1、DEUTSCHE NORM Oktober 2003VornormMedizinische InformatikFr die Bluttransfusion bentigte NachrichtenTeil 2: Fr die Erzeugnisse bentigte NachrichtenDeutsche Fassung ENV 13730-2:2002, Text EnglischVENV 13730-2ICS 35.240.80Healthcare Informatics Blood transfusion related messages Part 2: Product related
2、 messages (BTR-PROD);German version ENV 13730-2:2002, Text EnglishEine Vornorm ist das Ergebnis einer Normungsarbeit, das wegen bestimmter Vorbehalte zum Inhalt oderwegen des gegenber einer Norm abweichenden Aufstellungsverfahrens vom DIN noch nicht als Normherausgegeben wird.Zur vorliegenden Vornor
3、m wurde kein Entwurf verffentlicht.Erfahrungen mit dieser Vornorm sind erbeten ang190 vorzugsweise als Datei per E-Mail an nameddin.de in Form einer Tabelle. Die Vorlage dieserTabelle kann im Internet unter http:/www.din.de/stellungnahme abgerufen werden;g190 oder in Papierform an den Normenausschus
4、s Medizin (NAMed) im DIN Deutsches Institut frNormung e. V., 10772 Berlin (Hausanschrift: Burggrafenstr. 6, 10787 Berlin).Nationales VorwortDiese Vornorm enthlt unter Bercksichtigung des Prsidialbeschlusses 13/1983 den englischen Original-text der europischen Vornorm ENV 13730-2, Ausgabe September 2
5、002. Diese europische Vornormwurde in der WG I Information Models des CEN/TC 251 Medizinische Informatik erarbeitet. Der Fach-bereich G Medizinische Informatik und insbesondere die Mitarbeiter des Arbeitsausschusses G 1Modellierung des Normenausschusses Medizin (NAMed) im DIN haben an der Erarbeitun
6、g mitgewirkt.Fortsetzung Seite 2und 109 Seiten ENVNormenausschuss Medizin (NAMed) im DIN Deutsches Institut fr Normung e. V.DIN Deutsches Institut fr Normung e.V. .Jede Art der Vervielfltigung, auch auszugsweise,Ref. Nr. DIN V ENV 13730-2:2003-10nur mit Genehmigung des DIN Deutsches Institut fr Norm
7、ung e. V., Berlin, gestattet. Preisgr. 31 Vertr.-Nr. 2331Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 BerlinVornormDIN V ENV 13730-2:2003-102Fr die im Abschnitt 2 zitierten Internationalen Normen wird im Folgenden auf die entsprechendenDeutschen Normen hingewiesen:ISO 5218:1977 siehe DIN
8、ISO 5218:1980(Schreibfehler in der Norm, dort als ISO 5281:1997 bezeichnet).ISO/IEC 7826-1 und ISO/IEC 7826-2 wurden im Jahr 2001 zurckgezogen.Nationaler Anhang NA(informativ)LiteraturhinweiseDIN ISO 5218, Informationsverarbeitung Datenaustausch Darstellung des Geschlechts von Menschen.Vornorm EUROP
9、ISCHE VORNORMEUROPEAN PRESTANDARDPRNORME EUROPENNEENV 13730-2September 2002ICS 35.240.80Deutsche FassungMedizinische Informatik Fr die Bluttransfusion bentigte Nachrichten Teil 2: Fr die Erzeugnisse bentigte NachrichtenDeutsche Fassung ENV 13730-2:2002Healthcare Informatics Blood transfusionrelated
10、messages Part 2: Product relatedmessages (BTR-PROD)Diese Europische Vornorm (ENV) wurde vom CEN am 18. September 2001 als eine knftige Norm zur vorlufigen Anwendungangenommen.Die Gltigkeitsdauer dieser ENV ist zunchst auf drei Jahre begrenzt. Nach zwei Jahren werden die Mitglieder des CEN gebeten, i
11、hreStellungnahmen abzugeben, insbesondere ber die Frage, ob die ENV in eine Europische Norm umgewandelt werden kann.Die CEN-Mitglieder sind verpflichtet, das Vorhandensein dieser ENV in der gleichen Weise wie bei einer EN anzukndigen und die ENV aufnationaler Ebene unverzglich in geeigneter Weise ve
12、rfgbar zu machen. Es ist zulssig, entgegenstehende nationale Normen bis zurEntscheidung ber eine mgliche Umwandlung der ENV in eine EN (parallel zur ENV) beizubehalten.CEN-Mitglieder sind die nationalen Normungsinstitute von Belgien, Dnemark, Deutschland, Finnland, Frankreich, Griechenland, Irland,I
13、sland, Italien, Luxemburg, Malta, Niederlande, Norwegen, sterreich, Portugal, Schweden, Schweiz, Spanien, der Tschechischen Republikund dem Vereinigten Knigreich.EUROPISCHES KOMITEE FR NORMUNGEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONManagement-Zentrum: rue de Stassart, 36
14、B-1050 Brssel 2002 CEN Alle Rechte der Verwertung, gleich in welcher Form und in welchemVerfahren, sind weltweit den nationalen Mitgliedern von CEN vorbehalten.Ref. Nr. ENV 13730-2:2002 DVornorm ENV 13730-2:2002 (E)2ContentsPageForeword. 5Introduction 51 Scope. 62 Normative references. 83 Terms, def
15、initions and abbreviations. 94 Requirements 154.1 General conformance requirements. 154.2 Implementation recommendations . 165 Communication roles. 165.1 General. 165.1.1 Sending role requirements . 165.1.2 Receiving role requirements. 165.2 Use case diagram and scenarios (General use case) . 165.3
16、Group 2: Message sequences . 185.3.1 Blood component production message domain . 186 Requirements and General Message Descriptions 196.1 Conformance requirements 196.2 General Message Descriptions 206.3 Blood/blood component collection request message. 216.3.1 Scope of this message . 216.3.2 Blood/b
17、lood component collection request message. 236.4 Blood/blood component classification request message . 236.4.1 Scope of this message . 236.4.2 Blood/blood component classification request message . 266.5 Blood/blood component classification report message 266.5.1 Scope of the message 266.5.2 Blood/
18、blood component classification report message 296.6 Blood/blood component collected delivery note message . 296.6.1 Scope of this message . 296.6.2 Blood/blood component collected delivery note message . 326.7 Blood component request message. 326.7.1 Scope of this message . 326.7.2 Blood component r
19、equest message. 346.8 Blood component manufactured delivery note message . 346.8.1 Scope of this message . 346.8.2 Blood component manufactured delivery note message . 376.9 Blood component processing request message 376.9.1 Scope of this message . 376.9.2 Blood component processing request message
20、406.10 Blood component processed delivery note message. 406.10.1 Scope of this message . 406.10.2 Blood component processed delivery note message. 437 Domain information model (DIM) 437.1 Introduction. 437.1.1 The modelling approach. 447.1.2 Presentation of attributes from generalisations 447.2 Gene
21、ral message subsystem. 477.2.1 Requested item message. 48Vornorm ENV 13730-2:2002 (E)3Page7.2.2 Issued item message 497.2.3 Blood/blood components collector 507.2.4 Blood components manufacturer 507.2.5 Blood components dispenser517.2.6 Blood components processor517.3 Specific message subsystem527.3
22、.1 Original message identification .537.3.2 Blood/blood component collection request message .547.3.3 Blood/blood component classification request message 547.3.4 Blood/blood component classification report message.557.3.5 Blood/blood component collected delivery note message557.3.6 Blood component
23、request message .567.3.7 Blood component manufactured delivery note message567.3.8 Blood component processing request message.577.3.9 Blood component processed delivery note message .577.4 Communicating parties subsystem .587.4.1 Message sender597.4.2 Message receiver597.5 Healthcare agent subsystem
24、.607.5.1 Healthcare agent in context 617.5.2 healthcare agent relationship617.5.3 Healthcare agent 3.30.627.5.4 healthcare party 3.33 627.5.5 Healthcare organisation 3.32 637.5.6 Healthcare professional 3.34 637.6 Collected item subsystem .647.6.1 Collected item647.6.2 Blood component 3.9 657.6.3 Sa
25、mple 3.45 667.7 Requested item .677.7.1 Requested item .677.7.2 Requested blood component information .687.7.3 Delivery location697.8 Issued item subsystem707.8.1 Issued blood component.717.8.2 Blood component characteristic727.8.3 Blood component unit .727.8.4 Quantity of blood component 737.8.5 Is
26、sued blood component administrative details 737.8.6 Issued blood component information 747.8.7 Unit (container) characteristic .747.9 Payment guarantor subsystem .757.9.1 Payment details.767.9.2 Payment guarantor767.9.3 Payment authorisation 777.10 Laboratory investigation subsystem777.10.1 Laborato
27、ry investigation (ENV 1613) 787.10.2 Requested laboratory investigation (ENV 1613).787.10.3 Laboratory investigation report (ENV 1613)787.11 Blood donor subsystem.787.11.1 Blood donor 3.13.797.11.2 Clinical information 3.18797.11.3 Clinical information item807.12 Common subclasses.807.12.1 Address .
28、807.12.2 Event date and time 817.12.3 General message information.817.12.4 Identifier.82Vornorm ENV 13730-2:2002 (E)4Page7.12.5 Language details 827.12.6 Measurement 827.12.7 Message identification 837.12.8 Party identifier. 837.12.9 Person name details. 847.12.10 Structured address . 847.12.11 Stru
29、ctured person name. 857.12.12 Time interval . 857.12.13 Time period. 857.12.14 Unstructured address . 867.12.15 Unstructured name details 867.12.16 Value of quantity. 86Annex A (informative) How to read the models. 87Annex B (informative) Compound and simple data types Rationale and how to use the d
30、ata typesin messages 92Annex C (informative) Guide to usage of CEN/TC 251/ENV 1613 97Bibliography . 107Index 108Vornorm ENV 13730-2:2002 (E)5ForewordThis document (ENV 13730-2:2002) has been prepared by Technical Committee CEN/TC 251 Healthinformatics, the secretariat of which is held by SIS.It was
31、developed by Project Team 32 under mandate M/255 given by the European Commission and theEuropean Free Trade Association, order voucher BC/CEN/97/23.This is Part 2 of a multipart standard (ENV 13730) under the general heading Health Informatics Bloodtransfusion related messages with the following pa
32、rts:g190 Part 1: Subject of care related messagesg190 Part 2: Production related messagesAnnex C of this European Prestandard is normative, all other annexes are informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to
33、 announce this European Prestandard: Austria, Belgium, Czech Republic, Denmark,Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway,Portugal, Spain, Sweden, Switzerland and the United Kingdom.IntroductionPart 2 of this European Prestandard (ENV) provides
34、a set of messages that enables the electronic transfer ofmessages in the blood transfusion domain.The motivation for this ENV derives from a combination of the following factors:Electronic messages developed in the Healthcare Informatics domain contain sensitive healthcare informationabout specified
35、 individuals that requires a high level of confidence both in the parties sending and receivingmessages and that the information being made available is unchanged. Standards are required to facilitateelectronic transfer of blood transfusion related messages and reports between the many systems curre
36、ntlyused. Information transferred in the blood transfusion related messages and any reports passing betweenhealthcare parties form part of the information system of each of the communicating parties. Electronictransfer of these blood transfusion related messages and reports reduces the need for manu
37、al entry and therisk of transcription errors. It also results in greater efficiency leading to better healthcare provision.This ENV has been developed following the methods recommended in the CEN Report on MedicalInformatics Methodology for the development of healthcare messages (CR 12587:1996). How
38、ever, inaccord with the decisions of CEN TC251 WGI, a different modelling technique has been used. This is a subsetof the Unified Modelling Language (UML) as documented in Annex A.This ENV specifies messages in a syntax independent form. Its requirements for conformance define theminimum acceptable
39、content and structure for these messages. Compliant messages can be developed in avariety of implementation syntaxes and these syntax specific implementations may be the subject of futureStandards.Vornorm ENV 13730-2:2002 (E)6This ENV is directly relevant to suppliers of computer systems for use in
40、development. Its provisions are alsorelevant to those planning, specifying, procuring or implementing information systems for use in the bloodtransfusion domain.Particular note for implementers: Some attributes may have the same title but modified in meaning for use inPart two than in Part one.1 Sco
41、peTransfusion of blood 3.7 and blood components 3.9 (blood products) to subjects of care 3.48 is a medicalactivity that is subject to many legal regulations and constraints. Many problems may be encountered duringtreatment due to immunological conditions, transmitted diseases, sustainability and oth
42、er difficulties. Mistakesand failures may have serious or even fatal consequences. Minimising human activity through the increaseduse of data processing and automated messaging will introduce an additional safety mechanism.This ENV specifies general messages 3.41 for electronic information interchan
43、ge between computersystems used by healthcare 3.29 parties 3.33 in the blood transfusion 3.16 domain. The content andstructure of the messages specified in this ENV have been developed with the aim of optimising the safety ofblood transfusion activity and to facilitate compliance monitoring and secu
44、re audit trails 3.2.This ENV is applicable to blood transfusion related messages including those for:g190 the collection of blood/blood components 3.22 from blood donorg190 manufacturing 3.40 and processing 3.44 of blood componentsg190 classification 3.19 of blood donationsg190 issue of blood compon
45、ents to the blood components dispenserWithin the blood transfusion process there are a number of actors:(1) The blood components dispenser 3.10 obtains blood components and blood products from one or moreproviders, then stores and dispenses them to the user, in some countries this function is known
46、as theHospital Blood Bank. This actor may appear as a separate entity, or as subdivision, within either the classproducer or user. In certain circumstances communication may be required with a different blood componentsdispenser or with all dispensers within another region or a country.(2) The blood
47、 components manufacturer 3.11 prepares blood components for transfusion from donor bloodand issues blood components to the blood components dispenser 3.10 a blood components processor or toanother blood components manufacturer. In many countries the production process utilises a special bloodtransfu
48、sion data system providing internal communications between the subdivisions (blood collection,collected blood classification 3.17, manufacturing of blood components 3.40, processing of bloodcomponents 3.52), and issues blood components to a blood components dispenser.(3) The blood components process
49、or 3.12 receives blood components from a blood componentsmanufacturer 3.11 for processing into blood products.(4) The Laboratory service provider 3.39 provides a laboratory service (serological, biochemical,bacteriological and virological analyses), to classify a sample of donor blood received from the blood/bloodcomponents collector. The laboratory can be an integral part of the healthcare organisation.(5) The blood/blood components collector 3
