EN ISO TS 18530-2015 en Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification.pdf

1、BSI Standards PublicationPD CEN ISO/TS 18530:2015Health Informatics Automatic identificationand data capture markingand labelling Subject ofcare and individual provideridentificationPD CEN ISO/TS 18530:2015 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of The UK

2、 participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations 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 responsi

3、ble for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 90300 7ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards P

4、olicy and Strategy Committee on 30 April 2014.Amendments/corrigenda issued since publicationDate Text affectedCEN ISO/TS 18530:2015. It is identical to ISO/TS 18530:2014.31 March 2016 This corrigendum renumbers PD ISO/TS 18530:2014as PD CEN ISO/TS 18530:2015It supersedes PD ISO/TS 18530:2014 which i

5、s withdrawn.TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 18530 December 2015 ICS 35.240.80 English Version Health Informatics - Automatic identification and data capture marking and labelling - Subject of care and individual provider identification (ISO/TS 18530

6、:2014) Informatique de sant - Identification lisible par capture automatique et marquage - Identification des sujets de soins de sant et des professionnels de la sant (ISO/TS 18530:2014) Medizinische Informatik - Automatische Identifikation und Datenerfassungskennzeichnung und -beschriftung - Identi

7、fikation von Behandelten und individuellen Anbietern (ISO/TS 18530:2014) This Technical Specification (CEN/TS) was approved by CEN on 28 October 2015 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be req

8、uested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate for

9、m. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, D

10、enmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITT

11、EE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 18530:2015 EEuropean

12、 foreword The text of ISO/TS 18530:2014 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TS 18530:2015 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of whic

13、h is held by NEN. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national stan

14、dards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuan

15、ia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 18530:2014 has been approved by CEN as CEN ISO/TS 18530:2015 without any modification. ii ISO 2014 All rights re

16、servedISO/TS 18530:2014(E)PD CEN ISO/TS 18530:2015ISO/TS 18530:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Abbreviations. 45 GS1 specifications and ISO Standards 46 Data structures and semantics 46.1 Ap

17、plication 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 Why globally unique identification? 68.1 SoC identification and data process

18、ing 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 .56PD CEN ISO/TS 18530:2015ISO/TS 18530:2014(E)ForewordISO (the International Organization for Standardization) i

19、s 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 represe

20、nted 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

21、 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/IE

22、C 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

23、 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 on the meaning o

24、f ISO specific terms and expressions related to 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, Heal

25、th informatics. iv ISO 2014 All rights reservedPD CEN ISO/TS 18530:2015ISO/TS 18530:2014(E)IntroductionThe 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.

26、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 captu

27、re and share information across different systems and healthcare applications.Data carriers, such as bar codes 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

28、 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 bar codes). Furthermore, the semantics of data carried is defined by a number of organizations (also named “iss

29、uing agencies”), some of them having commercial activities, others nation-wide missions, as well as, standard development organizations. This Technical Specification focuses on the use of the GS1 System of Standards1)since a considerable majority of supplies in healthcare around the world are identi

30、fied 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 Indivi

31、dual 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 ca

32、re 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 medication administration, laboratory tes

33、ting 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 technologies based bar codes to help capt

34、ure 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 hospital environment with many care instances, the need for uniqueness of identifications is generally recognized, since this avoids iden

35、tification 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 var

36、iety 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 pla

37、n 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 SoCs identification, medication, administ

38、ration event, recording of relevant data about the medication 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

39、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 vPD CEN ISO/TS 18530:2015ISO/TS 18530:2014(E)Benefits from unique SoC Identification in AIDC can be documented from the f

40、ollowing 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 patient identi

41、fier 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 pa

42、tient 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

43、 “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

44、 numbers, one of “patient identification”, the other for “care identification”. A mismatch with serious incident occurred.vi ISO 2014 All rights reservedPD CEN ISO/TS 18530:2015TECHNICAL SPECIFICATION ISO/TS 18530:2014(E)Health Informatics Automatic identification and data capture marking and labell

45、ing Subject of care and individual provider identification1 ScopeThis Technical Specification outlines the standards 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 captu

46、re 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 medical health records.This Technical Specification serves as a reference for any organization which plans to implement or

47、 improve Automatic Identification and Data Capture (AIDC) in their delivery of care process. It is to be used in 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 th

48、e 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 27527.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in t

49、his document and are indispensable for its application. 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 careISO/TS 27527, Health informatics Provider identificationISO/IEC 15418, Information technology Automatic identification and data capture techniques GS1 Application Identifiers and ASC MH10 Data Identifiers and maintenanceISO/IEC 16022, Information technology