SIST ENV 13730-2:2003
(Main)Healthcare Informatics - Blood transfusion related messages - Part 2: Production related messages (BTR-PROD)
Healthcare Informatics - Blood transfusion related messages - Part 2: Production related messages (BTR-PROD)
Transfusion of blood [3.10] and blood components[3.12] to subjects of care[3.56] 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 prENV specifies general messages[3.43] for electronic information interchange between computer systems used by healthcare [3.34] parties [3.38] in the blood transfusion [3.18] 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 prENV is applicable to Blood transfusion related messages including those for:
- the collection of blood/blood components[3.25] from donor
- manufacturing [3.47]and processing[3.52] of blood components
- classification [3.19]of Blood donations
- dispensing [3.28]of blood components (to be transfused) to the recipient
Healthcare Informatics - Blood transfusion related messages - Part 2: Production related messages (BTR-PROD)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST ENV 13730-2:2003
01-oktober-2003
Healthcare Informatics - Blood transfusion related messages - Part 2: Production
related messages (BTR-PROD)
Healthcare Informatics - Blood transfusion related messages - Part 2: Production related
messages (BTR-PROD)
Ta slovenski standard je istoveten z: ENV 13730-2:2002
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST ENV 13730-2:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ENV 13730-2:2003
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SIST ENV 13730-2:2003
EUROPEAN PRESTANDARD
ENV 13730-2
PRÉNORME EUROPÉENNE
EUROPÄISCHE VORNORM
September 2002
ICS 35.240.80
English version
Healthcare Informatics - Blood transfusion related messages -
Part 2: Production related messages (BTR-PROD)
This European Prestandard (ENV) was approved by CEN on 18 October 2001 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, Malta, 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
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. ENV 13730-2:2002 E
worldwide for CEN national Members.
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SIST ENV 13730-2:2003
ENV 13730-2:2002 (E)
CONTENTS
FOREWORD .5
INTRODUCTION.6
1 SCOPE.7
2 NORMATIVE REFERENCES.9
3 TERMS, DEFINITIONS AND ABBREVIATIONS.9
4 REQUIREMENTS .17
4.1 GENERAL CONFORMANCE REQUIREMENTS.17
4.2 IMPLEMENTATION RECOMMENDATIONS.17
5 COMMUNICATION ROLES .17
5.1 GENERAL .17
5.1.1 Sending role requirements .17
5.1.2 Receiving role requirements.17
5.2 USE CASE DIAGRAM AND SCENARIOS (GENERAL USE CASE).18
5.3 GROUP 2: MESSAGE SEQUENCES .20
5.3.1 Blood component production message domain .20
6 REQUIREMENTS AND GENERAL MESSAGE DESCRIPTIONS .22
6.1 CONFORMANCE REQUIREMENTS.22
6.2 GENERAL MESSAGE DESCRIPTIONS .22
6.3 BLOOD/BLOOD COMPONENT COLLECTION REQUEST MESSAGE .24
6.3.1 Scope of this message.24
6.3.2 Blood/blood component collection request message.26
6.4 BLOOD/BLOOD COMPONENT CLASSIFICATION REQUEST MESSAGE .27
6.4.1 Scope of this message.27
6.4.2 Blood/blood component classification request message.29
6.5 BLOOD/BLOOD COMPONENT CLASSIFICATION REPORT MESSAGE.30
6.5.1 Scope of the message.30
6.5.2 Blood/blood component classification report message.32
6.6 BLOOD/BLOOD COMPONENT COLLECTED DELIVERY NOTE MESSAGE.33
6.6.1 Scope of this message.33
6.6.2 Blood/blood component collected delivery note message.35
6.7 BLOOD COMPONENT REQUEST MESSAGE .36
6.7.1 Scope of this message.36
6.7.2 Blood component request message.38
6.8 BLOOD COMPONENT MANUFACTURED DELIVERY NOTE MESSAGE.39
6.8.1 Scope of this message.39
6.8.2 Blood component manufactured delivery note message.41
6.9 BLOOD COMPONENT PROCESSING REQUEST MESSAGE.42
6.9.1 Scope of this message.42
6.9.2 Blood component processing request message.44
6.10 BLOOD COMPONENT PROCESSED DELIVERY NOTE MESSAGE .45
6.10.1 Scope of this message.45
6.10.2 Blood component processed delivery note message.47
7 DOMAIN INFORMATION MODEL (DIM).48
7.1 INTRODUCTION .48
7.1.1 The modelling approach .49
7.1.2 Presentation of attributes from generalisations.49
7.2 GENERAL MESSAGE SUBSYSTEM .51
Class Descriptions .52
7.2.1 requested item message .52
7.2.2 issued item message.53
7.2.3 blood/blood components collector.54
7.2.4 blood components manufacturer.54
7.2.5 blood components dispenser.55
7.2.6 blood components processor .55
7.3 SPECIFIC MESSAGE SUBSYSTEM.56
Class Descriptions .57
7.3.1 original message identification.57
7.3.2 blood/blood component collection request message.57
7.3.3 blood/blood component classification request message .58
7.3.4 blood/blood component classification report message .58
7.3.5 blood/blood component collected delivery note message.58
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ENV 13730-2:2002 (E)
7.3.6 blood component request message .59
7.3.7 blood component manufactured delivery note message .59
7.3.8 blood component processing request message .60
7.3.9 blood component processed delivery note message .60
OMMUNICATING PARTIES SUBSYSTEM
7.4 C .61
Class descriptions.62
7.4.1 message sender .62
7.4.2 message receiver.62
7.5 HEALTHCARE AGENT SUBSYSTEM.63
Class descriptions.63
7.5.1 healthcare agent in context .64
7.5.2 healthcare agent relationship .64
7.5.3 healthcare agent [3.30] .65
7.5.4 healthcare party [3.33].65
7.5.5 healthcare organisation [3.32] .66
7.5.6 healthcare professional [3.34].66
7.6 COLLECTED ITEM SUBSYSTEM .67
Class descriptions.67
7.6.1 collected item.67
7.6.2 blood component [3.9].68
7.7 REQUESTED ITEM .70
Class Descriptions .70
7.7.1 requested item.70
7.7.2 requested blood component information .71
7.7.3 delivery location .72
7.8 ISSUED ITEM SUBSYSTEM.73
Class Descriptions .74
7.8.1 issued blood component .74
7.8.2 blood component characteristic .75
7.8.3 blood component unit .75
7.8.4 quantity of blood component.76
7.8.5 issued blood component administrative details .76
7.8.6 issued blood component information.77
7.8.7 unit (container) characteristic .77
7.9 PAYMENT GUARANTOR SUBSYSTEM .78
Class Descriptions .79
7.9.1 payment details.79
7.9.2 payment guarantor.79
7.9.3 payment authorisation.80
7.10 LABORATORY INVESTIGATION SUBSYSTEM.81
7.10.1 laboratory investigation (ENV 1613) .82
7.10.2 requested laboratory investigation (ENV 1613) .82
7.10.3 laboratory investigation report (ENV 1613).82
7.11 BLOOD DONOR SUBSYSTEM.83
Class Descriptions .83
7.11.1 blood donor [3.13].83
7.11.2 clinical information [3.18].84
7.11.3 clinical information item .84
7.12 COMMON SUBCLASSES .85
Class Descriptions .85
7.12.1 address.85
7.12.2 event date and time.85
7.12.3 general message information.86
7.12.4 identifier .86
7.12.5 language details .87
7.12.6 measurement.87
7.12.7 message identification .87
7.12.8 party identifier .87
7.12.9 person name details .88
7.12.10 structured address .88
7.12.11 structured person name.89
7.12.12 time interval.89
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ENV 13730-2:2002 (E)
7.12.13 time period.89
7.12.14 unstructured address .89
7.12.15 unstructured name details .90
7.12.16 value of quantity.90
ANNEX A (INFORMATIVE) HOW TO READ THE MODELS .91
ANNEX B (INFORMATIVE) COMPOUND AND SIMPLE DATA TYPES RATIONALE AND HOW TO
USE THE DATA TYPES IN MESSAGES.96
ANNEX C (NORMATIVE) GUIDE TO USAGE OF CEN/TC 251/ENV 1613.101
INDEX.110
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SIST ENV 13730-2:2003
ENV 13730-2:2002 (E)
Foreword
This document (ENV 13730-2:2002) has been prepared by Technical Committee CEN/TC 251 “Health
informatics”, the secretariat of which is held by SIS.
It was developed by Project Team 32 under mandate M/255 given by the European Commission and the
European Free Trade Association, order voucher BC/CEN/97/23.
This is Part 2 of a multipart standard (ENV 13730) under the general heading Health informatics – Blood
transfusion related messages with the following parts:
Part 1: Subject of care related messages
Part 2: Production related messages
Annex C of this European Prestandard is normative, all other annexes are informative.
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, Malta, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.
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Introduction
Part 2 of this European Prestandard (ENV) provides a set of messages that enables the electronic transfer of
messages in the blood transfusion domain.
The motivation for this ENV derives from a combination of the following factors:
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 ENV 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 ENV 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 ENV 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.
Particular note for implementers: Some attributes may have the same title but modified in meaning for use in
Part two than in Part one.
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SIST ENV 13730-2:2003
ENV 13730-2:2002 (E)
1 Scope
Transfusion of blood [3.7] and blood components [3.9] (blood products) to subjects of care [3.48] 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 ENV specifies general messages [3.41] for electronic information interchange between computer systems
used by healthcare [3.29] parties [3.33] in the blood transfusion [3.16] domain. The content and structure of the
messages specified in this ENV have been developed with the aim of optimising the safety of blood transfusion
activity and to facilitate compliance monitoring and secure audit trails [3.2].
This ENV is applicable to blood transfusion related messages including those for:
- the collection of blood/blood components [3.22] from blood donor
- manufacturing [3.40] and processing [3.44] of blood components
- classification [3.19] of blood donations
- issue of blood components to the blood components dispenser
Within the blood transfusion process there are a number of actors:
(1) The blood components dispenser [ ] obtains blood components and blood products from one or more
3.10
providers, then stores and dispenses them to the user, in some countries this function is known as the
Hospital Blood Bank. 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
components dispenser or with all dispensers within another region or a country.
(2) The blood components manufacturer [ ] prepares blood components for transfusion from donor blood
3.11
and issues blood components to the blood components dispenser [ ] a blood components processor or to
3.10
another blood components manufacturer. In many countries the production process utilises a special blood
transfusion data system providing internal communications between the subdivisions (blood collection,
collected blood classification [ ], manufacturing of blood components [ ], processing of blood
3.17 3.40
components [ ]), and issues blood components to a blood components dispenser.
3.52
(3) The blood components processor [3.12] receives blood components from a blood components
manufacturer [3.11] for processing into blood products.
(4) The Laboratory service provider [3.39] provides a laboratory service (serological, biochemical,
bacteriological and virological analyses), to classify a sample of donor blood received from the blood/blood
components collector. The laboratory can be an integral part of the healthcare organisation.
(5) The blood /blood components collector [3.8] provides the service of collecting blood from a blood donor, to
be delivered to the manufacturer, and to forward a sample of the blood to the Laboratory service provider
[3.46] for the classification of blood donation [3.17].
The messages identified within scope are :
The messages used in :
• collection,
• classification
• production activities
They communicate messages between separately organised units within blood collection and production.
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Communication between the following parties should be exchanged according to ENV 1613 :
• the blood/blood components collector and the laboratory service provider
• the laboratory service provider and the blood/blood components manufacturer
Production related messages:
The use of the messages are dependent on the administrative procedures of the transfusion service provider and
are concerned with:
Blood/blood component collection request
Blood/blood component classification request
Blood/blood component classification report
Blood/blood component collected delivery note
Blood component request
Blood component manufactured delivery note
Blood component processing request
Blood component processed delivery note
Messages for the transmission of Requests for blood components, covered by the scope of this ENV, shall
enable electronic interchange of the semantic content defined in the General Message Descriptions (GMDs) for
Request for blood components in clause 6.
Messages for transmission of blood collection requests, covered by the scope of this ENV, shall enable
electronic interchange of the semantic content defined in the GMDs for blood collection requests in clause 6.
Messages for transmission of blood component classification requests/reports, covered by the scope of this
ENV, shall enable electronic interchange of the semantic content defined in the GMDs for blood component
classification request/reports in clause 6.
Messages for transmission of blood component processing requests, covered by the scope of this ENV, shall
enable electronic interchange of the semantic content defined in the GMDs for blood component processing
requests in clause 6.
Messages for transmission of blood component manufacturing delivery note and blood component processing
delivery note, covered by the scope of this ENV, shall enable electronic interchange of
...
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