0932192C_EN

Information contained in this document, in particular data, pictures, information, trademarks and
logos are exclusive property of Diagnostica Stago and are protected by copyrights and other
intellectual property rights.
© 2015, Diagnostica Stago, all rights reserved - 03/2016
Consequently, all representation and/or reproduction, whether in part or in full, is forbidden and
would be considered a violation of Diagnostica Stago’s copyrights and other intellectual property
rights.
Visual representations (diagrams, pictures, icons, pictograms, screenshots, spare parts, ...) are
not contractual.
ASTM LIS INTERFACE

Contents
1. Introduction ..............................................................................................................5

2. General Information..................................................................................................6

3. Physical Layer ..........................................................................................................7

3.1 Ethernet communication .............................................................. 7

3.2 RS-232 asynchronous serial communication ............................... 7
3.3 Settings ....................................................................................... 7
3.4 Data Communication Activation ................................................... 7
4. Description of messages ..........................................................................................8

4.1 Definition ..................................................................................... 8

4.2 Conventions ................................................................................ 8
4.3 Header record.............................................................................. 8
4.4 Patient record .............................................................................. 9
4.5 Test order .................................................................................. 11
4.6 Results ...................................................................................... 13
4.7 Manufacturer ............................................................................. 14
4.8 Comment ................................................................................... 16
4.9 Message terminator ................................................................... 16
5. Examples ...............................................................................................................18

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Revision History

This section of the document covers changes in the document or interface. A change to the interface
software does not always affect the document so there will not be a one-to-one correspondence
between code modifications and document modifications.

Revision Date Description

0932192 06/2015 Creation

0932192A 07/2015 Update of the document
0932192B 03/2016 Chapter 4.6 Results : Note 4 updated for
alphanumeric value ‘NO RESULT’
0932192C 05/2016 The fields above were mandatory are no longer
mandatory. Switch ‘Y’ to ‘O’ :
7.1.14, 8.1.14, 8.1.26, 9.4.17, 9.4.8, 9.4.33, 15.1.5

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1. Introduction
Foreword
The STA Coag Expert® ASTM Standard Interface manual provides the necessary information for
interfacing the STA Coag Expert® System with a Host system.

Customer Support
If you have any questions regarding this document, please contact your local representative.

Proprietary Statement
The STA Coag Expert® System software programs and system documentation are protected by
copyright (©1998, 2014 Stago, France). All rights are reserved. The software and manual were
developed solely for use with the STA Coag Expert®.

Disclaimers
All samples (printouts, graphics, displays, screens, etc.) are for information and illustration
purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample
printouts and screens do not reflect actual patient names or test results. The Information was
developed to be used by trained personnel, by other persons knowledgeable or experienced with
the operation and service of the product identified. In no event shall Stago or its affiliates be liable
for any damages or losses incurred in connection with or arising from the use of the Information
by persons not fully trained by Stago. No confidential relationship shall be established in the event
that any user of the Information should make any oral, written or electronic response to Stago
(such as feedback, questions, comments, suggestions, ideas, etc.). Such response and any
information submitted therewith shall be considered non-confidential.

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2. General Information

Low-level data transfer communications follow the ASTM E1381-91 “Specification for Low-Level
Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems”
standard.

High-level data transfer communications follow the ASTM E1394-91 “Standard Specification for
Transferring Information Between Clinical Instruments and Computer Systems” standard.

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3. Physical Layer
The method of Data transmission is Serial RS-232 or Ethernet.

3.1 Ethernet communication

It is assumed that the LIS and STA Coag Expert® PC reside in the same network that is protected by a
firewall. The transmission of information between the two systems is in clear text.
STA Coag Expert® may be configured to support one of the two modes of connection:
 LIS as client and STA Coag Expert® as server.
 LIS as server and STA Coag Expert® as client.

3.2 RS-232 asynchronous serial communication

The hardware interface is based on a RS 232 D standard. The signals available from a standard RS 232
shall be connected according to the following table.

Signal DB9 DB25 STA Coag Expert® Host

Shield Not Used 1 Connected Not Connected
Transmitted Data 3 2 Output Input
Received Data 2 3 Input Output
Signal Ground 5 7 Connected Connected

For the 9 Pin Connector (DB9), the shield may be connected (at one side only) to the Signal Ground.

3.3 Settings
Setting item Available values
Transmission speed 300 to 38400 bps (default is 9600 bps)
Parity Even, Odd or None (default is None)
Data bits 7 or 8 (default is 8)
Stop bits 1 or 2 (default is 1)
Flow control None, Xon-Xoff, Rts or Xon/Rts (default is None)

3.4 Data Communication Activation

 Results are automatically transferred when validated on STA Coag Expert®.
 Order dynamic download to STA Coag Expert® is the only order transmission mode
supported. Host query is NOT supported.

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4. Description of messages

4.1 Definition
Term Definition
Upload The transmission of data from the STA Coag Expert ® to the LIS.
Download The transmission of data from the LIS to the STA Coag Expert®.

4.2 Conventions
The following conventions are used in this document.

Notation Description
'x' Denotes a single character
"xxxx" Denotes a character string
N Not supported
Y Supported and required
O Supported and optional

4.3 Header record

The header contains general information and identifiers of the sender and the receiver.

Field # Field definition Contents Max Received Transmitted

length (from Host) (to Host)
7.1.1 Record type ID ‘H’ 1 Y Y
7.1.2 Delimiter definition “|\^&” 4 Y Y
* See note 1
7.1.3 Message control ID - - N N
7.1.4 Access password - - N N
7.1.5 Sender ID Code (“LIS” in reception 10 Y Y
and transmission)
^
Name N N
7.1.6 Sender street - N N
address
7.1.7 Reserved field - N N
7.1.8 Sender telephone - N N
number
7.1.9 Characteristics of - N N
sender
7.1.10 Receiver ID Code 10 N N
^ N N
Name

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Field # Field definition Contents Max Received Transmitted

length (from Host) (to Host)
7.1.11 Comment or special - - N N
instructions
7.1.12 Processing ID ‘P’ for patient results 1 Y Y
'Q' for QC results N Y
7.1.13 Version No. ‘LIS2-A2’ 8 Y Y
7.1.14 Data and time of YYYYMMDDHHMMSS 14 O O
message

* Note 1:

Delimiter Type Character Description

Field | Separates fields within records.
Repeat \ Separates multiple occurrences for the same type of information
within a field.
Component ^ Separates a field into smaller groups of characters.
Escape & Allows embedding of special characters within the data.

e.g.

H|\^&|||LIS|||||||P|LIS2-A2|20150403165858

4.4 Patient record

Field # Field definition Contents Max Received Transmitted
length (from Host) (To Host)
8.1.1 Record type ID ‘P’ 1 Y Y
8.1.2 Sequence number 'x' 1 Y Y
8.1.3 Practice assigned ‘’xxxx’’ 16 Y Y
patient ID
8.1.4 Laboratory - 16 N N
assigned patient ID
8.1.5 Additional Patient - 16 N N
ID
8.1.6 Patient name Last name 40 Y Y
^
First name 40 Y Y
^
Second first name - N N
^
Alias - N N
^
Title 5 O N
8.1.7 Mother's maiden ‘’xxxx’’ 40 O O
name
8.1.8 Birthdate YYYYMMDD 8 Y Y
8.1.9 Patient sex M,F,U 1 Y Y
8.1.10 Patient ethnic - - - -
origin

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Field # Field definition Contents Max Received Transmitted

length (from Host) (To Host)
8.1.11 Patient address Line 1 35 O N
^ ^
Line 2 25 O N
^ ^
City, State 20 O N
^ ^
Area 5 N N
^ ^
Zip Code 5 O N
^ ^
Country 5 N N
8.1.12 Reserved field - - O N
8.1.13 Patient telephone - - N N
number
8.1.14 Attending physician physician ID 9 O N
ID ^
physician name 50 O N
8.1.15 Special field 1. - - N N
Treatment 1.
8.1.16 Special field 2. - - N N
Treatment 2.
8.1.17 Patient height - cm ‘’xxxx’’ 3 O N
8.1.18 Patient weight - kg ‘’xxxx’’ 3 O N
8.1.19 Patient known or ‘’xxxx’’ 128 O N
suspected diagnosis
8.1.20 Patient active ‘’xxxx’’ 128 O N
medications
8.1.21 Patient's diet - - N N
8.1.22 Practice field No. 1 ‘’xxxx’’ 60 O N
(Comment 1)
8.1.23 Practice field No. 2 ‘’xxxx’’ 60 O N
(Comment 2)
8.1.24 Admission and - - N N
discharge dates
8.1.25 Admission status - - N N
8.1.26 Location Bed N N
^
Room N N
^
Location : service ID 10 O N
8.1.27 Nature of - - N N
alternative
diagnostic code and
classifiers
8.1.28 Alternative - - N N
diagnostic code and
classification
8.1.29 Patient religion - - N N

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Field # Field definition Contents Max Received Transmitted

length (from Host) (To Host)
8.1.30 Marital status - - N N
8.1.31 Isolation status - - N N
8.1.32 Language - - N N
8.1.33 Hospital service - - N N
8.1.34 Hospital institution - - N N
8.1.35 Dosage category - - N N

e.g.

P|1|100|||DOE^John^^^||19650501|F|||||DcJ^Doctor JONES||||||||||||

4.5 Test order

Field # Field description Contents Max Received Transmitted
length (from Host) (to Host)
9.4.1 Record type ID ‘O’ 1 Y Y
9.4.2 Sequence number 'x' 1 Y Y
9.4.3 Specimen ID "xxxx" 16 Y Y
^
Rack 6 N Y
^
Position 2 N Y
^
QC Lot Number 6 N Y
* See note 2
9.4.4 Instrument - - N N
specimen ID
9.4.5 Test ID ^
^ 10
^
Test code 60 Y Y
^
Test name - Y
9.4.6 Priority S : Stat 1 Y Y
R : Routine
9.4.7 Requested/ordered - - N N
date and time
9.4.8 Specimen collection YYYYMMDDHHMMSS 14 O O
date and time
9.4.9 Collection end time - - N N
9.4.10 Collection volume - - N N
9.4.11 Collector ID - - N N
9.4.12 Action code ‘C’ : cancel 1 Y N
‘N’ : New / add
9.4.13 Danger code - - N N
9.4.14 Relevant clinical - 50 O O
information

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Field # Field description Contents Max Received Transmitted

length (from Host) (to Host)
9.4.15 Date and time - - N N
specimen received
9.4.16 Specimen - - N N
descriptor
9.4.17 Ordering physician physician ID 9 O N
^
physician name 50 O N
^
^
service ID 10 O N
^
service name 50 O N
9.4.18 Physician’s - - N N
telephone number
9.4.19 User field No. 1 - - N N
9.4.20 User field No. 2. - - N N
9.4.21 Laboratory field No. - - N N
1
9.4.22 Laboratory field No. - - N N
2
9.4.23 Date and time - - N N
results reported or
last modified
9.4.24 Instrument charge - - N N
to computer
system
9.4.25 Instrument section - - N N
ID
9.4.26 Report types Upload only - N Y
"F" for ‘final’ result
9.4.27 Reserved field - - N N
9.4.28 Location or ward of - - N N
specimen collection
9.4.29 Nosocomial - - N N
infection flag
9.4.30 Specimen service - - N N
9.4.31 Specimen - - N N
institution
9.4.32 - - - N N
9.4.33 Operator Operator ID 20 N O
* See note 3

* Note 2: Rack and position are sent back to LIS for patient result upload only (STA R Max only). For QC results,
rack and position are not sent.

* Note 3:The User ID from the person who has validated the patient results is transmitted to the Host

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4.6 Results
Field # Field definition Contents Max Received Transmitted
length (From Host) (To Host)
10.1.1 Record type ID ‘R’ 1 Y Y
10.1.2 Sequence number 'x' 1 Y Y
10.1.3 Test ID ^
^
^
Test code 10 Y Y
^
Test name 60 - Y
^
^
Status result : (F) final 1 - Y
10.1.4 Data or ‘’xxxx’’ 12 Y Y
measurement * See note 4
value
10.1.5 Units ‘’xxxx’’ 15 Y Y
10.1.6 Reference range - - N N
10.1.7 Result abnormal 'x' 1 N Y
flags * See note 6
10.1.8 Nature of - - N N
abnormality
testing
10.1.9 Result status F: final -1 N Y
10.1.10 Date of change in - - N N
instrument
normative values
or units
10.1.11 Operator Uploal only : Operator ID 20 N Y
identification * See note 5
10.1.12 Date and time test - - N N
started
10.1.13 Date and time test YYYYMMDDHHMMSS 14 Y Y
completed
10.1.14 Instrument ‘’xxxx’’ 6 N Y
identification
* Note 4: Use decimal point and no separator. The measurement value can be a numeric or alphanumeric value.
In case an error of measurement is received from analyzer, the default alphanumeric value ‘NO RESULT’ is
transmitted to LIS.
* Note 5: The User ID who validated the patient result
* Note6:
Code Code Definition
A Validated
1 Results outside the ‘Validation Range’ defined on the Stago Analyzer
2 Technical error
3 >Mmax.
4 <Mmin.
6 QNS (Quantity Not Sufficient)

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8 Linearity

e.g.
Download (Previous result sent by Host):
R|1|^^^1|81|%||N||R||||20101105120000

Upload (New result sent by instrument) :

R|1|^^^1^PT%^^F|80|%||A||F||CxAutomate||20150403165841|RMAX

4.7 Manufacturer
Upload to the Host only.

This record is used to send details about Error and alarm flags

Field # Field Contents Max Received Transmitted

description length (From Host) (To Host)
15.1.1 Record type ID ‘M’ 1 N Y
15.1.2 Sequence 'x' 1 N Y
number Same as previous
segment "R"
15.1.3 Error flag * See note 6 1 N Y
15.1.4 Alarm flags * See note 7 10 N Y
15.1.5 Well * See note 8 2 N O
15.1.6 Reagent a Product identification 8 N O
^
Product name 16 N O
^
Lot number 8 N O
15.1.7 Reagent b Product identification 8 N O
^
Product name 16 N O
^
Lot number 8 N O
15.1.8 Reagent c Product identification 8 N O
^
Product name 16 N O
^
Lot number 8 N O
15.1.9 Reagent d Product identification 8 N Y
^
Product name 16 N Y
^
Lot number 8 N Y
15.1.10 Diluent Product identification 8 N O
^
Product name 16 N O
^
Lot number 8 N O

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Field # Field Contents Max Received Transmitted

description length (From Host) (To Host)
15.1.11 Cuvette Lot number 255 N Y
15.1.12 Cleaner Product identification 8 N Y
^
Product name 16 N Y
^
Lot number 255 N Y
15.1.13 Desorb a Product identification 8 N O
^
Product name 16 N O
^
Lot number 8 N O
15.1.14 Desorb b Product identification 8 N O
^
Product name 16 N O
^
Lot number- 8 N O
15.1.15 Desorb c Product identification 8 N O
^
Product name 16 N O
^
Lot number 8 N O
15.1.16 Desorb d Product identification 8 N O
^
Product name 16 N O
^
Lot number 8 N O
15.1.17 Calib Internal calibration 5 N Y
number

* Note 6:
Error Code Error Definition
A Validated
1 Results outside the ‘Validation Range’ defined on the Stago Analyzer
2 Technical error
3 >Mmax.
4 <Mmin.
6 QNS (Quantity Not Sufficient)
8 Linearity

* Note 7:
Alarm Code Alarm Definition
@ No alarm code
A Result is validated with M > Mmax.
C QC out of range or not performed
D QC - overruled
E Error Detection level 3

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Alarm Code Alarm Definition

F Error Detection level 2
G Error Detection level 1
H Main value: Peak shaving
I Result: Dilution change
J Result: repeated by user
K Reagents: temperature out of range
L Syringe #3: maintenance date exceeded
M Syringe #2: maintenance date exceeded
N Syringe #1: maintenance date exceeded
O Deviation > tolerance on double value
U Agitation Products

* Note 8: Fields 15.1.5 to 15.1.17 will be transmitted if option is set

e.g.

M|1|A|C\G|||||12300^STA-NEO CI^110558||S45113|CLEANER^STA-CLEANER^999999|||||7

4.8 Comment
Upload to the Host only.

This record may be incorporated after a result record and will then refer to this result.

Field # Field description Contents Max Received Transmitted

length (From Host) (To Host)
11.1.1 Record type ID ‘C’ 1 N Y
11.1.2 Sequence number 'x' 1 N Y
11.1.3 Comment source Upload: ‘I’ 1 N Y
11.1.4 Comment text Short comment 50 N O
^
Long comment 1 100 N O
^
Long comment 2 100 N O
^
Long comment 3 100 N O
^
Long comment 4 100 N O
^
Long comment 5 100 N O
e.g.

C|1|I|To Review^Suspicion of inhibitor (LA or anti-factor) : Run FVIII-IX-XI

4.9 Message terminator

Field # Field description Contents Max Received Transmitted
length (From Host) (To Host)
13.1.1 Record type ID ‘L’ 1 Y Y
13.1.2 Sequence number 'x' 1 Y Y

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Field # Field description Contents Max Received Transmitted

length (From Host) (To Host)
13.1.3 Termination code ‘N’ 1 Y Y
e.g.
L|1|N

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5. Examples
HOST STACOAGEXPERT
Download (requests):
<ENQ>
<ACK>
<STX>1H|\^&|||LIS|||||||P|LIS2-A2|20150403165858<CR ><ETX>77<CR ><LF >
<ACK>
<STX>2P|1|100|||Doe^John^^^||19650501|F<CR ><ETX>34<CR ><LF >
<ACK>
<STX>3O|1|141001001||^^^1\^^^2\^^^3\^^^4\^^^6\^^^7\^^^8|R||20150403100000||||N<CR
><ETX>6C<CR ><LF >
<ACK>
<STX>4L|1|N<CR ><ETX>07<CR ><LF >
<ACK>
<EOT>

Upload (results):
<ENQ>
<ACK>
<STX>1H|\^&|||LIS|||||||P|LIS2-A2|20150403165858<CR ><ETX>77<CR ><LF >
<ACK>
<STX>2P|1|100|||Doe^John||19650501|F<CR ><ETX>1A<CR ><LF >
<ACK>
<STX>3O|1|141001-001^288094^1^||^^^2^PTinr|R||||||||||||||||||||F<CR ><ETX>7D<CR ><LF >
<ACK>
<STX>4R|1|^^^2^PTinr^^F|0.94|INR||A||F||CxAutomate||20150403165841|RMAX<CR ><ETX>E2<CR ><LF >
<ACK>
<STX>5M|1|A|C|||||12300^STA-NEO CI^110558||S45113|CLEANER^STA-CLEANER^999999|||||7<CR ><ETX>33<CR
><LF >
<ACK>
<STX>6O|2|141001-001^288094^1^||^^^3^PTs|R||||||||||||||||||||F<CR ><ETX>AC<CR ><LF >
<ACK>
<STX>7R|1|^^^3^PTs^^F|12.8|Sec||A||F||CxAutomate||20150403165841|RMAX<CR ><ETX>40<CR ><LF >
<ACK>
<STX>0M|1|A|C|||||12300^STA-NEO CI^110558||S45113|CLEANER^STA-CLEANER^999999|||||7<CR ><ETX>2E<CR
><LF >
<ACK>
<STX>1O|3|141001-001^288094^1^||^^^4^PTrf|R||||||||||||||||||||F<CR ><ETX>0E<CR ><LF >
<ACK>
<STX>2R|1|^^^4^PTrf^^F|30.1|Sec||A||F||CxAutomate||20150403165841|RMAX<CR ><ETX>9A<CR ><LF >
<ACK>
<STX>3M|1|A|C|||||12300^STA-NEO CI^110558||S45113|CLEANER^STA-CLEANER^999999|||||7<CR ><ETX>31<CR
><LF >
<ACK>
<STX>4O|4|141001-001^288094^1^||^^^1^PT%|R||||||||||||||||||||F<CR ><ETX>5C<CR ><LF >
<ACK>
<STX>5R|1|^^^1^PT%^^F|80|%||A||F||CxAutomate||20150403165841|RMAX<CR ><ETX>97<CR ><LF >
<ACK>
<STX>6M|1|A|C|||||12300^STA-NEO CI^110558||S45113|CLEANER^STA-CLEANER^999999|||||7<CR ><ETX>34<CR
><LF >
<ACK>
<STX>7O|5|141001-001^288094^1^||^^^7^PTTAAUTOr|R||||||||||||||||||||F<CR ><ETX>81<CR ><LF >
<ACK>

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<STX>0R|1|^^^7^PTTAAUTOr^^F|0.80|Ratio||A||F||CxAutomate||20150403165841|RMAX<CR ><ETX>EB<CR ><LF >

<ACK>
<STX>1M|1|A|C||12203^STA-PTT A^110368|||11851^CaCl2 0.025 M^999||S45113|CLEANER^STA-
CLEANER^999999|||||7<CR ><ETX>69<CR ><LF >
<ACK>
<STX>2O|6|141001-001^288094^1^||^^^6^PTTAAUTOs|R||||||||||||||||||||F<CR ><ETX>7D<CR ><LF >
<ACK>
<STX>3R|1|^^^6^PTTAAUTOs^^F|32.0|Sec||A||F||CxAutomate||20150403165841|RMAX<CR ><ETX>07<CR ><LF >
<ACK>
<STX>4M|1|A|C||12203^STA-PTT A^110368|||11851^CaCl2 0.025 M^999||S45113|CLEANER^STA-
CLEANER^999999|||||7<CR ><ETX>6C<CR ><LF >
<ACK>
<STX>5O|7|141001-001^288094^1^||^^^8^PTTAAUTOrf|R||||||||||||||||||||F<CR ><ETX>E8<CR ><LF >
<ACK>
<STX>6R|1|^^^8^PTTAAUTOrf^^F|18.8|Sec||A||F||CxAutomate||20150403165841|RMAX<CR ><ETX>7D<CR ><LF >
<ACK>
<STX>7M|1|A|C||12203^STA-PTT A^110368|||11851^CaCl2 0.025 M^999||S45113|CLEANER^STA-
CLEANER^999999|||||7<CR ><ETX>6F<CR ><LF >
<ACK>
<STX>0L|1|N<CR ><ETX>03<CR ><LF >
<ACK>
<EOT>

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