BS PD ISO TS 18530-2014 Health Informatics Automatic identification and data capture marking and labelling Subject of care and individual provider identification《健康信息学 自动识别和数据采集标记和.pdf

1、BSI Standards PublicationPD ISO/TS 18530:2014Health Informatics Automatic identificationand data capture markingand labelling Subject ofcare and individual provideridentificationCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reprod

2、uction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of ISO/TS18530:2014.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of or

3、ganizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 201

4、4ISBN 978 0 580 81290 3ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 30 April 2014.Amendments issued since publicationDate Text affectedCopyright

5、British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014 ISO 2014Health Informatics Automatic identification and data capture marking and labelling Subject of care

6、and individual provider identificationInformatique de sant identification lisible par capture automatique et marquage identification des sujets de soins de sant et des professionnels de la santTECHNICAL SPECIFICATIONISO/TS18530First edition2014-04-01Reference numberISO/TS 18530:2014(E)Copyright Brit

7、ish Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014ISO/TS 18530:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unl

8、ess otherwise specified, 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

9、address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandCopyright British Standards Institution Provided by IHS under license with B

10、SI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014ISO/TS 18530:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Abbreviations. 45 G

11、S1 specifications and ISO Standards 46 Data structures and semantics 46.1 Application identifiers 46.2 Global service relation number (GSRN) 46.3 Service relation instance number (SRIN) 57 SoC and Individual Provider identification as a recognized priority 57.1 General . 57.2 Supported processes 68

12、Why globally unique identification? 68.1 SoC identification and data processing 68.2 Implementation challenges 78.3 Symbol placement on identification bands 78.4 Individual Provider identification 8Annex A (informative) Examples of use cases (UC) . 9Bibliography .56Copyright British Standards Instit

13、ution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014ISO/TS 18530:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards

14、 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 organiza

15、tions, 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 furt

16、her 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/directiv

17、es). 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 In

18、troduction 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 on the meaning of ISO specific terms and expressions related t

19、o conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informatics. iv ISO 2014 All rights reserve

20、dCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014ISO/TS 18530:2014(E)IntroductionThe delivery of healthcare relies heavily on the ability to uniqu

21、ely 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 th

22、ey 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 bar codes and Radio Frequency Identification (RFID), commonly refer

23、red 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 optic

24、al carriers (such as bar codes). 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 fo

25、cuses on the use of the GS1 System of Standards1)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 healthca

26、re 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, r

27、eferenced 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 experience

28、s a large number of care instances. Examples of these instances include: prescriptions and medication 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. Healthc

29、are providers (i.e. organisations that deliver healthcare to the SoC) have introduced AIDC technologies based bar codes to help capture the SoCs 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 hospi

30、tal 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 inst

31、ance 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 c

32、onditions, 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

33、 the treatment plan for the SoC for safety and stock purposes. AIDC enables capture of the SoCs identification, medication, administration event, recording of relevant data about the medication administered and other data such as batch number, expiration information and amount used. This should be d

34、one 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. ISO 2014 All right

35、s reserved vCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014ISO/TS 18530:2014(E)Benefits from unique SoC Identification in AIDC can be documented

36、from the following three examples: Patient, as well as, data can travel outside a providers environment: Following a devastating tornado in Joplin, Missouri, USA, in 2011, 183 SoCs from St Johns Hospital had to be swiftly evacuated to other regional hospitals. Under such “chaotic” conditions, a pati

37、ent 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 essent

38、ial 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 proc

39、esses: 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 havin

40、g the same numbers, one of “patient identification”, the other for “care identification”. A mismatch with serious incident occurred.vi ISO 2014 All rights reservedCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or netwo

41、rking permitted without license from IHS-,-,-PD ISO/TS 18530:2014TECHNICAL SPECIFICATION ISO/TS 18530:2014(E)Health Informatics Automatic identification and data capture marking and labelling Subject of care and individual provider identification1 ScopeThis Technical Specification outlines the stand

42、ards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as 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

43、 for other purposes, such as recording the identity of the SoC in medical 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 to be used in

44、 conjunction with the GS12)system of standards. This Technical Specification describes good practices to reduce/avoid variation and workarounds which challenge the efficiency of AIDC at the point of care and compromise patient safety.This Technical Specification specifies how to manage identifiers i

45、n the AIDC process, and completes the information found in ISO/TS 22220 and ISO/TS 27527.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. Fo

46、r undated references, the latest edition of the referenced document (including any amendments) applies.ISO/TS 22220, Health informatics Identification of subjects of health careISO/TS 27527, Health informatics Provider identificationISO/IEC 15418, Information technology Automatic identification and

47、data capture techniques GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenanceISO/IEC 16022, Information technology Automatic identification and data capture techniques Data Matrix bar code symbology specification3 Terms and definitions3.1application identifierAIGS1 prefix that de

48、fines the meaning and purpose of the data element that follows, as defined in ISO/IEC 15418 and GS1 General SpecificationsSOURCE: ISO 19762-1:2008, 01.01.942) 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. ISO 2014 All rights reserved 1Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 18530:2014ISO/TS 18530:2014(E)3.2A