Health informatics -- Automatic identification and data capture marking and labelling -- Subject of care and individual provider identification

This document outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as identification (wrist) bands, identification tags or other objects, to enable automatic data capture using data carriers in the care delivery process. It provides for a unique SoC identification that can be used for other purposes, such as recording the identity of the SoC in individual health records. This document serves as a reference for any organization which plans to implement or improve Automatic Identification and Data Capture (AIDC) in their delivery of care process. It is based on the use of the GS1® system of standards. Other solutions, such as using other identification systems (for example, systems based on ISBT 128), are possible but not addressed by this document. This document describes good practices to reduce/avoid variation and workarounds which challenge the efficiency of AIDC at the point of care and compromise patient safety[5][6]. This document specifies how to manage identifiers in the AIDC process, and completes the information found in ISO/TS 22220 and ISO/TS 27527.

Informatique de santé -- Marquage et étiquetage à l’aide de l’identification et de la saisie automatiques des données -- Identification du sujet des soins et du prestataire considéré

Le présent document décrit les normes nécessaires pour identifier et étiqueter le sujet des soins (SdS) et le prestataire considéré sur des objets tels que des bracelets d'identification, des étiquettes d'identification ou autres, afin de permettre la saisie automatique de données ŕ l'aide de porteuses de données dans le cadre du processus de prestation de soins. Il présente le processus d'identification unique des SdS qui peut ętre utilisé ŕ d'autres fins, par exemple l'enregistrement de l'identité des SdS dans les dossiers individuels de santé. Le présent document sert de référence pour toutes les organisations qui prévoient de mettre en œuvre ou d'améliorer l'identification et la saisie automatiques des données (AIDC) dans leur processus de prestation de soins. Il s'appuie sur l'utilisation du systčme de normes GS1®. D'autres solutions, telles que l'utilisation d'autres systčmes d'identification (par exemple, des systčmes basés sur l'ISBT 128), sont possibles, mais elles ne sont pas traitées dans le présent document. Le présent document décrit les bonnes pratiques qui permettent de réduire/éviter les variations et les solutions de contournement qui affectent l'efficacité de l'AIDC sur le site des soins et qui compromettent la sécurité du patient[5][6]. Le présent document explique comment gérer les identificateurs au sein du processus AIDC et complčte les informations disponibles dans l'ISO/TS 22220 et l'ISO/TS 27527.

General Information

Status
Published
Publication Date
26-Jan-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
27-Nov-2020
Completion Date
27-Nov-2020
Ref Project

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INTERNATIONAL ISO
STANDARD 18530
First edition
2021-01
Health informatics — Automatic
identification and data capture
marking and labelling — Subject
of care and individual provider
identification
Informatique de santé — Marquage et étiquetage à l’aide de
l’identification et de la saisie automatiques des données —
Identification du sujet des soins et du prestataire considéré
Reference number
ISO 18530:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 18530:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 18530:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 GS1® specifications and ISO deliverables.................................................................................................................................. 3

5 Data structures and semantics .............................................................................................................................................................. 3

5.1 Application identifiers ...................................................................................................................................................................... 3

5.2 Global service relation number (GSRN) ............................................................................................................................ 4

5.3 Service relation instance number (SRIN) ........................................................................................................................ 4

6 SoC and Individual Provider identification as a recognized priority ............................................................4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Supported processes .......................................................................................................................................................................... 5

7 The purpose of globally unique identification ...................................................................................................................... 6

7.1 SoC identification and data processing .............................................................................................................................. 6

7.2 Implementation challenges .......................................................................................................................................................... 6

7.3 Symbol placement on identification bands .................................................................................................................... 6

7.4 Individual Provider identification .......................................................................................................................................... 7

Annex A (informative) Examples of use cases (UC) ............................................................................................................................... 8

Bibliography .............................................................................................................................................................................................................................51

© ISO 2021 – All rights reserved iii
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ISO 18530:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). 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 non-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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health

informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).

This first edition cancels and replaces ISO/TS 18530:2014, which has been technically revised.

The main changes compared to the previous edition are as follows:
— new definitions added;
— use case and UML diagrams updated;
— bibliography expanded.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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ISO 18530:2021(E)
Introduction

The delivery of healthcare relies heavily on the ability to uniquely and accurately identify people when

they attend for care, i.e. the Subject of Care (SoC), as well as, when they provide care, i.e. the Individual

Provider.

Health informatics, supporting healthcare delivery, requires a clear specification to identify the SoC

and the Individual Provider so that they are correctly associated with the health information contained

within a healthcare application. This has led to the need to capture and share information across

different systems and healthcare applications.

Data carriers, such as barcodes and Radio Frequency Identification (RFID), commonly referred to

as Automatic Identification and Data Capture (AIDC), have amplified the importance of defining the

identifier data structures for the SoC and Individual Provider to prevent ambiguity when information

is being captured. AIDC provides a wide spectrum of solutions, in particular, regarding optical carriers

(such as barcodes). Furthermore, the semantics of data carried is defined by a number of organizations

(also named “issuing agencies”), some of them having commercial activities, others nation-wide

missions, as well as, standard development organizations. This document focuses on the use of the

® 1)

GS1 System of Standards since a considerable majority of supplies in healthcare around the world

are identified in accordance to this multisectorial and global system of standards. Interoperability is

easier to secure once a single system of standards is used in the healthcare setting.

Interoperability, where information is shared and used by different information systems, requires

a common SoC and Individual Provider identification semantic to ensure that shared information is

consistent and unambiguous. The same SoC and Individual Provider are accurately identified, referenced

and cross-referenced in each system. Effective data capture systems and information sharing is the key

to improving the care of SoCs and delivery by Individual Providers in terms of conformance, accuracy

and integrity of the health data.

In hospitals, a SoC (as in-patient) usually experiences a large number of care instances. Examples of

these instances include: prescriptions and medicinal product administration, laboratory testing of

SoC bio-samples and subsequent analysis and reporting. Each of these instances requires accurate

reconciliation of the instance and delivery to the SoC. Healthcare providers (i.e. organizations that

deliver healthcare to the SoC) have introduced AIDC technology based barcodes to help capture the

SoC's identity, as well as, identification of other related items such as biology samples, so that manual

key entry can be replaced by AIDC. In the complex hospital environment with many care instances, the

need for uniqueness of identifications is generally recognized, since this avoids identification conflicts,

overlaps, uncertainty and risks.

The use of AIDC in the context of chronic care reinforces the need for standards. The SoC in the chronic

care instance is not always in the same fixed location where a single technology is available. AIDC can

therefore be interoperable with a variety of technologies, solutions and devices. This will enable a

continuum of care.

As out-patients, SoCs may be self-medicating. A SoC undergoing treatment for chronic conditions, in

particular, should administer and record their medication according to a prescribed treatment plan.

This treatment plan can be very prescriptive, on an as-needed basis, or be preventive in nature to avoid

dangerous clinical outcomes.

There is also a need to manage and clinically monitor the treatment plan for the SoC for safety and

stock purposes. AIDC enables capture of the SoC’s identification, medicinal product, administration

event, recording of relevant data about the medicinal product administered and other data such as

batch number, expiration information and amount used. This should be done for in-patients as well as

out-patients. This same data capture can be used to efficiently manage and replenish stock.

1) GS1 is a registered trademark. This information is given for the convenience of users of this document and does

not constitute an endorsement by ISO.
© ISO 2021 – All rights reserved v
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ISO 18530:2021(E)

Benefits from unique SoC Identification in AIDC can be documented from the following three examples:

— Patient, as well as, data can travel outside a provider's environment: Following a devastating tornado

in Joplin, Missouri, USA, in 2011, 183 SoCs from St John's Hospital had to be swiftly evacuated to

other regional hospitals. Under such “chaotic” conditions, a patient identifier that is truly unique

would prevent replacing identification bands immediately for every SoC admitted to a different

hospital.

— For regional referral laboratories, especially those performing blood bank testing: positively

identifying SoCs and linking them to previous records, is essential for patient safety. Two different

SoC with the same name, hospitalized at two different facilities using identical patient identification

numbering schemes (perhaps because they use the same IT system), could lead to serious errors.

— A provider uses two identifiers for the management of care processes: the “patient identification”

and the “case identification”. One provider organized the number banks for the two identifiers in

such a way, that data collision was excluded. After years of use of that solution, number banks started

overlapping without anyone noticing, until two SoCs were having the same numbers, one of “patient

identification”, the other for “care identification”. A mismatch with serious incident occurred.

vi © ISO 2021 – All rights reserved
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INTERNATIONAL STANDARD ISO 18530:2021(E)
Health informatics — Automatic identification and data
capture marking and labelling — Subject of care and
individual provider identification
1 Scope

This document outlines the standards needed to identify and label the Subject of Care (SoC) and the

Individual Provider on objects such as identification (wrist) bands, identification tags or other objects,

to enable automatic data capture using data carriers in the care delivery process.

It provides for a unique SoC identification that can be used for other purposes, such as recording the

identity of the SoC in individual health records.

This document serves as a reference for any organization which plans to implement or improve

Automatic Identification and Data Capture (AIDC) in their delivery of care process. It is based on the

use of the GS1® system of standards. Other solutions, such as using other identification systems (for

example, systems based on ISBT 128), are possible but not addressed by this document.

This document describes good practices to reduce/avoid variation and workarounds which challenge

[5][6]
the efficiency of AIDC at the point of care and compromise patient safety .

This document specifies how to manage identifiers in the AIDC process, and completes the information

found in ISO/TS 22220 and ISO/TS 27527.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
application identifier

GS1® prefix that defines the meaning and purpose of the data element that follows, as defined in

ISO/IEC 15418 and GS1® General Specifications
[SOURCE: ISO/IEC 19762:2016, 01.01.82]
3.2
automatic identification and data capture
AIDC

methods or technologies for automatically identifying objects, collecting data about them, and entering

that data directly into computer systems, eliminating manual entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include barcodes, which can be

linear or 2-dimensional symbols, and Radio Frequency Identification (RFID) tags/chips.

© ISO 2021 – All rights reserved 1
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ISO 18530:2021(E)
3.3
data capture

deliberate action that results in the registration of a record into a record keeping system

3.4
care unit
ward

subdivision of an organization where the subject of care (3.15) receives the care they need during

their stay
3.5
global service relation number
GSRN

identification key to identify the relationship between an organization offering services and the

recipient or provider of services

Note 1 to entry: GSRN are encoded on data carriers with an Application Identifier 8018 for the recipient of a

service (Subject of Care) and with an Application Identifier 8017 for the provider of a service (Individual

Provider).
3.6
healthcare provider
organization or facility that delivers healthcare to subjects of care
3.7
integrating the healthcare enterprise
IHE®

initiative by healthcare professionals and industry to improve the way computer systems in healthcare

share information

Note 1 to entry: IHE® promotes the coordinated use of established standards to address specific clinical need in

support of optimal patient care.

Note 2 to entry: Systems developed in accordance with IHE® communicate with one another better, are easier to

implement, and enable care providers to use information more effectively.
3.8
individual provider
person who provides or is a potential provider of a health care service

Note 1 to entry: An individual provider is an individual person and is not considered to be a group of providers.

Note 2 to entry: Not all health care providers are recognized by professional bodies. It is for this reason that

'health care professional' has not been used to describe them. All health care professionals are providers, but not

all providers are health care professionals.
3.9
individual provider identification

unique number or code issued for the purpose of identifying an individual provider

3.10
information system

organized collection of hardware, software, supplies, policies, procedures and people that stores,

processes and provides access to information

2) GSRN is the GS1® identifier for service relations and is supplied by the GS1® System. This information is given

for the convenience of users of this document and does not constitute an endorsement by ISO of the service relation

identifier named. Equivalent products may be used if they can be shown to lead to the same results.

3) IHE is the registered trademark of the Healthcare Information Management Systems Society. This information

is given for the convenience of users of this document and does not constitute an endorsement by ISO.

2 © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 18530:2021(E)
3.11
machine readable code

code, readable by a machine, which contains information used to establish a relationship between a

physical object such as a medical product package and data sources such as medical, production,

logistical and/or reimbursement coding systems
3.12
record

recorded information, in any form, including data in computer systems, created or received and

maintained by an organization or person in the transaction of business or the conduct of affairs and

kept as evidence of such activity
3.13
registration
act of giving a record a unique identity in a record keeping system
3.14
service relation instance number
SRIN

attribute to a global service relation number (3.5) to identify an instance within a care process

EXAMPLE An identification band, an order sheet, a test-tube, etc.
3.15
subject of care
SoC
person seeking to receive, receiving or having received health care
4 GS1® specifications and ISO deliverables

In this document, automatic identification and data capture (AIDC) refers to selected data carriers which

are widely used across many industries, jurisdictions and which are already based on and specified in

ISO deliverables. The benefit of this approach is to use the already widely available applications and

devices for encoding and reading the different types of data carriers. It should, however, be noted that

certain types of data carriers such as data matrix may only be read by image-based scanners.

AIDC solutions should be in accordance with GS1® general specifications, which in-turn are based on

ISO deliverables. If the recommendation is followed, then information contained in the data carriers

shall be structured and standardized according to the GS1® semantics. The identification key (global

service relation number, GSRN) is the identifier for service relations (such as SoC and Individual

Providers) and is supplied by the GS1® System of Standards.
5 Data structures and semantics
5.1 Application identifiers

The GS1® item identification system and related encoding standard are complemented by the GS1®

maintained application identifiers, hereafter referred to as “GS1® Application Identifiers” or “GS1®

AIs”. This document comprises two principal elements that are the key to any encoding system: the

data content and the data carrier.
The use of GS1® AIs is subject to the rules established by GS1®.

GS1® maintains a list of over 200 AIs which support various processes with automatic identification

and data capture.
© ISO 2021 – All rights reserved 3
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ISO 18530:2021(E)
5.2 Global service relation number (GSRN)

The GSRN is the GS1® Identification Key used to identify the relationship between an organization

offering services and the recipient or provider of services. The key comprises of a GS1® Company

Prefix, Service Reference and Check Digit, with an 18 numeric digits fix length.

Two different AIs are used to distinguish SoC from individual provider as illustrated in Figure 1.

Figure 1 — Global service relation number (GSRN)
5.3 Service relation instance number (SRIN)

The SRIN is an attribute to the GSRN which allows distinguishing different encounters during the

same episode, or the reuse of the same GSRN in different episodes. SRIN is a 10 numeric digits variable

length filed. AI 8019 shall only be used in conjunction with AI 8017 or 8018; Figure 2 illustrates the

combination for a SoC.
Figure 2 — Service relation instance number (SRIN)

For the purpose of this document, for conformance with ISBT 128, the SRIN shall be used as a fixed

length string with the first two digits (NN) reserved for the ISBT 128 location code (Table RT018); the

selection of the remaining eight (8) digits is left to the discretion of the user and may be incremental.

6 SoC and Individual Provider identification as a recognized priority
6.1 General

The World Health Organization (WHO) and the Joint Commission International (JCI) have developed

a list of priority solutions to enhance patient (meaning SoC) safety. Among the list of solutions WHO

and JCI recommended is the use of AIDC technology (when the technical framework permits). Among

[1] [2]

the "Nine patient safety solutions" given by WHO, the second solution addresses patient (SoC)

identification and the use of “barcodes” to reduce the risk of identification errors. Other solutions

(communication during patient hand-over; performance of correct procedures at correct body site;

assuring medication accuracy at transitions in care) require security of a patient’s (SoC’s) identification.

4 © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 18530:2021(E)

Annex A illustrates how SoC and Individual Provider identification should be enabled for different

types of healthcare care use cases. If used, the Annex A explains the type of care and how AIDC can be

implemented as a good practice in different use cases. The following use cases (UC) are included:

— UC 01 to 04 covers the typical overall SoC flow through a hospital (see Figure A.1);

— UC 05 to 11 describes specific care instances that might arise within a hospital environment (see

Figure A.2);

— UC 12 to 19 looks at machine readable coding in complex point of care environments (see Figures

A.3 and A.4);

— UC 20 to 24 looks at machine readable coding in the blood transfusion processes (see Figures A.4

and A.5);

— UC 25 to 27 describes machine readable coding for chronic outpatients (see Figure A.6);

— UC 28 to 30 examines the need to integrate nationwide SoC and Individual Provider identification

(see Figure A.7).

The textual presentation of the use cases is completed with UML diagrams where, in particular, data

capture is positioned; instructions are included in the “good practice” section.

In each of the use cases, there is requirement to provide unambiguous data qualifiers to distinguish

between the SoC, the Individual Provider and the product for data capture. Without qualifiers, it is

impossible to guarantee that the captured information (or data) is what was intended. There is also

the possibility of duplication of identity. This is avoided by using a standardized globally unique

identification.
6.2 Supported processes

Annex A provides examples of a series of processes that are supported by capturing SoC identifier, SRIN

and Individual Provider identification. Table 1 (based on the examples found in Annex A) provides an

overview so that implementers can evaluate their needs and the appropriate solution to adopt.

Table 1 — Overview of supported processes
Usage Requirements SoC identifier SRIN Individual Provider
Identification
SoC and Individual Pro- X X
vider Identification as a
recognized priority
Machine readable coding X X X
for clinical purpose (point
of care)
Machine readable coding X X X
in complex point of care
environments
Machine readable coding X X X
to avoid workarounds
Machine readable coding X X X
in the blood transfusion
processes
Machine readable coding X X X
for chronic outpatient
Machine readable coding X X X
by integrating nationwide
SoC identification
© ISO 2021 – All rights reserved 5
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ISO 18530:2021(E)
7 The purpose of globally unique identification
7.1 SoC identification and data processing

When GSRN is used in data processing, solutions have been developed by IHE® International as Master

Patient Indexes (MPI), which secure uniqueness of the identification in a defined environment and

associates defined demographics to a SoC identifier. MPI should be interconnected by using IHE® tools

so that heterogenic identifications are linked together by using the associated demographics. The use of

GSRN, as described in this document, does not impact data processing and the use of IHE® tools, since

IHE’s ®MPI are conceived to address situations where SoC are identified with any identifier.

[8]

GSRN are fixed length 18 digits numeric keys according GS1® General Specifications . In a GS1®

DataMatrix, the SoC GSRN shall be headed by a GS1® AI 8018.
7.2 Implementation challenges

Modern CIS require the use of a SoC identifier and an Individual Provider identification so that processes

can be captured with scanning technologies. Some implementation challenges have been noticed, such

as the following:

— Acceptance by Individual Provider: To prevent AIDC technologies consuming the Individual

Provider’s time, it is important to associate these professionals to the implementation steps,

including working ergonomic, graphic user interfaces, etc. A benefit of AIDC should be the reduction

of administrative work (manual key entries in the nursing files, reordering of consumed products,

etc.). Furthermore, it is important that any implementation requires scanning prior care processes,

so that alerts are issued to prevent errors (scanning after care process would be too late to avoid

error). Some processes require even two data captures: one prior to the care process (checking

adequacy) and one after the care process (confirming end of process). An example for this double

[3]
step is the administration of cytostatics .

— CIS data-field limitations: the length of the Individual Provider identification and the SoC identifier,

when using GSRN, is 18 numeric digits. The optional SRIN for a SoC is a numeric field of up to 10

digits. The CIS is frequently not able to work with such data fields. It is important that healthcare

providers and vendors collaborate to understand the value and the flexibility of the solution so that

CIS support evolutions for the benefit of efficiencies (reducing manual key entries for documentation

[5] [6]

processes) and patient safety (combating workarounds , , checks ahead of care processes, etc.).

It is recommended to add appropriate reference in the future call for tender. As an intermediary

(temporary) solution, a middleware (e.g. in the form a web service) can be developed or found on

the market, to link SoC’s GSRN, SRIN, as well as, Individual Provider identification (GSRN) to the

existing CIS.
7.3 Symbol placement on identification bands

Barcoding technologies have addressed SoC identifiers on identification bands for years. Therefore, the

following experiences should be leveraged:

— Linear/2-dimensional barcodes: linear barcodes are frequently too long to be easily read on

identification bands (i.e. because of the curve of the band around the limb). Therefore, DataMatrix

is recommended for carrying GSRN and when possible SRIN.

— Two data carriers on the identification band may be necessary for a transition period, since some

software may not be able to handle long identification keys. It is a common situation which adds

to the potential risk that the two identifiers (the long a
...

NORME ISO
INTERNATIONALE 18530
Première édition
2021-01
Informatique de santé — Marquage et
étiquetage à l’aide de l’identification
et de la saisie automatiques des
données — Identification du sujet des
soins et du prestataire considéré
Health informatics — Automatic identification and data capture
marking and labelling — Subject of care and individual provider
identification
Numéro de référence
ISO 18530:2021(F)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 18530:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 18530:2021(F)
Sommaire Page

Avant-propos ..............................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Domaine d'application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Spécifications GS1® et livrables ISO ................................................................................................................................................ 3

5 Structures et sémantique des données ......................................................................................................................................... 4

5.1 Identifiants d'application ............................................................................................................................................................... 4

5.2 Numéro international de relation de service (GSRN) ........................................................................................... 4

5.3 Numéro d'instance de relation de service (SRIN) .................................................................................................... 4

6 Identification du SdS et du prestataire considéré en tant que priorité reconnue ...........................5

6.1 Généralités .................................................................................................................................................................................................. 5

6.2 Processus disponibles ....................................................................................................................................................................... 6

7 But de l'identification unique mondiale ...................................................................................................................................... 6

7.1 Identification SdS et traitement des données .............................................................................................................. 6

7.2 Difficultés liées à la mise en œuvre ....................................................................................................................................... 6

7.3 Emplacement des symboles sur les bracelets d'identification ...................................................................... 7

7.4 Identification du prestataire considéré ............................................................................................................................. 8

Annexe A (informative) Exemples de cas d'utilisation (UC) ......................................................................................................... 9

Bibliographie ...........................................................................................................................................................................................................................56

© ISO 2021 – Tous droits réservés iii
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ISO 18530:2021(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

Le présent document a été élaboré par le comité technique ISO/TC 215, Informatique de santé, en

collaboration avec le comité technique CEN/TC 251, Informatique de santé, du Comité européen de

normalisation (CEN), conformément à l'Accord de coopération technique entre l'ISO et le CEN (Accord

de Vienne).

Cette première édition annule et remplace l'ISO/TS 18530:2014, qui a fait l'objet d'une révision

technique.

Les principales modifications par rapport à l'édition précédente sont les suivantes:

— ajout de nouvelles définitions;
— mise à jour des cas d'utilisation et des diagrammes UML;
— enrichissement de la Bibliographie.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
iv © ISO 2021 – Tous droits réservés
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ISO 18530:2021(F)
Introduction

La prestation de soins de santé est intrinsèquement liée à l'aptitude à identifier de manière unique et

précise la personne qui se présente pour des soins, c'est-à-dire le sujet des soins (SdS), ainsi que la

personne qui les dispense, c'est-à-dire le prestataire considéré.

L'informatique de santé, dans le cadre de la prestation de soins de santé, exige une spécification

claire permettant d'identifier le SdS et le prestataire considéré afin de les associer correctement aux

informations de santé contenues dans une application de soins de santé. Il est donc devenu nécessaire

de saisir et de partager les informations sur les différents systèmes et les différentes applications de

soins de santé.

Les porteuses de données, telles que les codes à barres et l'identification par radiofréquence (RFID),

communément appelées «identification et saisie automatiques des données» (AIDC), ont renforcé la

nécessité de définir les structures de données des identificateurs pour le SdS et le prestataire considéré

afin d'éviter toute ambiguïté lors de la saisie des informations. L'AIDC propose un grand nombre de

solutions, notamment en ce qui concerne les supports optiques (tels que les codes à barres). En outre,

la sémantique des données transportées est définie par un certain nombre d'organisations (également

appelées «organismes émetteurs»), qui peuvent être dédiées à des activités commerciales, investies de

missions nationales ou chargées de l'élaboration de normes. Le présent document décrit l'utilisation

®1)

du système de normes GS1 . En effet, la grande majorité des fournitures de santé dans le monde sont

identifiées selon ce système mondial et multisectoriel de normes. L'utilisation d'un système unique de

normes dans une structure de soins de santé permet de garantir une meilleure interopérabilité.

Une sémantique d'identification commune du SdS et du prestataire considéré est indispensable à

l'interopérabilité, qui favorise le partage et l'utilisation d'informations au sein de différents systèmes

d'information, afin de garantir la cohérence des informations partagées et l'absence d'ambiguïté.

Le même SdS et le même prestataire considéré sont identifiés, référencés et croisés de manière précise

dans chaque système. Des systèmes efficaces de saisie de données et le partage d'informations sont

essentiels à l'amélioration des soins apportés aux SdS et de la prestation de ces soins par les prestataires

considérés en termes de conformité, de justesse et de fidélité, et d'intégrité des données de santé.

Dans les hôpitaux, un SdS (en tant que patient hospitalisé) passe généralement par un grand nombre

d'instances de soins. Il peut s'agir, par exemple, de la dispensation d'ordonnances et de l'administration

de médicaments, d'examens en laboratoire de prélèvements biologiques effectués sur le SdS, et de

l'analyse et de la consignation des rapports concernant ces examens. Il est indispensable de réconcilier

de manière précise chacune de ces instances avec la prestation du soin au SdS. Les prestataires de soins

de santé (c'est-à-dire les organisations qui dispensent des soins de santé au SdS) utilisent désormais des

codes à barres basés sur la technologie AIDC pour saisir l'identité du SdS et pour identifier les autres

éléments associés, tels que les prélèvements biologiques, afin de remplacer la saisie manuelle au clavier

par l'AIDC. Dans l'environnement hospitalier complexe où les instances de soins sont nombreuses, la

nécessité de recourir à l'identification unique des éléments est généralement reconnue, car elle permet

d'éviter les conflits, chevauchements, incertitudes et risques liés à l'identification.

L'utilisation de l'AIDC dans le contexte des soins aux malades chroniques renforce le besoin de

normalisation. Un SdS qui est dans l'instance de traitement des maladies chroniques ne se trouve pas

toujours dans un même lieu où une seule technologie est disponible. L'AIDC peut donc fonctionner avec

d'autres technologies, solutions et dispositifs. La continuité des soins est ainsi assurée.

Les SdS non hospitalisés peuvent pratiquer l'automédication. Il convient qu'un SdS traité pour une

maladie chronique, notamment, s'administre et enregistre les médicaments décrits dans le plan de

traitement qui lui a été spécifié. Ce plan peut être très prescriptif et destiné à répondre aux besoins du

patient, ou être de nature préventive afin d'éviter tout résultat clinique dangereux.

Il est également nécessaire de gérer et de surveiller cliniquement le plan de traitement du SdS à des

fins de sécurité et de gestion des stocks. L'AIDC permet de saisir l'identification du SdS, le médicament,

1) GS1 est une marque déposée. Cette information est donnée par souci de commodité à l'intention des utilisateurs

du présent document et ne saurait constituer un engagement de la part de l'ISO.
© ISO 2021 – Tous droits réservés v
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ISO 18530:2021(F)

l'événement d'administration, l'enregistrement des données pertinentes relatives au médicament

administré, et d'autres données telles que le numéro de lot, la date de péremption et la quantité utilisée.

Il convient de suivre ce processus pour les patients hospitalisés et pour les patients non hospitalisés.

Ce même processus de saisie de données peut être utilisé pour gérer et réapprovisionner efficacement

le stock.

Les trois exemples suivants démontrent les avantages liés à l'identification unique des SdS par l'AIDC:

— le patient, comme les données, peut se déplacer en dehors de l'environnement d'un prestataire: à la

suite d'une tornade dévastatrice survenue à Joplin, dans le Missouri (États-Unis) en 2011, 183 SdS

de l'Hôpital St John's ont dû être rapidement évacués vers d'autres hôpitaux régionaux. Dans des

conditions aussi «chaotiques», un identificateur de patient véritablement unique éviterait de devoir

remplacer immédiatement le bracelet d'identification de chaque SdS admis dans un autre hôpital;

— pour les laboratoires régionaux vers lesquels les patients sont renvoyés, notamment ceux qui

effectuent des essais dans une banque de sang: identifier formellement les SdS et les associer à

des dossiers existants est essentiel à la sécurité du patient. L'enregistrement de deux SdS distincts

portant le même nom, hospitalisés dans deux structures différentes, dans des systèmes identiques

de numérotation des patients (du fait de l'utilisation possible du même système informatique),

pourrait entraîner de graves erreurs;

— un prestataire utilise deux identificateurs pour gérer les processus de soins: l'«identification du

patient» et l'«identification du cas». Un prestataire a organisé les banques de numéros des deux

identificateurs de telle manière que toute collision de données soit exclue. Après plusieurs années

d'utilisation de cette solution, les banques de numéros ont commencé à se chevaucher sans que

personne ne le remarque, jusqu'à ce que deux SdS soient associés au même numéro, l'un correspondant

à l'«identification du patient» et l'autre à l'«identification du soin». Une erreur de correspondance

associée à un incident grave s'est produite.
vi © ISO 2021 – Tous droits réservés
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NORME INTERNATIONALE ISO 18530:2021(F)
Informatique de santé — Marquage et étiquetage à l’aide
de l’identification et de la saisie automatiques des données
— Identification du sujet des soins et du prestataire
considéré
1 Domaine d'application

Le présent document décrit les normes nécessaires pour identifier et étiqueter le sujet des soins (SdS)

et le prestataire considéré sur des objets tels que des bracelets d'identification, des étiquettes

d'identification ou autres, afin de permettre la saisie automatique de données à l'aide de porteuses de

données dans le cadre du processus de prestation de soins.

Il présente le processus d'identification unique des SdS qui peut être utilisé à d'autres fins, par exemple

l'enregistrement de l'identité des SdS dans les dossiers individuels de santé.

Le présent document sert de référence pour toutes les organisations qui prévoient de mettre en œuvre

ou d'améliorer l'identification et la saisie automatiques des données (AIDC) dans leur processus de

prestation de soins. Il s'appuie sur l'utilisation du système de normes GS1®. D'autres solutions, telles

que l'utilisation d'autres systèmes d'identification (par exemple, des systèmes basés sur l'ISBT 128),

sont possibles, mais elles ne sont pas traitées dans le présent document.

Le présent document décrit les bonnes pratiques qui permettent de réduire/éviter les variations et les

solutions de contournement qui affectent l'efficacité de l'AIDC sur le site des soins et qui compromettent

[5][6]
la sécurité du patient .

Le présent document explique comment gérer les identificateurs au sein du processus AIDC et complète

les informations disponibles dans l'ISO/TS 22220 et l'ISO/TS 27527.
2 Références normatives
Le présent document ne contient aucune référence normative.
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions suivants s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
identifiant d'application

préfixe GS1® qui définit la nature et la structure de l'élément de données qui suit, comme défini dans

l'ISO/IEC 15418 et les spécifications générales GS1®
[SOURCE: ISO/IEC 19762:2016, 01.01.82]
© ISO 2021 – Tous droits réservés 1
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ISO 18530:2021(F)
3.2
identification et saisie automatiques des données
AIDC (Automatic Identification and Data Capture)

méthodes ou technologies automatiques d'identification des objets, de recueil des données concernant

ces objets, et de saisie de ces données directement dans les systèmes informatiques, sans saisie manuelle

Note 1 à l'article: Les méthodes ou technologies généralement considérées comme entrant dans le cadre de l'AIDC

incluent les codes à barres, par exemple sous forme de symboles linéaires ou bidimensionnels, et les étiquettes/

puces RFID.
3.3
saisie de données

action délibérée ayant pour résultat l'indexation d'un enregistrement dans un système d'archivage

3.4
unité de soins
service

sous-division d'une organisation dans laquelle le sujet des soins (3.15) reçoit les soins dont il a besoin

lors de son séjour
3.5
numéro international de relation de service
GSRN (Global Service Relation Number)

clé d'identification qui permet d'identifier la relation entre une organisation qui offre des services, et le

bénéficiaire ou le prestataire de ces services

Note 1 à l'article: Le GSRN est codé sur les porteuses de données avec l'identifiant d'application 8018 pour le

bénéficiaire d'un service (sujet des soins) et avec l'identifiant d'application 8017 pour le prestataire d'un service

(prestataire considéré).
3.6
prestataire de soins de santé
organisation ou structure qui dispense des soins de santé au sujet des soins
3.7
Integrating the Healthcare Enterprise
IHE®

initiative prise par des professionnels de la santé et l'ensemble du secteur pour améliorer le partage des

informations par les systèmes informatiques de ce secteur

Note 1 à l'article: L'IHE® favorise l'utilisation coordonnée de normes établies pour répondre à des besoins

cliniques spécifiques en vue d'optimiser les soins aux patients.

Note 2 à l'article: Les systèmes développés selon l'IHE® communiquent mieux les uns avec les autres, sont plus

faciles à mettre en œuvre et permettent aux prestataires de soins d'utiliser plus efficacement les informations.

3.8
prestataire considéré

personne qui dispense ou qui est un prestataire potentiel d'un service de soins de santé

Note 1 à l'article: Un prestataire considéré est une personne et un groupe de prestataires ne peut pas être

considéré comme un prestataire considéré.

2) Le GSRN est l'identificateur GS1® d'une relation de service fourni par le système GS1®. Cette information

est donnée par souci de commodité à l'intention des utilisateurs du présent document et ne saurait constituer un

engagement de la part de l'ISO à l'égard de l'identificateur de relation de service désigné. Des produits équivalents

peuvent être utilisés s'il est démontré qu'ils conduisent aux mêmes résultats.

3) IHE est la marque déposée de la Healthcare Information Management Systems Society. Cette information est

donnée par souci de commodité à l'intention des utilisateurs du présent document et ne saurait constituer un

engagement de la part de l'ISO.
2 © ISO 2021 – Tous droits réservés
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ISO 18530:2021(F)

Note 2 à l'article: Tous les prestataires de soins de santé ne sont pas reconnus par les organisations

professionnelles. C'est pour cette raison que le terme «professionnel de la santé» n'est pas utilisé pour les décrire.

Tous les professionnels de la santé sont des prestataires, mais tous les prestataires ne sont pas des professionnels

de la santé.
3.9
identification du prestataire considéré
numéro ou code unique émis dans le but d'identifier un prestataire considéré
3.10
système d'information

ensemble organisé de matériels, logiciels, fournitures, politiques, procédures et personnes qui permet

d'entreposer et de traiter les informations et d'y accéder
3.11
code lisible par une machine

code qui peut être lu par une machine, et qui contient des informations permettant d'établir une relation

entre un objet physique, tel que l'emballage d'un médicament, et des sources de données telles que des

systèmes de codage médicaux, logistiques, de production et/ou de remboursement
3.12
enregistrement

informations enregistrées, sous quelque forme que ce soit, y compris les données de systèmes

informatiques, créées ou reçues et gérées par une organisation ou une personne dans le cadre d'une

transaction commerciale ou de la conduite d'affaires, et considérées comme une preuve de cette activité

3.13
indexation

fait de donner à un enregistrement une identité unique dans un système d'archivage

3.14
numéro d'instance de relation de service
SRIN (Service Relation Instance Number)

attribut d'un numéro international de relation de service (3.5) permettant d'identifier une instance au

sein d'un processus de soin
EXEMPLE Bracelet d'identification, bon de commande, tube de prélèvement, etc.
3.15
sujet des soins
SdS
personne qui souhaite recevoir, qui reçoit ou qui a reçu des soins de santé
4 Spécifications GS1® et livrables ISO

Dans le présent document, l'identification et la saisie automatiques des données (AIDC) font référence

à certaines porteuses de données très largement utilisées dans de nombreux secteurs d'activité et

juridictions, et qui s'appuient déjà sur des livrables ISO et sont déjà définies dans ceux-ci. Cette approche

a pour avantage d'utiliser des applications et dispositifs déjà disponibles à grande échelle pour le codage

et la lecture des différents types de porteuses de données. Toutefois, il convient de noter que certains

types de porteuses de données, telles que les matrices de données, peuvent uniquement être lus par des

lecteurs imageurs.

Il convient que les solutions AIDC soient conformes aux spécifications générales GS1®, qui s'appuient

à leur tour sur des livrables ISO. Si cette recommandation est suivie, les informations contenues dans

les porteuses de données doivent être structurées et normalisées selon la sémantique GS1®. La clé

d'identification (numéro international de relation de service, GSRN) permet d'identifier les relations

de service (SdS ou prestataire considéré, par exemple); elle est fournie par le système de normes GS1®.

© ISO 2021 – Tous droits réservés 3
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ISO 18530:2021(F)
5 Structures et sémantique des données
5.1 Identifiants d'application

Le système GS1® d'identification d'éléments et la norme de codage associée sont complétés par

les identifiants d'application gérés par GS1®, ci-après appelés «identifiants d'application GS1®»

ou «AI GS1®». Le présent document inclut les deux éléments principaux qui constituent le fondement de

tout système de codage: le contenu de données et la porteuse de données.
L'utilisation des AI GS1® est soumise aux règles établies par GS1®.

GS1® gère une liste de plus de 200 AI qui soutiennent divers processus faisant intervenir l'identification

et la saisie automatiques des données.
5.2 Numéro international de relation de service (GSRN)

Le GSRN est la clé d'identification GS1® qui permet d'identifier la relation entre une organisation qui

offre des services, et le bénéficiaire ou le prestataire de ces services. La clé se compose d'un préfixe

entreprise, d'une référence de service et d'un chiffre de contrôle GS1® indiqués sur une longueur fixe

de 18 chiffres.

Deux AI différents sont utilisés, ce qui permet de faire la distinction entre le SdS et le prestataire

considéré, comme l'illustre la Figure 1.
Figure 1 — Numéro international de relation de service (GSRN)
5.3 Numéro d'instance de relation de service (SRIN)

Le SRIN est un attribut du GSRN qui permet de distinguer différents événements au cours du même

épisode, ou de réutiliser le même GSRN au cours de plusieurs épisodes. Le SRIN est un champ d'une

longueur variable de 10 chiffres maximum. L'AI 8019 ne doit être utilisé que conjointement avec

l'AI 8017 ou l'AI 8018; la Figure 2 illustre la combinaison à utiliser pour un SdS.

4 © ISO 2021 – Tous droits réservés
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ISO 18530:2021(F)
Figure 2 — Numéro d'instance de relation de service (SRIN)

Pour les besoins du présent document, et afin d'en assurer la conformité avec l'ISBT 128, le SRIN doit

être utilisé sous la forme d'une chaîne de longueur fixe dont les deux premiers chiffres (NN) sont

réservés au code d'emplacement ISBT 128 (Tableau RT018); la sélection des huit (8) chiffres restants

est laissée à la discrétion de l'utilisateur et peut être incrémentielle.

6 Identification du SdS et du prestataire considéré en tant que priorité reconnue

6.1 Généralités

L'Organisation mondiale de la Santé (OMS) et la Joint Commission International (JCI) ont élaboré une

liste des solutions prioritaires pour améliorer la sécurité des patients (c'est-à-dire du SdS). L'utilisation

de la technologie AIDC figure dans la liste des solutions recommandées par l'OMS et la JCI (lorsque

[1]

l'infrastructure technique le permet). Parmi les «Neuf solutions pour la sécurité des patients»

[2]

proposées par l'OMS, la deuxième concerne l'identification des patients (SdS) et l'utilisation de

«codes à barres» pour réduire les risques d'erreur d'identification. Les autres solutions (communication

durant le transfert des patients; traitement comme il faut là où il faut; précision de la médication lors de

transitions dans les soins) exigent une identification sécurisée du patient (SdS).

L'Annexe A illustre comment il convient d'activer l'identification du SdS et du prestataire considéré

pour différents types de cas d'utilisation des soins de santé. Lorsqu'elle est utilisée, l'Annexe A explique

le type de soins et le mode de mise en œuvre de l'AIDC en tant que bonne pratique dans différents cas

d'utilisation. L'Annexe A contient les cas d'utilisation (UC) suivants:

— les UC 01 à 04 décrivent le flux SdS global type au sein d'un hôpital (voir Figure A.1);

— les UC 05 à 11 décrivent les instances spécifiques de soins pouvant exister au sein de l'environnement

hospitalier (voir Figure A.2);

— les UC 12 à 19 étudient le codage lisible par une machine dans les environnements de soins complexes

(voir Figures A.3 et A.4);

— les UC 20 à 24 étudient le codage lisible par une machine dans les processus de transfusion sanguine

(voir Figures A.4 et A.5);

— les UC 25 à 27 décrivent le codage lisible par une machine pour les patients non hospitalisés atteints

d'une maladie chronique (voir Figure A.6);

— les UC 28 à 30 étudient le besoin d'intégrer l'identification du SdS et du prestataire considéré à

l'échelle nationale (voir Figure A.7).

La présentation sous forme de texte des cas d'utilisation est complétée par des diagrammes UML dans

lesquels la saisie de données, notamment, est représentée; la section «Bonnes pratiques» contient des

instructions.

Dans chacun de ces cas d'utilisation, il est nécessaire de fournir des qualificatifs de données non

ambigus afin de distinguer le SdS, le prestataire considéré et le produit lors de la saisie des données.

Sans qualificatif, il est impossible de garantir que les informations (ou les données) saisies renvoient

bien aux éléments correspondants. La duplication d'identité est également possible. L'utilisation d'une

identification unique normalisée au niveau mondial permet de l'éviter.
© ISO 2021 – Tous droits réservés 5
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ISO 18530:2021(F)
6.2 Processus disponibles

L'Annexe A fournit les exemples d'une série de processus reposant sur la saisie de l'identificateur de SdS,

du SRIN et de l'identification du prestataire considéré. Le Tableau 1 (basé sur les exemples donnés à

l'Annexe A) contient une présentation générale qui permet aux responsables de la mise en œuvre

d'évaluer
...

INTERNATIONAL ISO
STANDARD 18530
First edition
Health informatics — Automatic
identification and data capture
marking and labelling — Subject
of care and individual provider
identification
Informatique de santé — Marquage et étiquetage à l’aide de
l’identification et de la saisie de données automatiques —
Identification du sujet des soins et du prestataire individuel
PROOF/ÉPREUVE
Reference number
ISO 18530:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 18530:2020(E)
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© ISO 2020

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ISO 18530:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references. ..................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 GS1® specifications and ISO deliverables.................................................................................................................................. 3

5 Data structures and semantics .............................................................................................................................................................. 3

5.1 Application identifiers ...................................................................................................................................................................... 3

5.2 Global service relation number (GSRN) ............................................................................................................................ 4

5.3 Service relation instance number (SRIN) ........................................................................................................................ 4

6 SoC and Individual Provider identification as a recognized priority ............................................................4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Supported processes .......................................................................................................................................................................... 5

7 The purpose of globally unique identification ...................................................................................................................... 6

7.1 SoC identification and data processing .............................................................................................................................. 6

7.2 Implementation challenges .......................................................................................................................................................... 6

7.3 Symbol placement on identification bands .................................................................................................................... 6

7.4 Individual Provider identification .......................................................................................................................................... 7

Annex A (informative) Examples of use cases (UC) ............................................................................................................................... 8

Bibliography .............................................................................................................................................................................................................................51

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ISO 18530:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). 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 non-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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health

informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).

This first edition cancels and replaces ISO/TS 18530:2014, which has been technically revised.

The main changes compared to the previous edition are as follows:
— new definitions added;
— use case and UML diagrams updated;
— bibliography expanded.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 18530:2020(E)
Introduction

The delivery of healthcare relies heavily on the ability to uniquely and accurately identify people when

they attend for care, i.e. the Subject of Care (SoC), as well as, when they provide care, i.e. the Individual

Provider.

Health informatics, supporting healthcare delivery, requires a clear specification to identify the SoC

and the Individual Provider so that they are correctly associated with the health information contained

within a healthcare application. This has led to the need to capture and share information across

different systems and healthcare applications.

Data carriers, such as barcodes and Radio Frequency Identification (RFID), commonly referred to

as Automatic Identification and Data Capture (AIDC), have amplified the importance of defining the

identifier data structures for the SoC and Individual Provider to prevent ambiguity when information

is being captured. AIDC provides a wide spectrum of solutions, in particular, regarding optical carriers

(such as barcodes). Furthermore, the semantics of data carried is defined by a number of organizations

(also named “issuing agencies”), some of them having commercial activities, others nation-wide

missions, as well as, standard development organizations. This document focuses on the use of the

® 1)

GS1 System of Standards since a considerable majority of supplies in healthcare around the world

are identified in accordance to this multisectorial and global system of standards. Interoperability is

easier to secure once a single system of standards is used in the healthcare setting.

Interoperability, where information is shared and used by different information systems, requires

a common SoC and Individual Provider identification semantic to ensure that shared information is

consistent and unambiguous. The same SoC and Individual Provider are accurately identified, referenced

and cross-referenced in each system. Effective data capture systems and information sharing is the key

to improving the care of SoCs and delivery by Individual Providers in terms of conformance, accuracy

and integrity of the health data.

In hospitals, a SoC (as in-patient) usually experiences a large number of care instances. Examples of

these instances include: prescriptions and medicinal product administration, laboratory testing of

SoC bio-samples and subsequent analysis and reporting. Each of these instances requires accurate

reconciliation of the instance and delivery to the SoC. Healthcare providers (i.e. organizations that

deliver healthcare to the SoC) have introduced AIDC technology based barcodes to help capture the

SoC's identity, as well as, identification of other related items such as biology samples, so that manual

key entry can be replaced by AIDC. In the complex hospital environment with many care instances, the

need for uniqueness of identifications is generally recognized, since this avoids identification conflicts,

overlaps, uncertainty and risks.

The use of AIDC in the context of chronic care reinforces the need for standards. The SoC in the chronic

care instance is not always in the same fixed location where a single technology is available. AIDC can

therefore be interoperable with a variety of technologies, solutions and devices. This will enable a

continuum of care.

As out-patients, SoCs may be self-medicating. A SoC undergoing treatment for chronic conditions, in

particular, should administer and record their medication according to a prescribed treatment plan.

This treatment plan can be very prescriptive, on an as-needed basis, or be preventive in nature to avoid

dangerous clinical outcomes.

There is also a need to manage and clinically monitor the treatment plan for the SoC for safety and

stock purposes. AIDC enables capture of the SoC’s identification, medicinal product, administration

event, recording of relevant data about the medicinal product administered and other data such as

batch number, expiration information and amount used. This should be done for in-patients as well as

out-patients. This same data capture can be used to efficiently manage and replenish stock.

1) GS1 is a registered trademark. This information is given for the convenience of users of this document and does

not constitute an endorsement by ISO.
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ISO 18530:2020(E)

Benefits from unique SoC Identification in AIDC can be documented from the following three examples:

— Patient, as well as, data can travel outside a provider's environment: Following a devastating tornado

in Joplin, Missouri, USA, in 2011, 183 SoCs from St John's Hospital had to be swiftly evacuated to

other regional hospitals. Under such “chaotic” conditions, a patient identifier that is truly unique

would prevent replacing identification bands immediately for every SoC admitted to a different

hospital.

— For regional referral laboratories, especially those performing blood bank testing: positively

identifying SoCs and linking them to previous records, is essential for patient safety. Two different

SoC with the same name, hospitalized at two different facilities using identical patient identification

numbering schemes (perhaps because they use the same IT system), could lead to serious errors.

— A provider uses two identifiers for the management of care processes: the “patient identification”

and the “case identification”. One provider organized the number banks for the two identifiers in

such a way, that data collision was excluded. After years of use of that solution, number banks started

overlapping without anyone noticing, until two SoCs were having the same numbers, one of “patient

identification”, the other for “care identification”. A mismatch with serious incident occurred.

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INTERNATIONAL STANDARD ISO 18530:2020(E)
Health informatics — Automatic identification and data
capture marking and labelling — Subject of care and
individual provider identification
1 Scope

This document outlines the standards needed to identify and label the Subject of Care (SoC) and the

Individual Provider on objects such as identification (wrist) bands, identification tags or other objects,

to enable automatic data capture using data carriers in the care delivery process.

It provides for a unique SoC identification that can be used for other purposes, such as recording the

identity of the SoC in individual health records.

This document serves as a reference for any organization which plans to implement or improve

Automatic Identification and Data Capture (AIDC) in their delivery of care process. It is based on the

use of the GS1® system of standards. Other solutions, such as using other identification systems (for

example, systems based on ISBT 128), are possible but not addressed by this document.

This document describes good practices to reduce/avoid variation and workarounds which challenge

[5][6]
the efficiency of AIDC at the point of care and compromise patient safety .

This document specifies how to manage identifiers in the AIDC process, and completes the information

found in ISO/TS 22220 and ISO/TS 27527.
2 Normative references.
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
application identifier

GS1® prefix that defines the meaning and purpose of the data element that follows, as defined in

ISO/IEC 15418 and GS1® General Specifications
[SOURCE: ISO/IEC 19762:2016, 01.01.82]
3.2
automatic identification and data capture
AIDC

methods or technologies for automatically identifying objects, collecting data about them, and entering

that data directly into computer systems, eliminating manual entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include barcodes, which can be

linear or 2-dimensional symbols, and Radio Frequency Identification (RFID) tags/chips.

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ISO 18530:2020(E)
3.3
data capture

deliberate action that results in the registration of a record into a record keeping system

3.4
care unit
ward

subdivision of an organization where the subject of care (3.15) receives the care they need during

their stay
3.5
global service relation number
GSRN

identification key to identify the relationship between an organization offering services and the

recipient or provider of services

Note 1 to entry: GSRN are encoded on data carriers with an Application Identifier 8018 for the recipient of a

service (Subject of Care) and with an Application Identifier 8017 for the provider of a service (Individual

Provider).
3.6
healthcare provider
organization or facility that delivers healthcare to subjects of care
3.7
integrating the healthcare enterprise
IHE®

initiative by healthcare professionals and industry to improve the way computer systems in healthcare

share information

Note 1 to entry: IHE® promotes the coordinated use of established standards to address specific clinical need in

support of optimal patient care.

Note 2 to entry: Systems developed in accordance with IHE® communicate with one another better, are easier to

implement, and enable care providers to use information more effectively.
3.8
individual provider
person who provides or is a potential provider of a health care service

Note 1 to entry: An individual provider is an individual person and is not considered to be a group of providers.

Note 2 to entry: Not all health care providers are recognized by professional bodies. It is for this reason that

'health care professional' has not been used to describe them. All health care professionals are providers, but not

all providers are health care professionals.
3.9
individual provider identification

unique number or code issued for the purpose of identifying an individual provider

3.10
information system

organized collection of hardware, software, supplies, policies, procedures and people that stores,

processes and provides access to information

2) GSRN is the GS1® identifier for service relations and is supplied by the GS1® System. This information is given

for the convenience of users of this document and does not constitute an endorsement by ISO of the service relation

identifier named. Equivalent products may be used if they can be shown to lead to the same results.

3) IHE is the registered trademark of the Healthcare Information Management Systems Society. This information

is given for the convenience of users of this document and does not constitute an endorsement by ISO.

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ISO 18530:2020(E)
3.11
machine readable code

code, readable by a machine, which contains information used to establish a relationship between a

physical object such as a medical product package and data sources such as medical, production,

logistical and/or reimbursement coding systems
3.12
record

recorded information, in any form, including data in computer systems, created or received and

maintained by an organization or person in the transaction of business or the conduct of affairs and

kept as evidence of such activity
3.13
registration
act of giving a record a unique identity in a record keeping system
3.14
service relation instance number
SRIN

attribute to a global service relation number (3.5) to identify an instance within a care process

EXAMPLE An identification band, an order sheet, a test-tube, etc.
3.15
subject of care
SoC
person seeking to receive, receiving or having received health care
4 GS1® specifications and ISO deliverables

In this document, automatic identification and data capture (AIDC) refers to selected data carriers which

are widely used across many industries, jurisdictions and which are already based on and specified in

ISO deliverables. The benefit of this approach is to use the already widely available applications and

devices for encoding and reading the different types of data carriers. It should, however, be noted that

certain types of data carriers such as data matrix may only be read by image-based scanners.

AIDC solutions should be in accordance with GS1® general specifications, which in-turn are based on

ISO deliverables. If the recommendation is followed, then information contained in the data carriers

shall be structured and standardized according to the GS1® semantics. The identification key (global

service relation number, GSRN) is the identifier for service relations (such as SoC and Individual

Providers) and is supplied by the GS1® System of Standards.
5 Data structures and semantics
5.1 Application identifiers

The GS1® item identification system and related encoding standard are complemented by the GS1®

maintained application identifiers, hereafter referred to as “GS1® Application Identifiers” or “GS1®

AIs”. This document comprises two principal elements that are the key to any encoding system: the

data content and the data carrier.
The use of GS1® AIs is subject to the rules established by GS1®.

GS1® maintains a list of over 200 AIs which support various processes with automatic identification

and data capture.
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ISO 18530:2020(E)
5.2 Global service relation number (GSRN)

The GSRN is the GS1® Identification Key used to identify the relationship between an organization

offering services and the recipient or provider of services. The key comprises of a GS1® Company

Prefix, Service Reference and Check Digit, with an 18 numeric digits fix length.

Two different AIs are used to distinguish SoC from individual provider as illustrated in Figure 1.

Figure 1 — Global service relation number (GSRN)
5.3 Service relation instance number (SRIN)

The SRIN is an attribute to the GSRN which allows distinguishing different encounters during the

same episode, or the reuse of the same GSRN in different episodes. SRIN is a 10 numeric digits variable

length filed. AI 8019 shall only be used in conjunction with AI 8017 or 8018; Figure 2 illustrates the

combination for a SoC.
Figure 2 — Service relation instance number (SRIN)

For the purpose of this document, for conformance with ISBT 128, the SRIN shall be used as a fixed

length string with the first two digits (NN) reserved for the ISBT 128 location code (Table RT018); the

selection of the remaining eight (8) digits is left to the discretion of the user and may be incremental.

6 SoC and Individual Provider identification as a recognized priority
6.1 General

The World Health Organization (WHO) and the Joint Commission International (JCI) have developed

a list of priority solutions to enhance patient (meaning SoC) safety. Among the list of solutions WHO

and JCI recommended is the use of AIDC technology (when the technical framework permits). Among

[1] [2]

the "Nine patient safety solutions" given by WHO, the second solution addresses patient (SoC)

identification and the use of “barcodes” to reduce the risk of identification errors. Other solutions

(communication during patient hand-over; performance of correct procedures at correct body site;

assuring medication accuracy at transitions in care) require security of a patient’s (SoC’s) identification.

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ISO 18530:2020(E)

Annex A illustrates how SoC and Individual Provider identification should be enabled for different

types of healthcare care use cases. If used, the Annex A explains the type of care and how AIDC can be

implemented as a good practice in different use cases. The following use cases (UC) are included:

— UC 01 to 04 covers the typical overall SoC flow through a hospital (see Figure A.1);

— UC 05 to 11 describes specific care instances that might arise within a hospital environment (see

Figure A.2);

— UC 12 to 19 looks at machine readable coding in complex point of care environments (see Figures

A.3 and A.4);

— UC 20 to 24 looks at machine readable coding in the blood transfusion processes (see Figures A.4

and A.5);

— UC 25 to 27 describes machine readable coding for chronic outpatients (see Figure A.6);

— UC 28 to 30 examines the need to integrate nationwide SoC and Individual Provider identification

(see Figure A.7).

The textual presentation of the use cases is completed with UML diagrams where, in particular, data

capture is positioned; instructions are included in the “good practice” section.

In each of the use cases, there is requirement to provide unambiguous data qualifiers to distinguish

between the SoC, the Individual Provider and the product for data capture. Without qualifiers, it is

impossible to guarantee that the captured information (or data) is what was intended. There is also

the possibility of duplication of identity. This is avoided by using a standardized globally unique

identification.
6.2 Supported processes

Annex A provides examples of a series of processes that are supported by capturing SoC identifier, SRIN

and Individual Provider identification. Table 1 (based on the examples found in Annex A) provides an

overview so that implementers can evaluate their needs and the appropriate solution to adopt.

Table 1 — Overview of supported processes
Usage Requirements SoC identifier SRIN Individual Provider
Identification
SoC and Individual Pro- X X
vider Identification as a
recognized priority
Machine readable coding X X X
for clinical purpose (point
of care)
Machine readable coding X X X
in complex point of care
environments
Machine readable coding X X X
to avoid workarounds
Machine readable coding X X X
in the blood transfusion
processes
Machine readable coding X X X
for chronic outpatient
Machine readable coding X X X
by integrating nationwide
SoC identification
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ISO 18530:2020(E)
7 The purpose of globally unique identification
7.1 SoC identification and data processing

When GSRN is used in data processing, solutions have been developed by IHE® International as Master

Patient Indexes (MPI), which secure uniqueness of the identification in a defined environment and

associates defined demographics to a SoC identifier. MPI should be interconnected by using IHE® tools

so that heterogenic identifications are linked together by using the associated demographics. The use of

GSRN, as described in this document, does not impact data processing and the use of IHE® tools, since

IHE’s ®MPI are conceived to address situations where SoC are identified with any identifier.

[8]

GSRN are fixed length 18 digits numeric keys according GS1® General Specifications . In a GS1®

DataMatrix, the SoC GSRN shall be headed by a GS1® AI 8018.
7.2 Implementation challenges

Modern CIS require the use of a SoC identifier and an Individual Provider identification so that processes

can be captured with scanning technologies. Some implementation challenges have been noticed, such

as the following:

— Acceptance by Individual Provider: To prevent AIDC technologies consuming the Individual

Provider’s time, it is important to associate these professionals to the implementation steps,

including working ergonomic, graphic user interfaces, etc. A benefit of AIDC should be the reduction

of administrative work (manual key entries in the nursing files, reordering of consumed products,

etc.). Furthermore, it is important that any implementation requires scanning prior care processes,

so that alerts are issued to prevent errors (scanning after care process would be too late to avoid

error). Some processes require even two data captures: one prior to the care process (checking

adequacy) and one after the care process (confirming end of process). An example for this double

[3]
step is the administration of cytostatics .

— CIS data-field limitations: the length of the Individual Provider identification and the SoC identifier,

when using GSRN, is 18 numeric digits. The optional SRIN for a SoC is a numeric field of up to 10

digits. The CIS is frequently not able to work with such data fields. It is important that healthcare

providers and vendors collaborate to understand the value and the flexibility of the solution so that

CIS support evolutions for the benefit of efficiencies (reducing manual key entries for documentation

[5] [6]

processes) and patient safety (combating workarounds , , checks ahead of care processes, etc.).

It is recommended to add appropriate reference in the future call for tender. As an intermediary

(temporary) solution, a middleware (e.g. in the form a web service) can be developed or found on

the market, to link SoC’s GSRN, SRIN, as well as, Individual Provider identification (GSRN) to the

existing CIS.
7.3 Symbol placement on identification bands

Barcoding technologies have addressed SoC identifiers on identification bands for years. Therefore, the

following experiences should be leveraged:

— Linear/2-dimensional barcodes: linear barcodes are frequently too long to be easily read on

identification bands (i.e. because of the curve of the band around the limb). Therefore, DataMatrix

is recommended for carrying GSRN and when possible SRIN.

— Two data carriers on the identification band may be necessary for a transition period, since some

software may not be
...

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