Immulite Interface Specifications

IMMULITE® / IMMULITE® 1000
IMMULITE® 2000 / IMMULITE® 2500 / IMMULITE® 2000XPi

Immunoassay Systems
Interface Specifications
600892-0003, Rev. A, 2009-03

© 2009 by Siemens Healthcare Diagnostics Inc. 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, IMMULITE 2000, VersaCell, and ADVIA are registered trademark of
Siemens Healthcare Diagnostics. All other products mentioned are trademarks of their
respective companies.
Origin: USA
www.siemens.com/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.
Siemens Healthcare Diagnostics Inc.
Certificate No: UQA0113493
Siemens quality products are manufactured under a quality
system that is registered to ISO 13485:2003.
2 600892-0003 Rev. A
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 interfaces Section 1, LIS Overview

with an LIS or LAS
determine the IMMULITE installation and Section 2, IMMULITE / LIS

configuration settings for both bi-directional or Configurations.
uni-directional settings, the LAS, or look up error
messages,
determine the IMMULITE 1000 installation and Section 3, IMMULITE 1000 / LIS
configuration settings for both bi-directional or uni- Configurations.
directional settings, or look up error messages,
determine the IMMULITE 2000/2500/XPi Section 4,

installation and configuration settings for both bi- IMMULITE 2000/2500/XPi / LIS
directional or uni-directional settings, or look up Configurations.
error messages,
review biohazard guidelines, Appendix A, Protecting Yourself

from Biohazards.
contact Siemens Healthcare Diagnostics, Appendix B, Service and

Warranty Information.
review the wiring elements from the IMMULITE Appendix C, IMMULITE to LIS
systems to the LIS, Cable Wiring
600892-0003 Rev. A 1
Immulite Systems Interface Specifications
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.
Italic Italic 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.
2 600892-0003 Rev. A
BASIC LIS TERMS

Term Desciption
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.
L message Terminator Message
Last message sent in a transaction, contains termination
codes.
600892-0003 Rev. A 3
Term Desciption
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.
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 IMMULITE 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.
4 600892-0003 Rev. A
Term Desciption
All information in a patient message.
Rocket Card A computer board used on IMMULITE 2000, 2000 XPi,
and 2500 systems to provide the serial ports used for LIS
communications.
Sender ID The identity of the system sending a message.
For example, If IMMULITE 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.
600892-0003 Rev. A 5
LIS CONFIGURATION SCREEN TERMS

Screen term Description
Auto Send Control The instrument sends QC results automatically to the LIS
Results 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 the
Control controls for an assay do not meet criteria configured as
single rule or multi rule in the QC Data Entry screen.
Auto-Send Invalid If selected, the instrument auto sends patient results that
Range 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 2000/2500/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.
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.
6 600892-0003 Rev. A
Screen term Description

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 IMMULITE 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.
Uni-Directional Data is transmitted from the instrument to the LIS only.
600892-0003 Rev. A 7
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.
8 600892-0003 Rev. A
Contents
1 LIS Overview
2 IMMULITE Interface to LIS
3 IMMULITE 1000 Interface to LIS
4 IMMULITE 2000/2500/XPi Interface to LIS
A Safety Instructions
B Service and Warranty
C IMMULITE to LIS Cable Wiring
600892-0003 Rev. A
IMMULITE Interface Specifications
600892-0003 Rev. A
1 LIS Overview
WHAT IS AN LIS? ................................................................................................ 3
HOW DOES AN LIS WORK? ............................................................................... 3

GENERAL SCHEMATIC OF AN LIS........................................................................ 4
SUMMARY OF LIS WORKFLOW STEPS ................................................................ 4
Order Entry........................................................................................................... 4
Sample Receiving ................................................................................................ 4
Results Entry/Verification ..................................................................................... 5
Example Patient Report ....................................................................................... 6
HOW DO INSTRUMENTS COMMUNICATE WITH AN LIS? .............................. 6
CABLE SPECIFICATIONS................................................................................... 8
REFERENCES .................................................................................................... 8
LAB AUTOMATION CONFIGURATION .............................................................. 9
COMMUNICATION PROTOCOL........................................................................ 10
ASTM HANDSHAKING ...................................................................................... 10
IMMULITE/LIS MESSAGING ............................................................................. 11
BASIC MESSAGE HIERARCHY (LOWER NUMBER HAS HIGHER PRIORITY) .............. 11
HIERARCHY EXAMPLE OF LIS TO IMMULITE SYSTEMS TRANSFER .................... 11
HIERARCHY EXAMPLE OF IMMULITE TO LIS TRANSFER ................................... 12
HIERARCHY EXAMPLE OF IMMULITE 2000/2500/XPI TO LIS TRANSFER
(IMMUNOASSAY) .............................................................................................. 12
HIERARCHY EXAMPLE OF IMMULITE 2000/2500/XPI TO LIS TRANSFER
(ALLERGY) ...................................................................................................... 13
HIERARCHY EXAMPLE OF QUERY TO LIS .......................................................... 13
HIERARCHY EXAMPLE OF RESPONSE TO QUERY ............................................... 13
BASIC FORMAT OF A MESSAGE ........................................................................ 14
Header Message.................................................................................................14
Patient Message .................................................................................................14
Order Message ...................................................................................................15
Result Message ..................................................................................................15
MAXIMUM VALUES FOR DATABASE FIELDS ACROSS INSTRUMENTS.... 16
TRANSFER EXAMPLES OF BI-DIRECTIONAL AND UNI-DIRECTIONAL,

IMMULITE 2000/2500/XPI TO LIS...................................................................... 16
HOST QUERY EXAMPLE, QUERY TO LIS....................................................... 20
600892-0003 Rev. A 1
1 -2 600892-0003 Rev. A
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).
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.
600892-0003 Rev A. 1 -3
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.
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 barcoded 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.
1. The LIS creates work orders for patients or they may be transferred from the
HIS.
2. The LIS does the following:

• assigns accession numbers to patient samples
• produces barcode labels
• produces collection lists to facilitate sample collection
3. Work orders are downloaded to instruments.
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 barcoded sample tube is read by the instrument, the
1 -4 600892-0003 Rev. A
unique ID is read off the sample tube label and the instrument matches it with the
order.
4. 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.
5. 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.
6. If configured for Bi-Directional Query, the operator places the barcoded

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.
7. 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.
600892-0003 Rev A. 1 -5
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 Feb. 2nd,
she had 2 of the same tests run at different times. Each had a different accession
number.
St. CEC Hospital Laboratory Medical Dir: Dr. F. Eel Good
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.
1 -6 600892-0003 Rev. A
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 simplest and most obvious possibility: the cable connection.
600892-0003 Rev A. 1 -7
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 IMMULITE
with an RJ45-DB9 converter. More recently, standard RJ45 network cables or
USB based cable connections are becoming more widely used.
You can purchase the cable at an electronics store. Since troubleshooting LIS
errors may involve testing the cable, you should have a spare one available.
When using a serial (RS232) connection, the IMMULITE systems do the

following:
• send on pin 3
• receive on pin 2
• use pin 5 as the ground.
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
http://www.medtechnet.com/public_pdf/mtc16pdf.pdf
http://en.wikipedia.org/wiki/Laboratory_information_system
1 -8 600892-0003 Rev. A
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.
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.
600892-0003 Rev A. 1 -9
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).
1 -10 600892-0003 Rev. A

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>
600892-0003 Rev A. 1 -11

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>
Hierarchy Example of IMMULITE 2000/2500/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>
1 -12 600892-0003 Rev. A

Hierarchy Example of IMMULITE 2000/2500/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>
Hierarchy Example of Response to Query

<ENQ>
Header
Patient 1
Order 1
Order 2
Order 3
Terminator
<EOT>
600892-0003 Rev A. 1 -13

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>
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|||RikerÂl||19611102|F|||||Bashere<CR><ETX>[2ACheck
Sum] <CR><LF>
1 -14 600892-0003 Rev. A

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>
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|199310
11091233|19931011091233|DPC<CR><ETX>[8FCheckSum]
<CR><LF>
600892-0003 Rev A. 1 -15

Maximum Values for Database Fields Across

Instruments
IMMULITE
Record Type Field One 1000 2000/ 2500
/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 & First 30 Last & 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 6
Priority 1 1 1
Order Date/Time 14 14 14
Collection Date/Time 14 14 14
Transfer Examples of Bi-Directional and Uni-Directional,

Immulite 2000/2500/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|||20001102140
412|20001102144054|E0872
A7
5P|2|66412558|||||||||||
1 -16 600892-0003 Rev. A

B8
6O|1|66412558||^^^HCG|||200011081530||||||Normal|||||||||||E
0872
CB
7R|1|^^^HCG|>5000|mIU/mL|1.00\1.00^5000\5000|>|N|F|||2000110
8153251|20001108160934|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|||2000110811
2235|20001108123235|E0872
D3
3L|1
3C
Example 2
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|||200011070
51521|20001107062514|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|||20001104035
557|20001104043253|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|||20001
103035444|20001103050438|E0872
600892-0003 Rev A. 1 -17

FD
3L|1
3C
Example 3
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|||2000110711
5846|20001107123532|E0872
F8
5L|1
3E
Example 4 (Allergy)
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|2001061
9095655|
F1420
85
5R|2|^^^SPE
E1|II|SCLASS||H|N|F|||20010619084600|20010619095655|
F1420
F9
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
1 -18 600892-0003 Rev. A

[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

[S] _1H|\^&||MARY|PATH|111 Canfield
Ave^Randolph^NJ^07869||(201)927-
2828|N81|MISYS||P|1|20050321142922
_2D
600892-0003 Rev A. 1 -19

3/21/05 2:29:22 PM 52162.8

[R] <ACK>
3/21/05 2:29:22 PM 52162.8

[S] _2Q|1|Ê05002038||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||(201)927-
2828|N81|Your System||P|1|19940407120613
51
2Q|1|^123ABC||ALL||||||||O
76
3L|1
3C
1 -20 600892-0003 Rev. A

2 IMMULITE Interface to LIS
CONFIGURING THE IMMULITE .......................................................................... 3
REQUIRED FLAGS .............................................................................................. 4
QUALITATIVE TESTS .......................................................................................... 4
UPLOAD/DOWNLOAD CODES .............................................................................. 5
IMMULITE BI-DIRECTIONAL LIS SPECIFICATION ASTM E1394 .................... 5
BI-DIRECTIONAL TRANSFER EXAMPLE, IMMULITE TO LIS ..................................... 5
HEADER RECORD DEFINITION (7.1 - 7.1.14) ....................................................... 7
PATIENT INFORMATION RECORD DEFINITION (8.1 - 8.1.35).................................. 8
ORDER RECORD DEFINITION (9.4.1-9.4.31) ..................................................... 10
RESULT RECORD DEFINITION (10.1 - 10.1.14).................................................. 12
REQUEST INFORMATION RECORD DEFINITION (HOST QUERY) (12.1 - 12.1.13) . 14
MESSAGE TERMINATOR RECORD DEFINITION (13.1 - 13.1.3) ............................ 15
IMMULITE UNI-DIRECTIONAL LIS SPECIFICATION ASTM E1394................ 16
UNI-DIRECTIONAL TRANSFER EXAMPLE, IMMULITE TO LIS................................. 16
HEADER RECORD DEFINITION (7.1 – 7.1.14) .................................................... 17
PATIENT INFORMATION RECORD DEFINITION (8.1 – 8.1.35)............................... 18
REQUEST INFORMATION RECORD (12.1 - 12.1.13) ........................................... 24
IMMULITE LIS ERROR MESSAGE DEFINITIONS............................................ 25
600892-0003 Rev. A 2 -1
2 -2 600892-0003 Rev. A
Configuring the IMMULITE

The IMMULITE has 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 setup a connection between the IMMULITE and an LIS, follow these steps:
1. Connect the Cable
Refer to Appendix C, LIS Cable specifications. 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 Params.
The LIS Params screen password is CONNECT.
b) Select Yes for either Unidirectional or Host Query, but not both.
NOTE: 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 Chapter 1, Sample Receiving.
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 cannot auto-send results to the 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.
600892-0003 Rev. A 2 -3
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 IMMULITE).
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 13.
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|1994040708
5044|19940407085148|Siemens
• 75.0 is the Assay Max

• > is the Result Flag
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
2 -4 600892-0003 Rev. A
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 to LIS

1H|\^&||PASSWORD|SenderID|Randolph^New^Jersey^07869||(201)9
27-2828|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|199501190
84508|19950119092826|SenderID
0B
5O|2|130000445||^^^TU|||19950118085700
84
6R|1|^^^TU|26.6|Percnt|23\10^35\70|N|N|F||test|199501190845
08|19950119092756|SenderID
07
7P|2|325031;AH|||Last 2^First 2|||F|||||
EB
0O|1|130000617||^^^FER|||19950118103000
A3
1R|1|^^^FER|173.|ng/mL|.5\.5^1500\1500|N|N|F||test|19950119
084641|19950119092858|SenderID
42
2P|3|326829;AH|||Last 3^First 3|||F|||||
F9
3O|1|130000722||^^^FER|||19950118102000
A2
084741|19950119092928|SenderID
46
5P|4|124462;TGH|||Last 4^First 4|||F|||||
4E
6O|1|130000724||^^Ê2|||19950118122000
43
7R|1|^^Ê2|25.3|pg/mL|12\12^2000\2000|N|N|F||test|199501190
84815|19950119100049|SenderID
CC
0O|2|130000724||^^^FSH|||19950118122000
A8
1R|1|^^^FSH|60.6|mIU/mL|.1\.1^170\170|N|N|F||test|199501190
84815|19950119093030|SenderID
0B
600892-0003 Rev. A 2 -5
2O|3|130000724||^^^LH|||19950118122000
5E
3R|1|^^^LH|24.4|mIU/mL|.7\.7^400\400|N|N|F||test|1995011908
4815|19950119093101|SenderID
C1
4P|5|556395;AH|||Last 5^First 5|||M|||||
0B
5O|1|130000741||^^^FER|||19950118115500
AE
084949|19950119093132|SenderID
46
7P|6|556357;MB|||Last 6^First 6|||M|||||
15
0O|1|130000790||^^ÎGE|||19950118120000
9C
1R|1|^^ÎGE|517.|IU/mL|.01\.01^600\600|N|N|F||test|19950119
085018|19950119093202|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|19950119
085049|19950119093233|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|19950119
085254|19950119093609|SenderID
45
0P|9||||Last 9^First 9||||||||
C1
1O|1|130000911||^^Ê2
01
2R|1|^^Ê2|71.3|pg/mL|12\12^2000\2000|N|N|F||test|199501190
85423|19950119100800|SenderID
BF
3P|10|358069;TGH|||Last 10^First 10|||F|||||
DF
4O|1|130000929||^^^FER|||19950118123000
AF
085628|19950119093843|SenderID
48
6L|1
3A
2 -6 600892-0003 Rev. A
Header Record Definition (7.1 - 7.1.14)

Sample Header Message
<STX>[FrameNumber]H|\^&||Password|Siemens|Randolph^New^Jers
ey^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
(7.1.6) Sender Street Address SUPPORTED
(7.1.7) Reserved Field NOT SUPPORTED
(7.1.8) Senders Telephone SUPPORTED
Number
(7.1.9) Characteristics of Sender SUPPORTED
(8 bits No Parity 1 Stop Bit)
(7.1.10) Receiver ID REQUIRED
(7.1.11) Comments/ NOT SUPPORTED
Special Instructions
600892-0003 Rev. A 2 -7
(7.1.12) Processing ID Definition

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)
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|||RikerÂl||19611102|F|||||Basher
e<CR><ETX>[CheckSum]<CR><LF>
P Patient Identity Record REQUIRED
(8.1.2) Sequence # Definition REQUIRED

(8.1.3) Practice Assigned REQUIRED
Patient ID
(maximum of 15 characters)
(8.1.4) Laboratory Assigned NOT SUPPORTED
Patient ID
(8.1.5) Patient ID NOT SUPPORTED
2 -8 600892-0003 Rev. A
(8.1.6) Patient Name SUPPORTED

(Last^FirstÎnitial; 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 NOT SUPPORTED
Origin
(8.1.11) Patient's Address 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
(8.1.17) Patient Height NOT SUPPORTED
(8.1.18) Patie nt Weight NOT SUPPORTED
(8.1.19) Known or Suspected NOT SUPPORTED
Diagnosis
(8.1.20) Active Medications NOT SUPPORTED
(8.1.21) Patient's Diet NOT SUPPORTED
(8.1.22) Practice Field 1 NOT SUPPORTED
(8.1.24) Admission and NOT SUPPORTED
Discharge Dates
(8.1.25) Admission Status NOT SUPPORTED
(8.1.26) Location NOT SUPPORTED
(8.1.27) Nature of Alt. Diag. NOT SUPPORTED
Code
(8.1.28) Alt. Diag. Code and NOT SUPPORTED
Classifications
(8.1.29) Patient Religion NOT SUPPORTED
600892-0003 Rev. A 2 -9
(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)

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
Sample Test Order Message
<STX>[FrameNumber]O|1|1550623||^^^LH|R|19931011091233|19931
011091233<CR><ETX>[CheckSum]<CR><LF>
(9.4.1) Record types Definition-
O Test Order Record REQUIRED
(9.4.2) Sequence # REQUIRED

(9.4.3) Specimen ID REQUIRED
(accession # on primary tube;
(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
2 -10 600892-0003 Rev. A

(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 SUPPORTED
and Time
(YYYYMMDDHHMMSS; Maximum
of 14 characters)
(9.4.8) Specimen Collection SUPPORTED
Date and Time
(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 NOT SUPPORTED
Information
(9.4.15) Date/Time Specimen NOT SUPPORTED
Received
(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 NOT SUPPORTED
Number
(9.4.19) Users Field No. 1 NOT SUPPORTED
(9.4.21) Lab Field No. 1 NOT SUPPORTED
(9.4.23) Date/Time Results NOT SUPPORTED
Reported
(9.4.24) Instrument Charge to NOT SUPPORTED
Computer Sys.
(9.4.25) Instrument Section ID NOT SUPPORTED
(9.4.26) Report Types NOT SUPPORTED
600892-0003 Rev. A 2 -11


(9.4.28) Location of Specimen NOT SUPPORTED
Collection
(9.4.29) Nosocomial Infection NOT SUPPORTED
Flag
(9.4.30) Specimen Servic e NOT SUPPORTED
(9.4.31) Specimen Institution NOT SUPPORTED
Result Record Definition (10.1 - 10.1.14)

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|19931011091233|Siemens<CR><ETX>[CheckS
um]<CR><LF>
R Result Record REQUIRED

(10.1.3) Universal Test ID PARTIALLY SUPPORTED / REQUIRED
NOTE: For Universal Test ID, (^^^[Test Code])
only the Record Types
Example Test Codes:
Definition status reads as
Partially Supported or TSH, LH, FSH, DGX, T4, HCG, TU, RTH,
Required. Under Order Types T3, FER, PSA, PAP
Definition, Universal Test ID
status is Required.
(10.1.4) Data or REQUIRED
Measurement
Value (Result)
(10.1.5) Units REQUIRED
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])
2 -12 600892-0003 Rev. A

(10.1.7) Result Abnormal Flags

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

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
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
(10.1.10) Date systems NOT SUPPORTED

values/units changed
(10.1.11) Operator Name/ID# SUPPORTED
600892-0003 Rev. A 2 -13

(10.1.12) Date+Time Test SUPPORTED

Started
(YYYYMMDDHHMMSS)
Completed
(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>
Q Request information Record SUPPORTED
(UPLOAD ONLY)
(12.1.2) Sequence Number SUPPORTED

(12.1.3) Starting Range ID REQUIRED
Number
(12.1.4) Ending Range ID NOT SUPPORTED
Number
(12.1.6) Request Time Limits NOT SUPPORTED
(12.1.7) Beginning Request NOT SUPPORTED
Results
(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
2 -14 600892-0003 Rev. A

12.1.13) Request information status codes

C Correction of previous 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
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>
L Terminator Record SUPPORTED
(13.1.3) Termination Code

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 query REQUIRED WITH QUERY
F Last request for information Processed REQUIRED WITH QUERY
600892-0003 Rev. A 2 -15

Immulite Uni-Directional LIS Specification ASTM E1394
Uni-Directional Transfer Example, Immulite to LIS

1H|\^&||PASSWORD|Siemens|Randolph^New^Jersey^07869||(201)92
7-2828|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|1994040708
4325|19940407084457|Siemens
DF
5O|2|123ABC||^^^T4
B4
6R|1|^^^T4|3.7|ug/dL|4.5\.4^12.5\24|L|N|F||test|19940407084
325|19940407084556|Siemens
6A
7O|3|123ABC||^^^T3
B6
0R|1|^^^T3|35|ng/dL|82\35^179\600|<|N|F||test|1994040708432
5|19940407084630|Siemens
F9
1O|4|123ABC||^^^TU
D3
2R|1|^^^TU|10|Percnt|23\10^35\70|<|N|F||test|19940407084325
|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|19940407084
907|19940407084923|Siemens
A9
6P|3||||Jones^||||||||
72
7O|1|HIJ456||^^^TSH
3A
5044|19940407085148|Siemens
D7
1P|4||||Riker^William||19601111|M|||||Doctor
87
2O|1|LMN141||^^^TSH
38
234|19940407085352|Siemens
A2
2 -16 600892-0003 Rev. A

4L|1
3D
Header Record Definition (7.1 – 7.1.14)

ey^07869||(201)927-2828|8N1|Receiver||P|1|19920521132100
(7.1.1) Record Types Definition-
H Header Record REQUIRED


(Configurable in LIS PARAMETERS
window; Maximum of 15 characters)
(Configurable in LIS PARAMETERS
Number
(Configurable in the LIS
PARAMETERS window; Maximum of
15 characters)
600892-0003 Rev. A 2 -17

(7.1.11) Comments/Special NOT SUPPORTED

Instructions

(Currently 1)
(7.1.14) Date+Time of Message SUPPORTED
(YYYYMMDDHHMMSS)
Patient Information Record Definition (8.1 – 8.1.35)

Sample Patient Information Record
<STX>[FrameNumber]P|1||||Jones^Jane^L||19640804|F|||||Docto
r<CR><ETX>[CheckSum]<CR><LF>

(8.1.3) Practice Assigned NOT SUPPORTED
Patient ID
Patient ID
2 -18 600892-0003 Rev. A


(Last^FirstÎnitial; maximum of 20
characters for Last Name; maximum of
(YYYYMMDD; maximum of 8
characters)
Origin
(Last Name Only; maximum of 20
characters)
(8.1.18) Patient Weight NOT SUPPORTED
Diagnosis
Discharge Dates
Code
Classifications
600892-0003 Rev. A 2 -19



Sample Test Order Message:
<STX>[FrameNumber]O|1|123456||^^^TSH<CR><ETX>[CheckSum]
<CR><LF>
(9.4.1) Record types Definition-
(9.4.2)Sequence # REQUIRED
(ACCESSION # ON PRIMARY
TUBE; maximum of 20 characters)
(^^^[Test Code]) Example Test Codes:
TSH, LH, FSH, DGX, TT4, HCG, TU,
RTH, T3, FER, PSA, PAP
2 -20 600892-0003 Rev. A

(9.4.6) Priority NOT SUPPORTED

(maximum of 1 character)
(9.4.7) Requested/Ordered Date NOT SUPPORTED
and Time
(9.4.8) Specimen Collection NOT SUPPORTED
Date and Time
Information
Received
Number
Reported
Computer Sys
Collection
(9.4.29) Nosococmial Infection NOT SUPPORTED
Flag
600892-0003 Rev. A 2 -21

(9.4.30) Specimen Service NOT SUPPORTED


Sample Result Message:
<STX>[FrameNumber]R|1|^^^TSH|8.19|uIU/mL|.4\.002^4\75|H|N|F
||test|1994032810834|19920526110500|Siemens<CR><ETX>[CheckS
um]<CR><LF>
(10.1.2 )Sequence # REQUIRED

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

High])
2 -22 600892-0003 Rev. A


N Normal SUPPORTED
(10.1.8)Nature of Abnormality Testing


(For example, Calculation Error)
R This result was previously transmitted NOT SUPPORTED

Started
(YYYYMMDDHHMMSS)
600892-0003 Rev. A 2 -23


Completed
(YYYYMMDDHHMMSS)
Program)
Request Information Record (12.1 - 12.1.13)

NOT SUPPORTED IN UNI DIRECTIONAL MODE

Record Types Definition
L Terminator record SUPPORTED

O Error in last request for information NOT SUPPORTED
I No information available from last query NOT SUPPORTED
F Last request for information Processed NOT SUPPORTED
2 -24 600892-0003 Rev. A

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 IMMULITE.
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 Frame The frame number in the message is not proper. Usually
Number indicates a programming bug in the LIS software, but may
be a bad message (E.G. line noise). See ASTM 1394 Logical
layer section 6.3.2 for further detail.
Invalid Sequence Number The sequence number in the message is not proper. Usually
indicates a programming bug in the LIS software, but may
be a bad message (E.G. 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 (E.G. line noise).
LIS Timeout The LIS is not responding to IMMULITE. Causes can be a
cabling problem, communication problem (hardware
related), or programming bug in the LIS software.
<CR> or <LF> Missing in Usually indicates a programming bug in the LIS software,
LIS Transmission but may be a bad message (E.G. line noise).
Error in last request This is a response FROM the LIS stating the LIS
encountered an error to the IMMULITE'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#).
600892-0003 Rev. A 2 -25

2 -26 600892-0003 Rev. A

3 IMMULITE 1000 Interface to LIS

CONFIGURING THE IMMULITE 1000 ................................................................. 3
SETTING UP ......................................................................................................... 3
MANAGE RESULTS ............................................................................................ 5
REQUIRED FLAGS .............................................................................................. 5
QUALITATIVE TEST RESULTS.............................................................................. 5
IMMULITE 1000 LIS CONFIGURATIONS ERROR! BOOKMARK NOT DEFINED.
UPLOAD/DOWNLOAD CODES .............................................................................. 5
IMMULITE 1000 BI-DIRECTIONAL LIS SPECIFICATION ASTM E1394 ........... 6
HEADER RECORD DEFINITION (7.1 - 7.1.14) .............................................. 6
PATIENT INFORMATION RECORD DEFINITION (8.1 - 8.1.35).................................. 7
REQUEST INFORMATION RECORD DEFINITION (HOST QUERY) (12.1 - 12.1.13) .. 14
IMMULITE 1000 UNI-DIRECTIONAL LIS SPECIFICATION ASTM E1394....... 17
HEADER RECORD DEFINITION (7.1 - 7.1.14) ..................................................... 17
PATIENT INFORMATION RECORD DEFINITION (8.1 - 8.1.35)................................ 18
REQUEST INFORMATION RECORD (12.1 - 12.1.13) ........................................... 24
IMMULITE LIS ERROR MESSAGE DEFINITIONS............................................ 25
600892-0003 Rev. A 2-1

3-2 600892-0003 Rev. A

Configuring the IMMULITE 1000

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 can be configured for European numbers such as
1.200,34.
If configured for European numbers, the concentration in the result record
will be in European number configuration. International LIS vendors should
be aware of this, as the IMMULITE did not have the capability to be
configured for European numbers.
Setting Up
To setup a connection between the IMMULITE 1000 and an LIS, follow the
steps below:
Use COM Port 4 on the back of the user-side computer.
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 and the
LIS for troubleshooting, select Diagnostics.
The LIS log should be disabled during normal operation.
4. Select Display Patients.
600892-0003 Rev. A 2-3

If the LIS sends test orders for control samples to the IMMULITE 1000,
select Display Controls.
5. To hide sent results from view on the LIS screen, select Hide Sent.
6. 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.
7. 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.
8. Select how to Report and Display Qualitative Infectious Disease Assay
Results.
Test the Communication
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.
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.
3-4 600892-0003 Rev. A

Manage Results
Results (including semi-quantitative ratio’s) are sent using floating decimals as
follows:
less than 1.00 * 2 0.45
1.00 – 9.99 2 1.23
10.0 - 99.9 1 10.2
* 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|1994040708
5044|19940407085148|Siemens
• 75.0 is the Assay Max

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:
Non-reactive 0
Reactive 1
Indeterminate 2
See assay package inserts for interpretation of qualitative assay ratio results.
Upload/Download Codes
IMMUITE Test Codes are used for upload and download codes and can be found
in IMMULITE Assay package inserts.
600892-0003 Rev. A 2-5

IMMULITE 1000 Bi-Directional LIS Specification ASTM

E1394
HEADER RECORD DEFINITION (7.1 - 7.1.14)

<STX>[FrameNumber]H|\^&||Password|Siemens|Flanders^New^Jers
ey^07836||973-927-2828|N81|YourSystem||P|1|19940323082858


(Configurable in LIS Parameters
screen; Maximum of 15 characters)
Number
(No Parity 8 bits 1 Stop Bit)
3-6 600892-0003 Rev. A


Instructions
(7.1.12) Processing ID Definition-

(Currently 1)
(7.1.14) Date + Time of Message SUPPORTED
(YYYYMMDDHHMMSS)


Patient ID
600892-0003 Rev. A 2-7


Patient ID
For patient sample
Last^FirstÎnitial
Maximum of 30 characters for Last & First name
For control sample
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)
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)
First 2 characters ~V (use uppercase letter)
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)

(YYYYMMDD
Origin
3-8 600892-0003 Rev. A


(Last Name Only)
(supported internal to Siemens)
(Siemens Field 1)
Diagnosis
Discharge Dates
Code
Classifications
600892-0003 Rev. A 2-9


011091233<CR><ETX>[CheckSum]<CR><LF>
(9.4.2)Sequence #
REQUIRED
(9.4.3) Specimen ID
REQUIRED (maximum of 30 characters)
For patient sample
Accession number on primary tube
For control sample
3 - 10 600892-0003 Rev. A


SUPPORTED INTERNAL TO
Siemens
(Sample Cup #)
(^^^[Test Code])
DGX, T4, HCG, TU, RTH, T3, FER,
PSA, PAP
(Maximum of 1 character)
S Stat
R Routine
C Callback
P Preoperative

and Time
(YYYYMMDDHHMMSS
(9.4.8) Specimen Collection Dat SUPPORTED
e and Time
Information
600892-0003 Rev. A 2 - 11

Received
Number
Siemens (Siemens Field 2)
Siemens (CPS)
Siemens (Kit Lot)
Reported
Computer Sys
Collection
(9.4.29) Nosocomial Infection NOT SUPPORTED
Flag

3 - 12 600892-0003 Rev. A

|test|19931011091233|19931011091233|Siemens<CR><ETX>
[CheckSum]<CR><LF>

(10.1.3) Universal Test ID PARTIALLY SUPPORTED \
REQUIRED
(^^^[Test Code])
DGX, T4, HCG, TU, RTH, T3, FER,
PSA, PAP
Value (Result)
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
High])
N Normal SUPPORTED
600892-0003 Rev. A 2 - 13


Started
(YYYYMMDDHHMMSS)
Completed
(YYYYMMDDHHMMSS)
Program)

(12.1 - 12.1.13)
3 - 14 600892-0003 Rev. A
Example Request Record:

<STX>[FrameNumber]Q|1|^1234ABC||ALL|||||||O<CR><ETX>[CheckSum]
<CR><LF>
Q Request information Record SUPPORTED (UPLOAD ONLY)

Number
Number
Results
(12.1.8) Ending Request Results SUPPORTED
12.1.13) Request information status codes
600892-0003 Rev. A 2 - 15

Example Termination Record

Q Error in last request for information REQUIRED WITH QUERY
I No information available from last query REQUIRED WITH QUERY
F Last request for information Processed REQUIRED WITH QUERY
3 - 16 600892-0003 Rev. A
IMMULITE 1000 Uni-Directional Lis Specification ASTM

E1394

<STX>[FrameNumber]H|\^&||Password|Siemens|Flanders^New^Jers
ey^07836|| 973-927-2828|N81|Receiver||P|1|19920521132100
(7.1.2) Delimiter Definition-


Number
600892-0003 Rev. A 2 - 17

(Configurable in the LIS Parameters
Instructions

(Currently 1)
(YYYYMMDDHHMMSS)


Patient ID
3 - 18 600892-0003 Rev. A

Patient ID
characters for Last Name, maximum of
characters)
Origin
(Last Name Only; maximum of 20
characters)
Diagnosis
Discharge Dates
600892-0003 Rev. A 2 - 19

Code
Classifications

Sample Test Order Message
<STX>[FrameNumber]O|1|123456||^^^TSH<CR><ETX>[CheckSum]<CR>
<LF>
(9.4.1) Record types Definition

3 - 20 600892-0003 Rev. A

Siemens
Sample Cup #
(^^^[Test Code])
DGX, TT4, HCG, TU, RTH, T3, FER,
PSA, PAP
(9.4.6) Priority NOT SUPPORTED
(maximum of 1 character)
and Time
Date and Time
Information
Received
Number
600892-0003 Rev. A 2 - 21

Siemens
(CPS)
Siemens
(Kit Lot)
Reported
Computer Sys.
Collection
Flag

um]<CR><LF>
3 - 22 600892-0003 Rev. A

(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
Measurement
Current
Value (Result)
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 SUPPORTED
Ranges ([Low]\[Panic\Low]^[High]\[Panic
High])
(10.1.7)Result Abnormal Flags
N Normal SUPPORTED
(10.1.8)Nature of Abnormality Testing

600892-0003 Rev. A 2 - 23

(For example, Calculation Error)

Started
(YYYYMMDDHHMMSS)
Completed
(YYYYMMDDHHMMSS)
Program)

Not supported in uni directional mode.

Record Types Definition
3 - 24 600892-0003 Rev. A
(13.1.3) Termination Code-

Q Error in last request for information NOT SUPPORTED
F Last request for information Processed NOT SUPPORTED
IMMULITE LIS Error Message Definitions
Error Message Definition

300 LIS Error Timeout During Receive The LIS is not responding to the
IMMULITE 1000. Causes can be a
cabling problem, hardware
communication problem or a
programming bug in the LIS software.
301 LIS Error Invalid Frame Number The frame number in the message is not
proper. Usually indicates a programming
bug in the LIS software, but may be a
bad message (e.g. 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 bug in
Character the LIS software, but may be a bad
message (e.g. line noise).
304 LIS Error Invalid Message Length Data within the message was dropped or
not sent. Usually indicates a
programming bug in the LIS software,
but may be a bad message (e.g. line
noise).
305 LIS Error Invalid Frame Sequence The sequence number in the message is
not proper. Usually indicates a
programming bug in the LIS software,
but may be a bad message (E.G. line
noise). See ASTM 1381 section 6.3.2.1
for further detail.
306 LIS Error No Acknowledgement There is no communication between the
from LIS IMMULITE 1000 and the LIS.
307 LIS Error Timeout During Send The LIS is not responding to
IMMULITE 1000. Causes can be a
cabling problem, communication
problem (hardware related), or
programming bug in the LIS software
308 LIS Error Excessive LIS errors are There are numerous LIS errors during a
600892-0003 Rev. A 2 - 25

occurring 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 or
Received 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 of
ENQ 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 properly
Communication Port or is not configured at all.
31421 LIS Error No Results Selected Tagged records are not found in the
database.
31422 LIS Error LIS Unavailable The LIS is not responding to the
IMMULITE 1000. The causes can be a
cabling problem, a hardware
communication problem or a bug in the
LIS software.
31423 LIS Error Terminator Code Error There is a terminator code error.
31424 LIS Error LIS Terminator Code The terminator code is invalid.
Invalid
31425 LIS Error Password Error 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.
31427 LIS Error Receiver ID Error This is the #1 question asked by LIS
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.
Example:
Receiver ID is set to “HOSPITAL” on
IMMULITE 1000
IMMULITE Sending: Sender ID field = Siemens
Receiver ID Field = HOSPITAL
LIS Sending Sender ID Field = HOSPITAL
Receiver ID field = Siemens
31428 LIS Error Patient ID Missing The LIS is missing a patient ID.
3 - 26 600892-0003 Rev. A

31429 LIS Error Patient ID exceeded 20 The Patient ID has exceeded the
characters allowable number of characters.
31430 LIS Error Accession Number The accession number is missing.
Missing
31431 LIS Error Accession Number The accession number has exceeded the
Exceeded 20 Characters allowable number of characters.
31433 LIS Error No Control Record Control information is not in the
Found database.
31435 LIS Error Invalid Control Data Control data is in an invalid format.
31437 LIS Error LIS Unavailable in Test Occurs when an underlying hardware or
Mode configuration error causes a software
communication error.
31439 LIS Error Call Technical Services Occurs when an underlying hardware or
configuration error causes a software
communication issue.
31440 LIS Error Query Failure The LIS encountered an error when
processing the IMMULITE 1000’s
request for information.
31520 LIS Error Query Communication The IMMULITE 1000 LIS software is
Error not responding. The LIS configuration
parameters may have changed.
600892-0003 Rev. A 2 - 27
3 - 28 600892-0003 Rev. A
4 IMMULITE 2000/2500/XPi Interface to LIS
Results Handling ................................................................................................. 2
Required Flags................................................................................................ 2
Qualitative Test Results .................................................................................. 2
IMMULITE 2000/2500/XPi LIS Configurations ................................................... 2
Test Codes...................................................................................................... 5
IMMULITE 2000/2500/XPi Bi-Directional Lis Specification ASTM E1394 ....... 5
Header Record Definition (7.1 - 7.1.14).......................................................... 5
Patient Information Record Definition (8.1 - 8.1.35) ....................................... 7
Order Record Definition (9.4.1-9.4.31) ........................................................... 9
Result Record Definition (10.1 - 10.1.14) ..................................................... 12
Request Information Record Definition (Host Query) (12.1 - 12.1.13) ......... 14
Message Terminator Record Definition (13.1 - 13.1.3)................................. 16
IMMULITE 2000/2500/XPi Uni-Directional LIS Specification ASTM E1394... 16
Header Record Definition (7.1 - 7.1.14)........................................................ 16
Patient Information Record Definition (8.1 - 8.1.35) ..................................... 18
Order Record Definition (9.4.1-9.4.31) ......................................................... 20
Result Record Definition (10.1 - 10.1.14) ..................................................... 22
Request Information Record (12.1 - 12.1.13) ............................................... 24
Message Terminator Record Definition (13.1 - 13.1.3)................................. 24
IMMULITE 2000/2500/XPi LIS Error Message Definitions.............................. 24
IMMULITE 2000/2500/XPi LIS Troubleshooting .............................................. 30
LIS 15 Second Timeout ................................................................................ 30
LIS 30 Second Timeout ................................................................................ 30
600892-0003 Rev. A 4-1

Results Handling
Results are sent using floating decimals as follows
less than 1.00 * 3 *TSH, RTH 0.025
1.00 – 9.99 2 1.23
10.0 - 99.9 1 10.2
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|199404070
85044|19940407085148|Siemens
• > or < flag included with the assay Min/Max
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:
Non-reactive 0.0
Reactive 1.00
Indeterminate 2.00
See assay package inserts for interpretation of qualitative assay ratio results.
IMMULITE 2000/2500/XPi LIS Configurations

To setup a connection between the IMMULITE 2000/2500/XPi and an LIS,
follow the steps below:
Use serial port 8 (labeled “LIS”) in the I/O panel on the back of the
Instrument (Note: The IMMULITE 2000/2500/XPi network ports cannot be
used for LIS communication.)
Individual fields are defined in Chapter 1, LIS Configuration Screen Terms.
4-2 600892-0003 Rev. A

3. At the instrument window, select Configurations > Configure > LIS.

For IMMULITE 2000 and IMMULITE 2000 XPi systems, at the instrument
window, select Menu > Configurations > 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.
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 re-queried
to an LIS
• Requery New Orders – Accession numbers are always re-queried 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
600892-0003 Rev. A 4-3

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
Indeterm
• Qualitative and Ratio

Results display on LIS screen as numerical ratio plus NR, R or I.
Figure 1 LIS Configuration Screen
4-4 600892-0003 Rev. A

Test Codes
IMMULITE 2000/2500/XPi Test Codes are upload and download Test codes,
and can be found in IMMULITE 2000/2500/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 2000/2500/XPi Bi-Directional Lis Specification

ASTM E1394

ey^07869||(201)927-2828|8N1|YourSystem||P|1|19940323082858
(7.1.2) Delimiter Definition REQUIRED

600892-0003 Rev. A 4-5


(Configurable by Siemens; Maximum
of 10 characters)
(Configurable by Siemens; maximum
of 10 characters)
Number
(Configurable by Siemens; maximum
of 10 characters)
Instructions

(Currently 1)
(YYYYMMDDHHMMSS)
4-6 600892-0003 Rev. A



Patient ID
Patient ID
For patient sample
(Last^FirstÎnitial; maximum of 30 characters for both Last&First name)
For control sample
NOTE: Control accession numbers that begin with ‘~C’ follow the above format.
Control accession numbers do not need to follow this convention. Alternatively,
controls may be defined using any allowed characters for a patient accession
number.
600892-0003 Rev. A 4-7

For adjustor sample

For verifier sample

characters)
Origin
(8.1.14) Attending Physician ID NOT SUPPORTED
(Value is sent only from Instruments to
LIS)
Diagnosis
4-8 600892-0003 Rev. A


Discharge Dates
Code
Classifications

011091233||||||Post Menopausal<CR><ETX>[CheckSum]<CR><LF>
600892-0003 Rev. A 4-9


For patient sample
Accession number on primary tube.
For control sample
NOTE: Control accession numbers that begin with ‘~C’ follow the above format.
Control accession numbers do not need to follow this convention. Alternatively,
controls may be defined using any allowed characters for a patient accession
number.
4 - 10 600892-0003 Rev. A

(^^^[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
• 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).
(All maximum of 1 character)
S Stat
R Routine
C Callback
P Preoperative

and Time
(YYYYMMDDHHMMSS; maximum
of 14 characters)
(9.4.8) Specimen Collection SUPPORTED
Date and Time
600892-0003 Rev. A 4 - 11

(9.4.14) Relevant Clinical SUPPORTED
Information
Received
(9.4.17) Ordering Physician SUPPORTED
Smith^Joseph (maximum of 30
characters)
Number
Reported
Computer Sys
(9.4.25) Instrument Section ID SUPPORTED
Collection
Flag

4 - 12 600892-0003 Rev. A

|test|19931011091233|19931011091233|Siemens<CR><ETX>[CheckS
um]<CR><LF>

(^^^[Test Code])
Example Test Codes:
TSH, LH, FSH, DGX, T4, HCG, RTH, SPE
D120
Measurement
Value (Result)
ng/mL, ng/dL, ug/dL, uIu/mL, mIU/mL,
pg/mL, nmol/L, pmol/L, mIU/L, ug/L, IU/mL,
IU/L, KU/L, SClass
(10.1.6) Reference SUPPORTED
Ranges ([Low]\[Panic\Low]^[High]\[Panic
High])
(10.1.7) Result Abnormal Flags-
N Normal SUPPORTED
600892-0003 Rev. A 4 - 13


Started
(YYYYMMDDHHMMSS)
Completed
(YYYYMMDDHHMMSS)
(Configurable from Siemens)

(12.1 - 12.1.13)
4 - 14 600892-0003 Rev. A
Example Request Record

<STX>[FrameNumber]Q|1|^1234ABC||ALL|||||||O<CR><ETX>[CheckS
um] <CR><LF>
Q Request information Record SUPPORTED (UPLOAD ONLY)

Number
Number
Results
(12.1.8) Ending Request Results NOT SUPPORTED
.
(12.1.13) Request information status codes
600892-0003 Rev. A 4 - 15


Q Error in last request for information REQUIRED WITH
QUERY
I No information available from last query REQUIRED WITH
QUERY
F Last request for information Processed REQUIRED WITH
QUERY
IMMULITE 2000/2500/XPi Uni-Directional LIS

Specification ASTM E1394

ey^07869||(201)927-2828|8N1|Receiver||P|1|19920521132100
4 - 16 600892-0003 Rev. A
(7.1.2) Delimiter Definition-

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

Configurable by Siemens
Maximum of 10 characters
Number
8 bits No Parity 1 Stop Bit
Instructions

Currently 1
600892-0003 Rev. A 4 - 17
(7.1.14)Date+Time of Message SUPPORTED

YYYYMMDDHHMMSS

P = Patient Identity Record REQUIRED

Patient ID
Patient ID
characters both First&Last name)
characters)
4 - 18 600892-0003 Rev. A

Origin
(8.1.14) Attending Physician ID NOT SUPPORTED
Diagnosis
Discharge Dates
Code
Classifications
600892-0003 Rev. A 4 - 19

<STX>[FrameNumber]O|1|123456||^^^TSH<CR><ETX>[CheckSum]<CR>
<LF>
O = Test Order Record REQUIRED

^^^[Test Code]
maximum of 10 characters
Example Test Codes:
TSH, LH, FSH, DGX, T4, HCG, RTH,
SPE D120
(All maximum of 1 character)
S Stat
R Routine
C Callback
P Preoperative
4 - 20 600892-0003 Rev. A

and Time
Date and Time
(9.4.14) Relevant Clinical SUPPORTED
Information
Received
(9.4.17) Ordering Physician SUPPORTED
Smith^Joseph; maximum of 30
characters
Number
SUPPORTED Internal to Siemens
(CPS of result)
SUPPORTED Internal to Siemens
(Kit lot to run, or was run on test)
Reported
Computer Sys
(9.4.25) Instrument Section ID SUPPORTED
600892-0003 Rev. A 4 - 21

Collection
Flag

um]<CR><LF>
R = Result Record REQUIRED

(^^^[Test Code])
Example Test Codes:
TSH, LH, FSH, DGX, TT4, HCG, TU,
RTH, SPE D120
Value (Result)
ng/mL, ng/dL, ug/dL, uIu/mL,
mIU/mL, pg/mL, nmol/L, pmol/L,
mIU/L, ug/L, IU/mL, IU/L, KU/L,
SClass
High])
4 - 22 600892-0003 Rev. A

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

A = Age population tested NOT SUPPORTED
S = Sex based Population NOT SUPPORTED
R = Race based Population NOT SUPPORTED
N = Normal generic range SUPPORTED
C = Correction of previously sent results REQUIRED
P = Preliminary Results NOT SUPPORTED
F = Final Results SUPPORTED
X = Results cannot be done NOT SUPPORTED
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 REQUIRED
N = This result record contains necessary NOT SUPPORTED

Started
(YYYYMMDDHHMMSS)
600892-0003 Rev. A 4 - 23

Completed
(YYYYMMDDHHMMSS)
(Configurable by Siemens
SOFTWARE)

Not supported in uni directional mode.

L = Terminator record SUPPORTED

Q Error in last request for information NOT SUPPORTED
in uni-directional mode
F Last request for information Processed in NOT SUPPORTED
uni-directional mode
IMMULITE 2000/2500/XPi LIS Error Message Definitions

2550 LIS Parse error due to An invalid sample type (e.g., ~D) was
unexpected sample type received from the LIS.
received from LIS.
2551 LIS An unexpected error Unable to query the LIS and receive a
was encountered during response. The SMS will continue to re-
query of the LIS. query while there are still barcodes
requiring a query.
4 - 24 600892-0003 Rev. A

2567 LIS The LIS is not enabled. This message appears when trying to
Enable the LIS to pause or activate the LIS or trying to
perform this action. manually send or resend 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.
Select RUN.
2571 LIS Error Patient ID exceeded 20 An order downloaded from the LIS
characters. contains a patient ID exceeding 20
characters. The order is not accepted
because Patient IDs cannot exceed 20
characters.
2572 LIS Error Accession Number An order downloaded from the LIS
exceeded 20 characters. contains an accession number exceeding
20 characters. The order is not accepted
because accession numbers cannot
exceed 20 characters.
12300 LIS Carriage return or Line The message is missing a required
Feed missing from Carriage return, line feed or both.
message. Violates ASTM E1381 Section 6.3.1.2.
12301 LIS Incorrect or Missing The frame number for a message is an
Frame Number. 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 the
5 characters). requisite five characters.
12304 LIS Invalid Password in The Password received does not match
Header Message. the password entered in the LIS
configuration on IMMULITE
2000/2500.
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
IMMULITE be modified to the value
they indicate. Violates ASTM E1394
Section 7.1.4.
600892-0003 Rev. A 4 - 25

12305 LIS Invalid Sender ID in The Sender ID received does not match
Header Message. the Sender ID entered in the LIS
2000/2500.
Contact the LIS vendor to determine the
proper Sender ID. If the Sender ID is
incorrect in the IMMULITE
2000/2500/XPi software, the LIS vendor
may change the Sender ID parameter on
the LIS or request that the Sender ID on
IMMULITE 2000/2500/XPi be modified
to the value they indicate. If the Sender
ID is correct on IMMULITE 2000/2500,
the LIS vendor most likely has an error
in their code. When sending FROM the
LIS to IMMULITE 2000/2500/XPi the
LIS vendor needs to place their ID
(Designated on IMMULITE
2000/2500/XPi as receiver ID) in the
Sender ID field of the header message.
Violates ASTM E1394 Section 7.1.5.
12306 LIS Invalid Receiver ID in The Receiver ID received does not match
Header Message. the Receiver ID entered in the LIS
2000/2500.
Contact the LIS to determine the proper
Receiver ID. If the Receiver ID is
incorrect in the IMMULITE
2000/2500/XPi software, the LIS vendor
may change the Receiver ID parameter
on the LIS OR request the Receiver ID
on IMMULITE 2000/2500/XPi be
modified to the value they indicate. If the
Receiver ID is correct on IMMULITE
2000/2500, the LIS vendor most likely
has an error in their code. When sending
FROM the LIS to IMMULITE
2000/2500/XPi the LIS vendor needs to
place the Instrument ID (Designated on
IMMULITE 2000/2500/XPi 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 the LIS
received. without sending an initial header
message. Violates ASTM E1394 Section
5.2.
12308 LIS Several LIS errors have More than 20 communication errors have
occurred the past hour. occurred within a one-hour time frame.
There may be a This is an IMMULITE 2000/2500/XPi
communication message only and is not part of the
problem. ASTM specification.
4 - 26 600892-0003 Rev. A

12309 LIS Null or Missing Patient The Patient ID field in the Patient
ID in Patient Record. message is not present. This is a required
field for IMMULITE 2000/2500.
12310 LIS Invalid Test Code or The test code received in an order
Format in Order record. message does not match a test code on
IMMULITE 2000/2500. The test code
may be incorrect or an initial kit for the
test code may not have been entered on
IMMULITE 2000/2500. 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 seven
message after sending times and was not accepted. The current
message 7 times. communication session is aborted.
Violates ASTM E1381 Section 6.5.1.2.
12312 LIS Time out, 30 seconds Information was received from the LIS
expired and no data was and a response to the message was
received from LIS. returned to the LIS. No additional data
was received from the LIS in 30 seconds.
The current communication session is
aborted. Violates ASTM E1381 Section
6.5.2.4.
Refer to IMMULITE 2000/2500/XPi LIS
Troubleshooting
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 when
sending LIS query sending a query to the LIS.
request. Host query
aborted.
12315 LIS Time out, No response Information was sent to the LIS and there
from LIS after waiting was no response after a 15 second time
15 seconds. period. The current communication
session is aborted. Violates ASTM
E1381 Section 6.5.2.3.
Refer to IMMULITE 2000/2500/XPi LIS
Troubleshooting
12316 LIS <ENQ> Contention. The LIS was attempting to initiate a
communication session at the same
moment the IMMULITE 2000/2500/XPi
was performing the same. This error is
handled as described in ASTM E1381
Section 6.2.7.1.
12317 LIS No accession number in No accession number was received in an
order record. order record. This is a required field for
IMMULITE.
600892-0003 Rev. A 4 - 27

12318 LIS The LIS encountered an The LIS informed IMMULITE
error for a query. 2000/2500/XPi 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 on a
information for query. requested sample (accession number) as
defined in ASTM E1394 Section 13.1.3.
12320 LIS An invalid terminator An invalid or unsupported terminator
code was received from code was received from the LIS. Violates
the LIS. ASTM E1394 Section 13.1.3.
12321 LIS Unique ID does not All records are stored on the IMMULITE
match retrieved file. 2000/2500/XPi with a unique number. A
Please call Technical retrieved file was expected to have a
Services. 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 the
marked sent, record not database to be sent to the LIS. This error
found. should not be encountered and indicates
a programming logic error.
12323 LIS Record could not be sent A tagged record could not be found in
to LIS, record not found. the database to be sent to the LIS. This
error may indicate a programming logic
error.
12324 LIS There are no The operator pressed the Send or RE-
"TAGGED" records to Send buttons on the LIS screen and no
sent to the LIS. records are tagged.
12325 LIS You can only display The LIS Screen has a limit of displaying
10,000 records at one 10,000 records at one time. The first
time. 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 Record The patient message must precede the
before Patient Record. order message in the LIS message. The
LIS has received the order message
before receiving the patient message.
12327 LIS Data is being received The LIS is currently receiving data or the
from the LIS or IMMULITE is actively sending data to
IMMULITE is already the LIS.
sending data to the LIS.
12328 LIS LIS reports an error in There was an error in the query request
query request as it was sent from the IMMULITE to
the LIS.
12329 LIS LIS reports no There was no information for an
information for Accession number in a query.
Accession Number in
query request.
4 - 28 600892-0003 Rev. A

12330 LIS An error occurred An unrecognized error occurred when
sending LIS query sending a query to the LIS.
request. Host query
aborted.
12331 LIS Parse error occurred The Control information was sent from
when downloading in the LIS in the wrong format. Contact
Control format. your laboratory LIS provider. If the
message persists, call Technical Service.
12332 LIS Parse error occurred The Adjustor information was sent from
when downloading in the LIS in the wrong format.
Adjustor format.
12333 LIS Control downloaded The control requested in the download
from LIS is new to the from LIS is new to the system. The
system. 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 was
when downloading in sent from the LIS in the wrong format.
Verifier 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.
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.
600892-0003 Rev. A 4 - 29
IMMULITE 2000/2500/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 2000/2500/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 (unlikely)
incorrect serial port configuration
LIS is not on or needs to be restarted
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
a malfunctioning rocket card
LIS cable length being greater than 50 feet
4 - 30 600892-0003 Rev. A
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 are 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.
• Dispose of contaminated materials according to your laboratory’s biohazard
control procedures.
600892-0003 Rev. A A-1

• 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.
Figure 1-1 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.
1-2 600892-0003 Rev. A

Only Siemens-trained field service personnel should perform procedures related

to laser assemblies.
Figure 1-2 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. Refer to
Protecting Yourself from Barcode Scanner Lasers, for more information.
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
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
600892-0003 Rev. A A-3

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

The instrument Operator’s Guide procedures that use the handheld barcode
scanner are introduced with the following laser warning:
LASER WARNING
Never look directly at the beam of a handheld 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, refer to Protecting Yourself from Barcode Scanner
Lasers.
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.
1-4 600892-0003 Rev. A

B Service and Warranty
This section provides the following information:
• address of the Siemens authorized representative, which is the Siemens
contact within the European community
• addresses for obtaining service and technical information and for ordering
supplies
• system warranty and service delivery policy information
Siemens Authorized Representative

Siemens Healthcare Diagnostics Inc.
Tarrytown, NY 10591-5097 USA
IMMULITE/LIS Interface Policy

The IMMULITE systems (IMMULITE), including IMMULITE, IMMULITE
1000, IMMULITE 2000®, IMMULITE 2500, 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.
600892-0003 Rev. A B-1

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.
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 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
1-2 600892-0003 Rev. A

Addresses
For technical assistance, contact your local technical support provider. For
customer service or additional information, contact your local technical support
distributor.
www.siemens.com/diagnostics
600892-0003 Rev. A
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Immulite Interface Specifications

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IMMULITE® / IMMULITE® 1000

IMMULITE® 2000 / IMMULITE® 2500 / IMMULITE® 2000XPi

600892-0003, Rev. A, 2009-03

How this Manual Is Organized

If you want to . . . Refer to . . .

read an overview of how an instrument interfaces Section 1, LIS Overview

determine the IMMULITE installation and Section 2, IMMULITE / LIS

determine the IMMULITE 2000/2500/XPi Section 4,

review biohazard guidelines, Appendix A, Protecting Yourself

contact Siemens Healthcare Diagnostics, Appendix B, Service and

Conventions Used in this Manual

Bold Bold type indicates the following:

Italic Italic type refers to the title of a document or a section title in

Caution statements alert you to conditions that may cause

NOTE: Note statements alert you to important information that requires

BASIC LIS TERMS

LIS CONFIGURATION SCREEN TERMS

Screen term Description

LIS WORKLIST SCREEN TERMS

2 IMMULITE Interface to LIS

3 IMMULITE 1000 Interface to LIS

4 IMMULITE 2000/2500/XPi Interface to LIS

B Service and Warranty

C IMMULITE to LIS Cable Wiring

WHAT IS AN LIS? ................................................................................................ 3

HOW DOES AN LIS WORK? ............................................................................... 3

TRANSFER EXAMPLES OF BI-DIRECTIONAL AND UNI-DIRECTIONAL,

HOST QUERY EXAMPLE, QUERY TO LIS....................................................... 20

Sometimes you may see an LIS listed as a Laboratory Information Management

How does an LIS work?

General Schematic of an LIS

Summary of LIS Workflow Steps

2. The LIS does the following:

3. Work orders are downloaded to instruments.

4. If the instruments are configured for Uni-Directional communication, the

5. If configured for Bi-Directional batch communication, the operator must

6. If configured for Bi-Directional Query, the operator places the barcoded

Example Patient Report

Patient Name: Doe, Jane Medical Record Number: 2564786

Date Time Accession No. Tests Ordered

Report Printed: Feb. 3, 2006 @23

How Do Instruments Communicate with an LIS?

Occasionally an LIS is not connected via a communications cable with any

The interface can have several components:

When using a serial (RS232) connection, the IMMULITE systems do the

Some common LIS communication errors may occur. The Troubleshooting

Lab Automation Configuration

1 -10 600892-0003 Rev. A

Basic Message Hierarchy (Lower number has higher

Hierarchy Example of LIS to IMMULITE Systems

600892-0003 Rev A. 1 -11

Hierarchy Example of IMMULITE to LIS Transfer

Hierarchy Example of IMMULITE 2000/2500/XPi to LIS

1 -12 600892-0003 Rev. A

Hierarchy Example of IMMULITE 2000/2500/XPi to LIS

Hierarchy Example of Query to LIS

Hierarchy Example of Response to Query

600892-0003 Rev A. 1 -13

Basic Format of a Message

[Record Type (P)][Sequence #][Practice Assigned

1 -14 600892-0003 Rev. A

[Record Type (O)][Sequence#][Specimen ID

[Record Type (R)][Sequence #][Universal Test ID][Data

600892-0003 Rev A. 1 -15