1、BRITISH STANDARDBS EN 14822-3:2005Health informatics General purpose information components Part 3: ClinicalThe European Standard EN 14822-3:2005 has the status of a British StandardICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g3
2、8g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 14822-3:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 22 November 2005 BSI 22 November 2005ISBN 0 580 47322 8National forewordThis Brit
3、ish Standard is the official English language version of EN 14822-3:2005. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics, which has the responsibility to:A list of organizations represented on this committee can be obtained on request to its s
4、ecretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Cata
5、logue or of British Standards Online.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 does not of itself confer immunity from legal obligations. aid enquirers to understand th
6、e text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cove
7、r, an inside front cover, the EN title page, pages 2 to 210, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORME
8、N 14822-3October 2005ICS 35.240.80English VersionHealth informatics - General purpose information components -Part 3: ClinicalInformatique de sant - Unit dinformation dans lesmessages - Partie 3: CliniqueMedizinische Informatik - Allgemein verwendbareInformationskomenten - Teil 3: Klinische Informat
9、ionenThis European Standard was approved by CEN on 16 August 2005.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
10、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
11、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,
12、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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 2005 CEN All rights of e
13、xploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14822-3:2005: EEN 14822-3:2005 (E) 2 Contents Page Foreword 4 Introduction5 1 Scope .6 2 Normative references .6 3 Terms and definitions.6 4 Abbreviations 10 5 Rules governing the use of general purpose i
14、nformation components .10 6 General Purpose Information Components an overview12 7 General Purpose Information Components 20 7.1 Analysable Object GPICs .20 7.1.1 Analysable Object.20 7.1.2 Analysable Object In Use .24 7.1.3 Specimen.26 7.1.4 Related Analysable Object .31 7.1.5 Manufactured Specimen
15、.32 7.1.6 Specimen Treatment.35 7.1.7 Related Specimen Treatment.38 7.1.8 Associated Specimen Treatment.39 7.1.9 Study Product .41 7.1.10 Object Characteristic 44 7.1.11 Preservation Material46 7.1.12 Acquired Analysable Object.49 7.1.13 Analysable Object Acquisition.51 7.1.14 Related Object Acquisi
16、tion.52 7.1.15 Acquisition Procedure54 7.1.16 External Data Reference.59 7.2 Clinical Information GPICs.61 7.2.1 Clinical Information.61 7.2.2 Clinical Information Complex.63 7.2.3 Clinical Information Context 66 7.2.4 Related Clinical Information Complex.68 7.2.5 Clinical Information Item 70 7.2.6
17、Related Clinical Information.74 7.3 Clinical Observation GPICs75 7.3.1 Clinical Observation .75 7.3.2 Related Patient Condition.78 7.4 Clinical Procedure GPICs.80 7.4.1 Clinical Procedure.80 7.4.2 Patient Preparation Procedure.84 7.4.3 Patient Preparation Substance 88 7.5 Counselling GPICs89 7.5.1 C
18、ounselling .89 7.6 Unclassified Clinical Information GPICs .92 7.6.1 Unclassified Clinical Information.92 7.7 Laboratory And Diagnostic Investigation GPICs95 7.7.1 Investigation Request.95 7.7.2 Related Investigation Request .101 7.7.3 Investigation Result Item103 7.7.4 Related Investigation Result
19、107 7.7.5 Reference Limit .109 EN 14822-3:2005 (E) 3 7.7.6 Reference Population .111 7.7.7 Investigation Specification.113 7.7.8 Body System .117 7.7.9 Related Body System .119 7.7.10 Measurement Procedure 121 7.8 Medication GPICs .124 7.8.1 Utilisation Guide .124 7.8.2 Medication Treatment.125 7.8.
20、3 Medication Supply 128 7.8.4 Medicinal Product .132 7.8.5 Ingredient 135 7.8.6 Medicinal Product in Use .137 7.8.7 Medicinal Product Pack139 7.8.8 Medicinal Product Pack in Use 143 7.8.9 Medication Appliance .145 7.8.10 Medication Appliance in Use147 7.8.11 Medication Treatment Regimen.148 7.8.12 D
21、ose Administration.150 7.8.13 Medication Treatment Condition .154 7.9 Treatment Routing GPICs 156 7.9.1 Routing Option156 7.9.2 Routing Device158 Care Encounter GPICs 161 7.9.3 Care Service Request .161 7.9.4 Related Service Request 165 7.9.5 Care Service Report166 7.9.6 Related Service Report.170 7
22、.9.7 Care Encounter .172 7.9.8 Related Care Encounter .176 7.10 Care Service Delivery GPICs178 7.10.1 Care Service Delivery .178 7.10.2 Previous Related Activity .181 8 Acts, their context and inheritance .183 8.1 Introduction.183 8.2 Inheritance of Act Context .184 8.2.1 Method.184 8.2.2 Participat
23、ion 184 8.2.3 Act Relationship185 9 Structural vocabularies 187 9.1 Act class 187 9.2 Act mood .192 9.3 Act status 193 9.4 Act Relationship193 9.5 Context Control Act Relationship198 9.6 Context Control Participation 198 Annex A (informative) Rationale for this document on general purpose informatio
24、n components 199 Annex B (informative) How to read the models200 B.1 Introduction.200 B.2 Classes 200 B.3 Associations between classes.200 B.4 Generalisation/Specialisation 201 Annex C (informative) Health Level 7 (HL7) reference information model.202 Annex D (informative) Common features of the gen
25、eral purpose information components204 Annex E (informative) Localisation of the general purpose information components .206 Bibliography.207 EN 14822-3:2005 (E) 4 Foreword This European Standard (EN 14822-3:2005) has been prepared by Technical Committee CEN/TC 251 “Health informatics”, the secretar
26、iat 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 April 2006, and conflicting national standards shall be withdrawn at the latest by April 2006. This is part three of a
27、multipart standard under the heading: Health informatics - General purpose information components: Part 1: Overview Part 2: Non-clinical Part 3: Clinical This European Standard is definition of a set of clinical general purpose information components. IMPORTANT Within this draft document each of the
28、 General Purpose Information Components and various sub-components are provided with identifiers, which are unique only internally within this European Standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement
29、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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 1
30、4822-3:2005 (E) 5 Introduction Many previous messaging and information structure standards for health have overlapping parts with a number of objects being defined in separate documents, sometimes with small variations making implementation of conformant applications more difficult. It therefore mak
31、es sense to define a set of general purpose components that can be used for definition of message structures for different purposes1. This approach was suggested and approved as a strategy for CEN/TC 251 in the Short Strategic Study on message standards alignment in 1999 examining a set of five Euro
32、pean prestandards for messages. This document is aiming to provide such a set of components and has been developed jointly with a new European standard for Service Request and Report messages that is using the components defined herein. Another important background to the development of this Europea
33、n Standard has been the wish for a harmonisation of information models for health developed in Europe and the USA expressed in the collaboration agreement entered March 2000 between CEN/TC 251 and HL7 (Health Level Seven, Ann Arbor. Michigan). The goal was set for a maximum degree of alignment while
34、 maintaining their independence and need to serve the business requirements of the respective markets but also to make the results available to ISO for possible international standardization. HL7 have adapted a general strategy similar to CEN/TC 251 using information modelling2expressed in UML (Unif
35、ied Modeling Language) for their new standards and a lot of interaction and information sharing has occurred between CEN experts and HL7 in an open spirit of collaboration. This European Standard includes a large number of objects which are technically identical to descriptions in draft documents of
36、 HL7, although partly described differently due to the fact that CEN is following the ISO rules for drafting and presentation of standards which HL7 is not. CEN wishes to express its gratitude towards HL7 experts for generously sharing their models with the European expert team. This European Standa
37、rd contains definition of a set of clinical general purpose information components. Many aspects of this document require explanation which is provided in EN 14822-1. 1See Annex A: Rationale for this document on General Purpose Information Components. 2Modelling is British English spelling whereas M
38、odeling is US English spelling. EN 14822-3:2005 (E) 6 1 Scope This European Standard specifies the definition and structuring of information relating to entities that are commonly encountered in communications with and between clinical information computer systems. Within the scope of this European
39、Standard is a description of components and their use. In particular, these components relate to the following sub-domains: Analysable objects: including samples, body parts, x-rays and other study products, together with their collection and properties. Clinical information: including observations,
40、 patient conditions, procedures, medication treatment, investigations, counselling plus how these items are organised within a record. Medicinal products: including appliances, dosage regimes,etc. Routing aspects of medication treatment or other procedures. Care Service information: including referr
41、als for care services, care encounter information and scheduling. 2 Normative references Not applicable. 3 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 3.1 analysable object something derived from or to be derived from a patient as part
42、 of a diagnostic or laboratory investigation ENV 12539:1997 - revised NOTE 1 Analysed object is a generalisation that includes samples taken from a patient and physical or digital records of information derived from a patient as part of a diagnostic service. An analysed object that is not a sample i
43、s referred to as a study product. NOTE 2 An analysed object need not exist in a tangible form but may represent something observed briefly by a diagnostic service provider. EXAMPLE 1 An x-ray image, a series of x-ray images, part of an x-ray image. The image may exist in a digitised form or as a fil
44、m. EXAMPLE 2 An electrocardiograph (ECG) monitor tracing or a twelve lead ECG. EXAMPLE 3 An organ removed during surgery or post-mortem, a biopsy, a particular slide containing a section taken from a biopsy. EXAMPLE 4 A view observed through an endoscope, an observation during an echocardiographic e
45、xamination. 3.2 analysable object in use information about an analysable object and the part it plays in an activity EN 14822-3:2005 (E) 7 EXAMPLE 1 Blood collected for a biochemical or hematological analysis during exploratory surgery. EXAMPLE 2 Urine sample taken by the patient to a routine examin
46、ation. 3.3 body system demarcated system that is related to a subject of care or component of a subject of care EXAMPLE 1 Systems: a man, an organ or anatomical structure. EXAMPLE 2 Components: pathological cells in a biopsy from an organ. 3.4 care encounter situation on the uninterrupted course of
47、which one or more health care professionals delivers health care services to a subject of care ENV 13940:2001 - modified 3.5 care service activity performed for a subject of care by a health care provider with the intention of directly or indirectly improving or maintaining the health of that subjec
48、t of care ENV 13940:2001 - modified 3.6 clinical information information about a patient, relevant to the health or treatment of that patient, that is recorded by or on behalf of a healthcare professional ENV 13606:2000 NOTE Clinical information about a patient may include information about the pati
49、ents environment or about related people where this is relevant. 3.7 clinical information complex healthcare record component representing an aggregation of other healthcare record components ENV 13606:2000 3.8 clinical observation clinical information excluding information about treatment and intervention NOTE The observer may be the patient or related person (information about symptoms, family history, occupation or life style), or a healthcare professional (information about physical signs, measurements, properties observed or diagnoses). Whil
