Immulite2000XPi LIS

LIS
Basics
Siemens Medical Solutions Diagnostics 600890-0001-A 1

Copyright © 2006 by Diagnostic Products Corporation. ALL RIGHTS RESERVED.
This manual, and the software described in this manual, are copyrighted. No part of this manual or the
described software may be copied, reproduced, translated or reduced to any electronic medium or
machine-readable form without the prior written consent of Diagnostic Products Corporation.
2 600890-0001-A Siemens Medical Solutions Diagnostics

Table of Contents
LIS Overview................................................................................................................................................ 5
What is an LIS? ......................................................................................................................................... 5
How does an LIS work? ............................................................................................................................ 5
General Schematic of an LIS .................................................................................................................... 6
Summary of LIS Workflow Steps............................................................................................................... 7
How do Instruments “TALK" with an LIS? ............................................................................................... 10
Cable Specifications ................................................................................................................................ 11
References .............................................................................................................................................. 11
DATA STREAM VERSUS PORT CONFIGURATION ............................................................................... 12
BASIC LIS TERMS..................................................................................................................................... 14
LIS CONFIGURATION SCREEN TERMS ................................................................................................. 17
LIS WORKLIST SCREEN TERMS............................................................................................................. 20
IMMULITE LIS SETUP ............................................................................................................................... 21
1) Connect the Cable .............................................................................................................................. 21
2) Configure LIS Parameters................................................................................................................... 21
3) Test the Communication ..................................................................................................................... 21
4) Test IMMULITE Host Query (if applicable) ......................................................................................... 21
5) Manage Results .................................................................................................................................. 21
IMMULITE 1000 LIS Setup ........................................................................................................................ 23
4) Test IMMULITE 1000 Host Query (if applicable) ................................................................................ 25
5) Manage Results .................................................................................................................................. 25
IMMULITE 2000/2500 LIS Setup ............................................................................................................... 27
4) Test IMMULITE 2000/2500 Host Query (if applicable) ....................................................................... 29
5) Manage Results .................................................................................................................................. 29
SMS LIS Setup........................................................................................................................................... 31
4) Test SMS Host Query (if applicable)................................................................................................... 35
5) Manage Results .................................................................................................................................. 35
Panels on SMS .......................................................................................................................................... 37
SMS LIS FAQs ........................................................................................................................................... 38
IMMULITE 2000/2500/SMS LIS Troubleshooting.................................................................................... 42
Siemens Diagnostics IMMULITE/ LIS Interface Policy ........................................................................... 42
LIS 15 Second Timeout........................................................................................................................... 43
LIS 30 Second Timeout........................................................................................................................... 43
LIS <ENQ> Contention Messages .......................................................................................................... 44
Invalid Password, Sender ID and/or Receiver ID.................................................................................... 44
Error 12327.............................................................................................................................................. 44
LIS Screen – 10,000 Records ................................................................................................................. 44
There are no “Tagged” Records.............................................................................................................. 45
Miscellaneous Errors............................................................................................................................... 45
APPENDIX.................................................................................................................................................. 46
IMMULITE LIS ERROR MESSAGE DEFINITIONS ................................................................................... 46
IMPACT OF LIS AND SMS SETTINGS ON SMS AUTO-RETRIEVAL BEHAVIOR ................................ 62

LIS OVERVIEW
What is an LIS?
A Laboratory Information System (LIS) is software which handles receiving,

processing, and storing information generated by laboratory processes. 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 an LIMS, “Laboratory Information

Management System”. A Laboratory Information Management System (LIMS) and a
Laboratory Information System (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. These individual pieces of
paper had to be organized for the doctors by taping them to a patient’s chart, or re-
typing all the results into a computer to collate onto separate pages. Both options are
very time consuming and cause risk for data entry errors. 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.

Input Output
Data : Clinical Patient Report
information, lab LIS
orders / results John Doe
PSA 2.0 mg/dl
General Schematic of an LIS
A generic schematic of how an LIS may be layed-out in a typical lab assumes there may
be multiple technologists operating instruments from several of the workstations. A
workstation is simply an LIS terminal or PC allowing the operator to work with the LIS
software.
Other configurations could be in place in larger facilities. In this case, there may be
fewer workstations, and the technologist would then accept results from multiple
instruments. Often, in larger more complex operations, the LIS connects multiple
sections within the lab, and could also be connected to the internet, and; therefore,
would also connect multiple off-site locations.

Summary of LIS Workflow Steps
1. Work orders for patients are created in the LIS or transferred from the HIS.
2. The LIS assigns accession numbers to patient samples, and produces barcode
labels and collection lists to facilitate sample collection.
Order Entry
The order or lab request placed in the system contains the request of tests to be
performed. An almost universal requirement for using an LIS is to have a unique
accession number for each and every patient sample. A patient may have
multiple accession numbers, so each patient must have a unique identifier as
well. The unique identifier is usually called a medical record number, patient ID
or patient record number. In addition, the LIS will print barcoded labels (with the
unique accession #) for the draw tubes. In some cases, more advanced LIS
products will also 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.
3. Work orders are downloaded to instruments.
Sample Receiving
Most LIS systems can be configured 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 unique ID is read off the sample tube label and matched with the order by the
instrument.
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.
8. Released results are often compiled and printed on patient-specific lab reports
and LIS patient records are updated with the result information.
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: Kidman, Nicole 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 “TALK" with an LIS?
Most laboratory Instruments and instruments have the capacity to communicate with an
LIS. Just like a group of computers interconnected in a network, instruments can be
“networked” or interfaced with an LIS. To accomplish this, an interface must be created
so the Instrument’s computer can “talk” with the LIS computer.
The interface is nothing more than a small program that translates what the Instrument
is “saying” into language that the LIS can understand. Likewise, this interface translates
what the LIS is “saying” into language that the instrument can understand. The
interface is usually written by the LIS vendor and comes at a cost to the lab ($5,000 or
more per instrument). 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 (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.
The interface can have several components:
Physical
Instrument has an active input/output port connected with a computer cable.
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,
an intermediate device, and instrument) are operating software and application
software.
o Operating software controls basic machine functions; such as interaction
with the I/O devices, memory management, disk access, and creating the
application software environment.
o Application software provides all of the “user visible” features and
functionality.
For the interface to “run” smoothly, all of these elements must be working in conjunction
with each other. There can be issues with the “language” used in communication;

however, when there are problems, it is generally best to start with the simplest and
most obvious possibility, so always check the cable connection first.
Cable Specifications
The LIS vendor or the Lab 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.
The cable can be purchased at Radio Shack or a similar electronics store. Since
troubleshooting LIS errors may involve testing the cable, it is a good idea to have a
spare one available.
When using a serial (RS232) connection, the IMMULITE systems send on pin 3 and
receive on pin 2 (see diagram below). Pin 5 is the ground.
There are some common LIS communication errors that 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

DATA STREAM VERSUS PORT CONFIGURATION
Historically, the connection between the LIS system and an instrument was made by
plugging one end of a cable into a COM port on the instrument, and the other end into a
COM port on the LIS instrument interface. At both ends of this connection, the
identification of which instrument was connected, was done by identifying which COM
port number the cable plugged into. Each instrument used its own COM port on the LIS
and identification of which results came from which instrument was unambiguous. We
still use this method of identification for the LIS connection to the IMMULITE systems.
Cable from
SMS COM
Port 10 Cable to
LIS COM
Port 1
This approach to instrument identification is no longer viable with the advent of lab
automation and systems like the Immunoassay Workcell. 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 method of instrument identification needs to change. The new method uses the
actual data stream itself to identify the instrument. We recognize that 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. However, the field has been available for use for a long time, and we now
need to embrace its capabilities.

The result message or DATA STREAM from the instrument looks like this:
[Record Type (R)][Sequence #][Universal Test ID][Data

(result)][Units][Reference Ranges] [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]
The Instrument ID field has to be read by the LIS in order for the result message to link
the instrument identification to the result. The laboratory must coordinate with their LIS
vendor to make this change, and the LIS vendor usually charges the laboratory.
Approximate charges have been about $1,200.
In an IA Workcell Configuration, there is still a Single Port Connection to the LIS. This
port cannot be used to identify which instrument results are coming from.

BASIC LIS TERMS
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
ETX (End of Text) – Indicates end of text for a specific message.
Header Message ("H" 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, etc. The intent of HL7 is to have all
healthcare information systems using the same
terms for the same test, etc. to facilitate

communications between the various
information systems.
Interface – A small program that translates what the

Instrument is “saying” into language that the
LIS can understand and translates what the
LIS is “saying” into language that the
Instrument can understand.
Line Noise – Unintended voltage; it 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.
Order Message ("O" message) – Defines which test, such as TSH or HCG,
should be performed on the patient sample for
a particular accession number.
Panel – Panel names may be sent to the Instrument.

All tests within a panel will be 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.
Patient Message ("P" message) – Contains patient information, patient ID, name.
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.

Query Message ("Q" message) – A request to the LIS for patient information and
test orders. Contains the primary tube
accession number.
Result Message ("R" 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.
Rocket Card – A computer board used on IMMULITE 2000,

2500 and SMS systems to provide the serial
ports used for LIS communications.
STX (Start of Text) – Indicates start of text for a specific message.
Terminator Message ("L" mesg.) – Last message sent in a transaction, contains

termination codes.
Test Codes – Test Codes are upload and download codes

and can be found in package inserts.
Note: Entering test codes into the LIS for
allergy assays is time consuming because
customers may run hundreds of allergy tests.
Use of common naming conventions like HL7
will make 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

LIS CONFIGURATION SCREEN TERMS
Auto Send Control Results – Send QC results automatically to the LIS when
complete.
Auto-Send Invalid Adjustment – If checked, will auto send patient results

flagged ADJ.
Auto-Send Invalid Control – If checked, will auto send patient results if the
controls for an assay do not meet criteria
configured as single rule or multi rule in the QC
Data Entry screen.
Auto-Send Invalid Range – If checked, will auto send patient results that
are < or > the Review Range.
Auto Send Patient Results – Patient results are sent to the LIS automatically
without operator intervention. Exceptions to
this may include:
• 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, 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 Screen – QC orders and results will appear on the LIS
Worklist screen.
Hide Sent – Defaults the Hide Sent/Show Sent button on

the LIS Worklist screen to Hide Sent (results
sent to the LIS disappear from the LIS Worklist
screen).
Network Connection – A port designed to use the RJ45 standard

network cable rather than the older DB9 serial
port connector. Network connections are
typically NOT serial communications.
No Re-query – If an accession number is found in the

Instrument database (pending or completed
tests), the accession number will not be re-
queried to an LIS.
Password – A password defined by the LIS software

company. This field may be left blank if
desired.
Query Controls – The Instrument will request QC orders from the

LIS when a QC barcode is read on the Sample
Carousel.
Receiver ID – The identity of the system receiving a

message; for example, if IMMULITE is
receiving a message, the receiver ID may be
“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.
Re-query All – Accession numbers are always re-queried and

duplicate test orders are run.

Re-query New Orders – Accession numbers are always re-queried 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 “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.
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.

LIS WORKLIST SCREEN TERMS
Clear – PERMANENTLY deletes selected records from

the Instrument’s database. There is no way to
recover the lost data. NO ONE SHOULD
EVER USE THIS FEATURE !!!
Hide Sent/Show Sent – Hide Sent only displays un-sent results. To

view sent results, touch Hide Sent to toggle 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.

IMMULITE LIS SETUP
The IMMULITE has the following limitations when communicating with an LIS
• Cannot auto-send results
• Cannot re-send a sent result
To setup a connection between the IMMULITE and an LIS, follow the steps below:
1) Connect the Cable

Use COM Port 2 on the back of the user-side computer
2) Configure LIS Parameters

From the Start Screen, select LIS Params
The LIS Params screen password is CONNECT.
• Activate LIS Select Yes to activate
• Activate Host Query Select Yes if host query desired
• Activate Uni-Directional Select Yes if desire to send results only
1. Select Yes for either Uni-directional or Host Query, but not both.
2. If No is selected for both Uni-directional and Host Query, communication
will be batch bi-directional.
• Password LIS Vendor must provide
• Sender ID LIS Vendor must provide
• Receiver ID LIS Vendor must provide
• Baud Rate LIS Vendor must provide, usually 9600
3) Test the Communication

Must run sample tube(s) after the LIS feature is activated.
Must 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 disappear
from the LIS Data Management screen.
4) Test IMMULITE Host Query (if applicable)

Enter sample cup number.
Use hand-held scanner to scan in accession number; the patient name should populate
the screen.
Load patient sample in specified cup number and run.
Results appear in the LIS Data Management screen.
If any LIS errors display, contact Technical Service.
5) Manage Results
Results must be tagged and sent to the LIS (there is no auto-send option on
IMMULITE).

Results are cleared from the LIS screen after sending to the LIS and cannot be re-sent.
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.
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

IMMULITE 1000 LIS SETUP
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

All configurations require log off to activate changes
• Select Tools, then Configurations and then LIS Parameters

• The LIS Parameters screen password is CONNECT
• 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.
• Select Diagnostics to enable a log of the communication between the
IMMULITE 1000 and the LIS for troubleshooting. The LIS log should be disabled
during normal operation.
• Select Display Patients
• Select Display Controls if the LIS sends test orders for control samples to the
IMMULITE 1000.
• Select Hide Sent to hide sent results from view on the LIS screen.
• Select Auto-Send Patient Results to automatically send each completed result
to the LIS. Completed results are not collated per accession number prior to
sending.
• Auto-Send Invalid control is not available at this time.
• Select Auto-Send Invalid Adjustment to automatically send patient results
flagged ADJ on review screens.
• Select Auto-Send Control Results only if the LIS sends test orders for control
samples.
• Select how to Report and Display Qualitative Infectious Disease Assay Results

IMMULITE 1000 LIS Configurations Screen
Password
and ID’s
come from “Display Patients”
the LIS only should be
provider selected unless the
LIS sends orders for
control samples
Must be 4
Serial Port 4
The LIS
Parameters
screen is
password
protected;
the
password is
connect
aHB and BcM are quantitative assays
with qualitative approval in the U.S.
The instrument default sends the
numerical concentration to the LIS. If
Qualitative Only is selected, the All changes must be saved and
Instrument interprets the assay and take effect after the next login.
sends a qualitative interpretation.

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
4) Test IMMULITE 1000 Host Query (if applicable)

Enter sample cup number.
Type or use hand-held scanner to enter accession number; the patient name should
populate the screen.
Load patient sample in specified cup number and run.
Results appear in the LIS Data Management screen.
If any LIS errors display, contact Technical Service.
5) 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.
Qualitative Test Results

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

Non-reactive 0
Reactive 1
Indeterminate 2
See assay package inserts for interpretation of qualitative assay ratio results.

IMMULITE 1000 LIS Data Management Screen
Filters
information by
date and time Tagged records
highlight blue
Organizes
information
displayed
on screen
What is
displayed on
the button is
displayed on
the screen
Button for
manually Permanently
removes selected Used to temporarily
tagging and stop communication
sending results records from the
database when between the
to the LIS Instrument and the
confirmed
SMS; when re-
activated, stored
records are sent to
the LIS

IMMULITE 2000/2500 LIS SETUP
To setup a connection between the IMMULITE 2000/2500 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 network ports cannot be used for LIS communication.)

Individual fields are defined in the LIS Configuration Screen Terms at the beginning of
this document. To access the LIS Configuration screen, select Configurations,
Configure and then LIS.
IMMULITE 2000/2500 LIS Configuration Screen
Selects the
communication mode
Defines default setting

LIS Parameters for button on LIS screen
– most come
from LIS
provider
Auto Send
behavior is
defined in
the Terms
section
aHB and BcM are semi-qualitative

All changes must be
assays that report concentration
saved and take effect
instead of ratio
after the next login

The Test Ranges screen (shown below) contains an optional field called “Review
Range” that determines the range of results that are automatically sent to the LIS when
configured to Auto Send results. If patient results fall outside of this range, they are
held on the LIS Worklist screen for further review unless configured to Auto Send Invalid
Range.
IMMULITE 2000/2500 Test Ranges Screen
Choose test to
set ranges on
This range is used

to flag patient
results High or
Low*
Be sure that
ranges entered
are in the same
units as
Patient results falling displayed
outside this range are not
sent to the LIS; may be
used as a critical or alert All changes must
range for patient results be saved
* Note: Results that fall outside of the Normal Range but within the Review Range will
not be flagged high or low.

After configuring the LIS, log off and back on to activate changes.
In the LIS Worklist screen, manually tag and send a result.
Results are successfully sent to the LIS if no errors occur and the message “sending
LIS” disappears from the LIS Worklist screen.
Verify the result is in the LIS.
Utilize the LIS log on the IMMULITE 2000/2500 for troubleshooting if needed.
4) Test IMMULITE 2000/2500 Host Query (if applicable)

Place sample tube(s) with new accession number(s) into the Sample Carousel and
select RUN to scan the carousel.
Test orders are successfully downloaded from the LIS if no errors appear and the
Worklist Display/Edit screen displays patient names and test orders.
If LIS errors occur or no test orders are downloaded, activate the LIS log to record data
stream for troubleshooting purposes. Contact Technical Service for assistance.
If no test orders are downloaded and there are no errors, verify the accession number
has not been used before.
Turn off the LIS log when troubleshooting is completed.
5) Manage Results

less than 1.00 3 *TSH, RTH 0.025
1.00 – 9.99 2 1.23
10.0 - 99.9 1 10.2

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

IMMULITE 2000/2500 LIS Worklist Screen
Permanently
Button for What is Filters removes selected
manually displayed on information by records from the
tagging and this button date, time and database when
sending results displays on category confirmed
to the LIS the screen
Used to temporarily
Hi, Lo, Out,
stop communication
Adj, QC
between the
(multirules)
Instrument and the
LIS; when re-
activated, stored
records are sent to
the LIS
Sent records
Tagged records display in gray
highlight green text

SMS LIS SETUP
To setup a connection between the SMS and an LIS, follow the steps below

Use COM Port 10 on the back of the SMS
Select Configurations, Configure and then LIS.
SMS LIS Configuration Screen Selects the LIS Re-Query

communication mode Options
Auto Send
behavior is
defined in
the Terms
section
Analogous to the
LIS Parameters – LIS log on the
most come from 2000/2500;
the LIS provider should be left on
All changes must be

saved and take effect
after the next login

The table below relates LIS configurations on the SMS to the corresponding
configuration on the 2000/2500. In the case of the IMMULITE 2000/2500, the LIS
Configuration screen no longer defines communication between the 2000/2500 and the
LIS, but between the 2000/2500 and the SMS.
Mode of Communication
SMS IMMULITE 2000/2500
Select the appropriate LIS mode Select Bi-Directional LIS Host Query mode.
LIS Comm Configurations

SMS 2000/2500
Receiver ID Provided by LIS vendor
Sender ID Provided by LIS vendor
Password Provided by LIS vendor
Baud Rate Provided by LIS vendor 115200
COM Parameters N81 N81
Serial Port 10 for LIS 8 for SMS
Note: The settings for Ports 5 5 for IMMULITE A
and 7 are set on the IMMULITE 7 for IMMULITE B
Comm configuration screen.
Auto Send Patient Results Option selected to Recommended to be
automatically send patient selected
results
Auto Send Invalid Adjustment N/A – Option selected to
Implements option automatically send patient
selected on the IMMULITE results flagged ADJ
Auto-Send Invalid Control 2000/2500 Option selected to
automatically send patient
results if the controls for an
assay are configured as
single or multi-rule in the QC
Data Entry screen
Auto-Send Invalid Range Option selected to
automatically send patient
results that are < and > the
Review Range
Auto Send Control Results Option selected to Recommended to be
automatically send control selected
results
Hide Sent Select if desire records to
disappear from the LIS
screen when sent
Diagnostics Always selected Always set to 0

Re-Query LIS – Controls (Select Query Controls to use)
SMS 2000/2500
No Re-query Select if no re-query to the Anything other than No
LIS is desired when an Requery
accession number is found
in the Instrument database
(pending or completed
tests)
Re-query New Orders Accession numbers are
always re-queried and
duplicate test orders are
not run if tests un-resulted
Re-query All Accession numbers are
duplicate test orders are
run
Re-Query LIS – Patients

SMS 2000/2500
No Re-query Select if no requery to the Anything other than No
LIS is desired when an Requery
accession number is found
in the Instrument database
(pending or completed
tests)
Re-query New Orders Accession numbers are
duplicate test orders are not
run if tests un-resulted
Re-query All Accession numbers are
duplicate test orders are run
Report Qualitative Assay Results to the LIS as

SMS 2000/2500
Qualitative Only N/A – Non-React – sent to SMS as 0.0
Implements option Reactive – sent to SMS as 1.00
selected on the Indeterm – sent to SMS as 2.00
Ratio Only IMMULITE Results sent to SMS as a ratio
2000/2500 (Patient cps/cutoff cps)

Display Qualitative Assay Results on the LIS screen as
SMS 2000/2500
Qualitative Only N/A – Display on LIS screen as:
Implements option Reactive
selected on the Non-React
IMMULITE Indeterm
Qualitative and Ratio 2000/2500 Results display on LIS screen as
numerical ratio plus NR, R or I
Report aHB and BcM to the LIS as

SMS 2000/2500
Qualitative Only N/A – Non-React – sent to SMS as 0.0
Implements option Reactive – sent to SMS as 1.00
selected on the Indeterm – sent to SMS as 2.00
Concentration IMMULITE Sent to SMS as numerical
2000/2500 concentration (dose)
Display aHB and BcM on the LIS screen as

SMS 2000/2500
Qualitative Only N/A – Display on LIS screen as:
Implements option Reactive
selected on the Non-React
IMMULITE Indeterm
Qualitative and Ratio 2000/2500 Results display on LIS screen as
numerical concentration plus NR,
R or I
LIS Allergen Results and Scoring Type

SMS 2000/2500
LIS Concentration N/A – The actual concentration
Implements option measured by the Instrument is
selected on the reported as the result
LIS Standard Class IMMULITE The class of the allergen is
2000/2500 reported based on the
concentration

After configuring LIS, log off and back on to activate changes.
In the LIS Worklist screen, tag and send a result.
Results are successfully sent to the LIS if no errors appear and the “sending LIS”
message disappears.
Check the LIS for the result.

4) Test SMS Host Query (if applicable)
Place sample tube(s) with new accession number(s) into a Drawer and select RUN to
scan sample tubes.
Test orders are successfully downloaded from the LIS if no errors appear and the LIS
Worklist screen displays patient names and test orders.
If LIS errors occur or no test orders are downloaded, contact Technical Service for
assistance.
If no test orders are downloaded and there are no errors, verify the accession number
has not been used before.
5) Manage Results

less than 1.00 3 *TSH, RTH 0.025
1.00 – 9.99 2 1.23
10.0 - 99.9 1 10.2

or Indeterminate or as a semi-quantitative ratio (patient CPS/Cutoff CPS), and can be
sent to the LIS via the SMS 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

The SMS LIS Worklist screen is very similar to that on the IMMULITE 2000/2500. SMS
operators should use this screen to review patient information.
SMS LIS Worklist Screen
LIS Status
Indicator
(displays
green,
No Sample, In New Inst ID yellow or
Sort by Queue, In column red)
column title; Progress, indicates
asterisk Waiting, which
indicates Resulted or Sent Instrument
column is
sorted processing
a test order

PANELS ON SMS
If test orders are sent as a panel from the LIS, the same panel must be defined on the
SMS. The SMS cannot display the individual inventories for each Instrument. Therefore,
test codes must be manually typed in the Panel Definition screen before selecting the
TEST button. See the SMS Operator’s Manual for more instructions on how to enter
information in the Panel Definition screen.

SMS LIS FAQS
1. Are two LIS connections needed, one for each IMMULITE® 2000/2500
connected to the SMS?
No, only one LIS connection is needed through the SMS to operate an
Immunoassay (IA) WorkcellTM. However, there are various factors that must be
considered in order to meet the CAP standard, which requires that “When
multiple identical instruments are used that they are uniquely identified such that
a test result may be appropriately traced back to the instrument performing the
test”.
If the laboratory started with two IMMULITE 2000/2500s not connected to an

SMS, those Instruments may be identified to the LIS by the port through which
each was connected. In this case, the distribution of assays is not considered for
either the LIS connection or compliance with the CAP standard.
When these two IMMULITE 2000/2500s are then connected to the SMS,
Siemens Diagnostics recommends a workflow evaluation to maximize efficiency
and throughput. One of the recommended guidelines is the “80/20” distribution
of onboard reagents, which recommends that the laboratory load their highest
volume tests on both Instruments so that the SMS can send sample tubes to
each Instrument in the most efficient manner possible.
If the laboratory adopts this recommendation, their LIS must be able to recognize
the unique Instrument identifier currently transmitted with the test results. This
recognition is usually done through a “data stream” transmission and not through
port identification. In this case, either the laboratory LIS specialist or the vendor
must make a modification to the LIS code to recognize the unique Instrument
identifier attached to each test result. This code change may or may not incur an
additional cost to the customer depending on who makes the change and which
vendor the customer uses.
2. What should be done if the SMS computer is not functioning and unable to
communicate with the LIS?
Although highly unlikely, if the computer fails, contact Technical Service for
assistance. The LIS cable can be moved to each IMMULITE 2000/2500 to
enable direct transmission from the LIS to the individual Instruments. When the
LIS cable is moved, it is necessary to change the baud rate on the IMMULITE
2000/2500 LIS Configuration screen from 115,200 to the baud rate
recommended by the LIS and to return the IMMULITE 2000/2500s to Non-
Integrated Mode.

Consult the LIS specialist in the laboratory before moving the connection, to
determine if this change will affect how information related to the
”unique Instrument identifier” is sent to the LIS.
3. Should the LIS cable be moved to the Instruments if the SMS Robotic Arm
is not functioning?
No. Contact Technical Service for assistance. It is not necessary to move the
LIS cable in this situation because communication with the LIS continues through
the SMS computer. Sample tubes may be sorted by test order and placed on the
appropriate IMMULITE 2000/2500 to continue processing. The IMMULITE
2000/2500 can query the LIS through the SMS computer and automatically
process test orders. See Question #5 for when to use Bypass Mode.
4. What happens if the LIS is not functioning?

In this case, there is no communication between the LIS and the SMS. Follow
standard laboratory procedures in handling a non-functioning LIS connection.
Until the LIS connection is re-established, sample tubes can still be loaded and
tests can still be ordered manually on the IMMULITE 2000/2500s.
5. What is Bypass Mode and when should it be used?

Bypass Mode is a mode of operation on the SMS in which the SMS functions
solely as the computer (LIS) link between the LIS and the IMMULITE
2000/2500s. In this mode, sample tubes are NOT transferred between the SMS
and the IMMULITE 2000/2500s. However, the IMMULITE 2000/2500s can
process manually loaded sample tubes.
Bypass Mode may be used in the event of an SMS hardware issue (see question
#3) to maintain LIS communication while the SMS is serviced. It is selected as
an option from the SMS Startup screen.
SMS Condition LIS Resolution

LIS Connection – SMS LIS computer Down Move LIS Cable – use
is not communicating Instrument as Stand Alone
SMS Robotic Arm is not functioning OK Use ByPass Mode
Unable to load samples in Drawers OK Use ByPass Mode

SMS Startup Screen
6. What are the things I should consider for processing repeat tests
such as reflex tests, auto dilution tests, and add-on tests through
the LIS on the SMS Workcell?
Because the SMS is the connection to the LIS the following should be
considered when deciding how processing will be done for repeat tests:
• How the SMS is configured regarding it’s “Requery Options”
o Requery none
o Requery all
o Requery New Orders
• How the LIS is configured regarding how orders are “sent”
o Query
o Batch Download
• How the LIS is configured for “Resend Options”
o Always send
o Never resend
o Resend if no result received or verified
Note: See the Table of LIS and SMS Settings in the Appendix.

7. Can I perform maintenance on one Instrument while the other one is
processing sample tubes?
YES, the SMS posts one communication error for the Instrument that enters
diagnostics and sample tubes are processed on the other Instrument. For tests
that are only available on the Instrument in diagnostics mode, “No Inventory”
errors are generated. Once this Instrument is returned to Run mode, sample
tubes with “No Inventory” errors are automatically rescheduled.
8. How do I keep the SMS from transferring sample tubes to one IMMULITE
2000/2500 so that I can troubleshoot QC issues?
To take one Instrument in an Immunoassay Workcell “off-line”, place the
IMMULITE 2000/2500 in Stop mode. From the Configurations drop-down menu,
select Instrument Mode and type in the password “sms”. Change the
configuration to Non-Integrated mode and SAVE the change. Return the
IMMULITE 2000/2500 to Run mode to troubleshoot the problem. Once the issue
is resolved, the operator must return the Instrument to Stop mode and return the
Instrument Mode to Integrated.
SMS Configuration Screen

IMMULITE 2000/2500/SMS LIS TROUBLESHOOTING
This section begins with a brief review of Siemens Diagnostics’ IMMULITE/LIS Interface
Policy followed by some basic LIS troubleshooting steps that should be performed on
site in collaboration with the key operator of the Instrument.
Siemens Diagnostics IMMULITE/ LIS Interface Policy
Siemens Diagnostics Responsibilities
1. TSS Responsibilities are limited to:

a. Distribution of Required Documents/Software
b. Provides LIS communication within the IMMULITE software that performs
to standards specified in ASTM E1394 and ASTM E1381 and according to
Siemens Diagnostics LIS communications specifications.
2. LIS communication specifications are supplied to the MIS director and the LIS
developer; an additional copy may be supplied to the Laboratory Management if
requested . NOTE: Siemens Diagnostics is not responsible for cabling errors,
software or hardware errors on middleware systems or for software or hardware
errors on the LIS.
3. Siemens Diagnostics is also responsible for proper hardware functionality (serial

port functionality) of the PC supplied with the IMMULITE systems.
4. Siemens Diagnostics may provide a Field Service Engineer on the day the
Interface is launched at no charge to the customer. The MIS director and lab
director must also be available to facilitate the process.
Laboratory Responsibilities
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 about two weeks.
During the validation period, all results sent to the LIS must be verified on the LIS by
comparing results and patient information to the IMMULITE results printout. Any
problems must be reported to Siemens Diagnostics and all other affected parties.
Upon successful completion of the validation process, the system is upgraded to “on-
line” status.

LIS 15 Second Timeout
The LIS 15 second timeout error appears when the IMMULITE 2000/2500 or SMS 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.
What causes this error to occur?

• An incorrect or damaged cable
• Instrument serial port failure (although unlikely)
• Incorrect serial port configuration
• LIS is not on or needs to be restarted
What questions need to be asked to help SIEMENS DIAGNOSTICS Technical Services

troubleshoot the issue?
• 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?
What actions should be taken? Contact Technical Service after asking the above
questions.
LIS 30 Second Timeout
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.
A common cause of LIS 30 second timeout errors is incorrect data sent by the LIS.
Other possible causes include line noise, a malfunctioning rocket card or the LIS cable
length being greater than 50 feet.
Troubleshooting steps for LIS 30 Second Timeout errors:

• Turn on LIS log.
• Recreate issue that caused the 30 second timeout error.
• Contact Technical Service.

LIS <ENQ> Contention Messages
This message informs the operator that both the LIS and the Instrument are trying to
communicate at the same time. At this point, the Instrument will allow the LIS to
communicate, and then begin its communication once the LIS is complete. No issues
should arise from this error.
Invalid Password, Sender ID and/or Receiver ID
There are 3 separate IMMULITE 2000/2500 and SMS errors regarding the password,
sender and receiver ID’s:
• Error # 12304 LIS – Invalid Password in Header Message
• Error # 12305 LIS – Invalid Sender ID in Header Message
• Error # 12306 LIS – Invalid Receiver ID in Header Message
Action Steps:
• Turn on the LIS log.
• Have LIS send down test orders for any patient sample.
• Contact Technical Service to inform account of expected header message
information.
Note: When the LIS log is activated on the IMMULITE 2000/2500, the error messages
disappear; however, it is still important to contact Technical Services to resolve this
issue.
• For IMMULITE Invalid Password and Invalid ID errors, the LIS vendor must help.
Error 12327
“LIS: Data is being received from the LIS or IMMULITE is already sending to the LIS”.
Usually occurs when test orders are being received and a result is ready to auto-send.
• Not a communication problem. The result will be automatically sent with the next
test result.
• May also occur if LIS timeout errors are occurring or the Instrument and LIS are
in a communication loop.
LIS Screen – 10,000 Records
• Error 12325 – “You can only display 10,000 records at a time” is displayed.
• Simply resort the LIS screen – it cannot display more than 10,000 records.

There are no “Tagged” Records
• Error 12324 – “There are no TAGGED records to send to the LIS” is displayed.
• This occurs if you try to “resend” a resulted record. You can only send (auto-
send) resulted records.
• Also occurs if you try to send (auto-send) a record that was previously sent.
Must select “resend” for records with a status of “sent”.
Miscellaneous Errors
The following require review of the LIS log. Notify Technical Service.
12300 – Carriage return or Line Feed missing

12301 – Incorrect or missing frame number
12307 – No Header message received
12309 – Null or missing patient ID in patient record
12310 – Invalid test code or format in order record
12317 – No accession number in order record.
12320 – An invalid terminator code was received

APPENDIX
IMMULITE LIS ERROR MESSAGE DEFINITIONS
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 Diagnostics
Receiver ID is set to HOSPITAL on IMMULITE
IMMULITE Sending
Sender ID field = Siemens Diagnostics, Receiver ID Field = HOSPITAL
LIS Sending
Sender ID Field = HOSPITAL, Receiver ID field = Siemens Diagnostics
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 Diagnostics
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 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).
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).
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 LIS Transmission

Usually indicates a programming bug in the LIS software, 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
patient sample (accession#).

IMMULITE 1000 LIS ERROR MESSAGE DEFINITIONS
Error Number Problem Cause Solution
300 LIS Error: Timeout The LIS is not Check the cable
During Receive responding to the connection.
IMMULITE 1000.
Re-download the
This can be caused by:
orders to the
A cable problem IMMULITE 1000.
A hardware If the error
problem continues to occur,
contact your LIS
An issue with the
provider.
LIS software
301 LIS Error: Invalid The frame number in Re-download the
Frame Number the message is not orders to the
proper. IMMULITE 1000.
Usually indicates an If the error
issue with the LIS continues to occur,
software; however, it contact your LIS
could be caused by a provider.
bad message (e.g. due
to line noise, etc.).
302 LIS Error: Invalid Checksum did not Re-download the orders
Checksum match (transmission to the IMMULITE 1000.
error).
303 LIS Error: Missing Usually indicates an Contact your LIS
Control Character. issue with the LIS provider.
software, but may be a
bad message (e.g., line
noise).
304 LIS Error: Invalid There are fewer than Contact your LIS
Message Length five characters in an provider.
incoming ASTM
formatted data message.
305 LIS Error: Invalid The frame number is Contact your LIS
Frame Sequence not sequential for an provider.
incoming ASTM
formatted data message.
306 LIS Error: No No communication Check LIS cable for
Acknowledgement from between the secure connection.
LIS IMMULITE 1000 and
If problem persists,
the LIS.
contact your LIS
provider.

307 LIS Error: Timeout The LIS is not Re-send the results
During Send responding to the to the LIS.
IMMULITE 1000.
If the error
continues to occur,
A cable problem contact your LIS
provider.
A hardware
problem
An issue with the
LIS software
308 LIS Error: Excessive There are numerous LIS Contact your LIS
LIS errors are errors during a session. provider.
occurring
309 LIS Error: Log File There was an error Check the LIS
Error while writing to the Log settings.
File.
Test the serial port
by trying a different
cable.
If the error
continues to occur,
contact your LIS
provider.
314 LIS Error: Header Either: Check the LIS
Message Not Received settings.
The Header
Message Password Test the serial port
is incorrect. by trying a different
cable.
OR
If the error
There is no header
continues to occur,
message.
contact your LIS
provider.
315 LIS Error: Patient A record required for Re-send the test
Message Not Received LIS communications is order to the
not found. IMMULITE 1000.
If the problem
persists, contact
your LIS provider.

316 LIS Error: EOT An LIS message was Contact your LIS
received prior to ENQ received out of provider.
sequence when
establishing a
317 LIS Error: Invalid An invalid message Contact your LIS
LIS Message type code was provider.
transmitted.
318 LIS Error: Unexpected Communication Error Call Technical Service.
Communication from
LIS
319 LIS Error: Cannot Serial port is not Check the LIS
open communication configured properly or settings.
port not at all.
Test the serial port
by trying a different
cable.
If the error
continues to occur,
contact your LIS
provider.
31421 LIS Error: No Results Tagged records are not Re-send the results
Selected found in the database. to the LIS.
If the problem
persists, call
Technical Service.
31422 LIS Error: LIS The LIS is not Re-download the
Unavailable responding to the orders from the LIS.
IMMULITE 1000.
Check the cable
connection.
A cable problem
If the problem
A hardware persists, contact
problem your LIS provider.
An issue with the
LIS software
31423 LIS Error: Terminator There is a terminator Contact your LIS
Code Error code error. provider.
31424 LIS Error: LIS The terminator code is Contact your LIS
Terminator Code invalid. provider.
Invalid

31425 LIS Error: Password Occurs when the Review password with
Error Header Message LIS provider and verify
Password is incorrect. that password in LIS
configurations matches
that of the LIS provider.
31427 LIS Error: Receiver The Receiver ID sent Call Technical Service
ID Error from the LIS does not to verify the Receiver ID
match the Sender ID and update your LIS
specified in the configuration
IMMULITE LIS accordingly.
configuration.
31428 LIS Error: Patient ID The LIS is missing a When the LIS is queried,
Missing patient ID. the Patient ID is not
sent. Contact your LIS
provider.
31429 LIS Error: Patient ID The Patient ID has Verify that the Patient
exceeded 20 exceeded the allowable ID is less than 20
characters. number of characters. characters.
31430 LIS Error: Accession The accession number When the LIS is queried,
Number Missing. is missing. the accession number is
not sent. Contact your
LIS provider.
31431 LIS Error: Accession The accession number Verify that the accession
Number exceeded 20 has exceeded the nmber is less than 20
characters. allowable number of characters.
characters.
31433 LIS Error: No Control Control information is Enter control
Record Found not in the database. information on the
Control Entry tab on
the Worklist screen.
Re-download the
control sample from
the LIS.
31435 LIS Error: Invalid Control data is in an Check format for control
Control Data invalid format. data and re-download
from the LIS.
31437 LIS Error: LIS Occurs when an Call Technical Service.
Unavailable in Test underlying hardware or
Mode. configuration error
causes a software
communication issue.

31439 Unexpected error Occurs when an Call Technical Service.
31439. Call underlying hardware or
Technical Service. configuration error
causes a software
communication issue.
31440 LIS Error: Query The LIS encountered an Initiate another
Failure error when processing query to the LIS.
the IMMULITE 1000’s
If the problem
request for information.
persists, contact
your LIS provider.
31520 LIS Error: Query IMMULITE 1000 LIS If LIS parameters have
Communication Error software is not changed, re-boot
responding. LIS software. If problem
Configuration persists, call Technical
parameters may have Service.
changed.

IMMULITE 2000/2500/SMS LIS ERROR MESSAGE DEFINITIONS
2550 LIS – Parse error due An invalid sample type Contact your laboratory
to unexpected sample (e.g., ~D) was received LIS provider.
type received from from the LIS.
LIS. If the message persists,
call Technical Service.
2551 LIS – An unexpected Unable to query the LIS Contact your laboratory
error was encountered and receive a response. LIS provider.
during query of the The SMS will continue
LIS. If the message persists,
to re-query while there
are still barcodes
requiring a query.
2567 LIS – The LIS is not This message appears To resolve this issue
enabled. Enable the when trying to pause or from the SMS:
LIS to perform this activate the LIS or
action. Set the LIS to
trying to manually send
bi-directional or
or resend results from
bi-directional host
the LIS screen when the
query from the LIS
LIS is configured to
screen
“off”.
Log off and then
back on the SMS
Select the RUN
button.
2571 LIS Error: Patient ID An order downloaded Contact your laboratory
exceeded 20 from the LIS contains LIS provider.
characters.
2572 LIS Error: Accession An order downloaded Contact your laboratory

Number exceeded 20 from the LIS contains a LIS provider.
characters. patient ID exceeding 20
characters. The order is
not accepted because
Patient IDs cannot
exceed 20 characters.
12300 LIS – Carriage return The message is missing Contact your laboratory
or Line Feed missing a required carriage LIS provider.
from message. return, line feed or both.
If the message persists,
12301 LIS – Incorrect or The frame number for a Contact your laboratory
Missing Frame Number. message is an incorrect LIS provider.
value or is not present.

12302 LIS – Incorrect The checksum, a Contact your laboratory
Checksum. scheme to indicate LIS provider.
whether a message was
received properly is
incorrect.
12303 LIS – Message is too LIS message received is Contact your laboratory
short less than the requisite LIS provider.
<5 characters). five characters.
12304 LIS – Invalid The Password received Contact your laboratory
Password in Header does not match the LIS provider to
Message. password entered in the determine the proper
LIS configuration on password. The LIS
IMMULITE vendor may change the
2000/2500. password parameter on
the LIS or request the
password on
IMMULITE is modified
to the value that the LIS
vendor indicates.

12305 LIS – Invalid Sender The Sender ID received Contact the LIS provider
ID in Header Message. does not match the to determine the proper
Sender ID entered in the Sender ID.
LIS configuration on
If the Sender ID is
IMMULITE
incorrect in the
2000/2500.
IMMULITE
2000/2500 software,
the LIS vendor may
change the Sender
ID parameter on the
LIS or request the
Sender ID on
IMMULITE
2000/2500 is
modified to the
value that the LIS
vendor indicates.
If the Sender ID is
correct on the
IMMULITE
2000/2500, the LIS
vendor most likely
has an error in their
code. When sending
FROM the LIS to
IMMULITE
2000/2500, the LIS
vendor needs to
place their ID
(Designated on
IMMULITE
2000/2500 as
receiver ID) in the
Sender ID field of
the header message.

12306 LIS – Invalid The Receiver ID Contact the LIS provider
Receiver ID in Header received does not match to determine the proper
Message. the Receiver ID entered Receiver ID.
in the LIS configuration
on IMMULITE If the Receiver ID is
2000/2500. incorrect in the
IMMULITE
2000/2500 software,
the LIS vendor may
change the Receiver
ID parameter on the
LIS or request the
Receiver ID on
IMMULITE
2000/2500 is
modified to the
value that the LIS
vendor indicates.
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 the LIS
vendor needs to
place the Instrument
ID (Designated on
IMMULITE
2000/2500 as sender
ID) in the Receiver
ID field of the
header message.
12307 LIS – No Header Records are being Contact your laboratory
Message Received. received from the LIS LIS provider.
without sending an
initial header message. If the message persists,

12308 LIS – Several LIS More than 20 Contact your laboratory
errors have occurred communication errors LIS provider.
the past hour. There have occurred within a
may be a one-hour time frame. If the message persists,
communication This is an IMMULITE call Technical Service.
problem. 2000/2500 message
only, and is not part of
the ASTM
specification.
12309 LIS – LIS Null or The Patient ID field in Contact your laboratory
Missing Patient ID in the patient message is LIS provider.
Patient Record. not present. This is a
required field for If the message persists,
IMMULITE call Technical Service.
2000/2500.
12310 LIS – Invalid Test The test code received Call Technical Service.
Code or Format in in an order message
Order record. 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 record
may have been violated.
12311 LIS – LIS cannot A message was sent to Contact your laboratory
accept message after the LIS seven times and LIS provider.
sending message 7 was not accepted. The
times. current communication If the message persists,
session is aborted. call Technical Service.
12312 LIS – Time out, 30 Information was Contact your laboratory
seconds expired and received from the LIS LIS provider.
no data was received and a response to the
from LIS. message was returned If the message persists,
to the LIS. No call Technical Service.
additional data was
received from the LIS
in 30 seconds. The
current communication
session is aborted.

12313 LIS – EOT prematurely An EOT was sent Contact your laboratory
while receiving data. before the transmission LIS provider.
was completed.
12314 LIS – An error An unrecognized error Contact your laboratory
occurred sending LIS occurred when sending LIS provider.
query request. Host a query to the LIS.
query aborted. If the message persists,
12315 LIS – Time out, No Information was sent to Contact your laboratory
response from the LIS the LIS and there was LIS provider.
after waiting 15 no response after a 15
seconds. second time period. The If the message persists,
current communication call Technical Service.
session is aborted.
12316 LIS - <ENQ> The LIS was attempting Contact your laboratory
Contention. to initiate a LIS provider.
communication session
at the same moment the If the message persists,
IMMULITE 2000/2500 call Technical Service.
was performing the
same.
12317 LIS – No accession No accession number Contact your laboratory
number in order was received in an order LIS provider.
record. record. This is a
required field for If the message persists,
IMMULITE. call Technical Service.
12318 LIS – The LIS The LIS informed Contact your laboratory
encountered an error IMMULITE 2000/2500 LIS provider.
for a query. that the LIS
encountered an error in If the message persists,
a request for a patient call Technical Service.
record from a query
message as defined in
ASTM E1394, Section
13.1.3.
12319 LIS – The LIS has no The LIS did not have Contact your laboratory
information for information on a LIS provider.
query. requested sample
(accession number) as If the message persists,
defined in ASTM call Technical Service.
E1394, Section 13.1.3.
12320 LIS – An invalid An invalid or Contact your laboratory
terminator code was unsupported terminator LIS provider.
received from the code was received from
LIS. the LIS. If the message persists,

12321 LIS - Unique ID does All records are stored Call Technical Service.
not match retrieved on the IMMULITE
file. Please call 2000/2500 with a
Technical Services. unique number. A
retrieved file was
expected to have a
particular number and
was incorrect. This
error should not be
encountered, and if so,
it indicates a
programming logic
error.
12322 LIS – Record could A sent record could not Call Technical Service.
not be marked sent, be found in the database
record not found. to be sent to the LIS.
This error should not be
encountered and
indicates a
programming logic
error.
12323 Record could not be A tagged record could Call Technical Service.
sent to the LIS, not be found in the
record not found. database to be sent to
the LIS. This error may
indicate a programming
logic error.
12324 LIS – There are no The operator pressed Verify records are
“TAGGED” records to the Send or Re-Send tagged for sending.
send to the LIS. buttons on the LIS
screen, and no records
are tagged.
12325 LIS – You can only The LIS Screen has a To view remaining
display 10,000 limit of displaying records, the operator is
records at one time. 10,000 records at one required to refine the
time. The first 10,000 date and time sorting
records meeting the criteria.
sorting criteria are used.

12326 LIS – Received Order The patient message Contact your laboratory
Record before Patient must precede the order LIS provider.
Record. message in the LIS
message. The LIS has
received the order
message before
receiving the patient
message.
12327 LIS – Data is being The LIS is currently If the message persists,
received from the LIS receiving data or the call Technical Service.
or IMMULITE is IMMULITE is actively
already sending data sending data to the LIS.
to the LIS.
12328 LIS – LIS reports an There was an error in Contact your laboratory
error in query the query request as it LIS provider.
request. was sent from the
IMMULITE to the LIS. If the message persists,
12329 LIS – LIS reports no There was no Contact your laboratory
information for information for an LIS provider.
Accession Number in Accession number in a
query request query. If the message persists,
12330 LIS – An error An unrecognized error Contact your laboratory
occurred sending LIS occurred when sending LIS provider.
query request. Host a query to the LIS.
query request. If the message persists,
12333 LIS – Control The control requested in Define the control
downloaded from LIS the download from LIS before querying or
is new to the system. is new to the system. downloading orders for
The control order was this sample.
not saved because the
control has not yet been
defined on the
Instrument.
12334 LIS – Parse error The calibration verifier Contact your laboratory
occurred when information was sent LIS provider.
downloading in from the LIS in the
Verifier format. wrong format. If the message persists,
12335 LIS – Sort Error An error was exhibited Contact your laboratory
when trying to sort in LIS provider.
the LIS.

12339 LIS – Send LIS Error An application error Contact your laboratory
generated when the LIS provider.
mail procedure was
running. If the message persists,
12341 LIS – Check Message An error occurred in the Contact your laboratory
Error Check Sum Message LIS provider.
routine when building
the message. If the message persists,
12342 LIS – Parse Error A programmer error Contact your laboratory
was generated during LIS provider.
the parsing routine.
12343 LIS – Listen Error A programmer error Contact your laboratory
occurred when LIS provider.
receiving information
from the LIS. If the message persists,
12344 LIS – Check Error A check sum error Contact your laboratory
occurred within the LIS LIS provider.
program.

IMPACT OF LIS AND SMS SETTINGS ON SMS AUTO-RETRIEVAL BEHAVIOR
***LIS is set to Host Query and SMS to Bidirectional Query***
LIS Query Recommended SMS Reason for Re-Query Limitations on SMS Operator Behavior
Configurations Re-query Setting Recommendation Required for LIS- Auto-Retrieval
generated repeats Behavior
Send/Resend All Requery None Recommended to Yes3 SMS cannot auto- Must manually order
(when LIS re-queried, (SMS will not re-query avoid resulted test retrieve sample tube repeat1 tests on
all test orders – LIS if the accession orders being resent for repeat1 testing IMMULITE 2000/2500
whether previously number is in its and rerun No4 SMS can auto-retrieve Can either leave sample
sent or not – are database) sample tube for repeat1 tube onboard SMS or
sent/resent to the testing remove it and return it
SMS) later
Send New Only Requery All Recommended to Yes3 SMS must rescan2 Must move sample tube
(when LIS re-queried, (SMS re-queries LIS for ensure all new test sample tube for repeat1 to force SMS to rescan2
only new test orders all test orders, regardless orders are sent to testing barcode
are sent to the SMS – of result status) the SMS for No4 SMS can auto-retrieve Can either leave sample
previously sent test processing sample tube for repeat1 tube onboard SMS or
orders are never testing remove it and return it
resent) later
Send/Resend Open Requery New Orders Recommended to Yes3 SMS can auto-retrieve Can either leave sample
Test Records (SMS re-queries LIS for ensure unresulted5 sample tube for repeat tube onboard SMS or
(when LIS re-queried, all test orders, but does records are never testing; remove it and return it
all open test orders – not rerun tests on rerun by the SMS later
whether previously unresulted5 records) No4 CAUTION: Ensure all
sent or not – are test results are verified
sent/resent to the before returning sample
SMS) tube to SMS or tests
may be rerun

***LIS is set to Host Query and SMS to Bidirectional Query***
LIS Query Recommended SMS Reason for Re-Query Limitations on SMS Operator Behavior
Configurations Re-query Setting Recommendation Required for LIS- Auto-Retrieval
Send/Resend All or Never Rerun Coming Soon! Recommended to Yes3 Cannot repeat the Can either leave sample
Send/Resend Open (Software revision in ensure resulted test same test order on an tube onboard SMS or
Test Records development that will orders (whether accession number3 remove it and return it
never rerun the same open or closed) are No4 later
test order on an never rerun by the
accession number) SMS
***LIS is set to Batch Download and SMS to Bidirectional***

LIS Re-Query Options Recommended SMS Reason for Re-Query Limitations on SMS Operator Behavior
Re-query Setting Recommendation Required for LIS- Auto-Retrieval
All No Re-Query Options Not necessary N/A SMS can auto- Can either leave sample
are Selected retrieve sample tube tube onboard SMS or
for repeat1 testing remove it and return it
1
Repeat testing refers to any add-on, reflex or auto dilution test orders generated by the LIS and not the Instruments.
2
Sample tubes are rescanned when placed in an SMS Drawer and the Drawer is reset; alternately, the sample tube can be placed in an unscanned
position of a Drawer and the Drawer continued.
3
LIS-generated repeat tests must receive a query to be transmitted
4
LIS-generated repeat tests are automatically downloaded without query
5
Unresulted records are either waiting to be processed, cannot process because of an error condition or are currently in progress
Siemens Medical Solutions Diagnostics 600890-0001-A Revised 030306 63

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LIS

Siemens Medical Solutions Diagnostics 600890-0001-A 1

2 600890-0001-A Siemens Medical Solutions Diagnostics

Siemens Medical Solutions Diagnostics 600890-0001-A 3

A Laboratory Information System (LIS) is software which handles receiving,

Sometimes you may see an LIS listed as an LIMS, “Laboratory Information

How does an LIS work?

Siemens Medical Solutions Diagnostics 600890-0001-A 5

General Schematic of an LIS

6 600890-0001-A Siemens Medical Solutions Diagnostics

3. Work orders are downloaded to instruments.

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

Siemens Medical Solutions Diagnostics 600890-0001-A 7

8 600890-0001-A Siemens Medical Solutions Diagnostics

Example Patient Report:

St. CEC Hospital Laboratory Medical Dir: Dr. F. Eel Good

Patient Name: Kidman, Nicole Medical Record Number: 2564786

Date: Time: Accession No: Tests Ordered:

Report Printed: Feb. 3, 2006 @23

Siemens Medical Solutions Diagnostics 600890-0001-A 9

The interface can have several components:

10 600890-0001-A Siemens Medical Solutions Diagnostics

Siemens Medical Solutions Diagnostics 600890-0001-A 11

12 600890-0001-A Siemens Medical Solutions Diagnostics

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

Siemens Medical Solutions Diagnostics 600890-0001-A 13

ACK (Acknowledge) – Response to sender message was properly

ASTM – American Society for Testing and Materials,

Channel codes – An interchangeable term with test code

Checksum – Error checking calculation performed on each

Data Stream – The data stream is the coded message that is

ENQ (Enquiry) – First character sent in a transaction, initiates

EOT (End Transmit) – Indicates the sender is done sending and is

ETX (End of Text) – Indicates end of text for a specific message.

HL7 – A communication protocol designed to

14 600890-0001-A Siemens Medical Solutions Diagnostics

Interface – A small program that translates what the

Line Noise – Unintended voltage; it may cause LIS 30

Middleware – An intermediate device used between

NAK (Negative Acknowledge) – Response to sender message was NOT

Panel – Panel names may be sent to the Instrument.

Port – A port is an access point allowing connection

Siemens Medical Solutions Diagnostics 600890-0001-A 15

Result Message ("R" message) – Contains test results and additional

Rocket Card – A computer board used on IMMULITE 2000,

STX (Start of Text) – Indicates start of text for a specific message.

Terminator Message ("L" mesg.) – Last message sent in a transaction, contains

Test Codes – Test Codes are upload and download codes

Workstation – An LIS terminal or PC that allows the operator

16 600890-0001-A Siemens Medical Solutions Diagnostics

Auto-Send Invalid Adjustment – If checked, will auto send patient results

Baud Rate – A field in the LIS Parameters screen that

Bi-Directional – Orders are manually transmitted from the LIS

Bi-Directional Query – Same as Bi-Directional but orders from the LIS

COM Parameters – A field in the LIS Parameters screen; the

COM Port – Another term commonly used to identify a

Diagnostics – A field in the LIS Parameters screen that

Siemens Medical Solutions Diagnostics 600890-0001-A 17

Hide Sent – Defaults the Hide Sent/Show Sent button on

Network Connection – A port designed to use the RJ45 standard

No Re-query – If an accession number is found in the

Password – A password defined by the LIS software

Query Controls – The Instrument will request QC orders from the

Receiver ID – The identity of the system receiving a