Lis 2 A Host protocol

This document describes the interface between a Laboratory Information System (LIS) and
an analyser.

This document is based on software version 4.0.0

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TABLE OF CONTENTS

Introduction 2
Purpose 2
Scope 2
Definitions, acronyms and abbreviations 2
References 2
Hardware interfaces 3
Serial port interface 3
Network interface 3
Data handling 4
General 4
Frame format 4
Messages 5
General 5
Record format 5
Messages to host 7
Header (H) 7
Patient information record (P) 9
Test order record (O) 10
Result record (R) 13
Comment record (C) 16
Message Terminator Record (L) 18
Request information record (Q) 19
Manufacturer Information Record (M) 20
Cuvette Blank information (B) 20
Error History 21
Reagent installation (I) 22
Extended version information 23
Appendix A Flags 24
Appendix B Units 25
Appendix C ASCII CODE Chart 26
Appendix D Examples 27
D.1 Analyser messages 27
D.2 Host messages 29

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Introduction

Purpose

This document defines the interface between a Laboratory Information System (LIS) and the
analyser. The LIS is in this document referred to as ‘Host’.
Scope

The scope of this document is limited to defining the external interface of the PC at the
analyser side.
Definitions, acronyms and abbreviations

Abbreviation Description
Host Computer that is part of the LIS and communicates with the analyser PC.
LIS Laboratory Information System

Definition Description
Request buffer The list of samples and tests that have been ordered at the analyser. The
samples are not yet loaded onto the analyser. A request can be modified.
Result buffer The list of samples and tests that are measured or currently being
measured.
References

[1] CLSI. Standard Specification for Low-Level Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer Systems. CLSI document LIS1-A [ISBN
1-56238-489-9].
CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA,
2003.
[2] CLSI. Standard Specification for Transferring Information Between Clinical Instruments
and Computer Systems. CLSI document LIS2-A [ISBN 1-56238-490-2]. CLSI, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.)

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Hardware interfaces

Serial port interface

The characteristics for the physical layer of the communication are defined in CLSI standard
LIS1-A (See [1]), Section 5 Physical Layer for Serial Binary Data Exchange.

The line signal definition is shown in the following table:

DB-25 DB-9 Signal name Direction Remarks

pin # pin #
7 5 SG Signal Ground
2 3 TD Transmit data output data from analyser-PC to host
3 2 RD Receive data input data from host to analyser-PC
4 7 RTS Request To Send output *
5 8 CTS Clear To Send input *
20 4 DTR Data Terminal Ready output *
6 6 DSR Data Set Ready input *
8 1 CD Carrier Detect input not used
22 9 RI Ring Indicator input not used

• The only pins really used are TX and RX, the usage of the rest (marked *) depends on
the settings of the COM-port of the analyser-PC.
• The default setting for communication will be 9600 baud, 8 data bits, no parity, 1 stop bit
(8-N-1).

Warning:
The XON-XOFF protocol (which can be set by Windows) must NOT be used, because this
can interfere with the protocol.
Network interface

The characteristics for the physical layer of the communication are defined in CLSI standard
LIS1-A (See [1]), Section 7 Physical Layer for TCP/IP Data Interchange

Configuration of TCP/IP network adapter on the analyser is outside the scope of this
document, refer to the analyser manual.

For host communication the analyser allows setting host IP address and port number to
define the host socket. The analyser will connect to host socket after reset or as soon as
communication is enabled in system settings.

The connection will remain active as long as the PC application is running on the analyser. If
for some reason the TCP/IP connection is lost (e.g., because host system was restarted),
then the analyser will continuously try to reconnect.

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Data handling

General

The properties for the message sending and receiving are defined in CLSI standard LIS1-A
(See [1]), Section 6 Data Link Layer. The analyser software implements the standard and
this section is only intended to provide a short summary. For detailed information on error
handling, time-out behaviour and contention, please refer to the standard.

The LIS1-A standard defines a line-bidding protocol that will define the receiver and sender
for communication. A system ready to send information will transmit an <ENQ> character.
The receiver will reply with <ACK> if it is ready to receive or <NAK> when it is busy. Refer to
the state diagram in Annex A1 of the standard [1].

After sender and receiver have been determined, the sender will transmit frames. Each
frame starts with an <STX> character and ends with <ETB> or <ETX> character, a
checksum and <CR> <LF>. The content of a frame is the message that is to be sent (see
chapter “Messages” page 5).

The receiver will acknowledge the frame with <ACK> or <EOT>, or it may indicate an error
by responding with <NAK>. The <EOT> character indicates that the receiver has information
to send and requests that the line is returned to idle state. The sender may honour the
<EOT> by responding with <EOT> or it may ignore the <EOT> and send the next frame.

After the sender has transmitted an <EOT> character, the line is returned into idle state.
Frame format

The format of frames is:

For intermediate frames:

<STX FN text <ETB> C1 C2 <CR> <LF>
>
For end frame:
<STX FN text <ETX> C1 C2 <CR> <LF>
>

<STX> = Start of Text transmission control character (ASCII 2)

FN = Single Digit Frame number ASCII ‘0’ to ‘7’, starting with ‘1’
text = Body of message, refer to following chapters
<ETB> = End of Transmission Block transmission control character (ASCII 23)
<ETX> = End of Text transmission control character (ASCII 3)
C1 = Most significant character of checksum 0 to 9 and A to F
C2 = Least significant character of checksum 0 to 9 and A to F
<CR> = Carriage Return ASCII character (ASCII 13)
<LF> = Line Feed ASCII character (ASCII 10)

The total size of a frame shall not exceed 64,000 bytes. Messages longer than 64,000 bytes
are split into multiple frames. A frame can contain only a single message.
The Frame number must start with the ASCII character ‘1’ for the first frame that is
transmitted after the <ENQ> character.

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Messages

General

This section describes the format of messages between the analyser and the host. These
messages are formatted according to the LIS2-A standard (See[1]).

Messages are can be sent spontaneously or as a response to a query for information.

Each message consists of one or more records, each record is terminated with a carriage
return character (ASCII 13). The following example shows the flow of control of a message
from a sender to a receiver. The characters below ASCII 32 are written in the notation: STX
(ASCII 2). The complete ASCII code chart is provided in Appendix C, for more examples,
refer to Appendix D.
E
Sender: NQ
A
Receiver: CK
S
Sender: TX1H|\^&|||SELE||||1.0|||P|LIS2-
A|20060126163201CRQ|1|^12936-A||ALL||||||||OCRL|1|FCRETX23CRLF
A
Receiver: CK
E
Sender: OT

A host may transmit more fields and records than are specified in this document. The
analyser shall ignore those fields and records.

If the analyser receives a message that does not contain the required fields, it will ignore the
message.

The analyser does not verify the correct sequential numbering of records from the host.
However, the record sequence number and record type fields are required fields by standard
LIS2-A and are included in the message. (In contrast, the frame number as defined in
Chapter 3 (LIS1-A) must be sequentially numbered and is checked by the analyser. Incorrect
frame numbering will lead to rejection of the frame.)
Record format

The message format texts follow standard LIS2-A (see [2]).

All records are formatted with delimiters. For the host protocol, the following delimiters are
used:

Field delimiter: Vertical bar (|) Latin-1 (124)

Repeat delimiter: Backslash (\) Latin-1 (96)
Component delimiter: Caret (^) Latin-1 (94)
Escape delimiter: ampersand (&) Latin-1 (38)

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The following escape sequences are recognized and transmitted by the analyser:

&F& imbedded Field delimiter character

&S& imbedded Component delimiter character
&R& imbedded repeat field delimiter character
&E& imbedded escape delimiter character

In cases where fields are limited to a maximum (e.g., sample_ID, patient name), this
maximum applies to the number of characters without replacing imbedded field delimiters by
their escape sequence. Example: Sample ID “15\a” is transmitted as “15&R&a”; but the
number of characters for maximum limit is 4.

Except for the record-ID, the text fields are case-sensitive. This means that the analyser
performs all text comparisons sensitive the case of the text field. For instance a request
containing a character ‘s’ in the priority field, will not be interpreted as ‘S’ (STAT) and a test
request ‘Asat’ will not match with a test called ‘ASAT’ on the analyser.

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Messages to host

This section describes the messages that are sent from the analyser to the host. For host
implementation, the minimally required fields are marked ‘yes’, unmarked fields are optional.
The numbering of the fields is identical to the numbering used in the CLSI LIS2A standard
[2].
Header (H)

Every message contains a header record. The header record contains the following fields:

Field Analyser Host Comment

(Transmitted to Received Required
host) from host
7.1.1 Record Type ID H H yes
7.1.2 Delimiter Definition |\^& |\^& yes Other field delimiters are not
supported.
7.1.3 Message Control ID <empty> <ignored>
7.1.4 Access Password <empty> <ignored>
7.1.5 Sender Name or ID device_id^ <ignored> device_id: text defined in
software_version or communication parameters of
host_id analyser application.
software_version: text containing
current software version of
sending application.
host_id: text identifying the host
(see note below)
7.1.6 Sender Street Address <empty> <ignored>
7.1.7 Reserved Field <empty> <ignored>
7.1.8 Sender Telephone <empty> <ignored>
Number
7.1.9 Characteristics of 1.7 <ignored> Version number of host protocol.
Sender
7.1.10 Receiver ID host_id <ignored> host_id: text identifying the host
or (see note below)
device_id
7.1.11 Comment or Special <empty> <ignored>
Instructions
7.1.12 Processing ID P <ignored>
7.1.13 Version No. LIS2-A <ignored>
7.1.14 Date and Time of current date/time <ignored> YYYYMMDDHHMMSS
Message

Device ID
The field device_id is used to identify the analyser and can be used as extra security that the
tests are performed on the correct analyser. It can be up to 20 characters long.

7.1.5 Sender Name or ID

If a host_id is defined in the analyser application, and a host_id is present in the received
message, then the message will be ignored if the host_id in the received message is not
equal to the host_id in the analyser application. A field may contain more components, these
will be ignored. Note that if the host_id in the message or the host_id in the analyser
application is empty, this rule does not apply.

7.1.10 Received ID
if a device_id is defined in the analyser application, and a device_id is present in the received
message, then the message will be ignored if the device_id in the received message is not
equal to the device_id in the analyser application. A field may contain more components,

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these will be ignored. Note that if the device_id in the message or the device_id in the
analyser application is empty, this rule does not apply.

Example header from analyser:

H|\^&|||SELXL^2.1.0||||1.0|HOST||P|LIS2-A|20060120153902

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Patient information record (P)

The patient record contains the patient information. Every request from the host starts with a
patient record, followed by one or more order records (see chapter “Test order record (O)”
page 10). Results from the analyser start with a patient record, followed by one or more other
records, where each order record is followed by one or more result records (see chapter
“Result record (R)” page13). Full examples are provided in Appendix D Examples.

Field Analyser Host Comment

(Transmitted Received Required
to host) from host
8.1.1 Record Type ID P P yes
8.1.2 Sequence Number number <ignored> yes Sequential number starting with
1 and continuing until the last
patient in the message
8.1.3 Practice Assigned <empty> <ignored>
Patient ID
8.1.4 Laboratory Assigned <empty> <ignored>
Patient ID
8.1.5 Patient ID No. 3 <empty> <ignored>
8.1.6 Patient Name sample_name sample_name maximum 20 characters
8.1.7 Mother’s Maiden Name <empty> <ignored>
8.1.8 Birthdate date_of_birth date_of_birth YYYYMMDD
8.1.9 Patient Sex M <empty> The contents of this field define
F M the applicable reference limits:
U F M: male
U F: female
U: pediatric
Default: M

8.1.9 Patient Sex

On the instrument, the operator may rename ‘male’, ‘female’ and ‘pediatric’, this does not
have an effect on the characters used in the host protocol. These are fixed to M, F and U
respectively.

Example patient information record from analyser:

P|1||||Henry Johnson||19650714|M

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Test order record (O)

The order record contains information on the test to be performed for the preceding patient
record (see chapter Patient information record (P), page9).

Field Analyser Host Comment

(Transmitted Received Required
to host) from host
9.4.1 Record Type ID O O yes
9.4.2 Sequence Number number <ignored> yes Sequential number starting with
1 and continuing until the last
order for the patient
9.4.3 Specimen ID <empty> <empty> yes Maximum 12 characters
sample ID sample ID Empty for calibrator, control and
blanks.
9.4.4 Instrument Specimen ID <empty> <empty> For analyser ‘samples’ like
Calibr. name Calibr. name calibrators, controls, and blank
Control name Control name measurements, the specimen ID
BLANK BLANK field (9.4.3) will be empty to
avoid conflicts. This field
identifies calibrator by name;
control by name or blank.
See notes below
9.4.5 Universal Test ID <empty> ^^^abbr_test yes Abbreviated test name max 4
characters long.
Host may send multiple requests
in single order record by use of
repeat delimiter.
See notes below
9.4.6 Priority S <empty> S (Stat)
A S A (ASAP / Pediatric)
R A R (Normal)
R All other will be treated as R.
Default: R
9.4.7 Requested/Ordered Date <empty> <ignored>
and Time
9.4.8 Specimen Collection <empty> <ignored>
Date and Time
9.4.9 Collection End Time <empty> <ignored>
9.4.10 Collection Volume <empty> <ignored>
9.4.11 Collector ID <empty> <ignored>
9.4.12 Action Code <empty> <empty> Empty and other will be treated
N as N
A See notes below
C
9.4.13 Danger Code <empty> <ignored>
9.4.14 Relevant Clinical <empty> <ignored>
Information
9.4.15 Date/Time Specimen <empty> <ignored>
Received
9.4.16 Specimen Descriptor sample type <empty> See notes below
BLANK sample type
CALIBRATOR
CONTROL
9.4.17 Ordering Physician Name <empty> Max 20 characters. In case this
name field contains multiple
components, only the first
component is used.
9.4.18 Physician’s Telephone <empty> <ignored>
Number
9.4.19 User Field No. 1 <empty> <ignored>
9.4.20 User Field No. 2 <empty> <ignored>
9.4.21 Laboratory Field No. 1 <empty> <ignored>
9.4.22 Laboratory Field No. 2 <empty> <ignored>

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9.4.23 Date/Time Results <empty> <ignored>
Reported or Last
Modified
9.4.24 Instrument Charge to <empty> <ignored>
Computer System
9.4.25 Instrument Section ID <empty> <ignored>
9.4.26 Report Types F <empty> see notes below
X O
I Q
Y
Z

9.4.4 Instrument Specimen ID

When a calibrator, control or blank is requested from the host, fields with sample information
will be ignored.

9.4.5 Universal Test ID

To request ISE tests, the value for abbr_test must be ISE. The analyser reports ISE results
as a single Order record and separate result records for each ISE result, containing
‘^^^ISE^K’, ‘^^^ISE^Na’, etc. in the result record.

Example ISE result from analyser:

O|1|12935-C|||R|||||||||||Dr. Carnegy|||||||||FCR
R|1|^^^ISE^K|4.2|mmol/l||||F||||20060120153902CR
R|2|^^^ISE^Na|139|mmol/l||||F||||20060120153902CR
R|3|^^^ISE^Cl|111|mmol/l||||F||||20060120153902CR

9.4.12 Action code

N New request: If a request with the same Sample ID already exists, that
request will overwritten. If the sample is in process or ready, and still loaded, a
new request is made and the name, birthdate, etc. must be equal to the
sample that is in process.
A Additional requests: The contents of the order record will be appended to an
existing sample request on the analyser. This means that the set of test
requests is extended with the test requests in the order record. If a request
does not exist or was already started a new request is created.
C Cancel: will remove the entire sample request from the request buffer. The
contents of field (9.4.5) will be ignored if C is specified.
If an action code is not provided the order will be treated as a New Request.

9.4.16 Specimen Descriptor

This (optional) field contains in full text the sample type. For instance if the sample is urine,
this field contains Urine. The text is compared case sensitive to the sample types defined on
the instrument. If the sample type is not known or not defined, it will default to Normal.

When transmitted by the analyser, this field can contain any of the defined sample types or
the fixed texts BLANK, CALIBRATOR or CONTROL.

Example Order record with sample type:

O|1|12935-C|||R||||||||||Urine|Dr. Carnegy|||||||||FCR

9.1.26 Report Type (transmitted by analyser):

F Final: Indicates a result is following and that it is the last result for the sample.
I Intermediate: Indicates a result is following and that the sample still has active
measurements.

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X Used to indicate a request to measure is not accepted by the analyser. The
request may be rejected for the following reasons:
- Sample_ID already exists, but demographic information doesn’t match, i.e.,
Patient name and birth date are not equal to an existing request.
- No space for request, i.e., the request buffer is full.
No results will be transmitted for the request.

9.1.26 Report Type (received by analyser):

The field will be ignored if action code (field 12) is C.
O, Q, <empty> The requests will replace an existing sample request.
Y, Z A Host can use these values in response to a host query to indicate that a
Sample ID is not known at the host. Depending on implementation, a message
may be shown on the screen of the analyser. See also Section 5.6, Field
13.1.3.
<others> The record will be ignored.

Limitations:
The sample ID in the order record is used to identify the sample request on the analyser,
cancelling the order means that the sample request – including patient information – is
deleted from the analyser.

If the analyser is active when the request is received and the sample is already loaded on the
analyser, the requested test is automatically started. This behaviour is intended for reflex
tests transmitted from host.

If a request (identified with a sample ID) has a name, birth date or other demographic
information that conflicts with a request on the analyser, the request will be rejected by the
analyser.

Example order record from analyser:

O|1|12934-A||^^^CHOL|R|||||||||||Dr. Carnegy|||||||||FCR

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Result record (R)

For every order record the analyser will report 1 or more result records.

Field Analyser Host Comment

(Transmitted to (Received
host) from host)

10.1.1 Record Type ID R

10.1.2 Sequence Number number Sequential number starting with 1 and
continuing until the last result for the
patient.
10.1.3 Universal Test ID ^^^abbr_test^full_test Abbreviated test name up to 4 characters
long;
Full test name up to 15 characters long.
See notes below
10.1.4 Data or Measurement result See notes below
Value
10.1.5 Units units See Appendix B
10.1.6 Reference Ranges cutoff_reference^ All components are floating point values.
low_reference_limit^ cutoff_reference contains the relevant
high_reference_limit reference value for positive/negative
reporting.
low_reference_limit and
high_reference_limit define the applicable
reference range (male/female/pediatric)
for the sample.
See notes below
10.1.7 Result Abnormal Flags normalcy_flags^ normalcy flags:
instrument_flags L : Below low reference limit
LL: Below low panic limit
H : Above high reference limit
This record HH: Above high panic limit
is always < : Below absolute limit
ignored
> : Above absolute limit
when
Instrument flags:
received
See Appendix A for an overview of
from host
possible values
10.1.8 Nature of Abnormality <empty>
Testing
10.1.9 Result Status F F indicates a final result
I I indicates a result is pending (Field
10.1.4 will contain BUSY or ------)
X X indicates the order cannot be done, it
will be transmitted immediately upon
request to perform tests that are not
known at the analyser, the result will
show UNKNOWN.
10.1.10 Date of Change <empty>
10.1.11 Operator Identification <empty>
10.1.12 Date/Time Test Started <empty>
10.1.13 Date/Time Test meas_datetime YYYYMMDDHHMMSS
Completed
10.1.14 Instrument Identification analyser_section^ analyser _section:
reagent_batch_nr^ (XL-series only:)
reagent_expiry_date L: Left analyser part
R: Right analyser part
reagent_batch_nr and
reagent_expiry_date contains the batch
number and expiry date of the first
reagent of the test.

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10.1.3 Universal Test ID
For ISE results, the field is formatted as follows:
^^^ISE^K
^^^ISE^Na
^^^ISE^Cl
^^^ISE^CO2
Refer to section Test order record (O), page 10 field 9.4.5 for an example.

10.1.4 Data or Measurement value

The field can contain the following:
Floating point The measured value in human readable format, the decimal separator is a period (.)
number
REJECT The test was rejected (either automatically by the analyser, or manually by the operator)
BUSY The test is being measured at the analyser.
------ The test is waiting for operator input. On screen displayed as *INFO*.
> n.nnnn Measurement above assay range. Where n.nnn is a floating point value representing the
highest concentration level defined in the test parameters.
< n.nnnn Measurement below analytical sensitivity. Where n.nnnn is a floating point value representing
the lowest concentration level defined in the test parameters.
UNKNOWN The test request was unknown at the analyser. Results records reporting UNKNOWN to the
host will not show in the result list of the analyser.

10.1.6 Reference ranges

When a control result is reported to the host, the reference ranges are replaced with control
limits as follows:
Control target^Confrol low limit^Control high limit
For blank and calibrator results, this field will be empty.

10.1.7 Result abnormal flags

The component normalcy_flags will specify ‘<’ or ‘>’ if the value is outside a range other than
a reference range. The component instrument_flags will provide more detail of the range that
was exceeded. The following table lists the instrument flags and the normalcy flags that will
be set accordingly:

Instrument flags Normalcy flag

n Reference low error L
y Reference panic low error LL
N Reference high error H
Y Reference panic high error HH
< Absorbance low limit error <
U Measurement counter under range
u Reference counter under range
v Measurement below low calibration limit
x Measurement below analytical sensitivity
> Absorbance high limit violation >
O Measurement counter over range
o Reference counter over range
V Measurement above high calibration limit
X Measurement above assay range

General
By default the analyser sends the results to the host as soon as they become available. This
means that the analyser will send multiple result messages for a single sample (1 for each
test result). It also means that if there is a tests that requires operator attention (the test has
an *INFO*), then this test will not hold back sending of results. The field Report Type (9.1.26)

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is used to indicate if the sample has still has active tests that are being measured, or if it is
the last test for the sample.

Alternatively, the option Collate Results may be set in the analyser, in which case the
analyser will not send the test results for a sample, until all tests for that sample are
completed. It will then send all results in a single message.

In case the test measurement is performed with a repeat value > 1 (The test must have been
requested at the analyser console, since the host request does not support specifying a
repeat value), each individual measurement is reported to the host. The host can identify
these results as different measurement by inspecting the value of the measurement
date/time field (Field 10.1.13).

Example result record from analyser:

R|1|^^^C300^+Cocaine 300|0.276|dAbs/m|0.301|^-
||F||||20060120153902|L^Z2820^20060701CR

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Comment record (C)

The format of the comment record depends on the context in which it is received or
transmitted.

Comments for Test order record (O)

Following a test order record there can be a comment record containing a specific comment
for the sample.

Field Analyser Host Comment

(Transmitted to host) (Received from
host)

11.1.1 Record Type ID C C

11.1.2 Sequence Number 1 <ignored> Sequential number starting with
1 and continuing until the last
comment on this level.
11.1.3 Comment Source I <ignored>
11.1.4 Comment Text text Text See below
11.1.5 Comment Type G <ignored>

If the instrument receives a comment record following the test order record, the text from the
comment record will be placed in the sample comment record. If multiple comment records
are received, only the last comment record will be copied into the sample comment record,
thereby overwriting any previously received comments.

The instrument will store only the first 100 characters of the received comment text.

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Comments for Result records (R)
If 'extended results' is enabled in communication settings, the instrument will add comment
records following the result record. These comment records contain raw result information for
the transmitted result.

Field Analyser Host Comment

(Transmitted to host) (Received from
host)

11.1.1 Record Type ID C The comment

11.1.2 Sequence Number 1 record following Sequential number starting with
the result record 1 and continuing until the last
is always comment on this level.
11.1.3 Comment Source I ignored when
11.1.4 Comment Text code^text received from See below
11.1.5 Comment Type G host

C|<sequence number>|I|M01^<abs_result>^<abs_units>|G
<abs_result> Calculated absorbance value based on raw measurements.
<abs_units> Relevant absorbance units (Abs, dAbs, dAbs/m)

C|<sequence number>|I|M02^<seconds>^<raw_result>^<used>|G
seconds Time at which measurement was performed. This is a floating
point value.
raw_result floating point value specifying the raw absorbance measurement
by the analyser
used 0 or 1: 1 indicates the point is used by the analyser to calculate the
concentration; 0 indicates the measurement was not used.
The field Comment Text is repeated for every raw measurement point.

In case a ‘test repeat’ is set in the test parameters, the raw measurements are sent for each
repeat. With a test repeat of 3, this means that 6 comment records will be appended for each
result.

Raw results from the ISE are reported in the format as they are received from the ISE unit.
Currently the ISE units reports only final results. Only an M01 field will be transmitted.

Example:
C|1|I|M01^0.276^dAbs/m|G
C|2|I|M02^24.5^0.2313^0\M02^51^0.2320^0\M02^77.5^0.7123^0\[additional
values skipped for brevity]|G

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Message Terminator Record (L)

Every message must be terminated with a Message Terminator record. Since every frame
can only contain 1 message, this also terminates the frame (See “Frame format”, page 4).

Field Analyser Host Comment

(Transmitted Received Required
to host) from host
13.1.1 Record Type ID L L yes
13.1.2 Sequence Number 1 <ignored> yes Always 1
13.1.3 Termination Code F Q
I

When Termination Code (13.1.3) received from host is Q or I then this is taken to mean that
the host has no information on the sample ID in the last request. Depending on
implementation, a message may be shown on screen.

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LIS 2-A Host Protocol

Request information record (Q)

Field Analyser Host Comment
(Transmitted Received Required
to host) from host
12.1.1 Record Type ID Q Q yes
12.1.2 Sequence Number 1 <ignored> yes Sequential number starting with
1 and continuing until the last
request for this message
12.1.3 Starting Range ID ^sample_ID ^sample_ID yes In case ALL is received by the
Number or analyser; the analyser will
ALL (re)send the last 100 results in
the result buffer.
12.1.4 Ending Range ID <empty> <ignored> Only a single sample ID can be
Number requested in each query record.
12.1.5 Universal Test ID ALL <ignored> By default ALL results for a
sample are transmitted.
12.1.6 Nature of Request Time <empty> <ignored>
Limits
12.1.7 Beginning Request <empty> <ignored>
Results Date and Time
12.1.8 Ending Request Results <empty> <ignored>
Date and Time
12.1.9 Requesting Physician <empty> <ignored>
Name
12.1.10 Requesting Physician <empty> <ignored>
Telephone Number
12.1.11 User Field No. 1 <empty> <ignored>
12.1.12 User Field No. 2 <empty> <ignored>
12.1.13 Request Information O <ignored>
Status Codes

Whenever the analyser encounters a new sample ID for which it can not find a request in the
request buffer, it sends a ‘request information record’ to the host system, requesting to send
test orders and demographics. The analyser will never cancel an outstanding request.

When the analyser receives a request it will always respond by sending all results for the
requested sample ID as they are at that time. These results may be Final (F) or in analyser
pending (I).

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LIS 2-A Host Protocol

Manufacturer Information Record (M)

This record is used for custom information exchange not covered in the CLSI protocol LIS2A.
These include:
- Sending cuvette blank information to the host
- Requesting full version information of all analyser parts
- Downloading error history information from analyser
- Reagent installation information and statistics
These information records are always level 1 records

Field Analyser Host Comment

(Transmitted to host) (Received from
host)

15.1.1 Record Type ID M M

15.1.2 Sequence Number 1 <ignored> Only 1 manufacturer information
record is allowed for each
message.

Cuvette Blank information (B)

The cuvette blank information is sent by the analyser when the operator presses Ctrl+F1 in
the Blank Rotor menu. The blank results of the selected filter (and for XL-series: analyser
half) are sent to the host.

If the host requests blank information by sending an M|1|B, then all blank information, for all
cuvettes and all wavelengths is transmitted to the host.

Field Analyser Host Comment

(Transmitted to (Received
host) from host)

3 Manufacturer Record Type ID B B

4 Analyser part <empty> <ignored> E / Junior: <empty>
L XL-Series: Left or Right analyser
R part.
5 Wavelength <wavelength> <ignored> Wavelength in nanometers.
6 Cuvette blank value <value> <ignored> Absorbance value for each
cuvette, the value is repeated 48
times.
7 Cuvette average <value> <ignored>
8 Cuvette Standard Deviation <value> <ignored>
9 Lamp average <value> <ignored>
10 Lamp Standard Deviation <value> <ignored>

Example message with cuvette blank information

H|\^&|||SELXL^2.1.0||||1.0|||P|LIS2-A|20051221153902CR
M|1|B|L|340|0.1029\0.1030\0.1041\0.1032<44 values skipped for
brevity>|0.1033
|0.0012|0.0291|0.0009CR
C
L|1|F R

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LIS 2-A Host Protocol
Error History

Note: this record is primarily intended for use by Vital Scientific BV during production and
service of the analyser and is subject to change.

The error history is only transmitted to the host after the host has requested the error history.
The host performs an error history request by sending an M|1|H record.

The following fields are appended to the Manufacturer Information Record:

Field Analyser Host Comment

(Transmitted to (Received
host) from host)

3 Manufacturer Record Type ID H H

4 Error History record error_datetime^ <ignored> Field is repeated for each item in
error_message^ error history
operator_action
5 Action code <empty> <empty>
C C: Clear error history

Component Content Length Comment

error_datetime YYYYMMDDHHMMSS 14 date and time of error
error_message text 5 Error code (e.g., E102)
operator_action digit 1 A code identifying the action of the operator:
0 – None
1 – Check Again
2 – Acknowledge
3 – Reset System
4 – Specific Reset
5 – Remain Inactive
6 – Halt
7 – Analyser side reset

Example message with error history:

H|\^&|||SELXL^2.1.0||||1.0|||P|LIS2-A|20051221153902CR
M|1|H|20050827151007^E12^0\20050827151210^E17^0\20051009101247^E13^6C
R
C
L|1|F R

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LIS 2-A Host Protocol
Reagent installation (I)

Reagent Installation information is sent automatically from the analyser to the host whenever
the reagent configuration on the analyser changes. Alternatively the host can request
reagent installation information by sending a M|1|I record.

The following fields are appended to the Manufacturer Information Record:

Field Analyser Host Comment

(Transmitted to (Received
host) from host)

3 Manufacturer Record Type ID I I

4 Reagent installation information position^ <ignored> Field is repeated for each
abbr_test^ installed reagent
full_test^
reagent_nr^
reagent_batch^
reagent_expiry^
test_count

Component Content Max Length Comment

position text 3 Text/Number identifying reagent position:
For Junior: 1..30
For E: 1..32
For XL-Series: L1..L32, R1..R32
abbr_test text 4 Abbreviated test name
full_test text 15 Full test name
reagent_nr number 1 1..3 for reagent 1..3
reagent_batch text 10 reagent batch number
reagent_expiry YYYYMMDD 8 Reagent Expiry date
test_count number Total test count for installed reagent

The location of reagents used for normal operation of the analyser (e.g., HCL and NEEDLE
RINSE) and shared reagents (e.g., SHARED BUFFER) are not reported to the host.

Example:
The following message indicates 2 tests are installed on the analyser; “+Cocaine 150” and
“LSD”. Reagent 1 for “+Cocaine 150” is on position 1; Reagent 3 on position 2. For LSD
reagent 1 is located on rotor position 5 and reagent 3 is located on position 6. “+Cocaine
150” has executed a total of 290 tests; while “LSD” has been used for 165 tests.

H|\^&|||JUNIOR^2.1.0||||1.0|||P|LIS2-A|20060120162301CR
M|1|I|1^+C15^+Cocaine 150^1^^^290\2^+C15^+Cocaine 150^3^^^290\
5^LSD^LSD^1^^^165\6^LSD^LSD^3^^^165CR
C
L|1|F R

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LIS 2-A Host Protocol

Extended version information

Note: this record is primarily intended to be used by Vital Scientific BV during production and
service of the analyser and is subject to change.

The extended version information is only transmitted to the host after the host has performed
a request by sending an M|1|V record.

Extended version information can be used to request version information for all parts used in
the analyser.

Field Analyser Host Comment

(Transmitted to (Received from
host) host)

3 Manufacturer Record Type ID V V

4 Version information part^ <ignored> Field is repeated for each
version analyser part

Component Content Length Comment

part number 2 Unique number identifying the analyser part:
1 PC release description
2 PC release version
3 PC application version
4 PC application date
5 CCB version (XL-series only)
6 Sample Disc Version
7 Barcode version (XL-series only)
8 (Left) Master version
9 (Left) Master Date
10 (Left) Pipettor version
11 (Left) Measurement unit version
12 (Left) Sample arm version
13 (Left) Reagent arm version (XL and E-series only)
14 (Left) Reagent discs version (XL and E-series only)
15 (Left) Wash arm version
16 Right master version (XL-series only)
17 Right master date (XL-series only)
18 Right Pipettor version (XL-series only)
19 Right Meas. Unit version (XL-series only)
20 Right Sample arm version (XL-series only)
21 Right Reagent arm version (XL-series only)
22 Right Reagent disc version (XL-series only)
23 Right wash arm version (XL-series only)
version text Text describing version or date as it was received from the
analyser.

Example response with version information:

H|\^&|||XL400^4.0.0||||1.7|Host||P|LIS2-A|20080103120702 CR
M|1|V|1^XL Analyser 4.0\2^4.0.0\3^4.0.0\4^20071225\5^XL/VTLV1.3.1\
6^DSC P0.03 \7^\8^XL/DRY V1.1.0(DUAL)\9^14-APR-2004 13:49\
10^DIL V1.10 \11^MDS V1.10 \12^SA V1.10 \13^RA V1.20 \
14^DSC V1.10 \15^WA V1.11 \16^XL/DRY V1.1.0(DUAL)\
17^14-APR-2004 13:49\18^DIL V1.10 \19^MDS V1.10 \
20^SA V1.10 \21^RA V1.20 \22^DSC V1.10 \23^WA V1.11 CR
L|1|F CR

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LIS 2-A Host Protocol

Appendix A Flags

When there are irregularities during the measurement of a test, the analyser will flag the
result with a single character describing the nature of the irregularity. There may be multiple
flags added to a result. The flags may appear in random order.

The analyser will transmit these flags to the host in the result record field 10.1.7.2 as
described in section “Result record (R)”, page 13.

Flag Error description

* Alinearity error
# Insufficient sample
A Calibrator point absorbance violation
a Reagent absorbance limit violation
B Barcode not matching (XL-series only)
b Barcode not scanned (XL-series only)
C Control limit violation
D Reagent absorbance deviation error/substrate depletion error
E Cut-off result near limit
F Test not performed because of disabled analyser part
G General hardware error
H Calculated result division by zero
h Calculated result condition not satisfied
I General ISE unit error
K Measurement above high calibration limit
k Measurement below low calibration limit
L Lamp error if combined with O, o, U, u flag; otherwise ISE electrode not calibrated
M Absorbance high limit violation
m Absorbance low limit error
N+ High reference limit violation
N- Low reference limit violation
O Measurement counter over range
o Reference counter over range
P Prozone error
R Insufficient reagent
r Rerun
T Cuvette temperature error
U Measurement counter under range
u Reference counter under range
V Cut-off positive
v Cut-off negative
W Westgard violation
X Measurement above assay range
x Measurement below analytical sensitivity
Y Reference panic high error
y Reference panic low error
Z Dup-diff error

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LIS 2-A Host Protocol

Appendix B Units

The next table shows all the possible units.

<empty> mEq/l ng/ml mg/24h

kU/l g/l IU/l µg/24h
U/l mg/l IU/ml sec
U/ml µg/l mIU/l units
µU/ml ng/l mIU/ml Abs
µkat/l g/dl µIU/ml ratio
mol/l mg/dl % dAbs
mmol/l µg/dl ‰ dAbs/m
µmol/l ng/dl % norm
nmol/l mg/ml m/24hr
fmol/g µg/ml g/24hr
Table 1: Available units in analyser

Character codes used for the special characters ‰ (Per mille sign; Latin-1 137) and µ (micro
sign; Latin-1 181) depend on the codepage that is currently active in the PC application on
the analyser. The transmitted code may differ based on the language that is used for the
user interface.

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LIS 2-A Host Protocol

Appendix C ASCII CODE Chart

000 NUL 016 DLE 032 SP 048 0 064 @ 080 P 096 ` 112 p
001 SOH 017 DC1 033 ! 049 1 065 A 081 Q 097 a 113 q
002 STX 018 DC2 034 “ 050 2 066 B 082 R 098 b 114 r
003 ETX 019 DC3 035 # 051 3 067 C 083 S 099 c 115 s
004 EOT 020 DC4 036 $ 052 4 068 D 084 T 100 d 116 t
005 ENQ 021 NAK 037 % 053 5 069 E 085 U 101 e 117 u
006 ACK 022 SYN 038 & 054 6 070 F 086 V 102 f 118 v
007 BEL 023 ETB 039 ‘ 055 7 071 G 087 W 103 g 119 w
008 BS 024 CAN 040 ( 056 8 072 H 088 X 104 h 120 x
009 HT 025 EM 041 ) 057 9 073 I 089 Y 105 i 121 y
010 LF 026 SUB 042 * 058 : 074 J 090 Z 106 j 122 z
011 VT 027 ESC 043 + 059 ; 075 K 091 [ 107 k 123 {
012 FF 028 FS 044 , 060 < 076 L 092 \ 108 l 124 |
013 CR 029 GS 045 - 061 = 077 M 093 ] 109 m 125 }
014 SO 030 RS 046 . 062 > 078 N 094 ^ 110 n 126 ~
015 SI 031 US 047 / 063 ? 079 O 095 _ 111 o 127 DEL
Table 2: 7-bit ASCII code chart

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LIS 2-A Host Protocol

Appendix D Examples

The following shows the flow of control of a message from a sender to a receiver. In this
case the sender is the analyser performing a query request at the host (See example 4)
E
Sender: NQ
A
Receiver: CK
S
Sender: TX1H|\^&|||SELE||||1.0|||P|LIS2-
A|20060126163201CRQ|1|^12936-A||ALL||||||||OCRL|1|FCRETX23CRLF
Receiver: ACK
E
Sender: OT

For readability the encapsulation of messages has been removed from the following
examples.

D.1 Analyser messages

Example 1.1 Standard result from analyser

The following example shows results send by the analyser based on the host request from
example 2.1. When the first result is ready (GLUC), the analyser sends the following
message to the host:
H|\^&|||SELE||||1.0|||P|LIS2-A|20060126162409CR
P|1||||Lindsey Blake||19650917|FCR
O|1|12934-A|||R|||||||||||Dr. Carnegy|||||||||ICR
R|1|^^^GLUC^Glucose|8.1|mmol/l|^4.0^6.9|H^N||F||||20060126162405CR
L|1|FCR

For the second result (+C15), the analyser sends the following message to the host:
H|\^&|||SELE||||1.0|||P|LIS2-A|20060126162503CR
P|1||||Lindsey Blake||19650917|FCR
O|1|12934-A|||R|||||||||||Dr. Carnegy|||||||||FCR
R|1|^^^+C15^+Cocaine 150|0.321|dAbs/m|0.231|^+||F||||20060126162459
|^3T797^20070601CR
C
L|1|F R

Example 1.2 Result from analyser as answer to host query

The same information as above can also be transmitted based on a query from the host or
by pressing Ctrl+F1 in while the sample is selected on screen. All the results for a sample are
then contained in a single message.

H|\^&|||SELJR||||1.0|||P|LIS2-A|20060126162409CR
P|1||||Lindsey Blake||19650917|FCR
O|1|12934-A|||R|||||||||||Dr. Carnegy|||||||||FCR
R|1|^^^GLUC^Glucose|8.1|mmol/l|^4.0^6.9|H^N||F||||20060126162405CR
R|2|^^^+C15^+Cocaine 150|0.321|dAbs/m|0.231|^+||F||||20060126162459CR
|^3T797^20070601CR
C
L|1|F R

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LIS 2-A Host Protocol
Example 1.3 Analyser query
This example shows a message that is sent by the analyser to query the host for information
for a sample ID “12936-A”.

H|\^&|||SELXL||||1.0|||P|LIS2-A|20060126163201CR
Q|1|^12936-A||ALL||||||||OCR
L|1|FCR

Example 1.4 Analyser result message for calibration of Valproic Acid assay
H|\^&|||SELE||||1.0|||P|LIS2-A|20060127081927CR
P|1|||||||CR
O|1||VPA Calibrator||R||||||||||||||||||||FCR
R|1|^^^VPA^Valproic Acid|0.2258|dAbs/m||||F||||20060127081456CR
R|2|^^^VPA^Valproic Acid|0.2524|dAbs/m||||F||||20060127081550CR
R|3|^^^VPA^Valproic Acid|0.2837|dAbs/m||||F||||20060127081644CR
R|4|^^^VPA^Valproic Acid|0.3084|dAbs/m||||F||||20060127081738CR
R|5|^^^VPA^Valproic Acid|0.3631|dAbs/m||||F||||20060127081832CR
R|6|^^^VPA^Valproic Acid|0.3892|dAbs/m||||F||||20060127081926CR
L|1|FCR

Example 1.5 Analyser result message for ISE measurements

H|\^&|||SELE||||1.0|||P|LIS2-A|20060120153907CR
P|1||||Jonathan Kardon||19650917|MCR
O|1|12939-C|||R||||||||||||||||||||FCR
R|1|^^^ISE^K|4.2|mmol/l||||F||||20060120153902CR
R|2|^^^ISE^Na|139|mmol/l||||F||||20060120153902CR
R|3|^^^ISE^Cl|111|mmol/l||||F||||20060120153902CR
L|1|FCR

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LIS 2-A Host Protocol

D.2 Host messages

The following examples are provided to show how a host may communicate with the
analyser. Fields that will be ignored by the analyser are mostly left empty in these examples,
but these may contain actual data when sent from the host.

Example 2.1 Standard host request

The host requests a series of tests to be performed on a number of samples.
H|\^&|||LABLIS|||||||P|LIS2-A|20060126155702CR
P|1||||Lindsey Blake||19650917|FCR
O|1|12934-A||^^^GLUC\^^^+C15|R|||||||||||Dr. Carnegy|||||||||OCR
L|1CR

Example 2.2 Minimal host request

This example presents a minimal host request for two tests (CREA & CHOL) to be performed
on a sample with ID “123”
H|\^&CR
P|1CR
O|1|123||^^^CREA\^^^CHOLCR
L|1CR

Example 2.3 Complex host request

The following shows a complex request from the host. Various methods are used to specify
the tests to be performed:

H|\^&|||LABLIS|||||||P|LIS2-A|20060126155702CR
P|1||||First SampleCR
O|1|12940||^^^GLUC\^^^CHOL|RCR
P|2||||Stat SampleCR
O|1|12941||^^^GLUC|SCR
O|2|12941||^^^CHOL|RCR
P|3||||ASAP SampleCR
O|1|12942||^^^GLUC|ACR
L|1|FCR

Note: The second sample request (Sample ID 12941), contains two order records: One test
to be performed immediately (STAT), and one test to be performed as routine (normal).
Since the priority in the analyser is set at sample level, the priority in the second test request
will overwrite the priority in the first test request. All tests will be executed at normal priority,
not STAT.

Example 2.4 Host response on analyser query

Upon an analyser query the host may respond in several ways. This example shows a
complete response with some fields that will be ignored by the analyser, but the host may
also respond with requests as shown in examples 1 and 3.

H|\^&|28319|PWD|HostSystem|||319 555-456||SELE||P|LIS2-
A|20060126170103CR
P|1|12936|12936||John Dibbly||19710702|M||||MNYCR
O|1|12936-A||^^^CREA|R|20060126150557|||||N|||||Dr.
Carnegy|||||||||QCR
L|1|FCR

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LIS 2-A Host Protocol
Example 2.4 Host response on analyser query if sample ID is unknown
If the sample ID is not known at the host, the host may respond with the following message:
H|\^&CR
L|1|ICR

Or a more extensive reply:

H|\^&|28320||HostSystem|||||||||20060126170103CR
P|1CR
O|1|12936-A|||||||||||||||||||||||ZCR
L|1|FCR

A response from a host is not required, the query will time-out on the analyser after a few
seconds.

Example 2.5 Sample request cancelled by host

Complete request is deleted:
H|\^&CR
P|1CR
O|1|12934-A|||||||||CCR
L|1|FCR

Example 2.6 Host queries results from analyser:

H|\^&CR
Q|1|^12940-ACR
L|1CR

Document number: 3084-103 30/30