1、DRAFT FOR DEVELOPMENT DD ENV 12539:1998 Medical informatics Request and report messages for diagnostic service departments ICS 11.040.50; 35.240.70DDENV12539:1998 This Draft for Development, having been prepared under thedirection of the DISC Board, was published under the authorityof the Standards
2、Committee and comes into effect on 15 November 1998 BSI 07-1999 ISBN 0 580 30528 7 National foreword This Draft for Development is the English language version of ENV12539:1997. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of pu
3、blications and is of a provisional nature due to the limited duration of the European prestandard. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requeste
4、d so that UK experience can be reported to the European organization responsible for its conversion into a European Standard. A review of this publication will be initiated2 years after its publication by the European organization so that a decision can be taken on its status at the end of its three
5、-year life. The commencement of the review period will be notified by an announcement in Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of th
6、e prestandard or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee IST/35, Medical informatics, at389 Chiswick High Road, LondonW44AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A li
7、st of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “Internatio
8、nal Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theENV title page, pages2 to177 and a back cover. This standard has been updated (see copyrig
9、ht date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsDDENV12539:1998 BSI 07-1999 i Contents Page National foreword Inside front cover Foreword 2 Text of ENV 12539 5ii blan
10、kEUROPEAN PRESTANDARD PRNORME EUROPENNE EUROPISCHE VORNORM ENV 12539 March 1997 ICS 11.040.50; 35.240.70 Descriptors: Medicine, diagnosis, data processing, information interchange, data transfer English version Medical informatics Request and report messages for diagnostic service departments Inform
11、atique de sant Messages de demandes et de comptes rendus de service de diagnostic Medizinische Informatik Anforderungs und Ergebnismitteilungen fr diagnostische Dienstleistungsstellen This European Prestandard (ENV) was approved by CEN on 1997-02-09 as a prospective standard for provisional applicat
12、ion. The period of validity of this ENV is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the ENV can be converted into an European Standard (EN). CEN members are required to announce the existance
13、 of this ENV in the same way as for an EN and to make the ENV available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final decision about the possible conversion of the ENV into an EN is reache
14、d. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisatio
15、n Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright reserved to CEN members Ref. No. ENV 12539:1997 EENV12539:1997 BSI 07-1999 2 Foreword This European Prestandard has been prepared by Technical Committee CEN/TC251 “Medical informatics”, the secre
16、tariat of which is held by IBN. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to announce this European Prestandard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Nether
17、lands, Norway, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom. Contents Page Foreword Introduction 1 Scope 6 2 Normative references 7 3 Definitions and abbreviations 8 4 Requirements 12 5 Communication roles and supported services 13 5.1 General 13 5.2 Message groups 13 5.3 Communication
18、 roles 13 5.4 Communication roles and General Message Descriptions 13 5.5 Communication roles and supported services 15 5.6 Message origination rules 15 6 Domain information model 16 6.1 Introduction 16 6.2 Domain Information Model diagrams 17 6.3 Textual description of the objects, their relationsh
19、ips and attributes 23 6.4 Textual descriptions of common attribute groups 62 7 General message descriptions 64 7.1 Introduction 64 7.2 New diagnostic service request GMD 65 7.3 Diagnostic service request modification GMD 77 7.4 Diagnostic service request cancellation GMD 85 7.5 New diagnostic servic
20、e report GMD 87 7.6 Diagnostic service report modification GMD 97 7.7 Diagnostic service report cancellation GMD 106 7.8 New diagnostic service plan report GMD 108 7.9 Diagnostic service plan report modification GMD 115 7.10 Attribute layer 121 Annex A (normative) How to read the models 149 A.1 Mode
21、l components 149 A.2 Symbols 149 A.3 Notes 151 A.4 Hierarchical GMDs 152ENV12539:1997 BSI 07-1999 3 Page Annex B (informative) Relating the models to actual requests and reports 153 B.1 Introduction 153 B.2 Requesting diagnostic services 154 B.3 Reporting the results of diagnostic investigations 157
22、 B.4 Reporting the planning or progress of diagnostic services 159 Annex C (informative) Scenarios 161 C.1 Summary of the scenarios 161 C.2 Request scenarios 162 C.3 Report scenarios 167 C.4 Illustrations of the different data types in a report 169 C.5 Acceptance, progress reporting and follow-up sc
23、enarios 172 C.6 Scenarios specific to post-mortem studies 174 C.7 Diagnostic services that involve two or more diagnostic service departments 174 Index 176 Figure 1 Relationship between communication roles and GMDs 14 Figure 2 State transition diagram for message origination 16 Figure 3 Diagnostic s
24、ervice requests and reports: Top level model 18 Figure 4 Diagnostic service requests and reports: Subject model for healthcare party 19 Figure 5 Diagnostic service requests and reports: Subject model for patient 20 Figure 6 Diagnostic service requests and reports: Subject model for analysed object 2
25、1 Figure 7 Diagnostic service requests and reports: Subject model for payment guarantor 21 Figure 8 New Diagnostic Service Request: Top level model 66 Figure 9 New Diagnostic Service Request: Subject model for healthcare party 67 Figure 10 New Diagnostic Service Request: Subject model for patient 68
26、 Figure 11 New Diagnostic Service Request: Subject model for analysed object 69 Figure 12 New Diagnostic Service Request: Subject model for payment guarantor 69 Figure 13 Diagnostic Service Request Modification: Top level model 77 Figure 14 Diagnostic Service Request Cancellation: Top level model 85
27、 Page Figure 15 Diagnostic Service Request Cancellation: Subject model for healthcare party 86 Figure 16 New Diagnostic Service Report: Toplevel model 88 Figure 17 New Diagnostic Service Report: Subject model for healthcare party 89 Figure 18 New Diagnostic Service Report: Subject model for analysed
28、 object 90 Figure 19 Diagnostic Service Report Modification: Top level model 98 Figure 20 Diagnostic Service Report Cancellation: Top level model 106 Figure 21 New Diagnostic Service Plan Report:Top level model 109 Figure 22 New Diagnostic Service Plan Report:Subject model for healthcare party 110 F
29、igure 23 New Diagnostic Service Plan Report:Subject model for patient 110 Figure 24 New Diagnostic Service Plan Report:Subject model for analysed object 111 Figure 25 Diagnostic Service Plan Report Modification: Top level model 116 Figure A.1 Legend 150 Figure A.2 Examples of model components 151 Fi
30、gure A.3 Representation of cardinalities intheDIM compared with SSADM 152 Figure A.4 The notation used in hierarchicalGMDs healthcare parties example 153 Figure A.5 The notation used in hierarchicalGMDs clinical investigation example 153 Table 1 Message groups 13 Table 2 Description of data types 22
31、 Table 3 Attribute layer General Message Description Matrix 122 Table 4 Attribute layer Common Attribute Groups 147 Table B.1 A simple diagnostic service request 154 Table B.2 A simple diagnostic service report 157 Table B.3 A simple diagnostic service plan report 1604 blankENV12539:1997 BSI 07-1999
32、 5 Introduction The increased use of data processing and telecommunications capabilities has made possible the interchange of information in machine readable and machine processable formats. As automated interchange of information in healthcare increases, it is essential to provide appropriate stand
33、ards. Computer systems are used for the storage and processing of information in many diagnostic service departments. Many of those asking for and receiving results of investigations also use computer systems to store and process patient related information. This information includes details of inve
34、stigations requested and results received. Diagnostic service departments carry out investigations requested by healthcare parties and send the results of these investigations to requesters and sometimes to other healthcare parties. Electronic transfer of requests and results, reduces the need for m
35、anual data entry and the risk of transcription errors. It also results in greater efficiency, leading to better healthcare provision. Standards are required to facilitate electronic transfer of requests for, and results of, investigations between the many systems currently used. Implementation of th
36、is European Prestandard will therefore: a) facilitate the electronic transfer of orders for diagnostic services from requesting healthcare parties, to diagnostic service departments; b) facilitate the electronic transfer of reports from diagnostic service departments to requesters and other healthca
37、re parties; c) reduce the need for human intervention in information interchange between applications used by diagnostic service departments and those used by other healthcare parties; d) minimise the time and effort required for the introduction of information interchange agreements; e) reduce the
38、development effort required by suppliers to allow communication between a wide range of applications in this field; f) reduce the cost of information interchange between diagnostic service departments and parties requesting diagnostic service department services. When implementing information exchan
39、ge based on this European Prestandard, data security services including confidentiality provisions must be ensured according to the laws actually in force in the different CEN member countries. The method by which this European Prestandard has been developed is based on the recommendations of the CE
40、N Report “Investigation of Syntaxes for Existing Interchange Formats to be used in Healthcare” (CR1350:1993). Extensions to the method, proposed by CEN TC251 PT3-025 while this document was being drafted, have also been applied where possible and relevant. This standard is intended for use by messag
41、e developers. Its provisions are directly relevant to suppliers of computer systems for use in diagnostic service departments, hospitals, general practices, clinical departments and specialist clinics. Its provisions are also relevant to those planning, specifying, procuring or implementing informat
42、ion systems for use in diagnostic service departments, hospitals, general practices, clinical departments and specialist clinics. The main normative provisions in this European Prestandard are expressed in clauses4 and5 and apply to the General Message Descriptions (GMDs), clause7. The symbols used
43、in this Prestandard have the meaning as defined in normative Annex A for the purposes of this Prestandard only. Informative Annex B explains how the Domain Information Model relates to actual requests and reports. Informative Annex C gives a number scenarios as examples of message use. A supporting
44、document to this ENV entitled “Generic EDIFACT message implementation guide for diagnostic service request and report messages” is being prepared. This will contain message definitions using the EDIFACT (Electronic data interchange for administration, commerce and transport) standard ISO9735, in lin
45、e with the procedures for submission of EDIFACT-based standards of the UN/ECE. These message definitions will be Implementable Message Specifications (IMSs) conforming with this European Prestandard. The supporting document will also contain message implementation guidelines for these messages. They
46、 should be considered an essential component of the IMS providing a generic EDIFACT implementation specification for use in Europe.ENV12539:1997 6 BSI 07-1999 The supporting document will be submitted to CEN for ballot as a CEN Report. The EDIFACT message definitions that it contains will also be su
47、bmitted to the UN/ECE as a proposal for a United Nations Standard Message (UNSM). Arrangements between CEN and the Western European EDIFACT Board ensure that UNSMs can become ENVs. The supporting document will therefore become an ENV in its own right through separate standardisation procedures. 1 Sc
48、ope 1.1 This European Prestandard specifies general messages to enable electronic exchange of requests for, and reports of, diagnostic services. The information exchanges covered are those between computer systems used by diagnostic service departments and computer systems used by healthcare parties
49、 requesting, or receiving results of, diagnostic services. 1.2 Within limits identified by subsequent clauses of this scope statement, this European Prestandard is applicable to messages requesting, or reporting on the results, of the following diagnostic services: Radiology; Nuclear medicine; Ultrasound; Other imaging techniques (e.g. magnetic resonance tomography); Electrophysiology; Physiological function tests; Diagnostic audiology; Cytology; Anatomic patholog
