1、BRITISH STANDARD BS EN ISO 18812:2003 Health informatics Clinical analyser interfaces to laboratory information systems Use profiles The European Standard EN ISO 18812:2003 has the status of a British Standard ICS 35.240.80 BS EN ISO 18812:2003 This British Standard was published under the authority
2、 of the Standards Policy and Strategy Committee on 24 June 2003 BSI 24 June 2003 ISBN 0 580 42084 1 National foreword This British Standard is the official English language version of EN ISO 18812:2003. It is identical with ISO 18812:2003. It supersedes DD ENV 13728:2001 which is withdrawn. The UK p
3、articipation 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 secretary. Cross-references The British Standards which implement international or
4、 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 Catalogue or of British Standards Online. This publication does not purport to incl
5、ude 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 the text; present to the responsible international/European committee any enqui
6、ries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword pa
7、ge, the ISO title page, pages ii to vi, pages 1 to 52, an inside back cover 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 CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO1
8、8812 March2003 ICS35.240.80 SupersedesENV13728:2000 Englishversion HealthinformaticsClinicalanalyserinterfacestolaboratory informationsystemsUseprofiles(ISO18812:2003) InformatiquedesantInterfacesdanalyseurcliniquepour systmesdinformationdelaboratoireProfilsdutilisation (ISO18812:2003) ThisEuropeanS
9、tandardwasapprovedbyCENon11March2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapp
10、licationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembers
11、arethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,SlovakRepublic,Spain,Sweden,Switzerland and UnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EU
12、ROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO18812:2003EForeword Thisdocument(ENISO18812:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC215 “Healthinformatics“incollab
13、orationwithTechnicalCommitteeCEN/TC251“Healthinformatics“, thesecretariatofwhichisheldbySIS. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbySeptember2003,andconflictingnational standardsshallbewithdrawnatthelatestbySepte
14、mber2003. ThisdocumentsupersedesENV13728:2000. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,
15、Malta,Netherlands,Norway,Portugal,SlovakRepublic,Spain,Sweden, SwitzerlandandtheUnitedKingdom. NOTEFROMCMC TheforewordissusceptibletobeamendedonreceptionoftheGerman languageversion.Theconfirmedoramendedforeword,andwhenappropriate,thenormative annexZAforthereferencestointernationalpublicationswiththe
16、irrelevantEuropean publicationswillbecirculatedwiththeGermanversion. Endorsementnotice ThetextofISO18812:2003hasbeenapprovedbyCENasENISO18812:2003withoutany modifications. ENISO18812:2003 Reference number ISO 18812:2003(E)INTERNATIONAL STANDARD ISO 18812 First edition 2003-03-15 Health informatics C
17、linical analyser interfaces to laboratory information systems Use profiles Informatique de sant Interfaces danalyseur clinique pour systmes dinformation de laboratoire Profils dutilisation ENISO18812:2003ii ENISO18812:2003 iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references
18、. 1 3 Terms and definitions. 1 4 Domains . 3 4.1 User domain 3 4.2 Interface domain . 3 5 Conformity . 4 6 Profiles . 4 6.1 General. 4 6.2 Message descriptions. 4 6.3 Profile descriptions. 5 6.4 Sequence diagrams 5 6.5 Attribute optionality and allowed values 7 Annex A (informative) How to read this
19、 International Standard 11 Annex B (informative) Scenarios and models . 14 Annex C (informative) Implementation guidelines 31 Bibliography . 52 ENISO18812:2003iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodie
20、s). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and n
21、on-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Pa
22、rt 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies castin
23、g a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 18812 was prepared by Technical Committee ISO/TC 215, Health informatics. ENISO18812:20
24、03 vIntroduction This International Standard describes messages for the transfer of data between analytical instruments (AIs) and laboratory information systems (LISs). AIs are mainly used in hospital laboratories to analyse samples from patients. Most of these are interfaced to LISs that process th
25、e result data and produce reports for use by healthcare practitioners. In the absence of standards for the interface, each LIS supplier has to write a new interface for each new analytical instrument. The cost of writing these interfaces can amount to between 10 % and 20 % of the total cost of the L
26、IS. One of the most effective ways of reducing this cost is to implement a standard interface between the AI and the LIS. In the early 1990s, the E31 committee of the American Society for Testing and Materials (ASTM) published a standard entitled Standard Specification for Transferring Information B
27、etween Clinical Instruments and Computer Systems (ASTM E1394-91). This improved the situation by standardizing the format of the message and the syntax. It also attempted to standardize the data transferred in the messages, but suffered from implementation problems because: the vast choice of data i
28、tems available gave implementers the choice to send the same data in many different ways; the relative lack of implementation guidelines meant that different implementers interpreted the same clauses of the standard in different ways; much of the information that is defined in the standard is intend
29、ed for use in North America and does not cover international requirements. The result of this is that each AI supplier has produced its own “standard”, based loosely on ASTM E1394. Whereas this has made interfacing easier for the analytical instrument suppliers, the LIS suppliers are still faced wit
30、h the need to write a different interface for most of the analytical instruments installed in a given laboratory. In particular, the LIS interface designer has to, in theory, take into account any implementation allowed by ASTM E1394. This means that even simple AIs are normally handled by using a h
31、ugely complex interface on the LIS. ASTM E1394-91 was reissued with minor revisions in 1997 as ASTM E1394-97. This International Standard is intended to make interfaces between AIs and LISs simpler to implement by defining standard ways of conveying the same information in the same circumstances; de
32、fining a series of levels of complexity so that it is possible to interface a simple AI using only easy-to- implement messages; adapting the original standard to cover actual requirements; giving advice and guidance on how particular data items and functions should be implemented so as to reduce mis
33、interpretation. This is done by defining a series of standard messages, each of which is a subset of a comparable ASTM E1394 message. These are detailed in Clause 6. Examples of scenarios covered by this International Standard, together with models and sequence diagrams, are given in Annex B. An inf
34、ormative implementation guide for both ASTM E1394 and this International Standard is given in Annex C. ENISO18812:2003vi There is a trend for all clinical laboratories to be certified or accredited under a suitable quality management scheme. ISO/IEC 17025 require the laboratory to keep records of ce
35、rtain data. This means that, for the support of the users when conforming to the standard, the instruments and LIS have to be capable of handling this data (input, storage, validation, output), and also of transmitting it. This is especially important in functions that produce large amounts of data
36、that cannot be handled effectively without automated processing. Typically, this is a task for the LIS, but certain items have to originally come from the instrument. ASTM E1394 does not explicitly handle data needed for quality management. In principle, it is capable of doing so, but the needed fie
37、lds have to be defined. This has been achieved in this International Standard by making recommendations as to which fields shall be implemented in order to satisfy the needs of quality management. These are identified in the implementation guideline included as Annex C. This International Standard i
38、ncludes provisions for using existing ASTM E1394 records and fields to meet quality management requirements. This International Standard defines records that are subsets of records defined in ASTM E1394. Therefore, all implementations conforming to this International Standard also conform to ASTM E1
39、394. It should be noted, however, that not all implementations that conform to ASTM E1394 will conform to this International Standard. Those not familiar with some of the concepts, e.g. profiling, described here should first refer to Annex A. ENISO18812:2003INTENRATIONAL TSANDADR IS:21881 O3002(E)I
40、SO 3002 All irhgts seredevr 1Health informatics Clinical analyser interfaces to laboratory information systems Use profiles 1 Scope This International Standard specifies general messages for electronic information exchange between analytical instruments (AIs) and laboratory information systems (LISs
41、) within a clinical laboratory. It is applicable to the specialities of clinical chemistry/biochemistry, haematology, toxicology, microbiology, virology and immunology. It is not applicable to the blood transfusion and blood bank speciality This International Standard covers the specification of mes
42、sages used by communicating parties and the syntax in which they are communicated. It does not cover the transport mechanisms used for the message interchange. This International Standard is applicable only to character-based message information. It is not applicable to the communication of graphica
43、l or image information. NOTE The provisions for this International Standard have been validated in the domains and for the purposes described above. However, messages conforming to this International Standard may be considered by some user communities to meet their needs for purposes outside this sc
44、ope. Use of the messages in these circumstances is not precluded by the scope. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the ref
45、erenced document (including any amendments) applies. ASTM E1394-97 1) , Standard Specification for Transferring Information between Clinical Instruments and Computer Systems 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 analyte component in
46、dicated in the name of a measurable quantity 3.2 analytical instrument AI named set of equipment that provides implementations of laboratory services NOTE 1 In ASTM E1394, the term “Clinical Laboratory Instrument” or “Clinical Instrument” is used. 1) Available from www.astm.org. ENISO18812:20031ISO
47、18812:2003(E) 2 I SO 3002 All irhgts seredevrNOTE 2 Workstations in laboratories can carry out communication between AIs and LISs. Such workstations can assume the dual role of both posing as an LIS to an AI, and as an AI to an LIS. Therefore, a workstation connected between an AI and an LIS may, in
48、 some circumstances, be considered as an AI, or, in other circumstances, as a LIS. 3.3 battery group of analytical instrument investigations ordered together NOTE This supplies a convention by which the user (the LIS) can order multiple analytical instrument investigations by specifying a single name. 3.4 component single data element or data ele
