1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | DRAFT FOR DEVELOPMENT DD ENV 13609-2:2000
2、ICS 35.240.80 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Healthcare informatics Messages for maintenance of supporting information in healthcare systems Part 2: Updating of Medical laboratory-specific informationThis British Standard, having been prepared under the direct
3、ion of the DISC Board, was published under the authority of the Standards Committee and comes into effect on 15 August 2000 BSI 08-2000 ISBN 0 580 35476 8 DD ENV 13609-2:2000 Amendments issued since publication Amd. No. Date Comments National foreword This Draft for Development is the English langua
4、ge version of ENV 13609-2:2000. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature due to the limited duration of the European Prestandard. It should be applied on this provisional basis,
5、 so that information and experience of its practical application 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 pub
6、lication will be initiated 2 years after its pulication by the European organization so that a decision can be taken on its status at the end of its three-year life. The commencement of the review period will be notified by an announcement in Update Standards. According to the replies received by th
7、e 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 the prestandard or to withdraw it. Comments should be sent in writing to the secretary of BSI Technical Committee IST/35, Health Informatics, at 389
8、 Chiswick High Road, London 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 impl
9、ement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. Summary of pages This document c
10、omprises a front cover, an inside front cover, the ENV title page, pages 2 to 46, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.EUROPEANPRESTANDARD PRNORMEEUROPENNE EUROPISCHEVORNORM ENV136092 May2000 ICS35.240.
11、80 Englishversion HealthinformaticsMessagesformaintenanceofsupporting informationinhealthcaresystemsPart2:Updatingofmedical laboratoryspecificinformation ThisEuropeanPrestandard(ENV)wasapprovedbyCENon29July1999asaprospectivestandardforprovisionalapplication. TheperiodofvalidityofthisENVislimitedinit
12、iallytothreeyears.AftertwoyearsthemembersofCENwillberequestedto submittheir comments,particularlyonthequestionwhethertheENVcanbeconvertedintoaEuropeanStandard. CENmembersarerequiredtoannouncetheexistenceofthisENVinthesamewayasforanENandtomaketheENVavailablepromp tly atnationallevelinanappropriatefor
13、m.Itispermissibletokeepconflictingnationalstandardsinforce(inparalleltothe ENV)untilthefinal decisionaboutthepossibleconversionoftheENVintoanENisreached. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Net
14、herlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG CentralSecretariat:ruedeStassart,36B1050Brussels 2000CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers
15、. Ref.No.ENV136092:2000EPage2 ENV136092:2000 Contents Foreword 3 Introduction 3 1.Scope. .4 2.NormativeReferences 5 3.Termsanddefinitions. 6 4 Requirements8 5GeneralMessageDescription. 8 5.1 Introduction 8 5.2 Themodellingapproach .8 5.3 MessagetoUpdateSupportingInformation .8 6DomainInformationMode
16、l 10 ANNEXA(Informative)ScenariosandMessageExplanation . .41 AnnexB(Informative)UnifiedModellingLanguageNotationusedwithinthisDocument 4 3Page3 ENV136092:2000 Foreword ThisEuropeanPrestandardhasbeenpreparedbyTechnicalCommitteeCEN/TC251“Healthinformatics“,the secretariatofwhichisheldbySIS. Accordingt
17、otheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountries areboundtoannouncethisEuropeanPrestandard:Austria,Belgium,CzechRepublic,Denmark,Finland,France, Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,Switzerland andtheUnite
18、dKingdom. ThisisPart2ofamultipartstandardon MessagesforMaintenanceofSupportingInformationinHealthcareSystems . Themultipartstandardconsistsofthefollowingparts: Part1:UpdatingofCodingSchemes Part2:UpdatingofMedicalLaboratorySpecificInformation ThisstandardwasdraftedusingtheconventionsoftheISO/IECdire
19、ctivepart3. AllAnnexesareInformative. Introduction ThisPrestandardcoversMessagesforMaintenanceofSupportingInformationinHealthcareSystemsandisconcerned withthespecificationofamessagethatmaybeusedtocreateorupdateinformationthatisappendedtoentriesina codingscheme.Inparticular,thismessageisusedtoprovide
20、supportinginformationthatmaybeusedtoaidhealthcare professionalswhentheyarerequestinglaboratoryinvestigations. Thismessagespecificationhasbeenvalidatedagainsttherequirementsidentifiedwhenusersrequestinvestigationsthat arewithinthedomaincoveredbyENV1613, MessagesforRequestandReportofLaboratoryInvestig
21、ations. The messageisusedtoprovideuptodateinformationtopersonsusingcomputersystemstorequestlaboratory investigations. ThisPrestandarddefinesasyntaxindependentspecificationofamessagethatmaybeusedtoprovideameansof supplyingreceivingsystemswithsufficientinformationtocreateorupdateadatabaseorotherinform
22、ationretrieval systemwithinformationconcerning: (a) thevolumeormassofsamplerequiredbythelaboratorywhencarryingoutthetests, (b)thesamplingprocedureandanyprocedurestobecarriedoutonthesampleorthesampledonor, (c) theidentificationofthesamplecontainer(s)thatshouldbeused, (d)anygroupsofteststhatarecarried
23、outconcurrentlyonthesamesampleatthesametimeasamatterofroutine, (e) informationthatshouldbeprovidedwiththesamplesuchasthepatientssex,age,weight,etc., (f) informationthatshouldbeprovidedtothepatient, (g) informationabouttheserviceprovidedbythelaboratoryvisvistheinvestigation,e.g.onlyasroutine,onlyas e
24、mergency,notatweekend. ThemainnormativeprovisionsinthisPrestandardareexpressedinclauses4,5and6. Much,althoughnotall,oftherepresentationusedinthisPrestandardisdrawnfromtheUnifiedModellingLanguage (UML).Thereadershall,however,interprettherepresentationswithinthisPrestandardaccordingtotheprovisionslaid
25、 outinInformativeAnnexB.Page4 ENV136092:2000 HealthinformaticsMessagesformaintenanceofsupportinginformation inhealthcaresystemsPart2:Updatingofmedicallaboratoryspecific information 1.Scope 1.1ThisPrestandardspecifiesmessagesforelectronicinformationexchangebetweencomputersystemsused byhealthcareparti
26、esforthepurposesofupdatingSupportinginformationthatisattachedtocodevalues withinacodingscheme.Inparticular,thismessageisintendedtoprovideinformationtocliniciansthatare requestingtestswithinthespecialtiesof: haematology, clinicalchemistry, cytology, biochemistry, immunology. 1.2. ThisPrestandardprovi
27、desadescriptionofamessagewhichprovidessufficientinformationtoallowa receivingsystemtoassociatesupportinginformationtocodevaluesrepresentinglaboratoryinvestigations thatmaybeperformedonsamplestakenfromthepatient.Therequirementsforthesupportinginformation havebeenvalidatedsolelyagainstthoseinvestigati
28、onsthatarewithinthescopeofENV1613, Messagesfor RequestandReportofLaboratoryInvestigations. Thesupportinginformationmayincludeanyorallofthe informationitemsrelatingto: (a) thesamplingprocedure,includingvolume/massofsamplerequired,samplecontainer,sample treatment,etc. (b)anyinformationthatshouldaccomp
29、anythesamplesuchasage,sex,cycle,height,weight,etc. (c) anyadvicetothepatient. (d)anypatientpreparationprocedures,etc Inaddition,thesupportinginformationmayprovideinformationaboutthesuppliersofthelaboratory services.Page5 ENV136092:2000 2.NormativeReferences ThisEuropeanPrestandardincorporatesbydated
30、orundatedreference,provisionsfromotherpublications. Thesenormativereferencesarecitedintheappropriateplacesinthetextandthepublicationsarelisted hereafter.Fordatedreferences,subsequentamendmentsandrevisionsofanyofthesepublicationsapplytothis EuropeanPrestandardonlywhenincorporatedinitbyamendmentandrev
31、ision.Forundatedreferencesthe latesteditionofthepublicationreferredtoapplies. ENV1613:1995 MessagesforRequestandReportofLaboratoryInvestigations CR1350:1993 InvestigationofsyntaxesforexistinginterchangeformatstobeusedinHealthcare ISO639:1988 Symbolsforlanguages,geographicalareasandauthorities ISO646
32、:1991 InformationtechnologyISO7bitcodedcharactersetforinformationinterchange ISO10871.2:1990 TerminologyworkVocabularyPart1:Theoryandapplication. ISO23824:1987 InformationprocessingVocabularyPart4:Organisationofdata ISO6523:1984 DatainterchangeStructurefortheidentificationoforganisations ISO/IEC7826
33、2IT:1984 Generalstructurefortheinterchangeofcodevalues ISO8601:1988 DataelementsandinterchangeformatsInformationinterchangeRepresentationof datesandtimes ISO8859:1987 InformationProcessingRegistrationofgraphicscharacterssubrepertoiresEight bitsinglebytecodedgraphiccharactersetsPart1:LatinNo1Page6 EN
34、V136092:2000 3.Termsanddefinitions Forthepurposesofthisstandard,thefollowingdefinitionsapply: 3.1 concept subsetofknowledgeconstructedthroughcombiningcharacteristics ISO23821987. 3.2 codedconcept elementwithinacodedset ISO23821987. EXAMPLE:“ParisCharlesDeGaulle“whichismappedontothethreeletterabbrevi
35、ation“CDG“bythe codingschemeforthreeletterabbreviationsofairportnames 3.3 codedset setofelementswhichismappedontoanothersetaccordingtoacode ISO23821987. EXAMPLE:Alistofthenamesofairportswhichismappedontoasetofthreeletterabbreviations 3.4 codemeaning Elementwithinacodedset. EXAMPLE:“ParisCharlesDeGau
36、lle“whichismappedontothethreeletterabbreviation“CDG“bythe codingschemeforthreeletterabbreviationsofairportnames ENV1613 3.5 codevalue resultofapplyingacodingschemetoaCodedconcept ISO23821987 EXAMPLE:“CDG“astherepresentationof“ParisCharlesDeGaulle“inthecodingschemeforthreeletter representationsofairp
37、ortnames 3.6 codingscheme collectionofrulesthatmapstheelementsofonesetontotheelementsofasecondset ISO23821987 3.7 domaininformationmodel DIM conceptualmodeldescribingcommonconceptsandtheirrelationshipsforcommunicationpartiesrequiredto facilitateexchangeofinformationbetweenthesepartieswithinaspecific
38、domainofhealthcare ENV1613Page7 ENV136092:2000 3.8 generalmessagedescription GMD subsetofadomaininformationmodelprescribingtheinformationcontentandsemanticstructureofamessage usedtomeetoneormoreidentifiedinformationinterchangerequirements ENV1613 3.9 healthcareorganisation organisationresponsiblefor
39、thedirectorindirectprovisionofhealthcareservices ENV1613 3.10 internationalcodingschemeidentifier ICSI uniqueidentifierofacodingschemeregisteredforuseininformationinterchangeinaccordancewithISO7826 3.11 messagetype identified,namedandstructuredsetoffunctionallyrelatedinformationwhichfulfilsaspecific
40、businesspurpose ENV1613 3.12 organisation uniqueframeworkofauthoritywithinwhichapersonorpersonsact,oraredesignatedtoacttowardssome purpose ISO65231984Page8 ENV136092:2000 4 Requirements 4.1AmessagefortransmissionofupdatestoSupportingInformationinHealthcareSystemscoveredbythe scopeofthissectionoftheP
41、restandard,shallconformtotheprovisionsdefinedintheGeneralMessage Descriptioninclause5andtheDomainInformationModelinclause6. 4.2Implementablemessagespecification(IMS)shallconformtotheGeneralMessageDescriptiondefinedin thispartofthePrestandard.Itshallsupportbothmandatoryandoptionalobjects.Whereappropr
42、iatethey shallalsosupporttherelationshipsbetweenobjectsasdefinedbytheGeneralMessageDescription. 4.3ImplementablemessagespecificationsshouldbeexpressedintermsofasyntaxwhichisanInternational StandardexceptwherethehealthcareuserrequirementscannotbemetbyusingsuchaStandardsyntax. 5GeneralMessageDescripti
43、on 5.1Introduction Thissectionprovidesadescriptionofthemessageusingahierarchicalstructure. ThisPrestandarddoesnotsetlimitsonthenumberofrepetitionsofobjectsandattributes,butimplementations whichdosetpracticallimitsarenotbythatreasonaloneconsideredtobedeviatingfromthestandard. TheGeneralMessageDescrip
44、tion(GMD)specifiestheobjectsandtheirrelationshipswithinthecontextofthe message. 5.2Themodellingapproach Thisclauseprovidesadescriptionofthemessageusingahierarchicalstructure.TheGeneralMessage Descriptionisshownintheformofahierarchicalstructureindicatingtheobjects(classinstances)andtheir associatedmultiplicitiesthatarerequiredtoimplementthemessage.ManyobjectswithintheGMDareshown asoptionalandforanimplementationintendedfora
