MERIL DIAGNOSTICS PVT LTD

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ASTM LIS Communication protocol

R&D
Meril Diagnostics PVT LTD
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Revision History

Date Version Description / Modifications Author

09.Nov.2013 1.0 Draft created Chandrakant
11 No. 2013 1.1 Added TCP/IP, multiple data retrieval and Chandrakant
serial port cable configuration
18 May 2017 1.2 Protocol updated with new changes Naveen.K

INDEX

1 Overview ................................................................................................................................... 3
1.1 Purpose: .............................................................................................................................. 3
1.2 Scope: ................................................................................................................................. 3
1.3 Conventions: ....................................................................................................................... 3
1.4 Primary Reference: ............................................................................................................. 3
2 Communication Specifications .................................................................................................. 4
2.1 Physical layer ...................................................................................................................... 4
2.1.1 INTERCONNECTION DIAGRAM-HARDWARE ........................................................... 4
2.1.2 Serial port configuration: ............................................................................................... 5
2.2 Data link layer ..................................................................................................................... 5
2.2.1 Communication Status.................................................................................................. 6
2.2.2 Transmission Characters .............................................................................................. 8
2.2.3 CHECKSUM CALCULATION ....................................................................................... 8
2.3 Record transmission protocol .............................................................................................. 8
2.3.1 Message Header Record .............................................................................................. 9
2.3.2 Patient Information Record ........................................................................................... 9
2.3.3 Test Order Record ...................................................................................................... 10
2.3.4 Result Record ............................................................................................................. 11
2.3.5 Comment Record ....................................................................................................... 12
2.3.6 Request Information Record ....................................................................................... 12
2.3.7 Message Terminator Record ...................................................................................... 13
3 Actual data Send and Receive through AutoQuant. ................................................................ 14
3.1 RECEIVE: ......................................................................................................................... 14
 Select appropriate com-port , on which serial port of LIS is connected. ............................ 15
 Baud Rate will be selectable during LIS communication. Same baud rate should be set at LIS
Software. ................................................................................................................................. 15
3.2 DATA UPLOAD(send) ....................................................................................................... 20

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Overview

Purpose:

This Document details the specifications for communication of Clinical Chemistry analyzer With LIS
Software using ASTM protocol. Explain the process for communication through instrument software
by user.

Scope:

Detailed information on operation of the system is beyond the scope of this document. The
information offered here is strictly to aid programmers in grasping very basic operational features of
the Analyzer –LIS communication.

Conventions:

This document consists primarily of a series of examples that show the information needed to
successfully interface to the system. The basic concept of data transfer in this interface is the
exchange of data and control frames between the host system and the analyzer.

Primary Reference:

E1381 – 02
Low-Level Protocol to Transfer Messages between Clinical Laboratory Instruments and Computer
Systems.

E1394 – 97
Standard specifications for Transferring Information between Clinical Instruments and Computer
Systems.

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Communication Specifications
Communication specifications are based on a layer protocol. The layers are:
Physical Layer
Data Link Layer
Presentation Layer

Physical layer

Specifies the sending and receiving of signals between the Analyzer PC and LIS PC through
Physical and electrical connections.

INTERCONNECTION DIAGRAM-HARDWARE

AutoQuant Analyzer

Analyzer PC

ASTM Communication Packets

Serial RS-232 or TCP/IP

LIS PC

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Serial port configuration:

Standard serial port configuration as shown below can be used for LIS communication.
 Serial cable used as communication medium ensures uninterrupted communication
channel.
 Being a Peer-To-Peer type of communication medium, management of transmittable
packets is easier and taken care of by the host application.
 The serial cable connecting the Host PC and LIMS PC must be a single chunk (without any
joints) and should be lesser than 15 meters in length.
 Odd, Even, No parity can be used during communication against the default “None”
 Data Length sets those can be used are “8”
 Start Bits are “1”.
DB 9 (Host) DB 9 (LIMS)

1 1

2 2

3 3

4 4

5 5

6 6

7 7

8 8

9 9

Data link layer

Specifies the sending and receiving of data by link connections and for each frame between
Analyzer PC and LIS PC.

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Communication Status
Transition is accomplished through the following three phases.
Establishment Phase
Establishes a communication line, and determines the direction of data transfer.
The sender sends an [ENQ] signal to the receiver to respond to the sender, the receiver performs
the following action:

ANALYZER <ENQ> LIS-PC

Returns an [ACK] signal when communications are enabled.

ANALYZER <ACK> LIS-PC

Returns a [NAK] if receiver is not ready (BUSY).

ANALYZER <NACK> LIS-PC

Transfer Phase
The sender transmits messages to the receiver until all messages are transferred.

ANALYZER <STX> Frame 1 <ETB> C1 C2 <CR> <LF> LIS-PC

<ACK>

<STX> Frame 2 <ETB> C1 C2 <CR> <LF>

<ACK>

Termination Phase
The sender notifies the receiver that all messages have been transferred.
After the termination phase, the status returns to neutral.

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The sender sends the <EOT> to inform the receiver that the message transmission has been
completed.

ANALYZER <EOT> LIS-PC

When the sender sends <EOT>, sender goes in to neutral status.

When the receiver receives <EOT>, receiver processes data packet and then gets into neutral
status.

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Transmission Characters
Sr. # CHAR HEX Description
VALUE
1 STX 02 Receiver will slice data from this character
onwards for actual data evaluation.
2 ETX 03 Receiver will slice data up to this character
from STX for actual data evaluation.
3 ACK 06 Positive acknowledgment.
Character used to confirm correct and
complete string sent by the counterpart
4 NACK 15 Negative acknowledgment
Character used to confirm that string
received is incorrect or incomplete
5 ENQ 5 Character used to initiate communication.
(BOT)
6 EOT 17 Character used to confirm that transmission
from the transmitting end is over.
7 Component Delimiter
^ 5E(decimal
94)
8 ` 60 Repeat Delimiter
9 & 38 Escape Delimiter
10 P,O,R,Q,C -- Record identification bytes
P -Patient Information Record
O -Test Order Record
R -Result Record
C -Comment Record
Q -Request Information Record

CHECKSUM CALCULATION
The checksum is the modulus 8 of the sum of ASCII values of the frame characters starting with and
including ‘FN’ till character before <ETX> (in case of single frame) or <ETB> (in case of multiple
frames).

Record transmission protocol

Specifies the messages that are sent and received by the Analyzer PC and LIS PC.
ASTM data is sent or received in terms of packets.
Packet starts with the Header (H) and ends with the Terminator (L).
Packet without header and terminator is treated as invalid and will be ignored.

ASTM Record Types :

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Sr No. Record Type Convention

1 Message Header Record H
2 Patient Information Record P
3 Test Order Record O
4 Result Record R
5 Comment Record C
6 Request Information Record Q
9 Message Terminator Record L

Fields marked as * are mandatory.

Message Header Record
Field Message Header Record Size
Fields String format
1* Record Type ID H 1
2* Delimiter Definition |`^& 4
12 Processing ID P: (Production) Treat message 1
as an active message to be
completed according to standard
processing.
13 Version No. ASTM version No. 1394-97 10
14 Date and Time of current date time 14
message YYYYMMDDHHMMSS
15* Carriage Return <CR> End of the string 1

Table 7: Message Header Record

Example String:
H|\^&||||||||||P|E 1394-97|20100705071134<CR>
About Delimiters
1 | Field Delimiter (Alt + 124)
2 ` Repeat Delimiter (Alt + 96)
3 ^ Component Delimiter (Alt + 94)
4 & Escape Delimiter (Alt + 38)

Patient Information Record

Field Patient Information Record Size
Fields String format
1* Patient Record P 1
2* Sequence Number Frame Number (only 1 digit) 1
3 Practice Assigned Patient Patient ID 40

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ID
6 Patient Name Name of the Patient (Last Name^First 30
Name^Middle Name^Title).
If Patient Name contains single quote i.e.” ‘”
then it will get replaced by “`” while saving
data.
8 BirthDate YYYYMMDDHHMMSS 14
9 Patient Sex M/F/U (Male/Female/Other) 1
11 Patient Address Street Address^City^State^Zip^Country 50
Code
If Patient Address contains single quote
i.e.” ‘” then it will get replaced by “`” while
saving data.
13 Patient Telephone No. Phone1`Phone2`Phone3 (It may contain 20
area code ,countrycode, beeper number,
hours to call) e.g.
+912212345678`+912212345679
14 Attending Physician ID (Ordering Physician `Attending Physician 40
`Referring Physician)
If Physician ID contains single quote i.e.” ‘”
then it will get replaced by “`” while saving
data.
17 Height Height/Weight and Unit are separated by 8
18 Weight component delimiter. 1.2^M 7
(Default unit is cms for ht and Kg for wt).
36* Carriage Return <CR> 1

Table 8: Patient Information Record

Example String:
P|1|patient1|||VICHARE^PAT1^V||19710704|M||ANDHERI^MAHARASHTRA|RES1|8756873`694
749387948|NENE^RAM|||1.2^M|23<CR>

Important: -
Test Order Record
Field Test Order Record Size
Fields String format
1* Test Order Identifier O 1
2* Sequence Number Frame No. 1
3* Specimen ID Sample ID^Container No. (Samp1^01) 25

Values of Container No:

1 = TUBE (10 ml) – Default Value
3 = TUBE (5-7 ml)

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5* Universal Test ID Test Name (^^^ALB`^^^ALP`^^^LIVER) 250

6* Priority S /A : Stat OR As soon as possible [i.e. 1
Emergency]
R : Routine
8 Specimen collection Date Actual date and time , the sample was 14
and Time collected (YYYYMMDDHHMMSS)
11 Collector ID The person and facility which collected the 20
specimen.
If Collector ID contains single quote i.e.” ‘”
then it will get replaced by “`” while saving
data.
12* Action Code A : Add the requested tests or batteries to 1
the existing sample
N : New requests accompanying a new
sample
P : Pending sample (Add but don't
schedule)
C : Cancel request for the battery or tests
named (Delete Test)
15 Date/ Time Specimen Date and Time recorded by laboratory 14
Received
16* Specimen Descriptor Sample Type : Blood, Urine, Serum, 6
Plasma, CSF (Not Case-Sensitive)
32* Carriage Return <CR> 1

Example String:
O|1|020100030286||^^^GLU`^^^UREA|R||||||A||||SERUM<CR>

Important
Specimen collection Date and Time:
If YYYYMMDD part is not Numeric then Analyzer Software will save the data received with Sample
Collection Date same as System Date.

Result Record
Field Result Record Size
Fields String format
1* Result Record Identifier R 1
2* Sequence Number Frame No. 1
3* Universal Test ID Test Name (^^^ALB) 8
4* Data or Measurement Result value 10
Value
5 Units ISO 2955 20
6 Reference Ranges Lower limit to Upper limit 30

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7* Result Abnormal Flags 50

8 Nature of Abnormality N :Generic Normal Range was applied 1
Testing to all patients
9 Result Status C : Correction of previously
transmitted results (Patient Report)
F : Final Results
13* Date / Time Test Result Date in YYYYMMDDHHMMSS 14
Completed format
15* Carriage Return <CR> 1
Example String:
R|1|^^^ALP|200|IU/L|DEFAULT|A|N|F||||20100513113450<CR>
R|2|^^^AMY|93|U/L|DEFAULT|N|N|F||||20100513113535<CR>

Comment Record
Field Comment Record Size
Fields String format
1* Comment Record Identifier C 1
2* Sequence Number Frame No. 1
L : Computer System (LIS) 1
3* Comment Source
I : Instrument (ASTM)
4* Comment Text Code ^Comment Text 1000
5* Comment Type G : Generic/Free text comment 1
T: Test Name comment
6* Carriage Return <CR> 1

Table 11: Comment Record

Example String:
C|1|I| Test ALB Does Not Exist For SampleID 01010125.|G<CR>

Request Information Record

Field Request Information Record Size

Fields String format
1* Request Record Identifier Q 1
2* Sequence Number Frame No. 1
3* Starting Range ID Number SampleID1`SampleID2 115
6 Nature of Request Time S : Sample Collection Date 14
Limits
R : Result Test Date 14
13* Request Information Status O : Requesting test orders and 1
Codes demographics only
15* Carriage Return <CR> 1
Example String:
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Q|1|^020100030279`020100030321`020100030304`020100030297|||S|||||||O<CR>

Message Terminator Record

Field Message Terminator Record Size
Fields String format
1* Message Terminator L 1
Record Identifier
2* Sequence Number 1 1
3* Termination Code N : Normal Termination 1

Table 12: Message Terminator Record

Example String:
L|1|N<CR>

Data packets format example-

Patient Request (Host to LIS)

Patient Details (LIS to Host)

<ENQ>(LIS to Host)
<ACK> (Host-> LIS)
<STX>1H|`^&||****|TBM-LIMS|Seepz||||||E-1394-
97|20131205090513<CR>P|1|PAT1|LPAT1|LPAT13 |Joshi^Pramila^V||19710704|M|W|ANDHE
RI^MAHARASHTRA|RES1|8756873`69749387948|`NENE^RAM|SP1|SP2|1.2^M|23|PDIG1|PACT
MED|DIET|PR1|PR2|20080929`20080929|OP|ANDHERI|NAltDig|AltDig|H|M|ARP|marathi|HpSer|
HpInst|A<CR>C|1|L|Patient
Information|G<CR>O|1|Pat1|IPat1|^^^ABCD1`^^^ALB`^^^TBIL|R|20080929|20080929|2008092
9|200^ml|preeta|N|DngC|RCIInfo|20080929|SERUM|`NENE^RAM|233245354|||LB1|LB2|2008092
9|566|B1|O|RES1|WARD1|NIF|SPSER|SPINST<CR>L|1|N<CR><ETX>6B<CR><LF> (LIS to
Host)
<ACK> (Host-> LIS)
<EOT> (LIS to Host)

Result Packet (Host to LIS)

<ENQ><ACK>
<STX>1H|\^&|||Meril^3.6^11052213||||||||E-1394-97|20131203141051<CR><ETX>28<CR><LF><ACK>
<STX>2P|1||||Chan Du|||M||||||25^Y<CR><ETX>49<CR><LF><ACK>

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<STX>3R|1|^^^TP|10.00|g/dL|0^0|||N|F||||20131203141051<CR><ETX>0F<CR><LF><ACK>
<STX>4R|2|^^^ALB|5.00|g/dL|0^0|||N|F||||20131203141051<CR><ETX>10<CR><LF><ACK>
<STX>5L|1|N<CR><ETX>06<CR><LF><ACK>
<EOT> <ACK>

Actual data Send and Receive through AutoQuant.

RECEIVE:

For TCP/IP settings, go to Maintenance > parameter settings > Enter password > enter TCP/IP
details with port number > Select.

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For serial port or TCP/IP communication, Go to Schedule screen, click the button shown below

‘LIS information’ window will open.

For Serial port:

Select the port number and Baud rate.
 Select appropriate com-port, on which serial port of LIS is connected.
 Baud Rate will be selectable during LIS communication. Same baud rate should be set at
LIS Software.
For TCP/IP:
Select TCP/IP and confirm the IP address and IP port. Start receiving directly.
 Click on Receive button as highlighted in above screen.
 On click patient Input Dialog will open. As displayed below

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 Enter patient ID for patient information to be receive and click on save. Multiple patient ID can
be saved similarly.

 After save Receive button will be enabled as shown in below screen.

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 Click on Receive, as highlighted in above screen.

 Application will send all patient ID data to LIS, in Response LIS will send patient information &
test order. Application will store this data & displayed in screen as shown below.

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 All details are shown in respective fields, Instrument sample ID and position will be
automatically taken up by the software based on already scheduled or run samples for that
day. User has to confirm all the details. If required to change Position and container type,
user can select that patient, change position and type, click OK, modified information will be
reflected for that sample.
 Data will be reflected in list. Click Save to schedule the details.
 Patient information receive process is completed. Work list can be seen as below.

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 User can run the schedule as per normal procedure.

DATA UPLOAD (send)

 After Run completion, results are displayed on report screen as displayed below.

Select Patient ID to send the results to LIS. Add information (details) if required, click saves and click
on Data upload button as displayed in above screen. If required, multiple patient data can be
selected by dragging mouse over required ID’s.
It will ask for LIS communication details select the fields as per below screen.

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LIS Port has to be selected.

Click on Select. Data will be uploaded to LIS.
Completion message will be displayed in screen.

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