SIST EN ISO 18812:2003

SLOVENSKI STANDARD
01-oktober-2003
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SIST ENV 13728:2003
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Health informatics - Clinical analyser interfaces to laboratry information systems - Use
profiles (ISO 18812:2003)
Informatique de santé - Interfaces d'analyseur clinique pour systemes d'information de
laboratoire - Profils d'utilisation (ISO 18812:2003)
Ta slovenski standard je istoveten z: EN ISO 18812:2003
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 18812
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2003
ICS 35.240.80 Supersedes ENV 13728:2000
English version
Health informatics - Clinical analyser interfaces to laboratry
information systems - Use profiles (ISO 18812:2003)
Informatique de santé - Interfaces d'analyseur clinique pour
systèmes d'information de laboratoire - Profils d'utilisation
(ISO 18812:2003)
This European Standard was approved by CEN on 11 March 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovak Republic, Spain, Sweden, Switzerland and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18812:2003 E
worldwide for CEN national Members.

Foreword
This document (EN ISO 18812:2003) has been prepared by Technical Committee ISO/TC 215
"Health informatics" in collaboration with Technical Committee CEN/TC 251 "Health informatics",
the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by September 2003, and conflicting national
standards shall be withdrawn at the latest by September 2003.
This document supersedes ENV 13728:2000.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovak Republic, Spain, Sweden,
Switzerland and the United Kingdom.
NOTE FROM CMC  The foreword is susceptible to be amended on reception of the German
language version. The confirmed or amended foreword, and when appropriate, the normative
annex ZA for the references to international publications with their relevant European
publications will be circulated with the German version.
Endorsement notice
The text of ISO 18812:2003 has been approved by CEN as EN ISO 18812:2003 without any
modifications.
INTERNATIONAL ISO
STANDARD 18812
First edition
2003-03-15
Health informatics — Clinical analyser
interfaces to laboratory information
systems — Use profiles
Informatique de santé — Interfaces d'analyseur clinique pour systèmes
d'information de laboratoire — Profils d'utilisation

Reference number
ISO 18812:2003(E)
©
ISO 2003
ISO 18812:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 18812:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Domains . 3
4.1 User domain . 3
4.2 Interface domain . 3
5 Conformity . 4
6 Profiles . 4
6.1 General. 4
6.2 Message descriptions. 4
6.3 Profile descriptions. 5
6.4 Sequence diagrams . 5
6.5 Attribute optionality and allowed values. 7
Annex A (informative) How to read this International Standard. 11
Annex B (informative) Scenarios and models . 14
Annex C (informative) Implementation guidelines. 31
Bibliography . 52

ISO 18812:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 18812 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2003 — All rights reserved

ISO 18812:2003(E)
Introduction
This International Standard describes messages for the transfer of data between analytical instruments (AIs)
and laboratory information systems (LISs).
AIs are mainly used in hospital laboratories to analyse samples from patients. Most of these are interfaced to
LISs that process the result data and produce reports for use by healthcare practitioners. In the absence of
standards for the interface, each LIS supplier has to write a new interface for each new analytical instrument.
The cost of writing these interfaces can amount to between 10 % and 20 % of the total cost of the LIS. One of
the most effective ways of reducing this cost is to implement a standard interface between the AI and the LIS.
In the early 1990s, the E31 committee of the American Society for Testing and Materials (ASTM) published a
standard entitled Standard Specification for Transferring Information Between Clinical Instruments and
Computer Systems (ASTM E1394-91). This improved the situation by standardizing the format of the
message and the syntax. It also attempted to standardize the data transferred in the messages, but suffered
from implementation problems because:
 the vast choice of data items available gave implementers the choice to send the same data in many
different ways;
 the relative lack of implementation guidelines meant that different implementers interpreted the same
clauses of the standard in different ways;
 much of the information that is defined in the standard is intended for use in North America and does not
cover international requirements.
The result of this is that each AI supplier has produced its own “standard”, based loosely on ASTM E1394.
Whereas this has made interfacing easier for the analytical instrument suppliers, the LIS suppliers are still
faced with the need to write a different interface for most of the analytical instruments installed in a given
laboratory.
In particular, the LIS interface designer has to, in theory, take into account any implementation allowed by
ASTM E1394. This means that even simple AIs are normally handled by using a hugely complex interface on
the LIS.
ASTM E1394-91 was reissued with minor revisions in 1997 as ASTM E1394-97.
This International Standard is intended to make interfaces between AIs and LISs simpler to implement by
 defining standard ways of conveying the same information in the same circumstances;
 defining a series of levels of complexity so that it is possible to interface a simple AI using only easy-to-
implement messages;
 adapting the original standard to cover actual requirements;
 giving advice and guidance on how particular data items and functions should be implemented so as to
reduce misinterpretation.
This is done by defining a series of standard messages, each of which is a subset of a comparable
ASTM E1394 message. These are detailed in Clause 6. Examples of scenarios covered by this International
Standard, together with models and sequence diagrams, are given in Annex B. An informative implementation
guide for both ASTM E1394 and this International Standard is given in Annex C.
ISO 18812:2003(E)
There is a trend for all clinical laboratories to be certified or accredited under a suitable quality management
scheme. ISO/IEC 17025 require the laboratory to keep records of certain data. This means that, for the
support of the users when conforming to the standard, the instruments and LIS have to be capable of handling
this data (input, storage, validation, output), and also of transmitting it. This is especially important in functions
that produce large amounts of data that cannot be handled effectively without automated processing. Typically,
this is a task for the LIS, but certain items have to originally come from the instrument. ASTM E1394 does not
explicitly handle data needed for quality management. In principle, it is capable of doing so, but the needed
fields have to be defined.
This has been achieved in this International Standard by making recommendations as to which fields shall be
implemented in order to satisfy the needs of quality management. These are identified in the implementation
guideline included as Annex C.
This International Standard includes provisions for using existing ASTM E1394 records and fields to meet
quality management requirements.
This International Standard defines records that are subsets of records defined in ASTM E1394. Therefore, all
implementations conforming to this International Standard also conform to ASTM E1394. It should be noted,
however, that not all implementations that conform to ASTM E1394 will conform to this International Standard.
Those not familiar with some of the concepts, e.g. profiling, described here should first refer to Annex A.

vi © ISO 2003 — All rights reserved

INTERNATIONAL STANDARD ISO 18812:2003(E)

Health informatics — Clinical analyser interfaces to laboratory
information systems — Use profiles
1 Scope
This International Standard specifies general messages for electronic information exchange between
analytical instruments (AIs) and laboratory information systems (LISs) within a clinical laboratory. It is
applicable to the specialities of clinical chemistry/biochemistry, haematology, toxicology, microbiology, virology
and immunology. It is not applicable to the blood transfusion and blood bank speciality
This International Standard covers the specification of messages used by communicating parties and the
syntax in which they are communicated. It does not cover the transport mechanisms used for the message
interchange.
This International Standard is applicable only to character-based message information. It is not applicable to
the communication of graphical or image information.
NOTE The provisions for this International Standard have been validated in the domains and for the purposes
described above. However, messages conforming to this International Standard may be considered by some user
communities to meet their needs for purposes outside this scope. Use of the messages in these circumstances is not
precluded by the scope.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
1)
ASTM E1394-97 , Standard Specification for Transferring Information between Clinical Instruments and
Computer Systems
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
analyte
component indicated in the name of a measurable quantity
3.2
analytical instrument
AI
named set of equipment that provides implementations of laboratory services
NOTE 1 In ASTM E1394, the term “Clinical Laboratory Instrument” or “Clinical Instrument” is used.

1) Available from www.astm.org.
ISO 18812:2003(E)
NOTE 2 Workstations in laboratories can carry out communication between AIs and LISs. Such workstations can
assume the dual role of both posing as an LIS to an AI, and as an AI to an LIS. Therefore, a workstation connected
between an AI and an LIS may, in some circumstances, be considered as an AI, or, in other circumstances, as a LIS.
3.3
battery
group of analytical instrument investigations ordered together
NOTE This supplies a convention by which the user (the LIS) can order multiple analytical instrument investigations
by specifying a single name.
3.4
component
single data element or data elements that express a finer aggregation or extension of data elements that
precede it
NOTE A part of a field or repeat field entry is a component. As an example, the patient's name is recorded as three
components: last name, first name and middle initial, each of which is separated by a component delimiter (components
cannot contain repeat fields).
3.5
download
transmission of data from an LIS to an AI
3.6
field
specific attribute of a record that may contain a single data element or aggregates of data elements
3.7
laboratory information system
LIS
information system which can provide services to one or more analytical instruments
NOTE 1 In ASTM E1394, the term “Computer System” is used.
NOTE 2 Workstations in laboratories can carry out communication between AIs and LISs. Such workstations can
assume the dual role of both posing as an LIS to an AI, and as an AI to an LIS. Therefore, a workstation connected
between an AI and an LIS may, in some circumstances, be considered as an AI, or, in other circumstances, as an LIS.
3.8
loadlist
subset of one or more worklists specifically assigned to an analytical instrument
3.9
order
set of one or more analytical instrument investigation requests submitted to an analytical instrument
3.10
profile
restricted subset of a standard intended for a particular purpose
3.11
record
aggregate of fields describing one aspect of the complete message
3.12
repeat field
field containing one or more data elements, each of which is to be treated as having equal priority or standing
NOTE The repeat field is used for demographics, requests, orders, etc. For example, the repeat field “Test ID” may
contain the three individual test IDs “Na”, “K” and ”Ca”.
2 © ISO 2003 — All rights reserved

ISO 18812:2003(E)
3.13
request
request for a single laboratory service and a corresponding analytical instrument procedure to be carried out
in respect of a specified subject of investigation
3.14
result
set of information including all essential or useful data relevant to the result of a single analytical instrument
investigation and a corresponding analytical instrument procedure
3.15
sample
one or more parts taken or to be taken from a system and intended to provide information on that system or
on a subsystem, or to provide a basis for decision on either of these
NOTE 1 In this context, “system” refers to a system under investigation, e.g. a human body, rather than a computer
system.
NOTE 2 The term "specimen" is used in ASTM E1394 to denote the term “sample”.
3.16
test
determination of a single analyte or a combination of values from other determinations or observations that
constitute a measure of a single system attribute
NOTE In this context, “system” refers to a system under investigation, e.g. a human body, rather than a computer
system.
3.17
trigger event
action or event causing a message to be sent
3.18
upload
transmission of data from an AI to an LIS
3.19
worklist
defined set of requested analytical instrument investigations that can be assigned to an analytical instrument
4 Domains
4.1 User domain
This International Standard has been specifically created to provide common conventions for interfacing AIs
and LISs in a clinical laboratory environment. It is also applicable to the interfacing of AIs to computers in
other clinical practice settings, such as physicians' offices, clinics and satellite laboratories. It is not applicable
to applications with a continuous flow of results from only one (or a few) implicitly identified subjects of
investigation, such as is found in the monitoring of vital signs. It may not be applicable to situations where the
AI is remote from the laboratory that controls it, i.e. near patient testing (NPT) or point of care (POC) AIs.
4.2 Interface domain
This applies to communication between parties where one party will assume the role of an AI and the other
party will assume the role of an LIS. It is therefore also intended for communication involving independent
workstations in the laboratory environment where these are capable of carrying out functions of
communication between AIs and LISs. Such workstations may assume the dual role of both posing as an LIS
to an AI, and as an AI to an LIS.
ISO 18812:2003(E)
5 Conformity
Messages for transmission of information between AIs and LISs covered in this International Standard shall
use only the message types, records, fields and values specified in Clause 6.
Implementations conforming to this International Standard shall be in accordance with one of the profiles
specified in Clause 6.
Conformity to a profile specified in Clause 6 shall entail support of the messages and records defined for that
profile in 6.3, and the sequence of messages for that profile specified in 6.4.
When claiming conformity to this International Standard, implementations shall state to which of the profiles
defined in Clause 6 the messages conform.
6 Profiles
6.1 General
This clause specifies the profiles to which implementations shall conform. For each profile it specifies
 the messages that shall be supported;
 the message sequence that shall be supported;
 the records allowed within each message;
 the optionality of the fields within the message;
 the values allowed within each field.
The sequence of messages that shall be supported by each profile are specified in 6.4.
6.2 Message descriptions
An overview of each message is given in Table 1.
Table 1 — Message descriptions
Message identifier Message title Comment
M1 Result For sending results from AI to LIS
M2 Results by query For sending results from AI to LIS in response to a query for results
a
message (M6) sent from LIS to AI
M3 Results by query For sending results from LIS to AI in response to a query for results
a
message (M6) sent from AI to LIS
M4 Order For sending orders from LIS to AI, either unsolicited or in response
to a query for order message (M5)
M5 Query for order For sending a query for an order from AI to LIS
M6 Query for results For sending a query for results from LIS to AI, or AI to LIS
a
ASTM E1394 requires different fields to be supported for records containing results in response to queries and different fields
depending on the direction of the response message. There are no such requirements for order messages.

4 © ISO 2003 — All rights reserved

ISO 18812:2003(E)
6.3 Profile descriptions
The messages included in each profile, the direction of message flow and the records included in each
message are specified in Table 2.
Table 2 — Profile descriptions

a b c
Profile Description
Direction Message Record
P1 Simple profile for the transfer of AI → LIS M1: Result H, L, P, O, R, C
results from AI to LIS
P2 Simple profile for the transfer of LIS → AI M4: Order H, L, P, O, C
orders from the LIS to the AI, and for

the transfer of results from the AI to
the LIS
M1: Result H, L, P, O, R, C
AI → LIS
P3 Bidirectional query profile for the M5: Query for order H, L, Q
AI → LIS
transfer of order queries from the AI
LIS → AI M4: Order H, L, P, O, C
to the LIS, orders from the LIS to the
AI, and results from the AI to the LIS
AI → LIS M1: Result H, L, P, O, R, C
P4 Bidirectional query profile for the M5: Query for order H, L, Q
AI → LIS
transfer of order queries from the AI
M4: Order H, L, P, O, C
LIS → AI
to the LIS, orders from the LIS to the
AI, result queries from the LIS to the
M1: Result H, L, P, O, R, C
AI → LIS
AI, orders from the LIS to the AI, and
results from the AI to the LIS
LIS ↔ AI M6: Query for results H, L, Q
M2: Results by query H, L, P, O, R, C
AI → LIS
LIS → AI M3: Results by query H, L, P, O, R, C
P5 Implementation compliant only with either/both (no restrictions) (no restrictions)
ASTM E1394
a
The sequence of messages that shall be supported by each profile is detailed in 6.4.
b The message identifiers correspond to the entries in Table 1.
c H = message header record; L = terminator record; P = patient information record; O = test order record; R = result record;
C = comment record; Q = request information record.

6.4 Sequence diagrams
6.4.1 Profile P1
Implementations of profile P1 shall support the following sequence of messages.

ISO 18812:2003(E)
6.4.2 Profile P2
Implementations of profile P2 shall support the sequence of messages defined for profile P1 plus the following
sequence of messages.
NOTE The message sequence defined above relates only to a single message-response sequence. It does not
preclude many order messages being followed by many result responses, e.g. Order-1, Order-2, Order-3, Result-1,
Result-2, Result-3; or Order-1, Order-2, Result-1, Order-3, Result-2, Result-3.
6.4.3 Profile P3
Implementations of profile P3 shall support the sequence of messages defined for profile P2 plus the following
sequence of messages.
NOTE The message sequence defined above relates only to a single message-response sequence. It does not
preclude, for example, many order query messages being followed by many order messages, followed by many results.
6 © ISO 2003 — All rights reserved

ISO 18812:2003(E)
6.4.4 Profile P4
Implementations of profile P4 shall support the sequence of messages defined for profile P3 plus the following
sequences of messages.
NOTE The message sequence defined above relates only to a single message-response sequence. It does not
preclude, for example, many result query messages being followed by many result messages.
6.4.5 Profile P5
There are no restrictions on the message sequence that shall be supported by profile P5.
6.5 Attribute optionality and allowed values
The attribute optionality and allowed values are specified in Table 3.
ISO 18812:2003(E)
Table 3 — Attribute optionality and allowed values
Message identifier M1 M2 M3 M4 M5 M6

a
Attribute optionality and allowed values
ASTM E1394
Message name/Attribute
reference
Result(s) Result(s) Query for Query for
Result Order
by query by query order(s) result(s)
Message header record
H 7 1 1 Record type ID M M M M M M
H 7 1 2 Delimiter definition M M M M M M
H 7 1 5 Sender name or ID O O O O O O
H 7 1 6 Processing ID O (P, Q) O (P, Q) O (P, Q) O (P, Q) O (P, Q) O (P, Q)
H 7 1 10 Receiver ID O O O O O O
H 7 1 13 Version No. O O O O O O
H 7 1 14 Date and time of message O O O O O O
Patient information record
P 8 1 1 Record type ID M M M M
P 8 1 2 Sequence No. M M M M
P 8 1 4 Laboratory assigned ID D D D O
P 8 1 6 Patient name D D D O
P 8 1 8 Birthdate D D D O
P 8 1 9 Patient sex D D D O
P 8 1 17 Patient height D D D O
P 8 1 18 Patient weight D D D O
P 8 1 26 Location D D D O
Test order record
O 9 4 1 Record type ID M M M M
O 9 4 2 Sequence No. M M M M
O 9 4 3 Sample ID D D M M
O 9 4 4 Instrument sample ID M M D D
O 9 4 5 Universal test ID D D D M
O 9 4 6 Priority O O O O
O 9 4 8 Sample collection date and D D D O
time
O 9 4 12 Action code O O O O
(Q) (Q) (Q) (N, Q,
C, A)
O 9 4 13 Danger code D D D O
O 9 4 16 Sample descriptor D D D O
O 9 4 16 1 Sample type D D D O
O 9 4 16 2 Sample source D D D O
O 9 4 17 Ordering physician D D D O

8 © ISO 2003 — All rights reserved

ISO 18812:2003(E)
Table 3 — (continued)
Message identifier M1 M2 M3 M4 M5 M6

a
Attribute optionality and allowed values
ASTM E1394
Message name/Attribute
reference
Result(s) Result(s) Query for Query for
Result Order
by query by query order(s) result(s)
O 9 4 18 Physician telephone No. D D D O
O 9 4 23 Date/Time results reported or O O O O
last modified
O 9 4 26 Report types D D D M
(O, X, Z, Q)
Result record
R 10 1 1 Record type ID M M M
R 10 1 2 Sequence No. M M M
R 10 1 3 Universal test ID M M M
R 10 1 4 Data or measurement value M O O
R 10 1 5 Units O O O
R 10 1 7 Result abnormal flags O O O
R 10 1 9 Result status O O O
(P, F, (P, F, X, (P, F, X,
M, R) I, M, R, Q) I, M, R, Q)
R 10 1 11 Operator identification O O O
R 10 1 13 Date/Time test completed O O O
R 10 1 14 Instrument identification O O O
Comment record
C 11 1 1 Record type ID M M
C 11 1 2 Sequence No. M M
C 11 1 4 Comment text M M
C 11 1 5 Comment type M M
(G, I) (G, I)
Request information record
Q 12 1 1 Record type ID   M M
Q 12 1 2 Sequence No.   M M
Q 12 1 3 Starting range ID No.   M M
Q 12 1 4 Ending range ID No.   O O
Q 12 1 5 Universal test ID   O O
Q 12 1 13 Request information status   O M
codes (O, D) (P, F, I,
M, N)
ISO 18812:2003(E)
Table 3 — (concluded)
Message identifier M1 M2 M3 M4 M5 M6

a
Attribute optionality and allowed values
ASTM E1394
Message name/Attribute
reference
Result(s) Result(s) Query for Query for
Result Order
by query by query order(s) result(s)
Message terminator record
L 13 1 1 Record type ID M M M M M M
L 13 1 2 Sequence M M M M M M
L 13 1 3 Termination code M M M M M M
(N) (N) (N) (N) (N) (N)
a
M = mandatory; O = optional; D = disallowed; values in brackets denote allowable values (from those specified in ASTM E1394).

10 © ISO 2003 — All rights reserved

ISO 18812:2003(E)
Annex A
(informative)
How to read this International Standard
A.1 Introduction
The Introduction gives further background to the concepts behind this International Standard and explains the
purpose of some of the other clauses.
A.2 Profiles
A.2.1 The concept of profiles
This International Standard consists of message definitions that are profiles of the ASTM E1394 standard. The
concept of profiling standards is common in European and international standardization: a profile of a
standard is a way of limiting the options within the standard so as to make it easier to use for a particular
purpose.
As an example of this, consider a communications network standard that supports both local area networks
(LANs) and wide area networks (WANs), but requires different options to be set depending on whether the
standard is implemented for a LAN or a WAN. Then consider two implementations: one that has the options
set for the LAN and another that has the options set for a WAN. Both implementations conform to the
standard, but they are incompatible. The LAN implementation will not interwork with the WAN.
What is needed, therefore, is some way of specifying that one implementation conforms to the standard but
has all the LAN options set, and the other conforms to the standard but has all the WAN options set. The way
this is normally done is by specifying two profiles: the one with all the LAN options set may be called the LAN
profile and the other with all the WAN options set may be called the WAN profile. Any implementation claiming
conformance to the LAN profile should interwork with any other implementation claiming conformance to the
LAN profile, and the same for the WAN profile. The LAN profile is not expected to work with the WAN profile.
The profiles, therefore, are a way of setting the options (or limiting the optionality) within the standard for a
particular purpose.
A.2.2 Profiles of ASTM E1394
The ASTM E1394 standard was originally written to allow almost any type of AI to communicate with any type
of LIS for almost any purpose. This has been its strength, the fact that it can be used in any situation. It has
also been its weakness in that every implementation is different and cannot easily work with a different
implementation. However, most implementations only need a limited range of the information that can be
carried in ASTM E1394, and only need it for a limited number of purposes.
For example, many AIs are only capable of sending single results to a LIS and cannot receive messages.
Therefore, they only need to use a very limited number of the facilities that ASTM E1394 offers, e.g.:
 message type: result message;
 record type: message header record, terminator record, patient information tecord, result record,
comment record;
 field: basic fields consisting of patient identifier, test identifier, result value, free text comment,
etc.
ISO 18812:2003(E)
If the LIS knew that it was only required to support this very limited range of functions, the LIS end of the
interface would be very simple. Unfortunately, however, ASTM E1394 implies that every interface has to be
capable of supporting an enormous range of record types and fields for a huge variety of purposes. Therefore,
the LIS interface has to be very complex, although in this case the complexity is unnecessary. It is impractical
for the LIS interface to support every available option, so the LIS interface would be designed or configured
specially to meet the needs of this simple AI. This keeps the cost and complexity down, but removes most of
the benefits of standardization.
What is required, therefore, is a way of specifying a simple one-way AI interface, conforming to ASTM E1394,
but only using those facilities required by typical unidirectional AIs. This could then be called the “simple
unidirectional AI interface”. The supplier of the LIS would then be able to write his own “simple unidirectional
AI interface” that could be used for all unidirectional AIs. On-site implementation of such interfaces would then
become much easier and cheaper, with a much lower chance of errors.
This could then be called the “simple unidirectional AI profile” of ASTM E1394.
A.2.3 Need for a range of profiles
Obviously, the simple profile would only be usable for a limited range of AIs. Even simple, bidirectional AIs (i.e.
those capable of receiving as well as transmitting messages) would not be able to use it. Many AIs would also
need to support more complex features, wider ranges of information and queries from one side of the interface
to another. However, nearly all these requirements can be satisfied by defining a range of profiles, e.g.:
 simple unidirectional AI profile: (as above; results from AI to LIS);
 simple bidirectional AI profile: (orders from LIS to AI, results from AI to LIS);
 bidirectional order query profile: (orders from LIS to AI, results from AI to LIS, order queries from
AI to LIS);
 bidirectional order/result query profile: (orders from LIS to AI, results from AI to LIS, order queries from
AI to LIS, result queries from LIS to AI).
All these profiles are much simpler than using the full ASTM E1394 standard. They should handle nearly all
requirements for interfacing AIs to LISs. However, some complex AIs may need facilities not included in these
profiles. These requirements would still be covered by ASTM E1394, but would not be covered by a profile.
For convenience, it is possible to define a fifth profile that includes the whole of ASTM E1394. This gives a
complete set of profiles:
 profile 1: simple unidirectional AI profile;
 profile 2: simple bidirectional AI profile;
 profile 3: bidirectional order query profile;
 profile 4: bidirectional order/result query profile;
 profile 5: the whole of ASTM E1394.
These are the profiles specified in Clause 6 of this International Standard. Each profile specifies:
 the messages supported in that profile;
 the direction in which each of the messages should flow;
 the records allowed in each message.
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ISO 18812:2003(E)
These are all specified in Table 2. Scientific and manufacturer records are not included in profiles 1 to 4, as
they are rarely used and there seems to be no consistent way of using them.
This International Standard also specifies (6.4) the sequence of messages that shall be supported by each
profile.
A.2.4 Limiting the fields and allowed values
Many of the fields specified in ASTM E1394 are never used in real implementations. Others are used rarely,
some are used wrongly and some are used where a more commonly used field would be more appropriate.
For this reason, many of the fields in messages specified by the profiles 1 to 4 are disallowed. These fields
are specified in Table 3 of this International Standard.
Table 3 also shows where fields can only have specific values. This is because the other values allowed by
ASTM E1394 have no known use or cannot be used safely (usually because the receiver of the information
cannot interpret it or use it safely).
Profile 5 (the whole of ASTM E1394) has no such restrictions.
A.3 Claiming conformity
In the past, an AI interface could claim general conformity to ASTM E1394. Now the interface can claim
conformity to one of the profiles specified in this International Standard, which should greatly limit the
complexity of the LIS interface implementation. As all the profiles are perfect subsets of ASTM E1394, any
implementation conforming to a profile is also in accordance with ASTM E1394. Therefore, any
implementation conforming to this International Standard is also in accordance with ASTM E1394.
However, the implementations conforming to ASTM E1394 may not in general be in accordance with this
International Standard.
Conformity to a profile specified in this International Standard consists of conformity to
 the messages allowed by the profile;
 the sequence of messages that shall be supported;
 the records allowed within each message;
 the optionality of the fields within the message;
 the values allowed within each field.
This is defined in Clause 5 of this International Standard.
A.4 Implementation guidelines
As well as defining the profiles above, this International Standard also gives guidelines for making interfaces
easier to implement and more reliable. These include
 advice on further restricting the allowed values in certain fields;
 information on the interpretation of ASTM E1394;
 the circumstances in which certain fields should be used.
These guidelines are included in Annex C.
ISO 18812:2003(E)
Annex B
(informative)
Scenarios and models
B.1 Overview
This annex shows the communication requirements supported by the use of profiles specified in this
International Standard. These requirements are identified in scenarios, which do not, however, form an
exhaustive list of circumstances in which these profiles are applicable.
The scenarios are described as text and as models using the Unified Modeling Language (UML).
In order to promote understanding, the scenarios are described in laboratory user terms in Clause B.2 and are
then stated formally in Clause B.3. Clause B.4 shows use case models in UML and the corresponding
sequence diagrams.
B.2 User-friendly scenarios
B.2.1 Introduction
This clause describes typical scenarios for information interchange between AIs and LISs in clinical
laboratories.
B.2.2 Analytical instrument with positive sample identification, bidirectional communication
in a chain
A varying number of tests are to be performed for a number of samples on a selective clinical chemistry AI.
Each sample cup carries a bar code label for identification. The samples are placed in a chain and entered to
the AI. For each sample, the following procedure is performed.
a) The AI reads the bar code label and transmits a message to the LIS asking for test requests for this
sample.
b) LIS has to transmit the test orders for this sample to the AI within a given time window.
c) The AI starts performing the ordered tests. Each time a test is completed, the result will be transmitted to
the LIS. LIS identifies the results with the help of sample ID and test ID.
d) The bar code label of the next sample is read by the AI. This typically happens during the processing of
the previous one.
B.2.3 Analytical instrument with positive sample identification, bidirectional communication
on a carousel
A varying number of tests are to be performed for a number of samples on a selective clinical chemistry AI.
Each sample cup carries a bar code label for identification. The samples are placed on a carousel and entered
to the AI. For each carousel, the following procedure is performed.
a) The AI reads the carousel ID and sends a message to LIS asking test orders for this carousel.
b) LIS downloads all sample IDs and test orders for these samples to the AI.
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c) The requested tests for the samples are performed on the AI and the results are uploaded to the LIS. The
LIS identifies the results with the help of sample ID and test ID.
d) When all the tests for this carousel have been performed, the AI reads the next carousel ID.
B.2.4 Batch analytical instrument, bidirectional communication
A number of tests are to be performed for a number of samples on a clinical chemistry AI. The samples are
placed in a chain. The following procedure is carried out for each test.
a) A loadlist is printed out by the LIS to determine the sample positions. The samples are pl
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