1、DRAFT FOR DEVELOPMENT Implementation of ENV 1613 : 1995 Medical informatics - Messages for exchange of laboratory information Product code 0062 11 1 1 ICs 11.100; 35.240.60 DD ENV 1613 : 1996 DD ENV 1613 : 1996 Amd. No. This Draft for Development having been prepared under the direction of the infor
2、mation Systems Technology Assembly, was published under the authority of the Standards Board and comes into effect on 15 January 1996 O BSI 1996 Date Text affected Committees responsible for this Draft for Development This Draft for Development was entrusted to Technical Committee ISTB5, Medid infor
3、matics, upon which the following bodies were represented BCS Nursing Specialist Group British Computer Society British Computer Society (Health Informatics Specialist Groups) College of Radiologists (Clinid Oncology) Computing Services and Software Association Conference of Royal Colleges Informatio
4、n Group Department of Health Electro Medid We Association Limited Faculty of Public Health Medicine of the Royal College of Institute of Medid Laboratory Sciences Management Consultancies Association Nationai Health Services “S (Infomation Management Centre) Nine ?Iles Computer System Ltd. Royal Col
5、lege of Surgeons of England Simpler lhde Procedures Board (SITPRO) Society for Computing - present to the responsible internationaVEuropean Committee any enquiries on interpretation, or proposais for change, and keep UK interests informed; - monitor related international and European developments an
6、d promylgate them in the UK. NOTE. International and European Standards, as well as overseas standards, are available from Customer Services, BSI, 389 Chiswick High Road, London W4 4AL. After two years this ENV will be reviewed by CEN members with a view to its: - conversion into a European Standard
7、 (which would be implemented in the UK as a British Standard); - extension once for a further two years; - replacement by a revised ENV (which would be published in the UK as a revised Draft for Development); - withdrawal. The future of this Draft for Development is therefore bound to that of the EN
8、V and the Draft for Development will not be reviewed or developed separately. This publication is not to be regarded as a British Standard. O BSI 1996 i BSI DD*ENV*LbL3 9b m Lb24bb 0520632 368 m EUROPEAN PRESTANDARD ENV 1613 PRNORME EUROPENNE EUROPALSCHE VORNORM July 1995 ICs 11.1OQ 35.240.60 Pescri
9、ptors: Medicine, data processing, information interchange, messages, laboratories, specifications English version Medical informatics - Messages for exchange of laboratory information This European Prestandard (E“) was approved by CEN on 199503-10 as a prospective standard for provisional applicatio
10、n. 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 existence o
11、f 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 reached.
12、 CEN members are the national standards bodies of Austria, Belgium, Denmark, Finiand, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation
13、Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1995 All righs of reproduction and communication in any form and by any means reserved in all countries to CEN and its members. Ref. No. ENV 1613 : 1995 E Page 2 ENV 1613 : 1995 Foreword This European Prestanda
14、rd has been prepared by the Technical Committee CENirC 251, Medical informatics, of which the secretariat is held by IBN. According to the CENKENELEC Internal Regulations, the following countries are bound to announce this European Frestandard: Austria, Belgium, Denmark, Finland, France, Germany, Gr
15、eece, Iceland, Ireland, Itay, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Foreword Introduction 1 Scope 2 Normative references 3 Dehitions 4 Requirements 5 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 Communication roles and supported services Domain inf
16、ormation Model Approach Domajn information Model diagrams Textual description of the objects, their relationships and attributes Textual description of common attribute groups General Message Descriptions Introduction New laboratory service order General Message Description Laboratory service order
17、modincation General Message Description 7.4 Laboratory service order cancellalion General Message Description 7.5 New laboratory service report General Message Description 7.6 Laboratory service report modincaiion General Message Description 7.7 Laboratory service report cancellation General Message
18、 Description 7.8 Attribute layer Annexes A How to read the models (normative) B Questions and answers (informative) C Example scenarios of message use (informative) D EDIFACT messages (informative) Index Page 2 3 5 7 8 11 12 16 16 16 20 44 46 46 46 50 52 53 56 58 59 77 80 86 89 106 BSI DD*ENV*Lb23 9
19、6 = 2624669 0520634 230 Page 3 ENV 1613 : 1995 The incrctled wc of dur prossag and tekamumauons apibiliucs has mdc pUsYbie ihc imxhange of information in michine radab b) facililalc ihe ela#mnic trcuisfcr of rrpons from clinical laboratona to quesen and othu halthare panics; c) rcdua the Leed for hu
20、man intemuon in infomuon interchange bmmcn appliaiions uscd by clinical iaboratoncs and Lhose wd by other healthcare pama; d) minimise the Lime and dion required for ahc introduction of inlomuon interchange agrumuits; e) rede the dcvelopmuit don required by suppliers to allow mmmuniauon krwcui a wid
21、e mg of applications in this kid; 0 reduct (in conscquccc of LhC foregoing) thc cost of inonruuon interchange bum clinical iabontorier Ud puua rqucffing dinial iaboniory MCQ. When irnplcmuiung information exchange bascd upon Lhrs Eutopeui Prrarnard dita protation Ud urrey pnnupics must be guaranicd
22、;locording to ihc hws audiy in forcc in the diflmt CEN mclltbQ QWZLLQ. The mahod by which Lhis Empan Prrauiar has becn dmlopcd is bued on ihc 1oommCld;u10 . NOfUYCEN Tahd Rcpon Invcsugation of SynUxa for Emng Intuchap FomU lo bc uscd in Hdiheur (CR 1350: 1993). This standard is intcndcd for UT by mc
23、iugc dcvclopcn. Ils pmviuons an drrccily rtlcvant to mppliEn of CornputCr syncm for UT in climcai Lbontona. hospitals. gem1 praaiccs, clinid dcpuuncnlr and proviuons arc ais0 rclcvant to thosc phng, rpccifyng, procuring or impiumiung infomuuoa syriunr for UT in dinial labontona. hospitais. ged pnaia
24、s. clima1 dcpuuncnu and spxulisa clima. ciirucr lb Thc main norrmlive pmsions in this European Prcstandar arc cxprcrsad in CLLKCS 4 and S Ud appiy to - Clinical Biochemistry; - Clinical Immunology; - immunohaematology; - Hiematology; - Clinical Microbiology (including Bactcriology. Mycology, Parasit
25、ology and Virology). - TOXICOOY; 1.3 This European Prcslanard is na appiicablc to messages requesting or reponing on the mlu of the KMOCS of the following spccialuts (scc I. 1 i) : - Anatomic Pathology; - HInop;rthology, - Cytology. and - Autopsies. I .4 llus European Prrstandard dw not specify the
26、manner in which clinical laboratory YMOCS are divided between sptciaitics as this vanes in potdanot with difercnt nauonai Ud iaai pnaicts. 1.5 The scope of ihc messages specified by his European prrstudud comprises rcqucsu and resuits dated to inmgalions camal out by clinicai iaboratoncs on subJcRs
27、of invcsugauon. This Europan ntnlndard IS applicable whether thc hcalchcarr party communicaiing with ihc CIINQI l;ibontory is a pcnon (rudi as a docior or other hcaiihcarc profcssorul) or an organtnuon (such as a hospital. clinic or department). A clinical laboratory may itself au as the healthcan p
28、arty submilung requests to, or receiving resuiks from ather ciinid Montones. Howcver. ltus European Prcstanard has no( bctn developed to mcu the necds of mcssagcs that arc specific to cmununiatnons bctwecn onc clinical laboratory and another. I .6 fhis Europcan Prcsluidud is applicablc to rcqueds fo
29、r invcmgauon and modifiations Ud anlhtions of prcviously issucd requests. It is appliabk both to samples that arc obtained from sub- of invcsligation a! ihe point of can or at any other locauon and submitted to the clinical iabontory. and to rcqucsu for invtnigation for which the laboratory is reque
30、sted to obtain umples. The messages it spectfies support sunding orden for laboratory semas. 1 7 This Europcan Prestandard is appliablc to rcporu of thc du of invcsiigauon and Wicauons and cancellations of prcviously LssuccI reports. Thc mcssagcs it specifies nippon the communtation of panui. supplc
31、mcnmy, final supplcmenury. complac and cumulative rcporu. Rcporung modes which can k implemented wing this Europcan Pfcnandard incluc: ding a laboratory YMCC repon only when all laboratory invaugauon rcsults arc availablc; sending individual results as thy bme available; scnding new rcsuiu as part O
32、ca cumulative rcporr; and sending panial resulis. I 8 This Europcan Pmndard is not applicable to the commwuon of graphical or image infomoon that forms part of a rcquest for or rdt of a Lbontory invesupoon. 1.9 Ths European Pnsilndard has not bacri developed to mccl the ncak of mesages supporting od
33、mininntion. financrng. management, intexperronal mil or external quality control nor of messaga communiaiing -le mllcction lists. work IW or qucnes. I IO This European prrstudud dw no( nippon negauve Icluwnvledgmcnt or emr indiauon at the appiiauon Itl. nor positive acknowledgment at the appliaiion
34、Iml. Page 6 ENV 1613 : 1995 I. 1 1 The provisions of this European Pnrianard haw ccn validaid in the dumiru rnd for iht above (a 1.2 and I. 3). Hornvrr rnamgcs conforming IO this Eumpn naundud my k amil Informatics - Hcalthcare information interchange -Registration of coding schemes Health c;irc iii
35、lormatics. Si nictiirc for nomenclature. classification and coding of observable propcnics III clinical 1;ibor;itoF sciences. Codcs or rcpresentatioii OC names of countries Data clciiierits and interc1i;iiigc formats - information interchange -Representation of dates and t i nics Electronic data int
36、erchliii-c Lor administration. commerce and transport (EDIFACT) - App1ic;itioii lcd ?nias nilcs Synibols tor Iringuages. ceoeraphical areas and authorities Iioriii;ition technology - IS0 7-bit coded character set for information interchange Intriimion processing - Vocabulary Pan 4 . Organisation of
37、dm Codes or the representation of currencies and funds Inforniation interchange - Representation of human sexes Data iiitcrchange - Stnicture for the identificauon of organisations 1nforiii;ition icchnoiop - Opai Systems Interconnection - Abstract Syntas Notation One (ASN I) Pan I : Specification of
38、 b;isic notation Inforiiimon technolor! - Opcn Systems Interconnection - Specification of ASN. 1 encoding rules Part 1 . Basic Encoding Riiics (BER) Inriiintion Processing - Registration of graphics character subrepertoires - Eight-bit single bye codcd graphic charlictcr scts Page 8 ENV 1613 : 1995
39、3. DEFINITIONS For ihc pirpusry of this siandid. thc following dcriniuons (listed in zlphrkucrl ordu) apply : 3.1 clinical informaiion : Inionnation about a patient, reicvant to the health or treatment of that patiui. that is rccordcd by or on bchalf of a halthcare professional. NOTE : Clinical info
40、muon aboui a paient may include infomuon about tht puents avironment or about rrktcd people or animais where thrs is rdm. 3.2 clncil invdg8tion : LIbontory. physiological, radiolocd or othu halthculc UUrmNUon thai Icartion. Tht obrcrvcr may c the patient or rcaiai person (inionnalion about symptoms.
41、 Wy histoy. -tion or life style). or a halthcuc professional (information about physical signs, mcrsurrments. propcrria obscwed or diagnoses). While idornuon about the nature of a piannal or puionned maUnait is cxciudtd by the cinitiois clinid obscxvations may bc mrdcd as the mlts of a treatment or
42、dung the anme of a treatment or as its resuit. 3.4 code meaning : Element within a coded se(. EXAMPLE : Paris Chules-Dc-Gauilc which is mappi on to the thredetter abrcvillion CDG“ by the coding schmc for thra-lcttu abbreviations of airport names. ENV 10681 35 code vduc : Result o applying a ding sch
43、eme to a code meaning. EXAMPLE : CDG“ u cbc rcprrscntation of “Paris chriUc to an individual, or involved in lhe pmvision of healthcare-relatai servias such u ainronmentd mcrrurrmuii du. 3.13 healthcare pr0ftWiw.l : Person who is enuunal with the dim or indirai phon of deiincd heallhare semas to a s
44、ubm or popdation of sub-. EXAMPLE : Primary care physician. dcntia nurse. d worker, vucnnary surgeon. 3.14 healthcam service : Servicc prwidcd with the intenuon of dimly or indiidaly improving the health of the pcoplc. populiions or minuls to whom it is prwidcd. 3.15 implementable message spcciTitio
45、a : Specifidon of a general message depcnption in a parlialar message SpiaX. NOTE : In this Pmsmdad the abbreviation IMS is used. 3.16 interchange format : Spcctlication of a message type according to a grvcn message syntax, covering the idcnticaiion of the message type components, their anangemmt n
46、prescntauon and intnIrtiomtups. 3.17 intcrvcntioa infomitioa : Infodon about medid or surgicd actions paformed on or phnncd to k pcrfonncd on a subject of invcstigation. NOTE : Intcrvenlion information ref to dinid information datal to pluubcd or muai incmirntiom as dwna from inlormation obcrined by
47、 ob#rvrtion. it induder but ir not iimitsd to prcsaiption or dminirurtion of drugs, thenpeutic and diagnosc pmocdurcr. 3.18 laboratory invatgation : dinid kbontory examination hat lads to the production of one or more d. EXAMPLE. k a labontory invcaigauon iz thc syniksis of its component paru and ma
48、y bc vanwsiy COnsUnited. thc follwng arc all cumpics of laboratory invcstigaiions : livcr funaion ICSU. bilirubin. album14 bld-ilkrmin- subsuncc conccnv?oon, giobuhn. iltcilinc phosphatase. aspmate anunovUirieng hrll blood anmi. giuc06e viral antigen isoluon. daeaion of antinucicu antibodies (ANA).
49、uuibodtcs to SutlwocooQ. VDRL iesf anlibtalc sensitivity tests. MIC/MBC damaauon, M- for ducaion of paraste. tolerancc test. murune clearanct. c-fcaane pm* ruklla uurbodia, mr- indiaid by the crm the rcqucstcr uses 10 dcscrik hislhcr wisha. or by thc tcrm(s) uscd for invcsligauons conductcd in thc laboratory in pursuit of ihosc wuha. 3.19 laboratory invatigation muit item : Scr of information including all csscntral or uscful tius object coorrrrponds to what IS normally ailed a line on a paper report. 3.20 (labo
