EN 1614-2006 en Health informatics - Representation of dedicated kinds of property in laboratory medicine《医药卫生信息 实验室医用器械表示法-1995》.pdf

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1、BRITISH STANDARDBS EN 1614:2006Health informatics Representation of dedicated kinds of property in laboratory medicineThe European Standard EN 1614:2006 has the status of a British StandardICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g

2、40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 1614:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006ISBN 0 580 49376 8National forewordThis British Stand

3、ard was published by BSI. It is the UK implementation of EN 1614:2006. It supersedes DD ENV 1614:1995 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on IST/35 can be obtained on request to

4、 its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN

5、 STANDARDNORME EUROPENNEEUROPISCHE NORMEN 1614September 2006ICS 35.240.80 Supersedes ENV 1614:1995 English VersionHealth informatics - Representation of dedicated kinds ofproperty in laboratory medicineMedizinische Informatik - Darstellung von bestimmten Artenvon Eigenschaften in der Laboratoriumsme

6、dizinThis 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 r

7、eferences 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 i

8、nto 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,

9、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All ri

10、ghts of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1614:2006: EEN 1614:2006 (E) 2 Contents Page Foreword3 Introduction .4 1 Scope 5 1.1 Purpose.5 1.2 Field of application 6 1.3 Uses 6 1.4 Limitations6 2 Normative references 6 3 Terms and definiti

11、ons .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

12、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 shal

13、l 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

14、 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, Luxembo

15、urg, 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

16、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: - i

17、nternational 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

18、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

19、, 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),

20、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;

21、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 schemeFigure 1

22、 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 s

23、tandardize 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 obj

24、ect 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. T

25、o 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

26、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 c

27、oding 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

28、 European Standard is applicable to all branches of laboratory medicine and other bodies offering laboratory analytic services. Examinations performed in the physicians office, at the bedside, or in the home are considered to be part of the laboratory medicine domain and thus this European Standard

29、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, includin

30、g 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 E

31、uropean 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 representin

32、g 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 p

33、rinted 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 o

34、f 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

35、 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 conve

36、niently regarded as components of the system. NOTE 2 Components may be complex in that they may be aggregates of other components. EN 1614:2006 (E) 7 3.3 property inherent state- or process-descriptive feature of a system (3.1) including any pertinent component (3.2) being determined EXAMPLE Mass of

37、 the body of a given person at a given point in time; amount-of-substance concentration of glucose in a portion of urine at a given point in time. 3.4 quantity attribute of a phenomenon, body or substance that may be distinguished qualitatively and determined quantitatively VIM EXAMPLE Mass of a giv

38、en object at a given point in time. NOTE 1 Quantity is more specific in relation to property (3.3). NOTE 2 The adjectives “measurable“ and “physical“ are used in VIM and in ISO 31, respectively, when required to point out that the word “quantity“ is used in its metrological sense. In general, these

39、adjectives can be omitted. 3.5 kind-of-property common defining aspect of mutually comparable properties (3.3) 1 EXAMPLE Colour; mass; amount-of-substance concentration. NOTE The hyphens are used to clarify that the modifier “kind“ should be seen as part of a connected whole. 3.6 dedicated kind-of-p

40、roperty kind-of-property (3.5) with a given kind of system (3.1) and a given kind of component (3.2) subject for determination EXAMPLE Mass of the body of a non-specified human being; amount-of-substance concentration of glucose in urine. 3.7 procedure specified way to carry out an activity or a pro

41、cess 9 3.8 measurement scale ordered set of values of quantities of a given kind, continuous or discrete, used in arranging quantities of the same kind by magnitude 12 3.9 unit scalar quantity, defined and adopted by convention, with which other quantities of the same kind are compared in order to e

42、xpress their magnitudes 12 4 Requirements 4.1 Representation of dedicated kind-of-property The following elements stemming from the ontology of property shall be used for the representation of dedicated kinds-of-property (3.6) in laboratory medicine: kind of system (3.1); EN 1614:2006 (E) 8 kind of

43、component (3.2); kind-of-property (3.5). Representations of additional entities shall be appended to any or all of the elements when this is necessary to further specify the dedicated kind-of-property (3.6) to the degree required for a given purpose. While the three elements above represent aspects

44、of the property examined, other aspects related to the examination of the property or the representation of the value of the property may need to be specified. Thus, a representation of a dedicated kind-of-property (3.6) may be further specified by: procedure (3.7); measurement scale (3.8); unit (3.

45、9). EXAMPLE Specification to the system plasma, may be the super-system venous blood; to the component chromium, the specification Stock notation IV; to the kind-of-property mass concentration, the specification may be the measuring scale. Procedure specifications often apply to the whole dedicated

46、kind-of-property. NOTE Components may be complex, i.e. consist of aggregates of other components, e.g. in the case of sums or ratios. EN 1614:2006 (E) 9 Annex A (informative) Representation of dedicated kinds-of-property In reports for medical diagnosis and treatment it is necessary to ensure connec

47、tivity between laboratory production databases, medical health records and request and report systems. A prerequisite to enable this connectivity is the ability to represent examined properties in a systematic standardized way. This European Standard aims to provide such a systematic standardized wa

48、y of representing the part of laboratory messages pertaining to the kind-of-property examined. To illustrate how a property can be represented in a laboratory message, the following diagram is given. The example chosen is the amount-of-substance concentration of glucose in plasma from venous blood o

49、f a fasting patient examined in a sample from the patient at a given point in time. The laboratory message representing the examined property contains, among other things, the spatiotemporal specification, i.e. the subject of care and the time of examination, and the dedicated kind-of-property examined. In a practical context more complex message formats are of course needed. The message refers to a representation of a dedicated kind-of-property, usually using a code value obtained from a laboratory reference terminology, which in turn uses a representation structu