ENV 13730-2-2002 en Healthcare Informatics - Blood transfusion related messages - Part 2 Production related messages (BTR-PROD)《健康信息学 输血相关信息 第2部分 制造相关信息(BTR-PROD)》.pdf

1、DRAFT FOR DEVELOPMENT DD ENV 13730-2:2002 Healthcare Informatics Blood transfusion related messages Part 2: Production related messages (BTR-PROD) ICS 35.240.80 DD ENV 13730-2:2002 This Draft for Development, having been prepared under the direction of the DISC Board, was published under the authori

2、ty of the Standards Policy and Strategy Committee on 21 October 2002 BSI 21 October 2002 ISBN 0 580 40597 4 National foreword T h i s D r a f t f o r D e v e l o p m e n t i s t h e o f f i c i a l E n g l i s h l a n g u a g e v e r s i o n o f ENV 13730-2:2002. This publication is not to be regard

3、ed as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature because of the limited duration of the European Prestandard. It should be applied on this provisional basis, so that information and experience of its practical application

4、 may be obtained. Comments arising from the use of this Draft for Development are requested 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 initiated 2 years after its publication by the

5、European organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies received by the end of the review period, the respo

6、nsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee IST/35, Health Informatics, at 389 Chiswick High Road, Lond

7、on W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or Eu

8、ropean 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 Catalogue or of British Standards Online. Summary of pages This document comprises a f

9、ront cover, an inside front cover, the ENV title page, pages 2 to 111 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANPRESTANDARD PRNORMEEUROPENNE EUROPISCHEVORNORM ENV1

10、37302 September2002 ICS35.240.80 Englishversion HealthcareInformaticsBloodtransfusionrelatedmessages Part2:Productionrelatedmessages(BTRPROD) ThisEuropeanPrestandard(ENV)wasapprovedbyCENon18October2001asaprospectivestandardforprovisionalapplication. TheperiodofvalidityofthisENVislimitedinitiallytoth

11、reeyears.AftertwoyearsthemembersofCENwillberequestedto submittheir comments,particularlyonthequestionwhethertheENVcanbeconvertedintoaEuropeanStandard. CENmembersarerequiredtoannouncetheexistenceofthisENVinthesamewayasforanENandtomaketheENVavailablepromp tly atnationallevelinanappropriateform.Itisper

12、missibletokeepconflictingnationalstandardsinforce(inparalleltothe ENV)untilthefinal decisionaboutthepossibleconversionoftheENVintoanENisreached. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Nether

13、lands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref

14、.No.ENV137302:2002EENV137302:2002(E) 2 CONTENTS FOREWORD .5 INTRODUCTION.6 1 SCOPE.7 2 NORMATIVEREFERENCES 9 3 TERMS,DEFINITIONSANDABBREVIATIONS9 4 REQUIREMENTS 17 4.1G ENERALCONFORMANCEREQUIREMENTS .17 4.2I MPLEMENTATIONRECOMMENDATIONS.17 5 COMMUNICATIONROLES 1 7 5.1G ENERAL 17 5.1.1 Sendingrolereq

15、uirements . .17 5.1.2 Receivingrolerequirements. 17 5.2U SECASEDIAGRAMANDSCENARIOS (GENERALUSECASE ).18 5.3G ROUP 2:M ESSAGESEQUENCES.20 5.3.1 Bloodcomponentproductionmessagedomain20 6 REQUIREMENTSANDGENERALMESSAGEDESCRIPTIONS .22 6.1C ONFORMANCEREQUIREMENTS 22 6.2G ENERAL MESSAGE DESCRIPTIONS .22 6

16、.3B LOOD/BLOODCOMPONENTCOLLECTIONREQUESTMESSAGE .24 6.3.1 Scopeofthismessage. 24 6.3.2 Blood/bloodcomponentcollectionrequestmessage26 6.4B LOOD/BLOODCOMPONENTCLASSIFICATIONREQUESTMESSAGE .27 6.4.1 Scopeofthismessage. 27 6.4.2 Blood/bloodcomponentclassificationrequestmessage.29 6.5B LOOD/BLOODCOMPONE

17、NTCLASSIFICATIONREPORTMESSAGE 30 6.5.1 Scopeofthemessage 30 6.5.2 Blood/bloodcomponentclassificationreportmessage.32 6.6B LOOD/BLOODCOMPONENTCOLLECTEDDELIVERYNOTEMESSAGE 33 6.6.1 Scopeofthismessage. 33 6.6.2 Blood/bloodcomponentcollecteddeliverynotemessage35 6.7B LOODCOMPONENTREQUESTMESSAGE 36 6.7.1

18、 Scopeofthismessage. 36 6.7.2 Bloodcomponentrequestmessage. 38 6.8B LOODCOMPONENTMANUFACTUREDDELIVERYNOTEMESSAGE 39 6.8.1 Scopeofthismessage. 39 6.8.2 Bloodcomponentmanufactureddeliverynotemessage.41 6.9B LOODCOMPONENTPROCESSINGREQUESTMESSAGE 42 6.9.1 Scopeofthismessage. 42 6.9.2 Bloodcomponentproce

19、ssingrequestmessage.44 6.10B LOODCOMPONENTPROCESSEDDELIVERYNOTEMESSAGE .45 6.10.1 Scopeofthismessage .45 6.10.2 Bloodcomponentprocesseddeliverynotemessage.47 7 DOMAININFORMATIONMODEL(DIM)48 7.1I NTRODUCTION .48 7.1.1 Themodellingapproach .49 7.1.2 Presentationofattributesfromgeneralisations. 49 7.2G

20、 ENERALMESSAGESUBSYSTEM .51 ClassDescriptions . .52 7.2.1 requesteditemmessage 52 7.2.2 issueditemmessage. .53 7.2.3 blood/bloodcomponentscollector 54 7.2.4 bloodcomponentsmanufacturer. 54 7.2.5 bloodcomponentsdispenser .55 7.2.6 bloodcomponentsprocessor 55 7.3S PECIFICMESSAGESUBSYSTEM 56 ClassDescr

21、iptions . .57 7.3.1 originalmessageidentification. 57 7.3.2 blood/bloodcomponentcollectionrequestmessage.57 7.3.3 blood/bloodcomponentclassificationrequestmessage .58 7.3.4 blood/bloodcomponentclassificationreportmessage .58 7.3.5 blood/bloodcomponentcollecteddeliverynotemessage.58ENV137302:2002(E)

22、3 7.3.6 bloodcomponentrequestmessage . 59 7.3.7 bloodcomponentmanufactureddeliverynotemessage .59 7.3.8 bloodcomponentprocessingrequestmessage .60 7.3.9 bloodcomponentprocesseddeliverynotemessage .60 7.4C OMMUNICATINGPARTIESSUBSYSTEM .61 Classdescriptions. 62 7.4.1 messagesender .62 7.4.2 messagerec

23、eiver .62 7.5H EALTHCAREAGENTSUBSYSTEM 63 Classdescriptions. 63 7.5.1 healthcareagentincontext . 64 7.5.2 healthcareagentrelationship . .64 7.5.3 healthcareagent3.30 . 65 7.5.4 healthcareparty3.33. .65 7.5.5 healthcareorganisation3.32 66 7.5.6 healthcareprofessional3.34. 66 7.6C OLLECTEDITEMSUBSYSTE

24、M .67 Classdescriptions. 67 7.6.1 collecteditem 67 7.6.2 bloodcomponent3.9. .68 7.7R EQUESTEDITEM.70 ClassDescriptions . .70 7.7.1 requesteditem .70 7.7.2 requestedbloodcomponentinformation . .71 7.7.3 deliverylocation . 72 7.8I SSUEDITEMSUBSYSTEM .73 ClassDescriptions . .74 7.8.1 issuedbloodcompone

25、nt .74 7.8.2 bloodcomponentcharacteristic 75 7.8.3 bloodcomponentunit .75 7.8.4 quantityofbloodcomponent. .76 7.8.5 issuedbloodcomponentadministrativedetails 7 6 7.8.6 issuedbloodcomponentinformation 77 7.8.7 unit(container)characteristic . 77 7.9P AYMENTGUARANTORSUBSYSTEM 78 ClassDescriptions . .79

26、 7.9.1 paymentdetails. 79 7.9.2 paymentguarantor. .79 7.9.3 paymentauthorisation. 80 7.10L ABORATORYINVESTIGATIONSUBSYSTEM 81 7.10.1 laboratoryinvestigation(ENV1613) .82 7.10.2 requestedlaboratoryinvestigation(ENV1613) .8 2 7.10.3 laboratoryinvestigationreport(ENV1613) 82 7.11B LOODDONORSUBSYSTEM .8

27、3 ClassDescriptions . .83 7.11.1 blooddonor3.13 .83 7.11.2 clinicalinformation3.18. 84 7.11.3 clinicalinformationitem . 84 7.12C OMMONSUBCLASSES85 ClassDescriptions . .85 7.12.1 address85 7.12.2 eventdateandtime .85 7.12.3 generalmessageinformation 86 7.12.4 identifier .86 7.12.5 languagedetails . .

28、87 7.12.6 measurement.87 7.12.7 messageidentification . .87 7.12.8 partyidentifier . .87 7.12.9 personnamedetails 88 7.12.10 structuredaddress .88 7.12.11 structuredpersonname .89 7.12.12 timeinterval. .89ENV137302:2002(E) 4 7.12.13 timeperiod. .89 7.12.14 unstructuredaddress .89 7.12.15 unstructure

29、dnamedetails . 90 7.12.16 valueofquantity 90 ANNEXA (INFORMATIVE) HOWTOREADTHEMODELS 91 ANNEXB (INFORMATIVE) COMPOUNDANDSIMPLEDATATYPESRATIONALEANDHOWTO USETHEDATATYPESINMESSAGES.96 ANNEXC (NORMATIVE) GUIDETOUSAGEOFCEN/TC251/ENV1613101 INDEX110ENV137302:2002(E) 5 Foreword Thisdocument(ENV137302:2002

30、)hasbeenpreparedbyTechnicalCommitteeCEN/TC251“Health informatics”,thesecretariatofwhichisheldbySIS. ItwasdevelopedbyProjectTeam32undermandateM/255givenbytheEuropeanCommissionandthe EuropeanFreeTradeAssociation,ordervoucherBC/CEN/97/23. ThisisPart2ofamultipartstandard(ENV13730)underthegeneralheading

31、HealthinformaticsBlood transfusionrelatedmessages withthefollowingparts: Part1:Subjectofcarerelatedmessages Part2:Productionrelatedmessages AnnexCofthisEuropeanPrestandardisnormative,allotherannexesareinformative. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefol

32、lowing countriesareboundtoannouncethisEuropeanPrestandard:Austria,Belgium,CzechRepublic,Denmark, Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal, Spain,Sweden,SwitzerlandandtheUnitedKingdom.ENV137302:2002(E) 6 Introduction Part2ofthisEuropeanPrestanda

33、rd(ENV)providesasetofmessagesthatenablestheelectronictransferof messagesinthebloodtransfusiondomain. ThemotivationforthisENVderivesfromacombinationofthefollowingfactors: ElectronicmessagesdevelopedintheHealthcareInformaticsdomaincontainsensitivehealthcareinformation aboutspecifiedindividualsthatrequ

34、iresahighlevelofconfidencebothinthepartiessendingandreceiving messagesandthattheinformationbeingmadeavailableisunchanged.Standardsarerequiredtofacilitate electronictransferofbloodtransfusionrelatedmessagesandreportsbetweenthemanysystemscurrentlyused. Informationtransferredinthebloodtransfusionrelate

35、dmessagesandanyreportspassingbetweenhealthcare partiesformpartoftheinformationsystemofeachofthecommunicatingparties.Electronictransferofthese bloodtransfusionrelatedmessagesandreportsreducestheneedformanualentryandtheriskoftranscription errors.Italsoresultsingreaterefficiencyleadingtobetterhealthcar

36、eprovision. ThisENVhasbeendevelopedfollowingthemethodsrecommendedintheCENReporton“MedicalInformatics Methodologyforthedevelopmentofhealthcaremessages“(CR12587:1996).However,inaccordwiththe decisionsofCENTC251WGI,adifferentmodellingtechniquehasbeenused.ThisisasubsetoftheUnified ModellingLanguage(UML)

37、asdocumentedinAnnexA. ThisENVspecifiesmessagesinasyntaxindependentform.Itsrequirementsforconformancedefinethe minimumacceptablecontentandstructureforthesemessages.Compliantmessagescanbedevelopedina varietyofimplementationsyntaxesandthesesyntaxspecificimplementationsmaybethesubjectoffuture Standards.

38、 ThisENVisdirectlyrelevanttosuppliersofcomputersystemsforuseindevelopment.Itsprovisionsarealso relevanttothoseplanning,specifying,procuringorimplementinginformationsystemsforuseintheblood transfusiondomain. Particularnoteforimplementers:Someattributesmayhavethesametitlebutmodifiedinmeaningforusein P

39、arttwothaninPartone.ENV137302:2002(E) 7 1Scope Transfusionofblood 3.7andbloodcomponents 3.9(bloodproducts)tosubjectsofcare 3.48isamedical activitythatissubjecttomanylegalregulationsandconstraints.Manyproblemsmaybeencounteredduring treatmentduetoimmunologicalconditions,transmitteddiseases,sustainabil

40、ityandotherdifficulties.Mistakes andfailuresmayhaveseriousorevenfatalconsequences.Minimisinghumanactivitythroughtheincreaseduse ofdataprocessingandautomatedmessagingwillintroduceanadditionalsafetymechanism. ThisENVspecifiesgeneralmessages 3.41forelectronicinformationinterchangebetweencomputersystems

41、 usedbyhealthcare 3.29parties 3.33inthebloodtransfusion 3.16domain.Thecontentandstructureofthe messagesspecifiedinthisENVhavebeendevelopedwiththeaimofoptimisingthesafetyofbloodtransfusion activityandtofacilitatecompliancemonitoringandsecureaudittrails 3.2. ThisENVisapplicabletobloodtransfusionrelate

42、dmessagesincludingthosefor: thecollectionofblood/bloodcomponents 3.22fromblooddonor manufacturing 3.40andprocessing 3.44ofbloodcomponents classification 3.19ofblooddonations issueofbloodcomponentstothebloodcomponentsdispenser Withinthebloodtransfusionprocessthereareanumberofactors: (1)Thebloodcompon

43、ents dispenser 3.10obtainsbloodcomponentsandbloodproductsfromoneormore providers,thenstoresanddispensesthemtotheuser,insomecountriesthisfunctionisknownasthe HospitalBloodBank.Thisactormayappearasaseparateentity,orassubdivision,withineithertheclass produceroruser.Incertaincircumstancescommunicationma

44、yberequiredwithadifferentblood componentsdispenserorwithalldispenserswithinanotherregionoracountry. (2) Thebloodcomponents manufacturer 3.11preparesbloodcomponentsfortransfusionfromdonorblood andissuesbloodcomponentstothebloodcomponentsdispenser 3.10abloodcomponentsprocessororto anotherbloodcomponentsmanufacturer.Inmanycountriestheproductionprocessutilisesaspecialblood transfusiondatasystemprovidinginternalcommunicationsbetweenthesubdivisions(bloodcollection, collectedbloodclassification 3.17,manufacturingofbloodcomponents 3.40,processingof