EN ISO 18812:2003
(Main)Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (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 systèmes 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
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 qualit
...
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