DIS - 0005 (Astm Automation Robotics Host Interface) ASTM E 1381-91 and E1394-91 PDF

Development Interface
Specification (DIS)
for
ASTM Automation/Robotics Host

Interface Document
Version 5.3
Data Innovations, Inc.
Document ID: DIS_0005

Last Updated: September 18, 2008
Development Interface Specification (DIS) for Data Innovations ASTM Automation/Robotics
© COPYRIGHT 2006
DATA INNOVATIONS, INC. ®
120 Kimball Avenue, Suite 100
South Burlington, Vermont 05403
Office: (802) 658-2850
Customer Support: (802) 658-1955
Support Email: support@datainnovations.com
The contents of this manual are subject to change

without notice and shall not be regarded as warranty.
Table of Contents
1. Revision History .................................................................................................................... iii
1. Introduction ............................................................................................................................. 1
1.1. Purpose ............................................................................................................................. 1
1.2. Definitions, Acronyms and Abbreviations ....................................................................... 1
1.3. Scope ................................................................................................................................ 1
1.4. References ........................................................................................................................ 1
2. Overall Description ................................................................................................................. 2
2.1. Cable Configuration ......................................................................................................... 3
2.2. Low-Level Protocol.......................................................................................................... 4
2.3. Message Hierarchy ........................................................................................................... 6
2.4. Message Segment Structure ............................................................................................. 7
2.4.1. Message Header Record (H) ..................................................................................... 8
2.4.2. Patient Information Record (P) ............................................................................... 10
2.4.3. Test Order Record (O) ............................................................................................ 12
2.4.4. Test Result Record (R)............................................................................................ 16
2.4.5. Comment Record (C) .............................................................................................. 18
2.4.6. Equipment Detail Record (M) ................................................................................ 20
2.4.7. Specimen and container Detail Record (M)............................................................ 22
2.4.8. Test Code Detail Record (M).................................................................................. 26
2.4.9. Terminator Record (L) ............................................................................................ 27
2.5. High-Level Protocol ....................................................................................................... 28
2.5.1. New Order/Add-on Test ......................................................................................... 28
2.5.2. Delete Test(s) from an Order .................................................................................. 28
2.5.3. Sample Status Message ........................................................................................... 29
2.5.4. Sample Result(s) Message ...................................................................................... 29
2.5.5. QC Result(s) Message............................................................................................. 31
2.5.6. Container Tracking Message .................................................................................. 32
2.6. Communication Examples ............................................................................................. 33
2.6.1. Examples ................................................................................................................. 34
3. External Interface Requirements........................................................................................... 37
3.1. Hardware Interfaces ....................................................................................................... 37
3.2. Software Interfaces ......................................................................................................... 37
4. Other Nonfunctional Requirements ...................................................................................... 38
4.1. Performance Requirements ............................................................................................ 38
4.2. Safety Requirements ...................................................................................................... 38
4.3. Security Requirements ................................................................................................... 38
5. Other Requirements .............................................................................................................. 39
Document ID: DIS_0005 v5.3 Page i

6. Approval Signatures.............................................................................................................. 40
Document ID: DIS_0005 v5.3 Page ii

1. Revision History
Name Date Reason For Changes Version

Don Jarvis 07.14.05 Original Document 1.0
Don Jarvis 07.20.05 Updated examples 1.1
David Thompson 05.30.08 10.1.9 – Updated description 2.0 Draft
11.1.1 - 11.1.5 – Updated table
David Thompson 05.30.08 Approved 2.0
David Thompson 05.30.08 Updated Revision History 3.0 Draft
David Thompson 06.27.08 9.4.19.1 - 9.4.19.5 – Updated table 4.0 Draft
Carl Maklad 8/26/2008 Formatted the whole document to follow the 5.0 Draft
standard DIS format structure
Carl Maklad 9/3/2008 2 – Moved sections 2.2, 2.3, 2.4, and 2.5 5.1 Draft
around to make the logical procession in the
same order as the layers of the protocol
2.2.5 – Fixed a font issue (the word “flag”)
2.4.3 – Fixed an “Error! Bookmark not
defined”
2.4.5 – Added a note explaining that any
comment containing <cr>, <lf>, or <cr><lf>
will be split into multiple comment records
2.4.8 – Added “M” to the title
2.6.1 – Fixed a font/size issue
Carl Maklad 9/4/2008 1.3 – Added File I/O to the list of supported 5.2 Draft
type of connections
2.1 – Re-numbered all figures and formatted
figures 2
2.2 – Re-numbered all figures and formatted
figures 3
Carl Maklad 9/15/2008 2.2 – Added a paragraph explaining Low Level 5.3 Draft
Protocol for File I/O with/without
semaphore/queue files
2.3 – Added message hierarchies for Specimen
Status, Container Status, Container Storage,
and Instrument messages
2.4.2-3 – Formatted Header and Table
2.4.5 – Changed Comment “is received” to “is
being sent”
Document ID: DIS_0005 v5.3 Page iii

Carl Maklad 9/18/2008 Approved 5.3
Document ID: DIS_0005 v5.3 Page iv

1. Introduction
1.1. Purpose
This document contains the Development Interface Specifications for the Data Innovations
ASTM Automation/Robotics LIS which are based on ASTM E 1381/1394-91 standards. In
addition to the ASTM Standard, this document also has requirements that relate to the DII
ASTM LIS Interface processing of messages.
1.2. Definitions, Acronyms and Abbreviations
ASTM American Society for Testing and Materials

IM Instrument Manager by Data Innovations, Inc.
DII Data Innovations, Inc.
1.3. Scope
The Data Innovations ASTM Automation/Robotics LIS interface is a bi-directional interface that
uses the standard Instrument Manager programming API for integration with the Instrument
Manager application. The interface will use the standard Instrument Manager I/O module that
allows for the following communications methods:
RS-232 serial
TCP/IP
LAT
File I/O
1.4. References
ASTM E 1381/1394-91
Document ID: DIS_0005 v5.3 Page 1

2. Overall Description
This section details the requirements for the interface between the Instrument Manager (IM) and the host
system. The IM can route information to automation and diagnostics equipment via one logical interface.
The IM uses “dynamic” or “unsolicited” download from the host system to populate the IM internal
database. The IM is then responsible for disseminating the information from that point to the instruments
or devices attached to it. The event that triggers a download to the IM is dependent on the device(s) that
are to be attached. If the customer’s implementation is to include devices that can notify the host systems
of a specimen status change, such as receipt of a sample in the laboratory, then the trigger event for a
download must be linked to a previous status change such as printing of the barcode, physically collected,
etc. Regardless of the trigger, it must occur before the sample arrives in the laboratory. If the
implementation is only for analytical and/or post-analytical devices, then downloading information can be
triggered by the sample reception within the laboratory.
Important: The IM’s ASTM-Serial implementation can have one bi-directional or multiple unidirectional
interfaces. The reason for multiple unidirectional interfaces is to increase bandwidth required for large-
scale automation systems and to remove line contention issues associated with ASTM-Serial
implementations. When implementing multiple unidirectional interfaces, one or more physical interfaces
are devoted to downloading information from the host system to the IM. The other physical interface(s)
are for uploading information from the IM to the host. Most implementations will be two or more
unidirectional interfaces.
Important: The IM’s ASTM-TCP/IP implementation can have one or more socket interfaces depending
on the host systems ability to service and receive multiple transactions on one or more sockets.
Note: Users of this document should have at least a basic understanding of:
• Transferring Information between Clinical Instruments and Computer Systems. American
Society for Testing and Materials. West Conshohocken, PA. 1997; E 1394-91. All rights
reserved.
• Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and
Computer Systems. American Society for Testing and Materials. West Conshohocken, PA.
1997; E1381-95. All rights reserved.
This document will describe a specific implementation of these standards, but will not act as a tutorial or
elaborate on definitions, concepts, etc., of these standards. For further information on these standards,
please contact:
American Society for Testing and Materials
100 Barr Harbor Drive
West Conshohocken, PA 19428-2959
Phone: +1(610) 832-9585

Fax: +1(610) 832-9555

www.astm.org
2.1. Cable Configuration
The wiring configuration for the bi-directional or unidirectional ASTM-Serial physical interface
connection is listed below.
Note: A majority of ASTM-Serial installations of the IM will be two unidirectional interfaces.
IM Cable Side Host Cable Side

DB-25 Male Connector
2 (Transmit) (Receive)
3 (Receive) (Transmit)
7 (S. Ground) (S. Ground)
Figure 1 - Wiring configuration for Serial cable connection
The diagram below illustrates the wiring configuration for 10Base-T cable connection.

IM Ethernet Card Side Host Ethernet Hub Cable Side

RJ-45 Connector RJ-45 Connector
1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8
T+
T-
R-
R+
Figure 2 - Wiring configuration for 10Base-T cable connection
2.2. Low-Level Protocol
In the ASTM-Serial interface, ASTM E 1381-91 and E1394-91 standards are utilized. ASTM E 1394-91
deals with the data to be transferred. This section is about ASTM E 1381-91, which deals with how this
data will be transferred.
There are two common implementations of E 1381-91 and the differences in these implementations lie in
with how the data is “broken up” into packets of information. One implementation, referred to in this
document as Method #1, or “Unpacked”, separates the information by the same means as the ASTM
E1394-91 standard does. This method is very logical but is very inefficient when large volumes of data
are being transferred.

Low Level Frame #1 Low Level Frame #2 Low Level Frame #3 Low Level Frame #4
Message Header Record Patient Information Record Test Order Record Message Terminator Record
Example:
E S E S E
C L C L
N T 1 E1394 Record #1 T C1C2 T 2 E1394 Record #2 T C1C2
R F R F
Q X B X X
Sender
A A
C C
K K
Reciever
Figure 3 - Method #1 (Unpacked)
The second implementation, referred to in this document as Method #2, or “Packed”, divides the data
being transferred by placing the maximum amount of data in each packet (240 bytes). This
implementation is more efficient at moving large volumes of data but is not as logical to those who are
familiar with using Method #1.
Low Level Frame #1 Low Level Frame #2
Message Header Record Patient Information Record Test Order Record Message Terminator Record
E
N
S
T 1 E1394 Record #1 ... E1394 Record #3A
E
T C1C2
C L
R F
S
T 2 E1394 Record #3B E1394 Record #4
E
T C1C2
C L
R F
E
O
Q X B X X T
A A A
C C C
K K K
Figure 4 - Method #2 (Packed)
Important: The IM can receive information from the host system using Method #1 (Unpacked) or Method
#2 (Packed). The IM will send the information by Method #2 (Packed) only.
In the ASTM-TCP/IP interface, the IM minimum lower-level protocol (MLLP) components are:
• IEEE 802.3
• Transmission Control Protocol / Internet Protocol (TCP/IP) implementation. The Internet Protocol
(IP) portion will conform to IAB/IETF Version 4.0 (IPv4).
• Socket-level connectivity acting as client, server or both. When implementing the IM as a
client, the IP address and port number of the server is required. When implementing the IM
as a server, only an IP address of the IM is needed to configure the connection.
The LIS can communicate with IM using File I/O. In this scenario, there are 2 methods for
communication: with semaphore/queue files, or without semaphore/queue files. In the case of

using semaphore/queue files for communication, the ASTM Automation/Robotics Host Interface
driver provides for configurable I/O file extensions as well as I/O queued file extensions. When
the LIS is done writing to the Input (Order) file with the Input file extension, it creates another 0
byte Input file with the Input queued file extension. IM, then, opens the Input file and reads its
content. Once done, IM deletes both files. The same methodology is used by IM when it is time
to transfer results back to the LIS. When IM is done writing to the Output (Result) file with the
Output extension, it creates another 0 byte Output file with the Output queued file extension. The
LIS, then, should open the Output file and read its content. Once done, LIS should delete both
files.
In the other case, not using the semaphore/queue files, IM tries to rename all input files from the
LIS. If a file is renamed successfully, then IM opens this file and reads its content, otherwise, IM
ignores this file since the LIS is still writing to it. The same methodology is used by IM when it
is time to transfer results back to the LIS.
2.3. Message Hierarchy
For various information flows various combinations of segments are relevant. Brackets, [ ], indicate
segments that are optional. Braces, {}, indicate segments that may be repeated.
Laboratory Order Message

H Message Header Record
P Patient Information Record
[{C}] Comment Record
O Test Order Record
{R} Result Record
L Terminator Record
Laboratory Result Message

P Patient Information Record
O Test Order Record
{R} Result Record
L Terminator Record
Laboratory Specimen Status Message

[P] Patient Information Record
[O] Test Order Record
[{M}] Manufacturer Record

L Terminator Record
Laboratory Container Status Message

[P] Patient Information Record
[O] Test Order Record
[{M}] Manufacturer Record
L Terminator Record
Laboratory Container Storage Message

{M} Container data
L Terminator Record
Laboratory Instrument Message

{M} Manufacturer Record
L Terminator Record
2.4. Message Segment Structure
This section contains information about the ASTM E 1394-91 records, fields and components that are
used in the IM interface to the host system.
Below is a detailed explanation of the table headings for the records in the following pages of this
chapter.
Heading Description
# Indicates the sequential position of this field in the record.
Field # A unique ASTM E 1394-91 reference number assigned to each field.
Name An ASTM E 1394-91 reference name assigned to each field.
Bytes Indicates the maximum length of this field.
Indicates significance of this field to this implementation. The column will have two
Direction variables (From Host/To Host). The “From Host” will denote the inbound or
download and “To Host” the outbound or upload from the Instrument Manager.
Code Description
Required Required
Required if an associated trigger event occurs. See
Required/T
notes on field for further details.
If downloaded to the Instrument Manager, it will be
Optional parsed and stored. The Instrument Manager will
upload to the host the same information if applicable.
Ignored Information will be discarded.
N/A The contents of this field will be empty.

Heading Description
This column provides quick reference notes for this field. Each significant field will
Comments be discussed in greater detail in the field notes section directly after the overview
section for that record.
2.4.1. Message Header Record (H)
This section describes the implementation of the ASTM E 1394 Message Header Record.
ASTM Direction
Field From
# Name Bytes To Host Type Comments
# Host
1 7.1.1 Record Type ID 1 Required Required Alphanumeric Value: H (ASCIIDEC 72)
2 7.1.2 Delimiter Definition 4 Required Required Alpha Value: | \ ^ &
3 7.1.3 Message Control ID - Ignored Ignored
4 7.1.4 Access Password - Ignored Ignored
See detailed description of
5 7.1.5 Sender Name or ID 0 - 20 Ignored Required/T Alphanumeric
this field
6 7.1.6 Sender Street Address - Ignored Ignored
7 7.1.7 Reserved Field - Ignored Ignored
8 7.1.8 Sender Telephone Number - Ignored Ignored
9 7.1.9 Characteristics of Sender - Ignored Ignored
10 7.1.10 Receiver ID - Ignored Ignored
See detailed description of
11 7.1.11 Comments Ignored Required Alphanumeric
this field
12 7.1.12 Processing ID 1 Required Required Alpha Value: P
13 7.1.13 Version Number 1 Required Required Numeric Value: 1 (ASCII DEC 49)
Format:
14 7.1.14 Date/Time of Message 14 Optional Required Date/Time
YYYYMMDDHHMMSS
Note: The parenthetical numbers following the field names are references to the American
Society for Testing and Materials (ASTM©) E 1394-91 Standard for transferring information
between clinical instruments and computer systems. For further information, refer to Storer, R.
et al, eds. General Methods and Instrumentation. In: Annual Book of ASTM Standards: West
Conshohocken, PA: ASTM; 1996; Vol. 14.01:380-394.
Record Type ID (7.1.1) Identifies the record as a message header record.

Value: H (ASCIIDEC 72)
Delimiter Definition (7.1.2) The following are the delimiter definitions for this
interface:
Code Definition

<CR> Record Delimiter

| Field Delimiter
\ Repeat Delimiter
^ Component Delimiter
& Escape Delimiter
Sender Name or ID (7.1.5) In the “IM-to-Host” communications, the contents of the

IM ID field in the IM configuration will be placed in this
field. If the IM ID field is blank, this field will also be
empty. In the “Host-to-IM” communications, the
contents of this field will be ignored.
Comment or Special Instructions (7.1.11) In the “IM-to-Host” communications, this will be the
version of the Instrument Manager ASTM interface. In
the “Host-to-IM” communications, the Instrument
Manager will ignore the contents of this field.
Format: V#.##
Processing ID (7.1.12) Support the following codes:
Code Definition
P Production (Patient) information
NOTE: If this field is not a “P”, then the whole

message will be discarded.
Version Number (7.1.13) Current value is 1 (ASCIIDEC 49).
NOTE: If this field is not a “1”, then the whole

Date and Time of Message (7.1.14) Format will be as defined in ASTM E 1394-91 in section
6.6.2.
Format: YYYYMMDDHHMMSS

2.4.2. Patient Information Record (P)
This section describes the implementation of the ASTM E 1394 Patient Information Record.
ASTM Direction
From Type
# Field # Name Bytes To Host Comments
Host
1 8.1.1 Record Type ID 1 Required Required Alpha Value: P (ASCIIDEC 80)
2 8.1.2 Sequence Number 1 Required Required Numeric
3 8.1.3 Practice Assigned Patient ID 1-25 Optional Required/T Alphanumeric Alphanumeric
4 8.1.4 Laboratory Assigned Patient ID - Ignored Ignored
5 8.1.5 Patient ID No. 3 30 Optional Ignored Alphanumeric See detailed description of this field
6 8.1.6 Patient Name 30 Optional Ignored Alpha See detailed description of this field
7 8.1.7 Mother’s Maiden Name - Ignored Ignored
8 8.1.8 Birthdate 8 Optional Optional Date Format: YYYYMMDD
9 8.1.9 Patient Sex 1 Optional Optional Alpha Values: M, F, U
10 8.1.10 Patient Race-Ethnic Origin - Ignored Ignored
11 8.1.11 Patient Address - Ignored Ignored
12 8.1.12 Reserved Field - Ignored Ignored
13 8.1.13 Patient Telephone Number - Ignored Ignored
14 8.1.14 Attending Physician ID 0-40 Optional Ignored Alphanumeric See detailed description of this field
15 8.1.15 Special Field #1 - Ignored Ignored
16 8.1.16 Special Field #2 - Ignored Ignored
17 8.1.17 Patient Height - Ignored Ignored
18 8.1.18 Patient Weight - Ignored Ignored
19 8.1.19 Patient’s Known Diagnosis - Ignored Ignored
20 8.1.20 Patient’s Active Medication - Ignored Ignored
21 8.1.21 Patient’s Diet - Ignored Ignored
22 8.1.22 Practice Field No. 1 - Ignored Ignored
23 8.1.23 Practice Field No. 2 - Optional Ignored Alphanumeric
24 8.1.24 Admission/Discharge Dates - Ignored Ignored
25 8.1.25 Admission Status - Ignored Ignored
26 8.1.26 Location 30 Optional Ignored Alphanumeric See detailed description of this field
Society for Testing and Materials (ASTM) E 1394-91 Standard for transferring information
Record Type ID (8.1.1) Identifies the record as a patient information record.

Value: P (ASCIIDEC 80)
Sequence Number (8.1.2) As defined in ASTM E 1394-91 specification.
Practice Assigned Patient ID (8.1.3) This field is used for the patient’s social security number,
medical record number or any other universal identification
number used for comment fields and reports for devices
connected.
Note: If the contents of field exceed the length of the
comment fields of the instruments or devices, the contents
will be truncated when transmitted to the instrument.

Patient ID No. 3 (8.1.5) It is used as a secondary patient identification field for

providing identification number used for comment fields
and reports for devices connected (Similar to Practice
Assigned Patient ID (8.1.3) field).
Patient Name (8.1.6) This field is used for the patient’s name. The format will
be as defined in ASTM E 1394-91 in section 6.6.6 and will
be used for comment fields and reports for devices
connected.
Birthdate (8.1.8) Format will be as defined in ASTM E 1394-91 in section

6.6.2.
Format: YYYYMMDD
Patient Sex (8.1.9) Identifies the sex of the patient. The following codes are
supported.
Code Definition
M Male
F Female
U Unknown
Null Use of field is optional
Attending Physician ID (8.1.14) This field is used for the patient’s physician or care giver’s
name. The format will be as defined in ASTM E 1394-91
in section 6.6.6 and will be used for comment fields and
reports for devices connected. Only 2nd, and 3rd
components will be used. No repeat delimiters are
permitted.
Format: ID^Lastname ^Firstname^Middle^suffix^title
Location (8.1.26) This field is used for the patient’s location. It will be used
for comment fields and reports for devices connected.

2.4.3. Test Order Record (O)
This section describes the implementation of the ASTM E 1394 Test Order Record.
ASTM Direction
# Field # Name Bytes From Host To Host Type Comments
1 9.4.1 Record Type ID 1 Required Required Alpha Value: O (ASCII DEC 79)
3 9.4.3 Specimen ID 1-13 Required Required Alphanumeric Alphanumeric
4 9.4.4 Instrument Specimen ID
9.4.4.1 Sequence # 5 Ignored Required/T Numeric Device sequence number
9.4.4.2 Carrier # - Ignored Required/T Numeric Rack or Carousel number
9.4.4.3 Position # - Ignored Required/T Numeric Position in rack or carousel
5 9.4.5 Universal Test ID
9.4.5.1 Universal Test ID - Ignored Ignored
9.4.5.2 Universal Test ID Name - Ignored Ignored
9.4.5.3 Universal Test ID Type - Ignored Ignored
Manufacturer’s / Local
9.4.5.4
Code
9.4.5.4.1 Test Code 1-10 Required Required/T Alphanumeric See detailed description of this field
9.4.5.4.2 Treatment Code 0-4 Optional Ignored Alphanumeric See detailed description of this field
9.4.5.4.3 Pretreatment Code - Ignored Ignored Reserved for Future Use
6 9.4.6 Priority 1 Required Required Alpha Values: R, S, A
Requested/Ordered Date
7 9.4.7 - Ignored Ignored
and Time
Specimen Collection Date Date/Time
8 9.4.8 14 Required Ignored Format: YYYYMMDDHHMMSS
and Time
9 9.4.9 Collection End Time - Ignored Ignored
10 9.4.10 Collection Volume - Ignored Ignored
11 9.4.11 Collector ID - Ignored Ignored
12 9.4.12 Action Code 1 Required Required/T Alphanumeric See detailed description of this field
13 9.4.13 Danger Code - Ignored Ignored
14 9.4.14 Relevant Information - Ignored Ignored
Date/Time Specimen Date/Time
15 9.4.15 - Ignored Required See detailed description of this field
Received
16 9.4.16 Specimen Descriptor
9.4.16.1 Specimen Type Required Required Alphanumeric See detailed description of this field
9.4.16.2 Specimen Source - Ignored Ignored
17 9.4.17 Ordering Physician - Ignored Ignored
18 9.4.18 Physician’s Telephone # - Ignored Ignored
19 9.4.19 User Field No. 1
9.4.19.1 Comment Field 1 - Optional Ignored Alphanumeric See detailed description of this field
25 9.4.18 Instrument ID - Ignored Optional Alphanumeric ID of sending device
Record Type ID (9.4.1) Identifies the record as a test order record.

Value: O (ASCIIDEC 79)
Sequence Number (9.4.2) As defined in ASTM E 1394-91

specification.
Specimen ID (9.4.3) In the “Host-to-IM” communications, this

field is the sample ID that is encoded in the
printed barcode on the primary tube or
appropriate specimen ID. In the “IM-to-
Host” communications, this field is the
sample ID that is encoded in the printed bar-
code on the primary tube or appropriate
specimen ID or the control material
identification.
Instrument Specimen ID (9.4.4)

Sequence # (9.4.4.1) In the “Host-to-IM” communications, if
samples without barcodes are placed on one
or more devices, then this becomes the
primary key for sample identification. Non-
barcode operation is not recommended. In
“IM-to-Host” communications, this is the
instrument or device sequence number if
available.
Carrier # (9.4.4.2) Rack or carousel number
Position # (9.4.4.3) Sample position within the rack or carousel
Universal Test ID (9.4.5) Only the fourth component of this field is

used. All other components are ignored.
Universal Test ID (9.4.5.1) Content is ignored
Universal Test ID Name (9.4.5.2) Content is ignored
Type (9.4.5.3) Content is ignored
Manufacturer’s or Local Code (9.4.5.4)
Test Code (9.4.5.4.1) For the host download and the IM upload of
results, this field adds the test selection
code(s) for the sample. For the IM upload
of sample status messages this field will be
empty. See Sample Status Message section
for further information.
Treatment Code (9.4.5.4.2) Reserved for future use.
Pretreatment Code (9.4.5.4.3) Reserved for future use.
Priority Code (9.4.6) This field indicates the priority of the test(s).
The sample status will be the status of the
last successful download for this sample.
The codes supported are listed below.

Code Definition
R Routine sample
S STAT sample
A As Soon As Possible
Specimen Collection Date and Time (9.4.8) This field indicates the date and time the
host associates with the creation of the
sample.
Action Code (9.4.12) This field indicates the action to be taken

with respect to the sample ID (9.4.3) and
Universal Test ID (9.4.5) on the host
downloads. On IM uploads, this field
indicates whether results are from control
material or patient samples.
Code Definition
1 Cancel request for test(s) named for an existing
C
patient/sample.
2 Add the test(s) named for an existing
A
patient/sample.
N2 New patient/sample and test(s).
Indicates control result upload from the
Q instrument in Instrument ID field in Results
Record (10.1.14.1).
Null Indicates patient sample result upload.
Notes:
1
Due to the auto-purging feature of the IM, the host is not
required to cancel tests or samples for data management
purposes.
2
If the host system does not track the initial download of a
sample as opposed to subsequent downloads for the same
sample, it is highly suggested to use “A” (ASCIIDEC 65) as the
action code value for all downloads. This eliminates
overwriting non-processed test selections or adding test
selections that have been previously processed.
Do not mix action codes for a series of order records for the
same sample. You can have a different action code for
another series of order records in the same message.
The chart below illustrates the logic used to create, add, or delete information from the IM via
the Action Code of the ASTM 1394 Test Order Record.

Test Order Record is

received.
Is the
Action Code Does the order Merge with existing
Yes Yes
(9.4.12) = A? exist in Host→ IM? test order.
Add
No
Create as new test

No
order.
Is the
Action Code Does the order Delete all existing
Yes Yes
(9.4.12) = N? exist in Host→ IM? test order(s).
New
Create as new test

No No
order.
Is the
Action Code Delete existing
Yes Stop
(9.4.12) = C? specified test order(s).
Cancel
No
Stop
(Invalid Action Code)
Date/Time Specimen Received (9.4.15) This field contains the date and time each
instrument was presented with the sample.
This will be used in the Sample Status and
Results Messages uploaded to the host from
the IM. The contents of this field will be
ignored if sent from the host.
Specimen Descriptor (9.4.16) Only the first component of this field is


Specimen Type (9.4.16.1) This field indicates the type of sample with
respect to the sample ID (9.4.3). If a sample
is processed on the system without a host
download, the contents will be the specimen
type provided by the instrument or device.
Note that the specimen type uploaded from
the IM could be null. The following codes
are suggested:
Code Definition
SE Serum / Plasma
UR Urine
CSF Cerebral Spinal Fluid
SUPER Supernatant
O Other
Important: There is a configuration option that if set and the host
omits a Specimen Type, then the download will be discarded.
Specimen Source (9.4.16.2) The contents of this component are ignored.
User Field No. 1 (9.4.19)

Comment Field # (9.4.19.#) This field (these components) contains
comments to be used in the comment fields
of the instrument and devices connected to
the IM.
Note: The contents of these components will

not be uploaded from the IM to the host.
Note: If the contents of components exceed

the length of the comment fields of the
instruments or devices, the components’
contents will be truncated.
Instrument ID (9.4.25) This field contains the ID from the sending

device, or the Connection name of the
sending device
2.4.4. Test Result Record (R)
This section describes the implementation of the ASTM E 1394 Results Record.
ASTM Direction
1 10.1.1 Record Type ID 1 Required Required Alpha Value: R (ASCIIDEC 82)

3 10.1.3 Universal Test ID

10.1.3.1 Universal Test ID - Ignored Ignored
10.1.3.2 Universal Test ID Name - Ignored Ignored
Universal Test ID Type - Ignored Ignored
Manufacturer’s/Local
10.1.3.4
Code
Alphanumeric See detailed description of this
10.1.3.4.1 Test Code 1-10 Required Required/T
field
10.1.3.4.2 Treatment Code - Ignored Ignored Reserved for Future Use
10.1.3.4.3 PreTreatment Code - Ignored Ignored Reserved for Future Use
Data or Measurement Numeric See detailed description of this
4 10.1.4 - N/A Required
Value field
5 10.1.5 Units - N/A Ignored
6 10.1.6 Reference Ranges - N/A Ignored
Alpha See detailed description of this
7 10.1.7 Result Abnormal Flags - N/A Required/T
field
Nature of Abnormal
8 10.1.8 - N/A Ignored
Testing
9 10.1.9 Results Status 1 N/A Required Alpha Values: F (ASCIIDEC 70) or C
Date of Change in
10 10.1.10 Instrument Normative - N/A Ignored
Values
11 10.1.11 Operator Identification - N/A Ignored
12 10.1.12 Date/Time Test Started - N/A Ignored
13 10.1.13 Date/Time Test Complete - N/A Ignored
14 10.1.14 Instrument Identification
Alphanumeric See detailed description of this
10.1.14.1 Instrument ID - N/A Required
field
10.1.14.2 Subcomponent #1 ID - N/A Ignored Reserved for future use
10.1.14.2 Subcomponent #2 ID - N/A Ignored Reserved for future use
Society for Testing and Materials (ASTM) E 1394-91 Standard for transferring information
Record Type ID (10.1.1) Identifies the record as a result record.

Value: R (ASCIIDEC 82)

specification.
Universal Test ID (10.1.3) Only the fourth component of this field is

Universal Test ID (10.1.3.1) Content is ignored
Universal Test ID Name (10.1.3.2) Content is ignored
Type (10.1.3.3) Content is ignored
Manufacturer’s or Local Code (10.1.3.4)
Test Code (10.1.3.4.1) For the host download and the Instrument
Manager upload of results, this field is the
test selection code for the sample. For the
Instrument Manager upload of sample status

messages this field will be empty. See

Sample Status Message section for further
information.
Treatment Code (10.1.3.4.2) Reserved for future use.
Pretreatment Code (10.1.3.4.3) Reserved for future use.
Data or Measurement Value (10.1.4) This field contains the result value for the
test in Manufacturer’s or Local Code field
(10.1.3.4).
Note: This value could be quantitative or

qualitative.
Result Abnormal Flags (10.1.7) This field contains the instrument result flag.
Important: The values in this field will not

represent the values illustrated in the ASTM
E 1394 standard for this field.
Note: Each model of instrument has a

different set of analyzer alarm codes and the
host system must be able to interpret
identifier in the Instrument ID field
(10.1.14) and this alarm and take the
appropriate action.
Result Status (10.1.9) This field will generally contain an F = Final

or a C = Corrected (e.g., rerun result), but
any value that is received by an instrument
will be sent.
Instrument Identification (10.1.14)

Instrument ID (10.1.14.1) This field identifies the instrument that
produced the results in Data or Measurement
Value field (10.1.4) of this Results Record.
Subcomponent ID #1 (10.1.14.2) Reserved for future use
Subcomponent ID #2 (10.1.14.3) Reserved for future use
2.4.5. Comment Record (C)
This section describes the implementation of the ASTM E 1394 Comment Record. Test,
Specimen, and Patient level Comment Records can be uploaded from the IM to the host system.
For download from the host system to IM only Patient and Specimen level comments can be
downloaded. The upload Comment Records will be used to notify the host system that a sample
is received on an instrument or device. In this case, the Comment Record will immediately
follow the Test Order Record and the Comment Record will contain the Instrument ID of the

machine that the sample was placed on. A software switch exists within the Instrument Manager
that will enable or disable this use of status messages. This function is useful in notifying the
host of sample reception. For Result messages, the Comment Record will contain the comment
sent from the sending device. For Order messages, the Comment Record will contain the
comment sent from the host system.
ASTM Direction
1 11.1.1 Record Type ID 1 Optional Required Alpha Value: C (ASCIIDEC 67)
2 11.1.2 Sequence Number 1 Optional Required Numeric
Alpha Value: I (ASCIIDEC 73)
3 11.1.3 Comment Source 1 Optional Required
Value: L (ASCIIDEC 76)
4 11.1.4 Comment Text Optional Required Alphanumeric Text Field
Alpha Value: I (ASCIIDEC 73)
5 11.1.5 Comment Type 1 Optional Required
Value: G (ASCIIDEC 71)
Record Type ID (11.1.1) Identifies the record as a comment record.

Value: C (ASCIIDEC 67)
Comment Source (11.1.3) This field indicates the source of the sample status
message.
Value: I (ASCIIDEC 73)
Value: L (ASCIIDEC 76) for Results
Comment Text (11.1.4) This field contains an instrument identification of

the instrument or device that the sample was placed
on. On Results, this field contains a comment sent
by the sending device. On Orders, this field
contains a comment sent by the host system.
Note: If a comment is being sent which has a <cr>,
a <lf>, or a <cr><lf> in it; then this comment will
be split into multiple comment records.
Comment Type (11.1.5) The field indicates the type of message contained in
the Comment Text field (11.1.4).
Value: I (ASCIIDEC 73)
Value: G (ASCIIDEC 71) for Results

2.4.6. Equipment Detail Record (M)
The following table describes the Equipment Detail Manufacturer Information Record. This
record is used to identify the equipment. This record is used together with the Specimen and
Container Detail Record (SAC) for sending the sample status and aliquot results to the LIS.
ASTM Direction
1 15.1.1 Record Type ID 1 - Required Alpha Value: M (ASCIIDEC 77)
2 15.1.2 Sequence Number 1 - Required Numeric
3 15.E.3 Record Type Sub-ID 3 - Required Alpha Value: EQU
4 15.E.4 Equipment Identifier
15.E.4.1 Identifier 1-10 - Required Alphanumeric
15.E.4.2 Text 1-20 - Optional Alphanumeric
Name of Coding Alpha
15.E.4.3 2 - Required Value: DII
System
Date/Time Format:
5 15.E.5 Event Date/Time 14 - Required
YYYYMMDDHHMMSS
6 15.E.6 Equipment State 2 - Required Alpha Value: OP
7 15.E.7 Local/Remote Control State 1 - Required Alpha Value: L (ASCIIDEC 76)
8 15.E.8 Alert Level 1 - Required Alpha Value: N (ASCIIDEC 78)
Record Type ID (15.1.1) Identifies the record as a Manufacturer

Information Record.
Value: M (ASCIIDEC 77)

specification.
Record Type Sub-ID (15.E.3) Identifies the ASTM Manufacturer

Information Record type.
Value: EQU (Equipment Detail)
Equipment Identifier (15.E.4) This field defines the equipment and the
type of information that follows.
Equipment Identifier (15.E.4.1) This component defines the type of

equipment including its application. The
following definitions are valid for current
Instrument Manager products and new codes
will be added as necessary.
Code Definition
SSR Specimen Storage and Retrieval Module
Equipment Text (15.E.4.2) This component defines the user-defined

name of the equipment. For example, the
user may have SSR units and named them
“Red”, “Fred” and “Ted”.

Equipment Identifier Equipment Text Value

Value (15.E.4.1) (15.E.4.2)
SSR User-defined name
Equipment Coding System (15.E.4.3) This component defines the source of the
Equipment Naming system (such as DII for
Data Innovations, Inc).
Code Definition
DII Data Innovations, Inc
Event Date and Time (15.E.5) Date and Time of the information event.
Format will be as defined in ASTM E 1394-
91 in section 6.6.2.
Equipment State (15.E.6) This field identifies the status that the
equipment was in at the time that the
transaction was initiated.
Code Definition
CL 1 Clearing
CO 1 Configuring
ES 1 E-stopped (emergency)
ID 1 Idle
IN 1 Initializing
OP 2 Normal Operation
PA 1 Pausing
PD 1 Paused
PU 1 Powered Up
Notes:
1
Reserved for future implementations
2
Currently the only code implemented.
Local/Remote Control State (15.E.7) This field identifies the state of control
associated with the equipment.
Code Definition
L2 Local
R1 Remote (Reserved for future use)
Notes:
1
Reserved for future implementations.
2
Alert Level (15.E.8) This field identifies the highest level of the
alert state (e.g. highest alarm severity) that is
associated with the indicated equipment.
Code Definition
C1 Critical
N2 Normal
S1 Serious

W1 Warning
Notes:
1
Reserved for future implementations
2
2.4.7. Specimen and container Detail Record (M)
The following table describes the Specimen and Container (SAC) Detail Manufacturer
Information Record. This record is used to transfer detailed sample information. The record is
single container oriented. Therefore, it is necessary to transfer multiple SAC records to complete
information transfer for a given carrier or tray.
ASTM Direction
3 15.S.3 Record Type Sub-ID 3 - Required Alpha Value: SAC
External Accession
4 15.S.4 22 - N/A Reserved for future use.
Identifier
5 15.S.5 Accession Identifier 1-24 - Required/T Alphanumeric See detailed description of field
6 15.S.6 Container Identifier 1-24 - Required/T Alphanumeric See detailed description of field
Primary Container
7 15.S.7 1-24 - Required/T Alphanumeric See detailed description of field
Identifier
Equipment Container
8 15.S.8 - - N/A Reserved for future use.
Identifier
9 15.S.9 Specimen Source - - N/A Reserved for future use.
10 15.S.10 Registration Date/Time 14 - Required/T Date/Time See detailed description of field
11 15.S.11 Container Status 1-20 - Required/T Alphanumeric See detailed description of field
12 15.S.12 Carrier Type 1-20 - Required/T Alphanumeric See detailed description of field
13 15.S.13 Carrier Identifier 1-20 - Required/T Alphanumeric See detailed description of field
14 15.S.14 Position in Carrier
15.S.14.1 X Position 1-20 - Required/T Numeric See detailed description of field
15.S.14.2 Y Position 1-20 - Required/T Numeric See detailed description of field
15.S.14.3 Z Position 1-20 - Required/T Numeric See detailed description of field
15 15.S.15 Tray Type 1-20 - Required/T Alphanumeric See detailed description of field
16 15.S.16 Tray Identifier 1-20 - Required/T Alphanumeric See detailed description of field
17 15.S.17 Position in Tray
15.S.17.1 X Position 1-20 - Required/T Numeric See detailed description of field
15.S.17.2 Y Position 1-20 - Required/T Numeric See detailed description of field
15.S.17.3 Z Position 1-20 - Required/T Numeric See detailed description of field
18 15.S.18 Location
15.S.18.1 Level 1 1-20 - N/A Reserved for future use.
19 15.S.19 Container Type 1-20 - N/A Reserved for future use.
20 15.S.20 Container Height 1-20 - N/A Reserved for future use.
21 15.S.21 Container Height Units 1-20 - N/A Reserved for future use.
22 15.S.22 Container Diameter 1-20 - N/A Reserved for future use.
Container Diameter
23 15.S.23 1-20 - N/A Reserved for future use.
Units
24 15.S.24 Container Volume 1-20 - N/A Reserved for future use.
25 15.S.25 Container Units 1-20 - N/A Reserved for future use.
26 15.S.26 Current Volume 1-20 - Required/T Numeric Volume in container
27 15.S.27 Current Volume Units 1-20 - N/A Reserved for future use.
28 15.S.28 Draw Volume 1-20 - N/A Reserved for future use.

29 15.S.29 Draw Volume Units 1-20 - N/A Reserved for future use.
30 15.S.30 Cap Type 1-20 - N/A Reserved for future use.
31 15.S.31 Fluid Additive 1-20 - N/A Reserved for future use.
32 15.S.32 Specimen Mixture 1-20 - N/A Reserved for future use.
Specimen Integrity
33 15.S.33 1-20 - N/A Reserved for future use.
Degree
34 15.S.34 Dilution Factor 1-20 - N/A Reserved for future use.
35 15.S.35 Treatment 1-20 - N/A Reserved for future use.
36 15.S.36 Temperature 1-20 - N/A Reserved for future use.
Record Type ID (15.1.1) Identifies the record as a Manufacturer Information

Record.
Record Type Sub-ID (15.S.3) Identifies the ASTM Manufacturer Information

Record type.
Value: SAC (Specimen And Container)
External Accession Identifier (15.S.4) Reserved for future use.
Accession Identifier (15.S.5) This field identifies the laboratory accession. This
field may contain less than, same as, or more than
the number of characters in the container bar code.
Container Identifier (15.S.6) This field identifies the container of this record. If
this SAC is for the primary tube information, the
container ID will be placed ONLY in this field. If
this SAC is for an aliquot tube, the aliquot container
ID will be placed in this field.
Equipment Identifier Container Identifier Value

Value (15.E.4.1) (15.S.6)
SSR Sample Bar Code ID
Primary Container Identifier (15.S.7) If this SAC is for the primary tube information only,
this field will be empty. If this SAC is for an
aliquot or secondary tube, this field will contain the
bar code ID of the primary tube from which the
aliquot or secondary tube has been prepared.
Equipment Identifier Primary Container

Value (15.E.4.1) Identifier (15.5.7)
SSR Not Used
Equipment Container Identifier (15.S.8) Reserved for future use.
Specimen Source (15.S.9) Reserved for future use.

Registration Date and Time (15.S.10) This field identifies the date and time that the
container last registered with the processing
equipment. For example, for the PSD 1, this would
be actual date and time stamp of the sort action.
Format will be as defined in ASTM E 1394-91 in
section 6.6.2.
Container Status (15.S.11) This field identifies the status of the unique
container in which the specimen resides at the time
the transaction was initiated.
Code Definition
I1 Identified - Reserved for future use
O1 In Process – Reserved for future use
Process Completed - Sent to indicate successful
R2 aliquot or sort operation on the container in this
SAC.
Cancelled - Sent to indicate unsuccessful aliquot
X1
or sort operation on the container in this SAC.
Notes:
1
Reserved for future implementations.
2
Carrier Type (15.S.12) This field identifies the type of carrier in which the
container has been placed. This is not a complete
list.
Equipment Identifier Carrier Type

Definition
Value (15.E.4.1) Value (15.S.12)
SSR Carrier Name User-defined name for carrier
Carrier Identifier (15.S.13) This field represents the carrier ID in which the
container has been placed. This is not a complete
list.
Equipment Identifier
Definition
Value (15.E.4.1)
Configurable in IM. An
example would be:
JJJNNN where:
SSR
JJJ = Julian Date
NNN = Sequential number from
001-999 that resets at midnight.
Position in Carrier (15.S.14) This field identifies the position of the container in
the carrier. The components identify multiple axis
information and their definition depends on the

Equipment Type and/or IM configuration. Use the

chart below to define the components of this field.
X Position (15.S.14.1) See chart below for component definition
Y Position (15.S.14.2) See chart below for component definition
Z Position (15.S.14.3) See chart below for component definition
Equipment Identifier X Position Y Position Z Position

Value (15.E.4.1) Definition Definition Definition
1-25 A-E -
SSR
Row Column -
Tray Type (15.S.15) This field identifies the type of tray in which the
container or carrier has been placed. This is not a
complete list.
Equipment Identifier Tray Type

Definition
Value (15.E.4.1) Value (15.S.15)
SSR Reserved for future use
Tray Identifier (15.S.16) This field represents the tray ID in which the carrier
or container has been placed. This is not a complete
list. In the future, this field may have multiple
components.
Tray Type
Definition
Value (15.S.15)
Reserved for future use
Position in Tray (15.S.17) This field identifies the position of the carrier in the
tray. The components identify multiple axis
information and their definition will depend on the
Equipment Type and/or IM configuration. Use the
chart below to define the components of this field.
X Position (15.S.17.1) Reserved for future use.
Y Position (15.S.17.2) Reserved for future use.
Z Position (15.S.17.3) Reserved for future use.
Location (15.S.18) This field identifies the Location of a carrier if no

tray is specified or the location of the tray if the tray
is specified. The definition of x, y and z will
depend on the Equipment Type and/or IM
configuration.
X Position (15.S.18.1) Reserved for future use.
Y Position (15.S.18.2) Reserved for future use.
Z Position (15.S.18.3) Reserved for future use.
Container Type (15.S.19) Reserved for future use.

Container Height (15.S.20) Reserved for future use.
Container Height Units (15.S.21) Reserved for future use.
Container Diameter (15.S.22) Reserved for future use.
Container Diameter Units (15.S.23) Reserved for future use.
Container Volume (15.S.24) Reserved for future use.
Container Units (15.S.25) Reserved for future use.
Current Volume (15.S.26) Volume of sample material in container.
Equipment Identifier Current Volume Value

Value (15.E.4.1) (15.S.26)
SSR 0000-9999 1
Notes:
1
Volume in microliters in aliquot tube only.
Fields 15.S.27 to 15.S.36 Reserved for future use.
2.4.8. Test Code Detail Record (M)
The following table describes the Test Code Details (TCD) Manufacturer Information Record.
This record is used to transfer test code information for a sample. The Test Code Details record
may follow a Specimen and Container Detail (SAC) record for a single container to transfer test
code information for the sample if the device transfers the information to the IM.
ASTM Direction
3 15.T.3 Record Type Sub-ID 3 - Required Alpha Value: TCD
4 15.T.4 Universal Service ID 1-20 - Required Alphanumeric
5 15.T.5 Auto-Dilution Factor 1-20 - N/A Reserved for future use.
6 15.T.6 Rerun Dilution Factor 1-20 - N/A Reserved for future use.
7 15.T.7 Pre-Dilution Factor 1-20 - N/A Reserved for future use.
Endogenous Content of
8 15.T.8 1-20 - N/A Reserved for future use.
Pre-Dilution Diluents
9 15.T.9 Automatic Rerun 1-20 - N/A Reserved for future use.
10 15.T.10 Reflex Allowed 1-20 - N/A Reserved for future use.
Record Type ID (15.1.1) Identifies the record as a Manufacturer Information

Record.

Record Type Sub-ID (15.T.3) Identifies the ASTM Manufacturer Information Record
type.
Value: TCD (Test Code Details)
Universal Service ID (15.T.4) Test code or instruction. This field may repeat.
Equipment Identifier
Implementation
Value (15.E.4.1)
Test codes associated with
SSR the primary or secondary
tube produced.
Fields 15.T.5 to 15.T.10 Reserved for future use.
2.4.9. Terminator Record (L)
This section describes the implementation of the ASTM E 1394 Message Terminator Record.
Direction
Name Bytes From Host To Host Type Comments
Record Type ID 1 Required Required Alpha Value: L (ASCIIDEC 76)
Sequence Number 1 Required Required Numeric Value:1 (ASCIIDEC 49)
Termination Code 1 Required Required Alpha Value: N (ASCIIDEC 78)
Note: The parenthetical numbers following the field names are references to the American Society for
Testing and Materials (ASTM) E 1394-91 Standard for transferring information between clinical
instruments and computer systems. For further information, refer to Storer, R. et al, eds. General
Methods and Instrumentation. In: Annual Book of ASTM Standards: West Conshohocken, PA: ASTM;
1996; Vol. 14.01:380-394.
Record Type ID (13.1.1) Identifies the record as a message terminator record.

Value: L (ASCIIDEC 76)
Sequence Number (13.1.2) This will always be 1 (ASCIIDEC 49).
Termination Code (13.1.3) The following code will be supported for all conditions.
Code Definition
N Normal termination

NOTE: If this field is not an “N”, then the whole

2.5. High-Level Protocol
This section describes the ASTM E 1394 records and fields that are relevant in transmitting patient and
sample information from the host system to the IM, and sending sample information from IM to the host
system.
Important: These examples are not intended to give a detailed listing of every character of the ASTM
records or fields but rather to focus on specific fields and to illustrate their relevance to the functions.
Note that many fields are omitted from this outline and for more detailed information on the records,
fields and their significance, refer to the ASTM Records and Fields section of this chapter. It is important
to note that one transmission may contain one or more of these messages as allowed by the standard.
Note: If the content of the value field is in italics, then the value is not the literal value shown.
2.5.1. New Order/Add-on Test
The following section outlines a series of ASTM records that will be downloaded from the host
system to the IM to create a new order or add test(s) to an existing order.
• Message Header Record

o Patient Information Record
Field # Field Name Value
8.1.3 Practice Assigned Patient ID Patient ID
Test Order Record

9.4.3 Specimen ID
Sample ID
9.4.5 Universal Test ID
Manufacturer’s
Test Code(s)
or Local Code
9.4.6 Priority R, S, A
9.4.8 Specimen Collection Date and Time Date/Time
9.4.12 Action Code N or A
9.4.16 Specimen Descriptor
Specimen Type
Sample Type
• Message Terminator Record
2.5.2. Delete Test(s) from an Order

The following section outlines a series of ASTM records that will be downloaded from the host
system to the IM to delete test(s) from an existing order.

Test Order Record

9.4.3 Specimen ID Sample ID
Manufacturer’s
Test Code(s)
or Local Code
9.4.8 Specimen Collection Date and Time Date/Time
9.4.12 Action Code C
Specimen Type Sample Type
2.5.3. Sample Status Message
The following section outlines a series of ASTM records that will be uploaded from the IM to
notify the host system that a sample is received on a pre-analytical, analytical and post analytical
device(s). A software switch exists within the IM that will enable or disable these types of status
messages.

Test Order Record

9.4.15 Date/Time Specimen Received Date/Time
Comment Record
11.1.3 Comment Source I
Instrument
11.1.4 Comment Text
Name
11.1.5 Comment Type I
2.5.4. Sample Result(s) Message

The following section outlines a series of ASTM records that will be uploaded from the IM to notify the
host system of a sample’s results. The messages will be sent to the host real-time when the instruments
upload to the IM or when retransmitted from the instrument.
Important: If a result has an error associated with it, the original instrument error will be sent in
the Result Abnormal Flag field (10.1.7). Each model of instrument has a different set of
analyzer alarm codes (refer to appendices) and the host system must be able to interpret identifier
in the Instrument ID field (10.1.14) in the Results Record and take the appropriate action.

Test Order Record

Manufacturer’s
Test Code(s)
or Local Code
9.4.12 Action Code -
• Results Record
Manufacturer’s
Test Code
or Local Code
10.1.4 Data or Measurement Value Result
10.1.7 Result Abnormal Flag Result Alarm
10.1.14 Instrument ID Instrument ID
Illustrated below is how the IM will send multiple patients, with test results from more than one
instrument. Not every results transmission will have this many combinations, but this is used to
illustrate multiple patients, multiple samples, multiple test results from multiple instruments
scenarios in order to program accordingly.

o Patient (ABC) Information Record
o Patient (ABC) Comment Record
Test (123) Order Record
Test (123) Comment Record
• Result (Instrument 1) Record

• Result (instrument 1) Comment Record

• …
• …
o Patient (DEF) Information Record
o Patient (DEF) Comment Record


• …
2.5.5. QC Result(s) Message
The following section outlines a series of ASTM records that will be uploaded from the IM to notify the
host system of a QC (control material) result. The messages will be sent to the host real-time when the
instruments upload to the IM or when retransmitted from the instrument.
Important: If a result has an error associated with it, the original instrument error will be sent in
the Result Abnormal Flag field (10.1.7). Each model of instrument has a different set of
analyzer alarm codes (refer to appendices) and the host system must be able to interpret identifier
in the Instrument ID field (10.1.14) in the Results Record and take the appropriate action.

8.1.3 Practice Assigned Patient ID -
Test Order Record
9.4.3 Specimen ID QC ID
Manufacturer’s
Test Code(s)
or Local Code
9.4.12 Action Code Q


• Results Record
Manufacturer’s
Test Code
or Local Code
10.1.4 Data or Measurement Value Result
10.1.7 Result Abnormal Flag Result Alarm
10.1.14 Instrument ID Instrument ID
Message Terminator Record
2.5.6. Container Tracking Message
This section describes the implementation of the ASTM E 1394 Manufacturer Information Records for
Container Tracking.
This information can be primary tube sorting, aliquotting, aliquot sorting, storage or sample assessment
information depending on the Equipment Identifier Record (EQU) and the data implemented in the
Specimen and Container Detail Record (SAC) and the Test Code Details Record (TCD).
This container tracking implementation is an adaptation of the NCCLS committee’s Lab Automation
Communications Standard written as an extension for HL7. To provide a consistent implementation for
our various devices and various host protocols, the decision was made to adapt this proposal for the IM’s
storage and aliquot information transfer method. For more information on NCCLS automation standard,
please contact:
NCCLS
940 West Valley Road, Suite 1400
Wayne, Pennsylvania 19087 USA.
Phone: +1(610)688.0100
Fax: +1(610)688.0700
www.nccls.org
Note: These messages can be enabled or disabled.
The following section outlines a series of ASTM records that will be uploaded from the IM to
notify the host system of sorting (archive or pre-analytical) information results. The messages
will be sent to the host real-time when the IM determines that data for a specific carrier or tray is
complete or when retransmitted from the Instrument Manager.

o Manufacturer Information Record (EQU)
4 Equipment Identifier
Equipment ID SSR
Equipment Text Instr. Name
Equipment Coding System

DII
5 Event Date/Time Date/Time
6 Equipment State OP
7 Local/Remote Control State L
8 Alert Level N
o Manufacturer Information Record (SAC)
6 Container Identifier Sample ID
10 Registration Date/Time Date/Time
11 Container Status R
12 Carrier Type Carrier Name
13 Carrier Identifier Carrier ID
14 Position in Carrier
X Position Row
Y Position Column
2.6. Communication Examples
This section contains sample transmissions from the Host → IM and from IM → Host.
Note: The host can send to the ASTM E 1391-94 information to the IM in “packed” and
“unpacked” method. For more information on “packed” and “unpacked” method, refer to the
Low-Level Protocol (LLP) section.
Message Header Record:

<STX>1H|\^&|||IM||||||v5.01|P|1|19990217201339<CR>
Patient Information Record:

P|1|||||||<CR>
Test Order Record:

O|1|04800003B||^^^767\^^^781|R||19990217172600||||A||||1|||Frost, Jack^4th
floor^Dr.Welby^^<CR>
Comment Record:
C|1|I|Modulr|I<CR>
Result Record:
R|1|^^^714|0.0|||27||F|||||02<CR>
Equipment Detail Record:

M|1|EQU|PSD^PSD#1^RD|20001026141526|OP|L|N<CR>
Specimen and Container Detail Record:

M|1|SAC|||G4895786W||||20001026141526|R|3G|3001020|14^E<CR>
Test Code Detail Record:

Message Terminator Record:

L|1|N<CR>
2.6.1. Examples
Test Order(s):
Host <ENQ>
IM <ACK>
Host <STX>1H|\^&||||||||||P|1|<CR><ETX>36<CR><LF>
IM <ACK>
Host <STX>2P|1|1|1||TEST^CCJ^||19580101|F|||||^THOMAS^ROBERTS|
||||^TEST DX
|||||||01<CR><ETX>B0<CR><LF>
IM <ACK>
Host <STX>3O|1|04800018B||^^^687\^^^781\^^^700\^^^714\^^^989\^
^^990\^^^991|R||19990217195600||||A||||V|||<CR><ETX>5B<CR
><LF>
IM <ACK>
Host <STX>4L|1|N<CR><ETX>07<CR><LF>
IM <ACK>
Host <EOT>
Status Message:
Host <ENQ>
IM <ACK>
Host <STX>1H|\^&|||IM||||||v8.00.0001|P|1|19990216170932<CR>P|
1|||||||<CR>
O|1|04700005A|00000^^||R|||||||||19990216170932|<CR>C|1|I
|Modulr|I<CR>L|1|N<CR><ETX>02<CR><LF>
IM <ACK>
1|||||||<CR>
O|1|04700006A|00000^^||R|||||||||19990216170932|<CR>C|1|I
|Modulr|I<CR>L|1|N<CR><ETX>04<CR><LF>
IM <ACK>
1|||||||<CR>
O|1|04700007A|00000^^||R|||||||||19990216170934|<CR>C|1|I
|Modulr|I<CR>L|1|N<CR><ETX>0A<CR><LF>
IM <ACK>
Host <EOT>
Sample Result(s):
Host <ENQ>
IM <ACK>
Host <STX>1H|\^&|||IM||||||v8.00.0001|P|1|19990216190146<CR>P|1|||||||<CR>
O
|1|04700010A|^5068^5|^^^767|R|||||||||18401231000000|V<CR>R|1|^^^767|
-1|||27||F||||| 01<CR>L|1|N<CR><ETX>59<CR><LF>
IM <ACK>
Host <STX>2H|\^&|||IM||||||v8.00.0001|P|1|19990216190146<CR>P|1|||||||<CR>
O
|1|04700010A|^5068^5|^^^773|R|||||||||18401231000000|V<CR>R|1|^^^773|

-0.4|||27||F||||| 02<CR>L|1|N<CR><ETX>B6<CR><LF>
IM <ACK>
Host <EOT>
QC Result(s):
Host <ENQ>
IM <ACK>
1|||||||<CR> O|1|PRECI-
N|00000^^|^^^989\^^^990\^^^991|R||||||Q|||18401231000000|
V<CR>R|1|
^^^989|148|||||F|||||01<CR>R|2|^^^990|6.6|||||F|||||01<CR
>R|3|^^^991|118|||||F|||||01<CR>L|1|N<CR><ETX>3E<CR><LF>
IM <ACK>
1|||||||<CR>O|1|PREC-
AB|00000^^|^^^989\^^^990\^^^991\|R||||||Q|||1840123100000
0|V<CR>R|1|^^^989|129|||||F|||||01<CR>R|2|^^^990|3.8|||||
F|||||01<CR>R|3|^^^991|97|||||F|||||01<CR>L|1|N<CR><ETX>F
F<CR><LF>
IM <ACK>
1|||||||<CR>O |1|PRECI-
N|00000^^|^^^763\^^^767\^^^427\^^^773\^^^660\^^^678\^^^41
3\ ^^^706\^^^781\
^^^433\^^^685\^^^687\^^^680\|R||||||Q|||18401231000000|V<
CR>R|1|^^^763|-2.8|||||F||||| 01<CR>R|2|
^^<ETB>E9<CR><LF>
Host <ACK>
IM <STX>4^767|-1|||||F|||||01<CR>R|3|^^^427|-
2|||7||F|||||01<CR>R|4|^^^773|-0.4|||||F|||||
01<CR>R|5|^^^660|0.1|||||F|||||01<CR>R|6|^^^678|2.5|||||F
|||||01<CR>R|7|^^^413|7.0|||||F|||||01<CR>R|8|^^^706|-
4.0|||||F|||||01<CR>R|9|^^^781|95|||||F|||||01
<CR>R|10|^^^433|-68|||||F|<ETB>54<CR><LF>
Host <ACK>
IM <STX>5||||01<CR>R|11|^^^685|13|||7||F|||||01<CR>R|12|^^^6
87|14|||7||F|||||01<CR>R|13|^^^680|-
1|||||F|||||01<CR>L|1|N<CR><ETX>4E<CR><LF>
Host <ACK>
IM <STX>6H|\^&|||IM||||||v8.00.0001|P|1|19990217114413<CR>P|
1|||||||<CR>O|1|PREC-
AB|00000^^|^^^763\^^^767\^^^427\^^^773\^^^660\^^^678\^^^4
13\^^^706\^^^781\^^^433\^^^685\^^^687\^^^680\|R||||||Q|||
18401231000000|V<CR>R|1|^^^763|-2.6|||8||F|||||01<CR>R|2|
^<ETB>B0<CR><LF>
Host <ACK>
IM <STX>7^^767|-2|||||F|||||01<CR>R|3|^^^427|-
1|||7||F|||||01<CR>R|4|^^^773|-
0.4|||||F|||||01<CR>R|5|^^^660|0.1|||||F|||||01<CR>R|6|^^
^678|2.5|||||F|||||01<CR>R|7|^^^413|7.0|||||F|||||01<CR>R
|8|^^^706|-4.0|||||F|||||01<CR>R|9|^^^781|211|||||F|||||
01<CR>R|10|^^^433|-65|||||<ETB>16<CR><LF>
Host <ACK>
IM <STX>0F|||||01<CR>R|11|^^^685|2|||7||F|||||01<CR>R|12|^^^
687|1|||7||F|||||01<CR>R|13|^^^680|-
1|||||F|||||01<CR>L|1|N<CR><ETX>A5<CR><LF>
Host <ACK>
IM <STX>1H|\^&|||IM||||||v8.00.0001|P|1|19990217114413<CR>P|
1|||||||<CR>O |1|PRECI-
N|00000^^|^^^767\^^^427\^^^773\^^^570\^^^700\^^^714\^^^68
8\^^^505\
^^^811\^^^661\^^^693\^^^733\|R||||||Q|||18401231000000|V<
CR>R|1|^^^767|75|||||
F|||||02<CR>R|2|^^^427|19||<ETB>45<CR><LF>

Host <ACK>
IM <STX>2|||F|||||02<CR>R|3|^^^773|1.3|||||F|||||02<CR>R|4|^
^^570|86|||||F|||||02<CR>R|5|^^^700|3.9|||||F|||||02<CR>R
|6|^^^714|499.2|||||F|||||02<CR>R|7|^^^688|152|||||F|||||
02<CR>R|8|^^^505|35|||||F|||||02<CR>R|9|^^^811|74|||||F||
|||02<CR>R|10|^^^661|226|||||F|||||02<CR>R|11<ETB>DD<CR><
LF>
Host <ACK>
IM <STX>3|^^^693|4.0|||||F|||||02<CR>R|12|^^^733|161|||||F||
|||02<CR>L|1|N<CR><ETX>DE<CR><LF>
Host <ACK>
IM <STX>4H|\^&|||IM||||||v8.00.0001|P|1|19990217114413<CR>P|
1|||||||<CR>O|1|PREC-
AB|00000^^|^^^767\^^^427\^^^773\^^^570\^^^700\^^^714\^^^6
88\^^^505\^^^811\^^^661\^^^693\^^^733\|R||||||Q|||1840123
1000000|V<CR>R|1|^^^767|287|||||F|||||02<CR>R|2|^^^427|67
|<ETB>F0<CR><LF>
Host <ACK>
IM <STX>5||||F|||||02<CR>R|3|^^^773|6.3|||||F|||||02<CR>R|4|
^^^570|459|||||F|||||02<CR>R|5|^^^700|7.8|||||F|||||02<CR
>R|6|^^^714|883.0|||||F|||||02<CR>R|7|^^^688|565|||||F|||
||02<CR>R|8|^^^505|305|||||F|||||02<CR>R|9|^^^811|388||||
|F|||||02<CR>R|10|^^^661|111|||||F|||||02<CR><ETB>CC<CR><
LF>
Host <ACK>
IM <STX>6R|11|^^^693|1.8|||||F|||||02<CR>R|12|^^^733|204||||
|F|||||02<CR>L|1|N<CR><ETX>14<CR><LF>
Host <ACK>
IM <EOT>

3. External Interface Requirements

3.1. Hardware Interfaces
None
3.2. Software Interfaces
None

4. Other Nonfunctional Requirements

4.1. Performance Requirements
None
4.2. Safety Requirements
None
4.3. Security Requirements
None

5. Other Requirements
None

6. Approval Signatures
Signatures required for approval of specification:
Role Signature Date

Development Manager
Quality Assurance Engineer
Author
Requester

DIS - 0005 (Astm Automation Robotics Host Interface) ASTM E 1381-91 and E1394-91 PDF

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Development Interface

ASTM Automation/Robotics Host

Document ID: DIS_0005

The contents of this manual are subject to change

Document ID: DIS_0005 v5.3 Page i

6. Approval Signatures.............................................................................................................. 40

Document ID: DIS_0005 v5.3 Page ii

Name Date Reason For Changes Version

Document ID: DIS_0005 v5.3 Page iii

Carl Maklad 9/18/2008 Approved 5.3

Document ID: DIS_0005 v5.3 Page iv

1.2. Definitions, Acronyms and Abbreviations

ASTM American Society for Testing and Materials

Document ID: DIS_0005 v5.3 Page 1

Document ID: DIS_0005 v5.3 Page 2

Fax: +1(610) 832-9555

2.1. Cable Configuration

IM Cable Side Host Cable Side

7 (S. Ground) (S. Ground)

Figure 1 - Wiring configuration for Serial cable connection

Document ID: DIS_0005 v5.3 Page 3

IM Ethernet Card Side Host Ethernet Hub Cable Side

Figure 2 - Wiring configuration for 10Base-T cable connection

2.2. Low-Level Protocol

Document ID: DIS_0005 v5.3 Page 4

Figure 3 - Method #1 (Unpacked)

Low Level Frame #1 Low Level Frame #2

Figure 4 - Method #2 (Packed)

Document ID: DIS_0005 v5.3 Page 5

2.3. Message Hierarchy

Laboratory Order Message

Laboratory Result Message

Laboratory Specimen Status Message

Document ID: DIS_0005 v5.3 Page 6

Laboratory Container Status Message

Laboratory Container Storage Message

Laboratory Instrument Message

2.4. Message Segment Structure

Document ID: DIS_0005 v5.3 Page 7

2.4.1. Message Header Record (H)

Record Type ID (7.1.1) Identifies the record as a message header record.

Document ID: DIS_0005 v5.3 Page 8

<CR> Record Delimiter

Sender Name or ID (7.1.5) In the “IM-to-Host” communications, the contents of the

Processing ID (7.1.12) Support the following codes:

NOTE: If this field is not a “P”, then the whole

Version Number (7.1.13) Current value is 1 (ASCIIDEC 49).

NOTE: If this field is not a “1”, then the whole

Document ID: DIS_0005 v5.3 Page 9

2.4.2. Patient Information Record (P)

Record Type ID (8.1.1) Identifies the record as a patient information record.

Sequence Number (8.1.2) As defined in ASTM E 1394-91 specification.

Document ID: DIS_0005 v5.3 Page 10

Patient ID No. 3 (8.1.5) It is used as a secondary patient identification field for

Birthdate (8.1.8) Format will be as defined in ASTM E 1394-91 in section

Document ID: DIS_0005 v5.3 Page 11

2.4.3. Test Order Record (O)

Record Type ID (9.4.1) Identifies the record as a test order record.

Document ID: DIS_0005 v5.3 Page 12

Value: O (ASCIIDEC 79)

Sequence Number (9.4.2) As defined in ASTM E 1394-91

Specimen ID (9.4.3) In the “Host-to-IM” communications, this

Instrument Specimen ID (9.4.4)