED

(12.1.7) Beginning Request Results

NOT SUPPORTED

(12.1.8) Ending Request Results .

NOT SUPPORTED

(12.1.9) Physician Name

NOT SUPPORTED

page 4 - 20 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

(12.1.10) Physician Phone #

NOT SUPPORTED

(12.1.11) User field #1

NOT SUPPORTED

(12.1.12) User field #2

NOT SUPPORTED

(12.1.13) Request Information Status Codes

Letter Record Type Status

C Correction of previous results NOT SUPPORTED
P Preliminary Results NOT SUPPORTED
F Final Results NOT SUPPORTED
X Results cannot be done, cancel NOT SUPPORTED
I Request Results Pending NOT SUPPORTED
S Request partial results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED
R Result previously transmitted NOT SUPPORTED
A Abort/cancel last request REQUIRED
N Requesting new results only NOT SUPPORTED
O Requesting orders and REQUIRED
demographics
D Requesting demographics only NOT SUPPORTED

Message Terminator Record Definition (13.1 - 13.1.3)

[Record Type ID (L)][Sequence Number][Temination
Code]

Example Termination Record:

<STX>[FrameNumber]L|1|N<CR><ETX>[CheckSum]<CR><LF>

(13.1.1) Record Types Definition

Letter Record Type Status

L Terminator record SUPPORTED

Interface Specifications page 4 - 21

IMMULITE 2000/XPi Interface to LIS

(13.1.2) Sequence #
REQUIRED

(13.1.3) Termination Code

Letter Record Type Status

N Normal termination SUPPORTED
T Sender Aborted NOT SUPPORTED
R Receiver Abort NOT SUPPORTED
E Unknown system error NOT SUPPORTED
Q Error in last request for information REQUIRED WITH QUERY
I No information available from last REQUIRED WITH QUERY
query
F Last request for information Processed REQUIRED WITH QUERY

IMMULITE 2000/XPi Uni-Directional LIS Specification

ASTM E1394
Header Record Definition (7.1 - 7.1.14)
[Record Type (H)] [Delimiter Def.] [Message Control
ID] [Password] [Sending systems company name]
[Sending Systems address] [Reserved] [Senders
Phone#] [Communication parameters] [Receiver ID]
[Comments/special instructions] [Processing ID]
[Version#] [Message Date + Time]

Sample Header Message

<STX>[FrameNumber]H|\^&||Password|Siemens|Randolph^
New^Jersey^07869||(201)927-
2828|8N1|Receiver||P|1|19920521132100
<CR><ETX>[CheckSum]<CR><LF>

(7.1.1) Record Types Definition

Letter Record Type Status

H Header record REQUIRED

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 IMMULITE 2000/XPi Interface to LIS

(7.1.2) Delimiter Definition

Symbol Record Type Status

¦ Field Delimiter REQUIRED
\ Repeat Delimiter REQUIRED
^ Component Delimiter REQUIRED
& Escape Delimiter DEFINED, NOT SUPPORTED

(7.1.3) Message Control ID

NOT SUPPORTED

(7.1.4) Access Password

REQUIRED (Configurable by Siemens )
Maximum of 10 characters

(7.1.5) Sender Name or ID

REQUIRED (Configurable by Siemens)
Maximum of 10 characters

(7.1.6) Sender Street Address

SUPPORTED

(7.1.7) Reserved Field

NOT SUPPORTED

(7.1.8) Senders Telephone Number

SUPPORTED

(7.1.9) Characteristics of Sender

SUPPORTED 8 bits No Parity 1 Stop Bit

(7.1.10) Receiver ID
REQUIRED (Configurable by Siemens)
Maximum of 10 characters

(7.1.11) Comments/Special Instructions

NOT SUPPORTED

Interface Specifications page 4 - 23

IMMULITE 2000/XPi Interface to LIS

(7.1.12) Processing ID Definition

Letter Record Type Status

P Normal production/running SUPPORTED
message
T Training message NOT SUPPORTED
D Debugging, used to debug a NOT SUPPORTED
program(s).
Q Message is for QC/regulatory SUPPORTED
purposes. (upload only)

(7.1.13) Version Number

SUPPORTED (Currently 1)

(7.1.14) Date+Time of Message

SUPPORTED (YYYYMMDDHHMMSS)

Patient Information Record Definition (8.1 - 8.1.35)

[Record Type (P)][Sequence #][Practice Assigned
Patient ID][Laboratory Assigned Patient ID][Patient
ID][Patient Name][Mother's Maiden
Name][BirthDate][Patient Sex][Patient Race][Patient
Address][Reserved][Patient Phone #][Attending
Physician ID][Special Field 1][Special Field
2][Patient Height][Patient Weight][Patients Known
or Suspected Diagnosis] [Patient active
medications][Patients Diet][Practice Field
#1][Practice Field #2][Admission and Discharge
Dates][Admission Status][Location][Nature of
Alternative Diagnostic Code and
Classification][Alternative Diagnostic Code and
Classification][Patient Religion][Marital
Status][Isolation Status][Language][Hospital
Service][Hospital Institution][Dosage Category]

Sample Patient Information Record

<STX>[FrameNumber]P|1||||Jones^Jane^L||19640804|F||
|||Doctor<CR><ETX>[CheckSum]<CR><LF>

(8.1.1) Record Types Definition

Letter Record Type Status

P Patient Identity Record REQUIRED

page 4 - 24 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

(8.1.2) Sequence # Definition

REQUIRED

(8.1.3) Practice Assigned Patient ID

NOT SUPPORTED

(8.1.4) Laboratory Assigned Patient ID

NOT SUPPORTED

(8.1.5) Patient ID
NOT SUPPORTED (maximum of 20 characters)

(8.1.6) Patient Name

SUPPORTED
(Last^First^Initial; maximum of 30 characters both First&Last name)

(8.1.7) Mother's Maiden Name

NOT SUPPORTED

(8.1.8) Birthdate
SUPPORTED (YYYYMMDD; maximum of 8 characters)

(8.1.9) Patient's Sex

SUPPORTED (M or F; maximum of 1 character)

(8.1.10) Patient Race-Ethnic Origin

NOT SUPPORTED

(8.1.11) Patient's Address

NOT SUPPORTED

(8.1.12) Reserved Field

NOT SUPPORTED

(8.1.13) Patient's Phone#

NOT SUPPORTED

(8.1.14) Attending Physician ID

NOT SUPPORTED

Interface Specifications page 4 - 25

IMMULITE 2000/XPi Interface to LIS

(8.1.15) Special Field 1

NOT SUPPORTED

(8.1.16) Special Field 2

NOT SUPPORTED

(8.1.17) Patient Height

NOT SUPPORTED

(8.1.18) Patient Weight

NOT SUPPORTED

(8.1.19) Known or Suspected Diagnosis

NOT SUPPORTED

(8.1.20) Active Medications

NOT SUPPORTED

(8.1.21) Patient's Diet

NOT SUPPORTED

(8.1.22) Practice Field 1

NOT SUPPORTED

(8.1.23) Practice Field 2

NOT SUPPORTED

(8.1.24) Admission and Discharge Dates

NOT SUPPORTED

(8.1.25) Admission Status

NOT SUPPORTED

(8.1.26) Location
NOT SUPPORTED

(8.1.27) Nature of Alt. Diag. Code

NOT SUPPORTED

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 IMMULITE 2000/XPi Interface to LIS

(8.1.28) Alt. Diag. Code and Classifications

NOT SUPPORTED

(8.1.29) Patient Religion

NOT SUPPORTED

(8.1.30) Marital Status

NOT SUPPORTED

(8.1.31) Isolation Status

NOT SUPPORTED

(8.1.32) Language
NOT SUPPORTED

(8.1.33) Hospital Service

NOT SUPPORTED

(8.1.34) Hospital Institution

NOT SUPPORTED

(8.1.35) Dosage Category

NOT SUPPORTED

Order Record Definition (9.4.1-9.4.31)

[Record Type (O)][Sequence#][Specimen ID
(Accession#)][Instrument Specimen ID][Universal
Test ID][Priority][Order Date/Time][Collection
Date/Time][Collection End Time][Collection
Volume][Collector ID][Action Code][Danger
Code][Relevant Clinical Info][Date/Time Specimen
Received][Specimen Descriptor,Specimen
Type,Specimen Source][Ordering
Physician][Physician's Telephone Number][User Field
No.1][User Field No.2][Lab Field No.1][Lab Field
No.2][Date/Time results reported or last
modified][Instrument Charge to Computer
System][Instrument Section ID][Report
Types][Reserved Field][Location or ward of Specimen
Collection][Nosocomial Infection Flag][Specimen
Service][Specimen Institution]

Interface Specifications page 4 - 27

IMMULITE 2000/XPi Interface to LIS

Sample Test Order Message

<STX>[FrameNumber]O|1|123456||^^^TSH<CR><ETX>[Check
Sum]<CR>
<LF>

(9.4.1) Record types Definition

Letter Record Type Status

O Test Order Record REQUIRED

(9.4.2) Sequence #
REQUIRED

(9.4.3) Specimen ID
REQUIRED (ACCESSION # ON PRIMARY TUBE; maximum of 30 characters)

(9.4.4) Instrument Specimen ID

NOT SUPPORTED

(9.4.5) Universal Test ID

REQUIRED ^^^[Test Code]
maximum of 10 characters
Example Test Codes: TSH, LH, FSH, DGX, T4, HCG, RTH, SPE D120

(9.4.6) Priority
SUPPORTED (All maximum of 1 character)

S Stat
A As soon as possible
R Routine
C Callback
P Preoperative

(9.4.7) Requested/Ordered Date and Time

NOT SUPPORTED (maximum of 14 characters)

(9.4.8) Specimen Collection Date and Time

NOT SUPPORTED

page 4 - 28 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

(9.4.9) Collection End Time

NOT SUPPORTED

(9.4.10) Collection Volume

NOT SUPPORTED

(9.4.11) Collector ID
NOT SUPPORTED

(9.4.12) Action Code

NOT SUPPORTED

(9.4.13) Danger Code

NOT SUPPORTED

(9.4.14) Relevant Clinical Information

SUPPORTED

(9.4.15) Date/Time Specimen Received

NOT SUPPORTED

(9.4.16) Specimen Descriptor

NOT SUPPORTED

(9.4.16.1) Specimen Type

NOT SUPPORTED

(9.4.17) Ordering Physician

SUPPORTED (Smith^Joseph; maximum of 30 characters)

(9.4.18) Physician's Telephone Number

NOT SUPPORTED

(9.4.19) Users Field No. 1

NOT SUPPORTED

(9.4.20) Users Field No. 2

NOT SUPPORTED

Interface Specifications page 4 - 29

IMMULITE 2000/XPi Interface to LIS

(9.4.21) Lab Field No. 1

NOT SUPPORTED (SUPPORTED Internal to Siemens)
(CPS of result)

(9.4.22) Lab Field No. 2

NOT SUPPORTED (SUPPORTED Internal to Siemens)
(Kit lot to run, or was run on test)

(9.4.23) Date/Time Results Reported

NOT SUPPORTED

(9.4.24) Instrument Charge to Computer Sys

NOT SUPPORTED

(9.4.25) Instrument Section ID

SUPPORTED

(9.4.26) Report Types

NOT SUPPORTED

(9.4.27) Reserved Field

NOT SUPPORTED

(9.4.28) Location of Specimen Collection

NOT SUPPORTED

(9.4.29) Nosococmial Infection Flag

NOT SUPPORTED

(9.4.30) Specimen Service

NOT SUPPORTED

(9.4.31) Specimen Institution

NOT SUPPORTED

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 IMMULITE 2000/XPi Interface to LIS

Result Record Definition (10.1 - 10.1.14)

[Record Type (R)][Sequence #][Universal Test
ID][Data (result)][Units][ReferenceRanges] [Result
abnormal flags][Nature of Abnormality
Testing][Result Status][Date of change in
instruments normal values or units][Operator
ID][Date\Time Test Started][Date\Time Test
Completed][Instrument ID]

Sample Result Message:

<STX>[FrameNumber]R|1|^^^TSH|8.19|uIU/
mL|.4\.002^4\75|H|N|F||test|1994032810834|199205261
10500|Siemens<CR><ETX>[CheckSum]<CR><LF>

(10.1.1) Record Types Definition

Letter Record Type Status

R Result Record REQUIRED

(10.1.2) Sequence #
REQUIRED

(10.1.3) Universal Test ID

REQUIRED (^^^[Test Code])
Example Test Codes: TSH, LH, FSH, DGX, TT4, HCG, TU, RTH, SPE D120

(10.1.4) Data or Measurement Value (Result)

REQUIRED

(10.1.5) Units
REQUIRED
Current Siemens Units of Measure: ng/mL, ng/dL, µg/dL, µIu/mL, mIU/mL,
pg/mL, nmol/L, pmol/L, mIU/L, µg/L, IU/mL, IU/L, KU/L, SClass

(10.1.6) Reference Ranges

SUPPORTED ([Low]\[Panic\Low]^[High]\[Panic High])

Interface Specifications page 4 - 31

IMMULITE 2000/XPi Interface to LIS

(10.1.7) Result Abnormal Flags

Letter Record Type Status

L Below Normal SUPPORTED
H Above Normal SUPPORTED
LL Below Panic NOT SUPPORTED
HH Above Panic NOT SUPPORTED
< Below readable limit REQUIRED
> Above readable limit REQUIRED
N Normal SUPPORTED
A Abnormal NOT SUPPORTED
U Significant change UP NOT SUPPORTED
D Significant change DOWN NOT SUPPORTED
B Better NOT SUPPORTED
W Worse NOT SUPPORTED

(10.1.8) Nature of Abnormality Testing

Letter Record Type Status

A Age population tested NOT SUPPORTED
S Sex based Population NOT SUPPORTED
R Race based Population NOT SUPPORTED
N Normal generic range SUPPORTED

page 4 - 32 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

(10.1.9) Results Status

Letter Record Type Status

C Correction of previously sent results REQUIRED
P Preliminary Results NOT SUPPORTED
F Final Results SUPPORTED
X Results cannot be done NOT SUPPORTED
For example, Calculation Error
I In instrument, results pending NOT SUPPORTED
S Partial Results NOT SUPPORTED
M Result is a MIC level NOT SUPPORTED
R This result was previously REQUIRED
transmitted
N This result record contains NOT SUPPORTED
necessary information to run a new
order

(10.1.10) Date systems values/units changed

NOT SUPPORTED

(10.1.11) Operator Name/ID#

SUPPORTED

(10.1.12) Date+Time Test Started

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.13) Date+Time Test Completed

SUPPORTED (YYYYMMDDHHMMSS)

(10.1.14) Instrument ID
SUPPORTED (Configurable by Siemens Software)

Request Information Record (12.1 - 12.1.13)

Not supported in uni directional mode.

Message Terminator Record Definition (13.1 - 13.1.3)

[Record Type ID (L)][Sequence Number][Temination
Code]

Interface Specifications page 4 - 33

IMMULITE 2000/XPi Interface to LIS

Example Termination Record:

<STX>[FrameNumber]L|1|N<CR><ETX>[CheckSum]<CR><LF>

(13.1.1) Record Types Definition

Letter Record Type Status
L Terminator record SUPPORTED

(13.1.2) Sequence #
REQUIRED

(13.1.3) Termination Code

Letter Record Type Status

N Normal termination SUPPORTED
T Sender Aborted NOT SUPPORTED
R Receiver Abort NOT SUPPORTED
E Unknown system error NOT SUPPORTED
Q Error in last request for information NOT SUPPORTED
I No information available from last NOT SUPPORTED
query in uni-directional mode
F Last request for information NOT SUPPORTED
Processed in uni-directional mode

IMMULITE 2000/XPi LIS Error Message Definitions

Error Message Definition
2550 LIS Parse error due to An invalid sample type (e.g., ~D)
unexpected sample was received from the LIS.
type received from
LIS.
2551 LIS An unexpected error Unable to query the LIS and receive
was encountered a response. The SMS will continue
during query of the to re-query while there are still
LIS. barcodes requiring a query.

page 4 - 34 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

Error Message Definition

2567 LIS The LIS is not This message appears when trying
enabled. Enable the to pause or activate the LIS or
LIS to perform this trying to manually send or resend
action. results from the LIS screen when
the LIS is configured to off.
To resolve this issue from the SMS,
do the following steps:
set the LIS to bi-directional or
bidirectional host query from the
LIS screen.
Log off and then back on the
VersaCell® system.
Select RUN.
2571 LIS Patient ID exceeded An order downloaded from the LIS
20 characters. contains a patient ID exceeding 20
characters. The order is not
accepted because Patient IDs
cannot exceed 20 characters.
2572 LIS Accession Number An order downloaded from the LIS
exceeded 20 contains an accession number
characters. exceeding 20 characters. The order
is not accepted because accession
numbers cannot exceed 20
characters.
12300 LIS Carriage return or The message is missing a required
Line Feed missing Carriage return, line feed or both.
from message. Violates ASTM E1381 Section
6.3.1.2.
12301 LIS Incorrect or Missing The frame number for a message is
Frame Number. an incorrect value or is not present.
Violates ASTM E1381 Section
6.3.2.1.
12302 LIS Incorrect Checksum. The checksum, a scheme to
indicate whether a message was
received properly, is incorrect.
Violates ASTM E1381 Section
6.3.3.1.
12303 LIS Message is too short LIS message received is less than
(< 5 characters). the requisite five characters.

Interface Specifications page 4 - 35

IMMULITE 2000/XPi Interface to LIS

Error Message Definition

12304 LIS Invalid Password in The Password received does not
Header Message. match the password entered in the
LIS configuration on IMMULITE
2000 system.
Contact the LIS vendor to
determine the proper password.
The LIS vendor may change the
password parameter on the LIS or
request that the password on the
IMMULITE system be modified to
the value they indicate. Violates
ASTM E1394 Section 7.1.4.
12305 LIS Invalid Sender ID in The Sender ID received does not
Header Message. match the Sender ID entered in the
LIS configuration on IMMULITE
2000 systems.
Contact the LIS vendor to
determine the proper Sender ID. If
the Sender ID is incorrect in the
IMMULITE 2000/XPi software, the
LIS vendor may change the Sender
ID parameter on the LIS or request
that the Sender ID on IMMULITE
2000/XPi systems be modified to
the value they indicate. If the
Sender ID is correct on IMMULITE
2000 systems, the LIS vendor most
likely has an error in their code.
When sending FROM the LIS to
IMMULITE 2000/XPi systems the
LIS vendor needs to place their ID
(Designated on
IMMULITE 2000/XPi systems as
receiver ID) in the Sender ID field
of the header message. Violates
ASTM E1394 Section 7.1.5

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 IMMULITE 2000/XPi Interface to LIS

Error Message Definition

12306 LIS Invalid Receiver ID in The Receiver ID received does not
Header Message. match the Receiver ID entered in
the LIS configuration on
IMMULITE 2000 systems.
Contact the LIS to determine the
proper Receiver ID. If the Receiver
ID is incorrect in the
IMMULITE 2000/XPi software, the
LIS vendor may change the
Receiver ID parameter on the LIS
OR request the Receiver ID on
IMMULITE 2000/XPi systems be
modified to the value they
indicate. If the Receiver ID is
correct on IMMULITE 2000
systems, the LIS vendor most likely
has an error in their code. When
sending FROM the LIS to
IMMULITE 2000/XPi systems the
LIS vendor needs to place the
Instrument ID (Designated on
IMMULITE 2000/XPi systems as
sender ID) in the Receiver ID field
of the header message. Violates
ASTM E1394 Section 7.1.10.
12307 LIS No Header message Records are being received from
received. the LIS without sending an initial
header message. Violates ASTM
E1394 Section 5.2.
12308 LIS Several LIS errors More than 20 communication
have occurred the errors have occurred within a one-
past hour. There hour time frame. This is an
may be a IMMULITE 2000/XPi message only
communication and is not part of the ASTM
problem. specification.
12309 LIS Null or Missing The Patient ID field in the Patient
Patient ID in Patient message is not present. This is a
Record. required field for IMMULITE 2000
systems.

Interface Specifications page 4 - 37

IMMULITE 2000/XPi Interface to LIS

Error Message Definition

12310 LIS Invalid Test Code or The test code received in an order
Format in Order message does not match a test
record. code on IMMULITE 2000 systems.
The test code may be incorrect or
an initial kit for the test code may
not have been entered on
IMMULITE 2000 systems. The
format for separating multiple test
orders in one order record may
have been violated. Violates ASTM
Section 9.4.5, and 6.6.1.
12311 LIS LIS cannot accept A message was sent to the LIS
message after seven times and was not accepted.
sending message 7 The current communication
times. session is aborted. Violates ASTM
E1381 Section 6.5.1.2.
12312 LIS Time out, 30 Information was received from the
seconds expired and LIS and a response to the message
no data was was returned to the LIS. No
received from LIS. additional data was received from
the LIS in 30 seconds. The current
communication session is aborted.
Violates ASTM E1381 Section
6.5.2.4.
See IMMULITE 2000/XPi LIS
Troubleshooting, page 4-43.
12313 LIS EOT received An EOT was sent before the
prematurely while transmission was completed.
receiving data.
12314 LIS An error occurred An unrecognized error occurred
sending LIS query when sending a query to the LIS.
request. Host query
aborted.

page 4 - 38 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

Error Message Definition

12315 LIS Time out, No Information was sent to the LIS
response from LIS and there was no response after a
after waiting 15 15 second time period. The current
seconds. communication session is aborted.
Violates ASTM E1381 Section
6.5.2.3.
See IMMULITE 2000/XPi LIS
Troubleshooting, page 4-43.
12316 LIS <ENQ> Contention. The LIS was attempting to initiate a
communication session at the
same moment the
IMMULITE 2000/XPi system was
performing the same. This error is
handled as described in ASTM
E1381 Section 6.2.7.1.
12317 LIS No accession No accession number was received
number in order in an order record. This is a
record. required field for IMMULITE
systems.
12318 LIS The LIS encountered The LIS informed
an error for a query. the IMMULITE 2000/XPi system the
LIS encountered an error in a
request for a patient record from a
query message as defined in ASTM
E1394 13.1.3.
12319 LIS The LIS has no The LIS did not have information
information for on a requested sample (accession
query. number) as defined in ASTM
E1394 Section 13.1.3.
12320 LIS An invalid An invalid or unsupported
terminator code was terminator code was received from
received from the the LIS. Violates ASTM E1394
LIS. Section 13.1.3.

Interface Specifications page 4 - 39

IMMULITE 2000/XPi Interface to LIS

Error Message Definition

12321 LIS Unique ID does not All records are stored on the
match retrieved file. IMMULITE 2000/XPi system with a
Please call Technical unique number. A retrieved file
Services. was expected to have a particular
number and was incorrect. This
error should not be encountered
and if so indicates a programming
logic error.
12322 LIS Record could not be A sent record could not be found in
marked sent, record the database to be sent to the LIS.
not found. This error should not be
encountered and indicates a
programming logic error.
12323 LIS Record could not be A tagged record could not be
sent to LIS, record found in the database to be sent to
not found. the LIS. This error may indicate a
programming logic error.
12324 LIS There are no The operator pressed the Send or
"TAGGED" records to RE-Send buttons on the LIS screen
sent to the LIS. and no records are tagged.
12325 LIS You can only display The LIS Screen has a limit of
10,000 records at displaying 10,000 records at one
one time. time. The first 10,000 records
meeting the sorting criteria are
used. To view remaining records
the operator is required to refine
the date and time sorting criteria.
12326 LIS Received Order The patient message must precede
Record before the order message in the LIS
Patient Record. message. The LIS has received the
order message before receiving
the patient message.
12327 LIS Data is being The LIS is currently receiving data
received from the or the IMMULITE system is actively
LIS or IMMULITE is sending data to the LIS.
already sending data
to the LIS.
12328 LIS LIS reports an error There was an error in the query
in query request. request as it was sent from the
IMMULITE system to the LIS.

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 IMMULITE 2000/XPi Interface to LIS

Error Message Definition

12329 LIS LIS reports no There was no information for an
information for Accession number in a query.
Accession Number
in query request.
12330 LIS An error occurred An unrecognized error occurred
sending LIS query when sending a query to the LIS.
request. Host query
aborted.
12331 LIS Parse error occurred The Control information was sent
when downloading from the LIS in the wrong format.
in Control format. Contact your laboratory LIS
provider. If the message persists,
call Technical Service.
12332 LIS Parse error occurred The Adjustor information was sent
when downloading from the LIS in the wrong format.
in Adjustor format.
12333 LIS Control downloaded The control requested in the
from LIS is new to download from LIS is new to the
the system. system. The control order was not
saved because the control has not
yet been defined on the
Instrument. Define the control
before querying or downloading
orders for this sample.
12334 LIS Parse error occurred The Calibration verifier information
when downloading was sent from the LIS in the wrong
in Verifier format. format.
12335 LIS Sort Error An error was exhibited when trying
to sort in the LIS.
12339 LIS Send LIS Error An application error generated
when the mail procedure was
running.
12341 LIS Check Message Error An error occurred in the Check
Sum Message routine when
building the message.
12342 LIS Parse Error A programmer error was
generated during the parsing
routine.

Interface Specifications page 4 - 41

IMMULITE 2000/XPi Interface to LIS

Error Message Definition

12343 LIS Listen Error A programmer error occurred
when receiving information from
the LIS.
12344 LIS Check Error A check sum error occurred within
the LIS program.

page 4 - 42 IMMULITE 2000/XPi Interface to LIS

 IMMULITE 2000/XPi Interface to LIS

IMMULITE 2000/XPi LIS Troubleshooting

This section offers possible causes and corrective actions for some
occurrences. Each section provides a list of troubleshooting information to
gather for the field service engineer (FSE) before calling for assistance.

LIS 15-Second Timeout

Error Description: This message displays when the IMMULITE 2000/XPi
instrument tries to send an enquiry message to the LIS but the LIS does not
respond within 15 seconds.
The timing is ASTM compliant and is not user configurable.
Gather this information before contacting your service provider.
• Is the issue intermittent?
• When did it first begin?
• Were there any recent updates/patches to the LIS?
• Are there any other issues with other medical devices running with the
LIS?

Possible causes Corrective Actions

an incorrect or damaged cable Contact your local technical
support provider or distributor.
instrument serial port failure Contact your local technical
(unlikely) support provider or distributor.
incorrect serial port configuration Contact your local technical
support provider or distributor.
LIS is not on or needs to be restarted Contact your local technical
support provider or distributor.

Interface Specifications page 4 - 43

IMMULITE 2000/XPi Interface to LIS

LIS 30-Second Timeout

Error Description: The LIS 30 second timeout error occurs when the LIS
does not properly follow ASTM specifications after initial communication,
or if the LIS is expected to continue to send information but nothing is
received within 30 seconds.
These are some actions to take before calling for technical assistance:
• Turn on LIS log.
• Recreate issue that caused the 30-second timeout error.

Possible Causes Corrective Actions

incorrect data sent by the LIS. Contact your local technical
support provider or distributor.
line noise Contact your local technical
support provider or distributor.
a malfunctioning rocket card Contact your local technical
support provider or distributor.
LIS cable length being greater than Contact your local technical
50 feet support provider or distributor.

page 4 - 44 IMMULITE 2000/XPi Interface to LIS

Appendix A: Safety Instructions

This information summarizes the established guidelines for handling

laboratory biohazards. This summary is based on the guidelines developed
by the Centers for Disease Control, the Clinical and Laboratory Standards
Institute Document M29-A3, Protection of Laboratory Workers from
Occupationally Acquired Infections, and the Occupational Safety and
Health Administration’s Bloodborne Pathogens Standard.1–3

Protecting Yourself from Biohazards

Use this summary for general information only. It is not intended to replace
or supplement your laboratory or hospital biohazard control procedures.
By definition, a biohazardous condition is a situation involving infectious
agents biological in nature, such as the hepatitis B virus, the human
immunodeficiency virus, and the tuberculosis bacterium. These infectious
agents may be present in human blood and blood products and in other
body fluids.
The following are the major sources of contamination when handling
potentially infectious agents:
• needle sticks
• hand-to-mouth contact
• hand-to-eye contact
• direct contact with superficial cuts, open wounds, and other skin
conditions that may permit absorption into subcutaneous skin layers
• splashes or aerosol contact with skin and eyes
To prevent accidental contamination in a clinical laboratory, strictly adhere
to the following procedures:
• Wear gloves while servicing parts of the instrument that have contact
with body fluids such as serum, plasma, urine, or whole blood.
• Wash your hands before going from a contaminated area to a
noncontaminated area, or when you remove or change gloves.
• Perform procedures carefully to minimize aerosol formation.
• Wear facial protection when splatter or aerosol formation is possible.
• Wear personal protective equipment such as safety glasses, gloves, lab
coats or aprons when working with possible biohazard contaminants.
• Keep your hands away from your face.
• Cover all superficial cuts and wounds before starting any work.
Interface Specifications page A - 1
Safety Instructions

• Dispose of contaminated materials according to your laboratory’s

biohazard control procedures.
• Keep your work area disinfected.
• Disinfect tools and other items that have been near any part of the
instrument sample path or waste area with 10% v/v bleach.
• Do not eat, drink, smoke, or apply cosmetics or contact lenses while in
the laboratory.
• Do not mouth pipette any liquid, including water.
• Do not place tools or any other items in your mouth.
• Do not use the biohazard sink for personal cleaning such as rinsing
coffee cups or washing hands.
To prevent needlestick injuries, needles should not be recapped, purposely
bent, cut, broken, removed from disposable syringes, or otherwise
manipulated by hand.

References
1. Centers for Disease Control. 1988. Update: Universal precautions for
prevention of transmission of human immunodeficiency virus,
hepatitis B virus and other bloodborne pathogens in healthcare
settings. MMWR, 37:377–382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS).
Protection of Laboratory Workers from Occupationally Acquired
Infections; Approved Guideline - Third Edition. CLSI Document M29-A3.
[ISBN 1-56238-567-4]. Clinical and Laboratory Standards Institute, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA,
2005.
3. Federal Occupational Safety and Health Administration. Bloodborne
Pathogens Standard. 29 CFR 1910. 1030.

Protecting Yourself from Barcode Scanner Lasers

To avoid damage to the eyes, never look directly at the laser beam or at its
reflection from a shiny surface. Never point a hand-held barcode scanner
at anyone.

Laser Safety Classification – IMMULITE Systems

During normal operation with all of the protective housings in place, the
instruments are classified as CDRH Class I and EN 60825-1 Class 1. No
direct exposure to laser hazard exists for persons in the immediate area.

page A - 2 Interface Specifications

 Safety Instructions

Figure 1: CDRH Class 1 Label

Some field service procedures require the removal of the protective

housings that prevent human access to the laser radiation. The removal of
the protective housings may change the classification of the system to
CDRH Class 2 and EN60825-1 Class 2. All field service procedures must be
followed precisely. Only Siemens-trained field service personnel should
perform procedures related to laser assemblies.

Figure 2: CDRH Class 2 Label

The laser labels are positioned on the instrument as shown below.

Laser Safety Classification of the Barcode Scanners

The laser safety classification of the reagent and sample barcode scanners
when they are unprotected by the system housings is CDRH Class 2 and EN
60825-1 Class 2. The laser safety classification of the hand-held barcode
scanner used with the system is CDRH Class 2 and EN 60825-1 Class 2.

Reagent and Sample Barcode Scanners

The instrument Operator’s Guide procedures for testing the reagent or
sample barcode scanners contain the following laser warning:

LASER WARNING
Never look directly at the laser beam or at its reflection from a shiny
surface. Looking directly at the laser beam or its reflection could cause
damage to the eyes. Only trained field service personnel should perform
procedures related to laser assemblies. For more information about laser
safety, see Protecting Yourself from Barcode Scanner Lasers, page A-2.

The specifications for the laser optical assemblies in the instrument

ancillary reagent, primary reagent, and sample barcode scanners are
summarized in the following table:

Characteristic Specification
Maximum Power Output 1.0 mW
Wavelength 670 nm

Interface Specifications page A - 3

Safety Instructions

Pulse Duration Continuous Wave (cw)

Units of Beam Divergence 0.7 mr

The locations of the reagent and sample barcode scanners and their
associated laser safety labels are shown below. The laser apertures for the
sample and ancillary reagent barcode scanners are directed into the system
away from the operator.
During normal operation, reflections from the sample barcode scanner
laser beam may be visible to persons in the immediate area, but no laser
safety hazard is associated with this exposure. The laser aperture for the
primary reagent barcode scanner is directed toward the barcode labels at
the end of the reagent packs inside the primary reagent compartment.
During normal operation, the barcode scanner does not scan the reagent
packs until the primary reagent compartment door is closed. When the
primary reagent compartment door is closed, no operator exposure to the
laser exists.

Hand-held Barcode Scanner

In the Operator’s Guide instrument procedures that use the handheld
barcode scanner are introduced with the following laser warning:

LASER WARNING
Never look directly at the beam of a hand-held barcode scanner or point
the scanner at another person. Also, do not look at the reflection of the
beam from a shiny surface. Only trained field service personnel should
perform procedures related to laser assemblies. For more information
about laser safety, see Protecting Yourself from Barcode Scanner Lasers,
page A-2.

This table contains a summary of the specifications for the laser optical
assembly in the handheld barcode scanner:
Characteristic Specification
Maximum Power Output 1.0 mW
Wavelength 650 nm
Pulse Duration 7.4 ms
Units of Beam Divergence 2mr

The laser aperture and laser safety label for the hand-held barcode scanner
are on the other side of the barcode scanner window.

page A - 4 Interface Specifications

Appendix B: Service and Warranty

IMMULITE/LIS Interface Policy

The IMMULITE systems, including IMMULITE, IMMULITE 1000,
IMMULITE 2000, and IMMULITE 2000 XPi, can interface with many LIS
hardware and software configurations. To ensure a smooth, successful
interface with your LIS or LAS, follow the policy outlined below. Every
interface is unique because individual laboratories have different needs,
requirements, and hardware. Therefore, the interface must be customized
for each lab by the laboratory’s software department or a software
development vendor.
Siemens is responsible for providing LIS/LAS communication software on
IMMULITE systems that performs according to standards specified in ASTM
E1394 and ASTM E1381, and according to the Siemens LIS/LAS
communications specifications. Siemens is also responsible for proper
hardware functionality (serial port functionality) of the PC supplied with
the IMMULITE systems. Siemens will supply the LIS communications
specifications to the MIS director and the LIS developer. Siemens is not
responsible for cabling errors, software or hardware errors on intermediary
systems, or for software and hardware errors on the LIS.
A Siemens field service engineer can be present on the day the laboratory
launches the IMMULITE system and LIS or LAS interface at no charge to the
customer. On that day, the lab director, MIS director and IMMULITE system
must be available to facilitate the process. Siemens recommends that a
representative of the LIS developer be on-site the day the interface is
launched. The laboratory and the LIS developer must make the decision to
have a representative present.
If you have a problem, the Siemens field service engineer will attempt to
identify the cause and find a solution. With all parties available when you
launch the interface, you can solve problems in a timely manner.
If a problem occurs that is generated by the instrument or instrument
configuration and requires several days to repair, the Siemens service
representative will leave only after demonstrating the proper operation of
the instrument connections to the LIS/LAS interface using diagnostic tools.
If, at a later date, you determine the problem could have been caused by
the Siemens instrument, a Siemens field service engineer will be sent to
further evaluate the problem. If the Siemens field service engineer
determines that the cause of this subsequent visit is a defect in the
Siemens software or hardware, the problem will be corrected under the
warranty or service contract, as applicable.
Interface Specifications page B - 1
Service and Warranty

If the instrument is no longer under warranty and a service contract is not

in effect, the visit will be billed at the prevailing rates. If the problem is not
the result of Siemens equipment or software, as in the case of cabling
problems, the service call will be billed at prevailing rates regardless of the
IMMULITE warranty or service contract.
For the duration of the initial testing and validation process, the status of
the IMMULITE system should be considered under evaluation. The
validation process is performed by the laboratory and the LIS developer
and typically lasts one to two weeks. During the validation period, any
problems can be identified and corrected. In extreme cases, it may be
necessary to disable the LIS feature until a problem has been corrected.
During the validation period, it is the responsibility of the lab director to
ensure that LIS communications are used in a manner consistent with
normal laboratory operations. All results sent to the LIS must be verified on
the LIS by comparing results and patient information to the IMMULITE
result printout. Any problems must be reported to Siemens and all other
affected parties. Upon successful completion of the validation process, the
system is upgraded to online status. When the system is online, the
requirement to verify results on the LIS should be in compliance with the
operating procedures of the lab.

Contacts
This section provides the following information:
• the address of the Siemens authorized representative, which is the
Siemens contact within the European community
• the Siemens addresses for obtaining service and technical information
and for ordering supplies

Addresses
For technical assistance, contact your local technical support provider. For
customer service or additional information, contact your local technical
support distributor.

page B - 2 Interface Specifications

 Service and Warranty

www.siemens.com/diagnostics

Interface Specifications page B - 3

Service and Warranty

page B - 4 Interface Specifications