SIST EN ISO 18530:2021
(Main)Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification (ISO 18530:2021)
Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification (ISO 18530:2021)
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.
Medizinische Informatik - Automatische Identifikation und Datenerfassungskennzeichnung und -beschriftung - Identifikation von Behandelten und individuellen Anbietern (ISO 18530:2021)
Informatique de santé - identification lisible par capture automatique et marquage - identification des sujets de soins de santé et des professionnels de la santé (ISO 18530:2021)
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 la sécurité du patient[5][6].
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.
Zdravstvena informatika - Samodejna identifikacija ter zajem podatkov za označevanje in etiketiranje - Predmet varstva in posamezna identifikacija (ISO 18530:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 18530:2021
01-maj-2021
Nadomešča:
SIST-TS CEN ISO/TS 18530:2016
Zdravstvena informatika - Samodejna identifikacija ter zajem podatkov za
označevanje in etiketiranje - Predmet varstva in posamezna identifikacija (ISO
18530:2021)
Health Informatics - Automatic identification and data capture marking and labelling -
Subject of care and individual provider identification (ISO 18530:2021)
Medizinische Informatik - Automatische Identifikation und
Datenerfassungskennzeichnung und -beschriftung - Identifikation von Behandelten und
individuellen Anbietern (ISO 18530:2021)
Informatique de santé - identification lisible par capture automatique et marquage -
identification des sujets de soins de santé et des professionnels de la santé (ISO
18530:2021)
Ta slovenski standard je istoveten z: EN ISO 18530:2021
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 18530:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 18530:2021
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SIST EN ISO 18530:2021
EN ISO 18530
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes CEN ISO/TS 18530:2015
English Version
Health Informatics - Automatic identification and data
capture marking and labelling - Subject of care and
individual provider identification (ISO 18530:2021)
Informatique de santé - Marquage et étiquetage à l'aide Medizinische Informatik - Automatische Identifikation
de l'identification et de la saisie automatiques des und Datenerfassungskennzeichnung und -beschriftung
données - Identification du sujet des soins et du - Identifikation von Behandelten und individuellen
prestataire considéré (ISO 18530:2021) Anbietern (ISO 18530:2021)
This European Standard was approved by CEN on 11 June 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18530:2021 E
worldwide for CEN national Members.
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SIST EN ISO 18530:2021
EN ISO 18530:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 18530:2021
EN ISO 18530:2021 (E)
European foreword
This document (EN ISO 18530:2021) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2021, and conflicting national standards shall
be withdrawn at the latest by August 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 18530:2015.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 18530:2021 has been approved by CEN as EN ISO 18530:2021 without any modification.
3
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SIST EN ISO 18530:2021
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SIST EN ISO 18530:2021
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
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SIST EN ISO 18530:2021
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
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SIST EN ISO 18530:2021
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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SIST EN ISO 18530:2021
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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SIST EN ISO 18530:2021
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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SIST EN ISO 18530:2021
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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SIST EN ISO 18530:2021
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
AI
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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SIST EN ISO 18530:2021
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
2)
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
3)
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
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SIST EN ISO 18530:2021
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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SIST EN ISO 18530:2021
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
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SIST EN ISO 18530:2021
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 18530:2020
01-marec-2020
Zdravstvena informatika - Samodejna identifikacija ter zajem podatkov za
označevanje in etiketiranje - Predmet varstva in posamezna identifikacija (ISO/DIS
18530:2020)
Health Informatics - Automatic identification and data capture marking and labelling -
Subject of care and individual provider identification (ISO/DIS 18530:2020)
Medizinische Informatik - Automatische Identifikation und
Datenerfassungskennzeichnung und -beschriftung - Identifikation von Behandelten und
individuellen Anbietern (ISO/DIS 18530:2020)
Informatique de santé - identification lisible par capture automatique et marquage -
identification des sujets de soins de santé et des professionnels de la santé (ISO/DIS
18530:2020)
Ta slovenski standard je istoveten z: prEN ISO 18530
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 18530:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 18530:2020
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oSIST prEN ISO 18530:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18530
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-01-17 2020-04-10
Health Informatics — Automatic identification and data
capture marking and labelling — Subject of care and
individual provider identification
Informatique de santé — identification lisible par capture automatique et marquage — identification des
sujets de soins de santé et des professionnels de la santé
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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Contents Page
Foreword .iv
Introduction .v
1 Scope (mandatory) . 1
2 Normative references. . 1
3 Terms and definitions . 1
4 Abbreviations. 4
5 GS1 specifications and ISO Standards . 4
6 Data structures and semantics . 4
6.1 Application identifiers . 4
6.2 Global service relation number (GSRN) . 4
6.3 Service relation instance number (SRIN) . 5
7 SoC and Individual Provider identification as a recognized priority .5
7.1 General . 5
7.2 Supported processes . 6
8 Why globally unique identification? . 6
8.1 SoC identification and data processing . 6
8.2 Implementation challenges . 7
8.3 Symbol placement on identification bands . 7
8.4 Individual Provider identification . 8
Annex A (informative) Examples of use cases (UC) . 9
Bibliography .51
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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.
This second edition cancels and replaces the first edition (ISO/TS 18350:2014), 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
— additional bibliography
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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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 Technical Specification focuses on the
1)
use of the 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 compliance, 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. organisations 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. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
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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, hospitalised 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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DRAFT INTERNATIONAL STANDARD ISO/DIS 18530:2020(E)
Health Informatics — Automatic identification and data
capture marking and labelling — Subject of care and
individual provider identification
1 Scope (mandatory)
This Technical Specification 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 may be used for other purposes, such as recording the
identity of the SoC in individual health records.
This Technical Specification 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
2)
to be used in conjunction with the GS1 system of standards. Other solutions, such as using other
3)
identification systems , are possible but not addressed by this Technical Specification.
This Technical Specification describes good practices to reduce/avoid variation and workarounds
[5][6]
which challenge the efficiency of AIDC at the point of care and compromise patient safety .
This Technical Specification specifies how to manage identifiers in the AIDC process, and completes the
information found in ISO/TS 22220 and ISO/TS 27575.
2 Normative references.
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/TS 22220, Health informatics — Identification of subjects of health care
ISO/TS 27527, Health informatics — Provider identification
ISO/IEC 15418, Information technology — Automatic identification and data capture techniques — GS1
Application Identifiers and ASC MH10 Data Identifiers and maintenance
ISO/IEC 16022, Information technology — Automatic identification and data capture techniques — Data
Matrix bar code symbology specification
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/
2) GS1 is a registered trademark. Any trademark used in this document is information given for the convenience
of users and does not constitute an endorsement.
3) For example, systems based on ISBT 128, maintained by ICCBBA (www .iccbba .org)
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3.1
application identifier
AI
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 19762-1:2008, 01.01.94]
3.2
AIDC
automatic identification and data capture
refers to the 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.
3.3
business entity
recognised formal business entity, such as a corporation or company
Note 1 to entry: This entity holds details of the formal ‘owner’ entity of the organization.
[SOURCE: ISO/TS 27527:2010, 3.1 — modified, Note 1 to entry added.]
3.4
data capture
deliberate action which results in the registration of a record into a record keeping system
3.5
care unit
subdivision of an organization where the subject of care (3.16) receives the care they need during
their stay
Note 1 to entry: A care unit may also be referred to as a ward.
3.6
4)
GSRN
global service relation number
used 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).
3.7
healthcare provider
organization or facility that delivers healthcare to Subjects of Care
4) 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.
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3.8
5)
IHE
integrating the healthcare enterprise
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.
3.9
individual provider
any 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 the term
health care professional has not been used to describe them. All health care professionals are providers, but not
all providers are health care professionals.
3.10
individual provider identification
unique number or code issued for the purpose of identifying an individual provider
3.11
information system
organized collection of hardware, software, supplies, policies, procedures and people that stores,
processes and provides access to information
3.12
machine readable code
code, readable by a machine, that 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
3.13
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
3.14
registration
act of giving a record a unique identity in a record keeping system
3.15
SRIN
service relation instance number
attribute to a global service relation number (3.6) to identify an instance within a care process
EXAMPLE Such as an identification band, an order sheet, test-tube etc.
3.16
SoC
subject of care
person seeking to receive, receiving or having received health caretext of the definition
5) IHE is a registered trade name. Any trade name used in this document is information given for the convenience
of users and does not constitute an endorsement.
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4 Abbreviations
AIDC Automatic Identification and Data Capture
CIS Clinical Information System
GSRN Global Service Relation Number
IHE Integrating the Healthcare Enterprise
ISBT ISBT 128 is the standard for blood transfusion and transplantation, maintained by the Inter-
national Council for Commonality in Blood Banking Automation (ICCBBA)
SCI Subject of Care Identifier
SOC Subject of Care
SRIN Service Relation Instance Number
5 GS1 specifications and ISO Standards
In this Technical Specification, 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 International Standards. 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 Standards. 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.
6 Data structures and semantics
6.1 Application identifiers
The GS1 item identification system and related encodation standard are complemented by the GS1
maintained application identifiers, hereafter referred to as “GS1 Application Identifiers” or “GS1 AIs”.
This Technical Specification 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 AIs identify generic and simple data fields for use in cross-sectorial and international supply chain
applications. The GS1 General Specifications provide rules for the definition, format and structure
of the data fields. Each GS1 AI consists of two or more characters. The first two digits determine the
length of the AI.
SOURCE: ISO/IEC 15418.
6.2 Global service relation number (GSRN)
The Global Service Relation Number (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.
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Figure 1 — Global service relation number (GSRN)
6.3 Service relation instance number (SRIN)
The Service Relation Instance Number (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.
Figure 2 — Service relation instance number (SRIN)
For the purpose of this Technical Specification, for compliance 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.
7 SoC and Individual Provider identification as a recognized priority
7.1 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.
Annex A illustrates how SoC and Individual Provider identification should be enabled for different
types of healthcare care use cases. If used, the Informative Annex explains the type of care and how
AIDC shall 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;
— UC 05 to 11 describes specific care instances that might arise within a hospital environment;
— UC 12 to 19 looks at machine readable coding in complex point of care environments;
— UC 20 to 24 looks at machine readable coding in the blood transfusion processes;
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— UC 25 to 27 describes machine readable coding for chronic outpatients;
— UC 28 to 30 examines the need to integrate nationwide SoC and Individual Provider identification.
The textual presentation of the use cases is completed with UML diagrams where, in particular, data
capture is positioned; normative recommendations 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.
7.2 Supported processes
Annex A provides examples of a series of processes which 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
...
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