Health informatics - Representation of dedicated kinds of property in laboratory medicine

1.1   Purpose
This European Standard provides a structure aiding the representation, e.g. systematic terms or coding systems, of dedicated kinds of property, including dedicated kinds of quantity, in laboratory medicine.  The structure for representation is intended to facilitate the unambiguous communication of messages containing information about properties.
1.2   Field of application
This European Standard is applicable to all branches of laboratory medicine and other bodies offering laboratory analytic services. Examinations performed in the physician's office, at the bedside, or in the home are considered to be part of the laboratory medicine domain and thus this European Standard applies.
1.3   Uses
This structure for representation constitutes the essential basis for development of nomenclatures and coding systems intended for use in unambiguous and fully informative communication about properties, which fall within the field of application. Every such communication, including requests to and reports from clinical laboratories, and information retrieval for management reporting, research and reimbursement, will require additional information which is outside the scope of this European Standard.
1.4   Limitations
It should be emphasized that it is not the purpose of this European Standard to standardize the language used by health care practitioners in requesting or reporting clinical laboratory data.  It may, however, be used as a guide by those who wish to adopt systematic terms for routine requesting and reporting of laboratory data.
The syntax used for representing dedicated kinds-of-property is outside the scope of this European Standard, as are syntactic rules for the construction of codes in coding schemes.
The purpose is not to standardize the presentation of properties or kinds-of-property in user interfaces of computer systems nor the presentation in printed documents.

Medizinische Informatik - Darstellung von bestimmten Arten von Eigenschaften in der Laboratoriumsmedizin

Informatique de santé - Représentation des différentes sortes de propriété dédiée dans la médecine de laboratoire

Objet
La présente Norme européenne fournit une structure d’aide a la représentation, par exemple les termes systématiques ou les systemes de codage des types de propriété dédiés, y compris les types de grandeur dédiés, utilisés dans la médecine de laboratoire. La structure de représentation a pour but de faciliter une communication non ambiguë des messages contenant des informations sur les propriétés.
Domaine d’application
La présente Norme européenne est applicable a toutes les branches de la médecine de laboratoire ainsi qu’aux autres organismes fournisseurs de services d’analyses médicales. Les examens pratiqués dans le bureau du médecin, a l’hôpital ou a domicile sont considérés comme relevant e la médecine de laboratoire et, partant, du domaine d’application de la présente Norme européenne.
Utilisations
La présente structure de représentation constitue la base indispensable a l’élaboration de nomenclatures et de systemes de codage destinés a etre utilisés pour une communication claire et complete sur les propriétés couvertes par le domaine d’application. Chaque communication de ce type, y compris les demandes adressées a des laboratoires d’analyses, les comptes rendus issus de ces laboratoires et la récupération d’informations pour les rapports de gestion, la recherche et les remboursements, nécessitera des informations supplémentaires qui sont hors du domaine d’application de la présente Norme européenne.
Restrictions
Il convient de souligner le fait que la présente Norme européenne n’a pas pour objet de normaliser le langage utilisé par les praticiens de la santé dans les demandes et les comptes rendus d’analyse médicales. Elle peut néanmoins servir de guide aux personnes souhaitant employer systématiquement certains termes dans les requetes et les comptes rendus d’analyses les plus courants.
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Zdravstvena informatika - Predstavitev posebnih vrst lastnosti v laboratorijski medicini

General Information

Status
Published
Publication Date
30-Nov-2006
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Dec-2006
Due Date
01-Dec-2006
Completion Date
01-Dec-2006

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Health informatics - Representation of dedicated kinds of property in laboratory medicineZdravstvena informatika - Predstavitev posebnih vrst lastnosti v laboratorijski mediciniInformatique de santé - Représentation des différentes sortes de propriété

dédiée dans la médecine de laboratoireMedizinische Informatik - Darstellung von bestimmten Arten von Eigenschaften in der LaboratoriumsmedizinTa slovenski standard je istoveten z:EN 1614:2006SIST EN 1614:2006en35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technologyICS:SIST ENV 1614:20031DGRPHãþDSLOVENSKI

STANDARDSIST EN 1614:200601-december-2006

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1614September 2006ICS 35.240.80Supersedes ENV 1614:1995

English VersionHealth informatics - Representation of dedicated kinds ofproperty in laboratory medicineMedizinische Informatik - Darstellung von bestimmten Artenvon Eigenschaften in der LaboratoriumsmedizinThis European Standard was approved by CEN on 14 August 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36

B-1050 Brussels© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1614:2006: E

EN 1614:2006 (E) 2 Contents Page Foreword..............................................................................................................................................................3 Introduction.........................................................................................................................................................4 1 Scope......................................................................................................................................................5 1.1 Purpose...................................................................................................................................................5 1.2 Field of application................................................................................................................................6 1.3 Uses........................................................................................................................................................6 1.4 Limitations..............................................................................................................................................6 2 Normative references............................................................................................................................6 3 Terms and definitions...........................................................................................................................6 4 Requirements.........................................................................................................................................7 4.1 Representation of dedicated kind-of-property...................................................................................7 Annex A (informative)

Representation of dedicated kinds-of-property.........................................................9 Annex B (informative)

C-NPU...........................................................................................................................12 Annex C (informative)

LOINC...........................................................................................................................13 Bibliography......................................................................................................................................................14

EN 1614:2006 (E) 3 Foreword This document (EN 1614:2006) has been prepared by Technical Committee CEN/TC 251 “Health informatics”, the secretariat of which is held by NEN. 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 March 2007, and conflicting national standards shall be withdrawn at the latest by March 2007. This document supersedes ENV 1614:1995. The major technical changes are that issues relating to the distinction between kinds and instances of property have been resolved and that normative references to IUPAC-IFCC C-NPU have been removed. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EN 1614:2006 (E) 4 Introduction This European Standard provides a model for the representation of dedicated kinds of property in laboratory medicine. The need for this work stems from the increasing use of computerized clinical laboratory information systems, and the increasing need for reliable communication between laboratory information systems and between laboratory and other health care information systems (HCIS). Potential users of this European Standard are: - international and national organizations responsible for development, maintenance or registration of nomenclatures, classifications and coding systems; - designers and developers of HCIS, e.g. laboratory information systems (LIS); - persons responsible for acquisition of HCIS and checking compliance with standards; - designers and developers of computerized diagnostic devices and data acquisition systems; - developers of communication standards. The degree to which a message (such as a clinical laboratory report) needs to be expressed in a formal, systematic language depends on the geographical, linguistic, social or professional distance between the communicating parties.

The greater the distance, the greater the risk of misunderstanding. Within any one clinical laboratory, local jargon terms may be used which are usually well understood between colleagues (Local Dialect A in Figure 1), but which would not be sufficiently widely known for communication with the outside world.

Likewise, a laboratory and its local community of users, such as hospital or community physicians, may use a "local dialect" of the language of clinical laboratories which is well understood by all concerned; but if communication possibilities are wider, even transnational, risks of serious misunderstanding arise.

EN 1614:2006 (E) 5 User BLocal dialect BUser CLocal dialect CUser A1User A2Local dialect AReferenceterminologyfor LaboratoryMedicineStandardized structurefor representationCoding scheme Figure 1 — Reference terminology as the bridge between local dialects Risks of misunderstanding also increase when the "professional distance" between communicating parties increases, e.g. laboratory to health administrator rather than laboratory to clinician. Two approaches to reducing this risk are: 1. To standardize the technical language used by clinical laboratory workers, users of the service, and other interested parties throughout the whole area in which communications may take place by eliminating all "local dialects". This is obviously impracticable.

Laboratory workers and clinicians would object to any such attempt from medical informatics.

In the long run, agreement between professional bodies, with the cooperation of educational institutions, may lead to a greater degree of uniformity in the language of clinical laboratories, but this will not happen quickly and cannot be forced. 2. To create a coding scheme and a reference terminology for laboratory medicine which can be used as the basis for coding the dedicated kind-of-property part of a clinical laboratory messages for transmission between different locations and which contains sufficient information to allow the message to be translated from and to the required "local dialect" at each end. The coding scheme should be based on a standardized representation structure. This is the more practical approach. 1 Scope 1.1 Purpose This European Standard provides a structure aiding the representation, e.g. systematic terms or coding systems, of dedicated kinds of property, including dedicated kinds of quantity, in laboratory medicine.

The structure for representation is intended to facilitate the unambiguous communication of messages containing information about properties.

EN 1614:2006 (E) 6 1.2 Field of application This European Standard is applicable to all branches of laboratory medicine and other bodies offering laboratory analytic services. Examinations performed in the physician's office, at the bedside, or in the home are considered to be part of the laboratory medicine domain and thus this European Standard applies. 1.3 Uses This structure for representation constitutes the essential basis for development of nomenclatures and coding systems intended for use in unambiguous and fully informative communication about properties, which fall within the field of application. Every such communication, including requests to and reports from clinical laboratories, and information retrieval for management reporting, research and reimbursement, will require additional information which is outside the scope of this European Standard. 1.4 Limitations It should be emphasized that it is not the purpose of this European Standard to standardize the language used by health care practitioners in requesting or reporting clinical laboratory data.

It may, however, be used as a guide by those who wish to adopt systematic terms for routine requesting and reporting of laboratory data. The syntax used for representing dedicated kinds-of-property is outside the scope of this European Standard, as are syntactic rules for the construction of codes in coding schemes. The purpose is not to standardize the presentation of properties or kinds-of-property in user interfaces of computer systems nor the presentation in printed documents. 2 Normative references Not applicable. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 system part or phenomenon of the perceivable or conceivable world consisting of a demarcated arrangement of a set of elements and a set of relationships or processes between these elements [1] EXAMPLE A given human being; a given portion of urine; the blood of a given person. NOTE A system is, with the exception of the universe, a part of at least one more comprehensive super system and can itself contain one or several subsystems. 3.2 component part of a system (3.1) EXAMPLE Body of a given human being; glucose in a given portion of urine; the process of coagulation of the blood of a given person. NOTE 1 Systems are open, i.e. transport occurs across their borders, both as input and output.

Such transported entities may be conveniently regarded as components of the system. NOTE 2 Components may be complex in that they may be aggrega

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