SIST EN ISO 18812:2003

Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003)

ISO 18812:2003 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
ISO 18812:2003 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.
ISO 18812:2003 is applicable only to character-based message information. It is not applicable to the communication of graphical or image information.

Informatique de santé - Interfaces d'analyseur clinique pour systemes d'information de laboratoire - Profils d'utilisation (ISO 18812:2003)

L'ISO 18812:2003 spécifie des messages généraux destinés à l'échange électronique d'informations entre les instruments d'analyse (IA) et les systèmes d'information de laboratoire (SIL) dans un laboratoire clinique. Elle est applicable aux spécialités suivantes: chimie/biochimie clinique, hématologie, toxicologie, microbiologie, virologie et immunologie. Elle n'est pas applicable à la transfusion sanguine ni à la banque de sang.
L'ISO 18812:2003 traite de la spécification des messages utilisés par les parties communicantes et de leur syntaxe. Elle ne traite pas des mécanismes de transport utilisés pour l'échange de messages.
L'ISO 18812:2003 est applicable uniquement aux messages basés sur des caractères. Elle n'est pas applicable à la communication d'informations graphiques ou en images.

Zdravstvena informatika – Vmesniki kliničnih analizatorjev do laboratorijskih informacijskih sistemov – Profili uporabe (ISO 18812:2003)

General Information

• Status: Published
• Publication Date: 30-Sep-2003
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Oct-2003
• Due Date: 01-Oct-2003
• Completion Date: 01-Oct-2003
• Mandate: M/255 - Standardization mandate to CEN, CENELEC and ETSI in the field of health care informatics
• Ref Project: EN ISO 18812:2003 - Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003)

Relations

• Replaces: SIST ENV 13728:2003 - Health informatics - Clinical analyser interfaces to laboratory information systems
• Effective Date: 01-Oct-2003

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 18812:2003
01-oktober-2003
1DGRPHãþD
SIST ENV 13728:2003
=GUDYVWYHQDLQIRUPDWLND±9PHVQLNLNOLQLþQLKDQDOL]DWRUMHYGRODERUDWRULMVNLK
LQIRUPDFLMVNLKVLVWHPRY±3URILOLXSRUDEH,62
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
SIST EN ISO 18812:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18812:2003

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SIST EN ISO 18812:2003
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.

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SIST EN ISO 18812:2003
EN ISO 18812:2003 (E)
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.
2

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SIST EN ISO 18812:2003


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

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SIST EN ISO 18812:2003
ISO 18812:2003(E)
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ii © ISO 2003 — All rights reserved

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SIST EN ISO 18812:2003
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

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SIST EN ISO 18812:2003
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

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SIST EN ISO 18812:2003
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.
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SIST EN ISO 18812:2003
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

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SIST EN ISO 18812:2003
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.
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SIST EN ISO 18812:2003
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”.
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SIST EN ISO 18812:2003
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.
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SIST EN ISO 18812:2003
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.

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SIST EN ISO 18812:2003
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.

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SIST EN ISO 18812:2003
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.
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SIST EN ISO 18812:2003
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.
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SIST EN ISO 18812:2003
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
...