SIST ENV 13730-1:2003
(Main)Health informatics - Blood transfusion related messages - Part 1: Subject of care related messages
Health informatics - Blood transfusion related messages - Part 1: Subject of care related messages
The domain of the blood transfusion related messages includes:-the collection of blood from donor; -preparation; - qualification; -dispensing of Blood components (to be transfused) to the recipient. Transfusion of blood and Blood components to patients is a medical activity that is subject to many legal instructions, regulations and constraints. Immunological conditions transmitted diseases; sustainability and other difficulties due to the fact that the treatment involves many problems, including those cause this. Mistakes and failures may have serious or even fatal consequences.
Zdravstvena informatika – Sporočila v zvezi s krvno transfuzijo – 1. del: Vsebina sporočil v zvezi z oskrbo
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST ENV 13730-1:2003
01-oktober-2003
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VSRURþLOY]YH]L]RVNUER
Health informatics - Blood transfusion related messages - Part 1: Subject of care related
messages
Ta slovenski standard je istoveten z: ENV 13730-1:2001
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST ENV 13730-1:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ENV 13730-1:2003
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SIST ENV 13730-1:2003
EUROPEAN PRESTANDARD
ENV 13730-1
PRÉNORME EUROPÉENNE
EUROPÄISCHE VORNORM
December 2001
ICS 35.240.80
English version
Health informatics - Blood transfusion related messages - Part
1: Subject of care related messages
This European Prestandard (ENV) was approved by CEN on 19 October 2000 as a prospective standard for provisional application.
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 a European Standard.
CEN members are required to announce the existence of 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.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. ENV 13730-1:2001 E
worldwide for CEN national Members.
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SIST ENV 13730-1:2003
ENV 13730-1:2001(E)
CONTENTS
FOREWORD .5
INTRODUCTION .6
1SCOPE.7
2 NORMATIVE REFERENCES .9
3 NORMATIVE DEFINITIONS AND ABBREVIATIONS .10
4 REQUIREMENTS .17
4.1 General conformance requirements .17
4.2 Implementation recommendations .18
5 COMMUNICATION ROLES .18
5.1 General.18
5.1.1 Sending role requirements.18
5.1.2 Receiving role requirements.18
5.2 Use case diagram and scenarios (General use case).18
5.3 Group 1: Message sequences.20
5.3.1 Testing activities (activities concerned with the testing of subjects of care and blood products)
(including serological and compatibility testing) (See ENV 1613) .20
5.3.2 Transfusion activities (directly concerned with transfusion of Blood components to subjects of
care) 21
6 REQUIREMENTS AND GENERAL MESSAGE DESCRIPTIONS .22
6.1 Conformance requirements .22
6.2 General Message Descriptions .22
6.3 Request for blood components message .24
6.3.1 Scope of this message .24
6.3.2 Request for Blood components message.26
6.4 Blood components recipient delivery note message .27
6.4.1 Scope of this message .27
6.4.2 Blood components recipient delivery note message .29
6.5 Blood Transfusion report message .30
6.5.1 Scope of the message.30
6.5.2 Blood Transfusion report message .32
7 DOMAIN INFORMATION MODEL DIM.33
7.1 Introduction .33
7.1.1 The modelling approach.34
7.1.2 Presentation of attributes from generalisations .34
7.2 General message subsystem .36
Class Descriptions.37
7.2.1 blood transfusion message .37
7.2.2 blood components user (Prescriber) .37
7.2.3 blood components dispenser.38
7.2.4 requested item message .38
7.2.5 issued item message.39
7.3 Specific message subsystem.40
Class Descriptions.41
7.3.1 blood transfusion report message.41
7.3.2 request for blood components message (blood components request message) .41
7.3.3 compatibility testing request message .41
7.3.4 blood grouping request message .42
7.3.5 blood components recipient delivery note message.42
7.3.6 compatibility test report message .42
7.3.7 blood group report message.42
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SIST ENV 13730-1:2003
ENV 13730-1:2001 (E)
7.3.8 original message identification .43
7.4 Communicating parties subsystem .44
Class descriptions.45
7.4.1 message sender.45
7.4.2 message receiver .45
7.5 Healthcare agent subsystem.46
Class descriptions.47
7.5.1 healthcare agent in context .47
7.5.2 healthcare agent relationship.47
7.5.3 healthcare agent.48
7.5.4 healthcare party [3.34]
.............................................................................................................................48
7.5.5 healthcare party identification .49
7.5.6 healthcare organisation [3.33] .49
7.5.7 blood components manufactor [3.13] .49
7.5.8 healthcare professional [3.36] .50
7.6 Requested item subsystem .51
Class descriptions.52
7.6.1 requested item.52
7.6.2 blood component [3.11] .53
7.6.3 requested blood component information .54
7.6.4 delivery location .55
7.7 Issued item subsystem.56
Class Descriptions
.....................................................................................................................................................57
7.7.1 issued blood component .57
7.7.2 blood component characteristic .58
7.7.3 blood component unit .58
7.7.4 quantity of blood component .59
7.7.5 container characteristic.59
7.7.6 use of blood components .60
7.7.7 instructions for use .61
7.7.8 issued blood component information.62
7.7.9 issued blood component administrative details.62
7.7.10 blood component cost.63
7.7.11 blood component delivery package .63
7.7.12 delivery details.63
7.8 Subject of care subsystem.65
Class Descriptions.66
7.8.1 subject of care [3.51] .66
7.8.2 patient matching information .66
7.8.3 clinical information .67
7.8.4 patient supplementary information.68
7.8.5 patient related party .69
7.8.6 patient characteristic details .69
7.8.7 clinical information item .69
7.9 Payment guarantor and conditions subsystem .70
Class Descriptions.71
7.9.1 payment details.71
7.9.2 payment guarantor .71
7.9.3 payment conditions.72
7.9.4 payment authorisation.72
7.10 Laboratory investigation subsystem .73
7.10.1 laboratory investigation.74
7.10.2 requested laboratory investigation.74
7.10.3 laboratory investigation report .74
7.11 Common subclasses .75
7.11.1 address.75
7.11.2 event date and time.75
7.11.3 general message information.75
7.11.4 identifier.76
7.11.5 language details
........................................................................................................................................76
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SIST ENV 13730-1:2003
ENV 13730-1:2001 (E)
7.11.6 measurement.76
7.11.7 message identification.77
7.11.8 party identifier
...........................................................................................................................................77
7.11.9 person name details.77
7.11.10 structured address .78
7.11.11 structured person name .78
7.11.12 time interval.78
7.11.13 time period.79
7.11.14 unstructured address .79
7.11.15 unstructured name details .79
7.11.16 value of quantity .79
7.11.17 message header .80
ANNEX A (INFORMATIVE) HOW TO READ THE MODELS.81
ANNEX B (INFORMATIVE) COMPOUND AND SIMPLE DATA TYPES: .86
ANNEX C (NORMATIVE) GUIDE TO USAGE OF ENV 1613
..................................................................................90
ANNEX D (INFORMATIVE) BIBLIOGRAPHY .98
INDEX .99
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SIST ENV 13730-1:2003
ENV 13730-1:2001 (E)
Foreword
This European Prestandard has been prepared by CEN/TC251 Health Informatics under mandate by the
European Commission and the European Free Trade Association and under the supervision of WG1 & of CEN
TC/251, the Technical Committee for Health Informatics. The Project Team members are experts from various
European countries, including representatives from:
France (Team Leader), Austria, Germany, Sweden and UK.
This European Prestandard complies with the third edition of ISO/IEC Directives, part 3, 1997.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this European Prestandard: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
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SIST ENV 13730-1:2003
ENV 13730-1:2001 (E)
Introduction
The use of data processing and telecommunications capabilities have made possible the interchange of
information in machine-readable and machine processable formats. The Information Technology and Data
Management environment consists of a variety of computer systems with numerous hardware and operating
system platforms. Application programs span a wide range of qualities of design and support. Interoperability –
the ability of software and hardware on multiple machines from multiple vendors to communicate – is the key to
automated interchange of information in healthcare. As interoperability increases, it is essential to provide
appropriate information interchange standards.
This European Prestandard provides a set of messages that enable the electronic transfer of messages in the
Blood transfusion domain.
A combination of the following factors provide the motivation for this European Prestandard:
Electronic messages developed in the Healthcare Informatics domain contain sensitive healthcare information
about specified individuals that requires a high level of confidence both in the parties sending and receiving
messages and that the information being made available is unchanged. Standards are required to facilitate
electronic transfer of Blood Transfusion related messages and reports between the many systems currently used.
Information transferred in the Blood Transfusion related messages and any reports passing between healthcare
parties form part of the information system of each of the communicating parties. Electronic transfer of these
Blood transfusion related messages and reports reduces the need for manual entry and the risk of transcription
errors. It also results in greater efficiency leading to better healthcare provision.
This Prestandard requires EDI messages in the domain of Blood transfusion to be defined in a way that
significantly reduces the risk of misinterpretation of issued blood transfusion related messages. Deliverables are
included that are usable by software implementers and health professionals working in the field of Blood
transfusion. This report includes the hierarchical and linear message descriptions, together with coding tables,
where appropriate. The outputs of this work may also be used in the domain of tissue and organ transplantation.
Implementation of the messages specified by this European Prestandard will enable the transmission of general
messages for electronic interchange between computer systems used by healthcare parties in the Blood
transfusion domain.
This European Prestandard has been developed following the methods recommended in the CEN Report on
"Medical Informatics - Methodology for the development of healthcare messages" (CR 12587:1996). However,
in accord with the decisions of CEN TC251 WGI, a different modelling technique has been used. This is a
subset of the Unified Modelling Language (UML) as documented in Annex A.
This European Prestandard specifies messages in a syntax independent form. Its requirements for conformance
define the minimum acceptable content and structure for these messages. Compliant messages can be developed
in a variety of implementation syntaxes and these syntax specific implementations may be the subject of future
Standards.
This European Prestandard is directly relevant to suppliers of computer systems for use in development. Its
provisions are also relevant to those planning, specifying, procuring or implementing information systems for
use in the Blood transfusion domain.
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SIST ENV 13730-1:2003
ENV 13730-1:2001 (E)
prENV 13730-1
Health Informatics - Blood Transfusion Related Messages
Part 1: Subject of Care Related Messages
1 Scope
Transfusion of blood [3.10] and Blood components[3.11] to subjects of care[3.51] is a medical activity that is
subject to many legal regulations and constraints. Many problems may be encountered during treatment due to
immunological conditions, transmitted diseases, sustainability and other difficulties. Mistakes and failures may
have serious or even fatal consequences. Minimising human activity through the increased use of data processing
and automated messaging will introduce an additional safety mechanism.
This European Prestandard (prENV) specifies general messages[3.43] for electronic information interchange
between computer systems used by healthcare [3.30] parties in the Blood transfusion [3.17] domain. The content
and structure of the messages specified in this prENV have been developed with the aim of optimising the safety
of Blood transfusion activity and to facilitate compliance monitoring and secure audit trails [3.4].
This European Prestandard is applicable to Blood transfusion related messages including those for:
- the collection of blood from donor
- preparation of Blood components
- classification of Blood donations
- dispensing of Blood components (to be transfused) to the recipient
Within the blood transfusion process there are a number of actors:
(1) The Blood component User, generally a member of a care unit, is the customer of a Blood component
dispenser. He establishes the need for transfusion and makes a request to the blood transfusion service.
Depending on the internal organisation [3.45] of the healthcare organisation, a request may be made for
preparatory investigations, such as serological tests, prior to the transfusion.
The Blood component User [3.15]:
receives reports of blood group analysis;
accomplishes the transfusion;
reports back any delay in the activity;
reports the outcome of any eventual complications.
The requesting party and the transfusing party can physically be two different healthcare professionals, but are
illustrated as instances of one generic actor, the Blood component user.
(2) The Blood component Dispenser [3.12] obtains Blood components from one or more providers, then stores
and dispenses them to the user. This actor may appear as a separate entity, or as subdivision, within either
the class producer or user. In certain circumstances communication may be required with a different Blood
component dispenser or with all Dispensers within another region or a country.
(3) The Blood component Producer [3.13] prepares Blood components for transfusion from donor blood. In
many countries the production process utilises a special Blood Transfusion Data System providing internal
communications between the subdivisions (Blood Collection, Donation classification [ ], preparation of
3.18
Blood components [3.47], transformation of Blood components[3.53]).
(4) The Laboratory Service provider [3.42] provides a laboratory service (serological, biochemical,
bacteriological and virological analyses). The laboratory can be an integral part of the healthcare organisation.
(5) The Relay Store. In some organisations, for example in France, this actor is physically ve
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