ENV 13730-1:2001

SLOVENSKI STANDARD
01-oktober-2003
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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
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
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
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.
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.
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 very close to the user,
but has a separate and distinct role to keep dispensed labile blood products [3.41] in special storage conditions.
Two groups of messages have been identified within Scope:
Group 1. Subject of care related messages (BTR – PAT)
Group 2. Production related messages (BTR – PROD)
The first group specify messages used in:

TESTING ACTIVITIES

TRANSFUSION ACTIVITIES
They consist of communications between the User, the Dispenser and the Laboratory. Acknowledgement
messages are also required at different stages between the two parties.
The second group specify messages used in:

production,

dispensing,

logistic activities,
They communicate messages between separately organised units within the Blood transfusion, production and
dispensing process.
Communication between the following parties should be exchanged according to ENV 1613

the User and the Laboratory

the User and the blood transfusion service (testing unit)

the blood transfusion service and the Laboratory
Group 1 Subject of care related messages :
This European Prestandard specifies 7 messages divided into two sub-groups concerned with:
1.Transfusion activities (activities directly related to the fact of transfusing blood components to
patients):
Request for blood components (Blood components prescription)
Blood component recipient delivery note
Transfusion report
2. Testing activities (activities related to the fact of testing patients and blood products) :
Blood grouping request
Blood group report
Compatibility testing request
Compatibility test report
Group 2 Production related messages :
These messages are dependent on the organisation of the transfusion service provider and concerned with:
Donor clinical information
Blood component classification request
Blood component classification report
Blood component manufacturing request
Blood component issue delivery note
Blood component processing request
Blood component process delivery note
For example, in France, the Blood component dispenser uses a different procedure for Blood component
recipient delivery from that for other forms of Blood component delivery.
In Scandinavia, the Laboratory Investigation service may be part of the transfusion service provider, the Request
for blood components and Blood component recipient delivery notes being exchanged between hospitals.
Messages for the transmission of Requests for blood components, covered by the scope of this European
Prestandard, shall enable electronic interchange of the semantic content defined in the General Message
Descriptions for Request for blood components in clause 6.
Messages for transmission of Blood component recipient delivery notes, covered by the scope of this European
Prestandard, shall enable electronic interchange of the semantic content defined in the General Message
Descriptions for Blood component recipient delivery notes in clause 6
Messages for transmission of Blood component delivery notes, covered by the scope of this European
Prestandard, shall enable electronic interchange of the semantic content defined in the General Message
Descriptions for Blood component recipient delivery notes in clause 6.
When implementing information exchange based upon this prENV, all generated messages must be
acknowledged by the receiver.
Messages for transmission of applicative acknowledgement of the above messages covered by the scope of this
European Prestandard are defined at an application level (ISO 7). They do not interfere with similar messages at
lower levels. These messages are reports that the target applicant has received the message, and whether or not
the message can be processed normally (if appropriate it may include additional information).
Implementable message specifications (IMS) [3.40] shall conform to the General Message Descriptions defined
in this prENV. They shall support both mandatory and optional objects, attribute [3.3] groups and attributes as
defined in the General Message Descriptions of this prENV. They shall also support the relationships between
objects as defined by the General Message Descriptions.
Implementable message specifications should be expressed in terms of a syntax that is an International Standard
[3.50] except where the healthcare user requirements cannot be met by using such a Standard syntax.
When implementing information exchange based upon this prENV, data protection and confidentiality principles
have to be guaranteed according to the laws actually in force in the different CEN member countries. The
mechanisms needed to secure data integrity [3.25], data protection and confidentiality, authentication [3.5] of
communicating parties and subjects of care are outside the scope of this prENV.
While the messages specified in this prENV may convey clinical and administrative information concerning
subjects of care, the way in which this information is treated in this prENV does not constrain the development
of future standards for the electronic healthcare record [3.28] or for other clinical and administrative messages.
The provisions of this prENV have been validated for the purposes described above. However, since the
messages described in this ENV are designed for general application in the Blood transfusion domain, the users
are required to decide for themselves whether or not these messages meet their particular requirements. A
requirement for using other messages, e.g. generic messages for cancellation or acknowledgement, in addition to
or instead of messages specified in this prENV, does not invalidate the use of this prENV.
2 Normative References
The following normative documents contain provisions that, through reference in the text, constitute provisions
of this draft European Prestandard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this draft European Prestandard are
encouraged to investigate the possibility of applying the most recent editions of the normative documents below.
For undated references, the latest edition of the normative document referred to apply. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 2382-4:1987 Information processing - Vocabulary Part 4: Organisation of data
ISO 5281 : 1997 Information interchange - Representation of human sexes
ISO/IEC 7826-1 : 1994 Information technology - General structure for the interchange of code values - Part 1 :
Identification of coding schemes
ISO/IEC 7826-2 : 1994 Information technology - General structure for the interchange of code values - Part 1 :
Registration of coding schemes
ENV 12539 Diagnostic services department request and report messages
ENV 1613 : 1995 Medical informatics - messages for exchange of laboratory informations
3 Normative definitions and abbreviations
For the purposes of this Draft European Prestandard (prENV), the following definitions (listed in
alphabetical order) apply:
3.1
accountability
the property that ensures the actions of an entity can be traced uniquely to the entity
[ISO 7498 – 2]
3.2
assurance
development, documentation, testing, procedural and operational activities carried out to ensure a
system’s security [3.49] services do in fact provide the claimed level of protection
[OMG 97]
3.3
attribute
a characteristic of an object or entity
3.4
audit trail
record of the resources which were accessed and/or used by whom.
Note: This may involve a formal monitoring technique for comparison between the actual use of a medical
information system and pre-established criteria
[ISO 7498 – 2]
3.5
authentication
the process of reliably identifying security subjects by securely associating an identifier and its
authenticator
[ISO 7498 –2]
3.6
authorise
granting of rights, which includes granting of access based on access rights
[ISO 7498-2]
3.7
autologous transfusion
transfusion of any blood component that was donated by a donor who is also the subsequent recipient
3.8
availability
the property of being accessible and useable upon demand by an authorised [3.6]entity
[ISO 7498-2]
3.9
batch
amount of material which is uniform in character and quantity as shown by compliance with production
and quality assurance requirements and produced during a defined validated process of manufacture. A
labile blood product batch is identified by unique blood donation number.
[EN 375:1992 E][EN 376:1992 E]
3.10
blood
blood is a complex fluid, consisting of cellular components (approximately 45% of the total volume)
suspended in a fluid environment, the plasma. It circulates in the arteries and veins of subjects of care and
acts both as a transport system and as a defence mechanism, fighting infection
3.11
blood component (BC)
blood or a substance derived from blood that is or may be provided for administration to a subject of care
or for production of medicinal products. There are two kinds of Blood components:
labile blood products – red blood cells; fresh frozen plasma; platelets; cryoprecipitate; white cells;
progenitor cells collected from peripheral blood (stem cells) and plasma derivatives – these are partially
purified human plasma proteins made under pharmaceutical manufacturing conditions, including
coagulation factors, immunoglobulins and albumin.
3.12
blood component dispenser
a person or other entity who obtains blood components from one or more providers. The Blood
component dispenser stores Blood components in order to assemble, prepare or dispense a Blood
component in accordance with a specification furnished by a Blood component requester [3.14] .
(In UK and in Scandinavia, a blood component dispenser is a Hospital Transfusion Laboratory)
3.13
blood component producer
a person or other entity authorised to prepare blood components for transfusion from donor blood. The
entity authorised to prepare blood components may be a manufacturer or a processor.
3.14
blood component requester
a person (usually a healthcare professional) who establishes the need for a transfusion of blood for a
specific subject of care and makes a request to the blood component dispenser to obtain blood
components for administration as a transfusion
3.15
blood component user
a healthcare professional who performs blood transfusions to subjects of care
3.16
blood group
one of several classifications into which the blood may be grouped. It is determined by the presence of
specific antigens on the surface of the erythrocytes
3.17
blood transfusion
the administration of blood components obtained and processed from blood donors into the bloodstream
of a recipient
3.18
classification of blood donation
the set of operations related to biological tests performed in laboratory investigation services, aimed to
establish the immuno-haematologic characteristics of the blood donated and to evaluate the safety of the
blood donated to prevent the transfusion of transmitted diseases, based on formal legal requirements
3.19
clinical information
information about a subject of care, relevant to the health or treatment of that subject of care, that is
recorded by or on behalf of a healthcare professional
NOTE Clinical information about a subject of care may include information about the subject of
care's environment, or related persons where this is relevant.
[CEN ENV 1613:1995]
3.20
code meaning
element within a coded set
EXAMPLE "Paris Charles-De-Gaulle" which is mapped on to the three-letter abbreviation "CDG" by
the coding scheme [3.22] for three-letter abbreviations of airport names.
[ENV 7826][ISO/IEC 7826]
3.21
code value
result of applying a coding scheme to a code meaning [3.20]
EXAMPLE "CDG" as the representation of "Paris Charles-De-Gaulle" in the coding scheme for
three-letter representations of airport names.
[ENV 7826] [ISO/IEC 7826][ISO 2382:1987, modified]
3.22
coding scheme
Collection of rules that map the elements of one set on to the elements of a second set
[ISO/IEC 7826][ISO 2382-1987, modified]
3.23
confidentiality
the property that information is not made available or disclosed to unauthorised individuals, entities or
processes
[ISO 7498-2]
3.24
consent
voluntary agreement with what is being done or proposed (express or implied)
[CIHI]
3.25
data integrity
the property that data or a message’s content has not been altered or destroyed in an unauthorised manner.
NOTE 1 In order to achieve this requirement for the data, the integrity of all system assets must be
preserved including hardware, system design, software design, implementation and maintenance.
NOTE 2 This definition includes both accidental and intentional events and actions.
[ISO 7498-2]
3.26
domain information model
conceptual model describing common concepts and their relationships for communication parties
required to facilitate exchange of information between these parties within a specific domain of
healthcare
[CR 12587]
3.27
edifact
Electronic Data Interchange for Administration, Commerce and transport. They comprise a set of
internationally agreed standards, directories and guidelines for the electronic interchange of structured
data (Also referred to as UN/EDIFACT)
3.28
electronic healthcare record
healthcare record concerning the subject of care in computer readable form
[CEN ENV 13606-1]
3.29
general message description
subset of a domain information model [3.26] prescribing the information content and semantic structure
of a healthcare message used to meet one or more identified information interchange requirements
NOTE General message descriptions are independent of the syntax used for constructing an actual
message. They provide a statement of the information interchange requirements in a form that can be
implemented using different syntaxes.
[CR 12587][ENV 1613]
3.30
healthcare
provision of health related services
NOTE This includes more than performing procedures on subjects of care. It includes also e.g. the
management of information about patients, their health status and their relationship with their healthcare
framework.
[CEN TC/251 PT30]
3.31
healthcare agent
healthcare person [3.35], healthcare organisation [3.33], healthcare device or healthcare software
component that performs a particular role in a healthcare activity
[CEN ENV 12265, modified]
...