EN ISO 22870-2016 en Point-of-care testing (POCT) - Requirements for quality and competence《定点照护检测( POCT )-质量和能力要求》.pdf

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1、BS EN ISO 22870:2016Point-of-care testing (POCT) Requirements for quality andcompetence (ISO 22870:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 22870:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 2287

2、0:2016. It supersedes BS EN ISO 22870:2006 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all th

3、e necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 94153 5 ICS 03.120.10; 11.100.01 Compliance with a British Standard cannot confer immunity from legal obligations.This

4、 British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22870 November 2016 ICS 03.120.10; 11.100.01 Super

5、sedes EN ISO 22870:2006English Version Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) Examens de biologie mdicale dlocalise (EBMD) - Exigences concernant la qualit et la comptence (ISO 22870:2016) Patientennahe Untersuchungen (point-of-care testing, POCT) - A

6、nforderungen an Qualitt und Kompetenz (ISO 22870:2016) This European Standard was approved by CEN on 14 October 2016. 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 a

7、ny 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 langu

8、age 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

9、, 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 and United Kingdom. EUROPEAN COMMITTEE FO

10、R STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22870:2016 EBS EN ISO 22870:2

11、016EN ISO 22870:2016 (E) 3 European foreword This document (EN ISO 22870:2016) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“ in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” the secreta

12、riat of which is held by DIN. 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 May 2017, and conflicting national standards shall be withdrawn at the latest by November 2019. Attention is drawn to

13、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. This document supersedes EN ISO 22870:2006. This document has been prepared under a mandate given to CEN by

14、the European Commission and the European Free Trade Association, and supports essential requirements of EC Regulation 765/2008. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, B

15、elgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, 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, Swi

16、tzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22870:2016 has been approved by CEN as EN ISO 22870:2016 without any modification. BS EN ISO 22870:2016ISO 22870:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Management requ

17、irements . 14.1 Organization and management 14.2 Quality management system . 24.3 Document control . 44.4 Service agreements . 44.5 Examination by referral laboratories 44.6 External services and supplies 44.7 Advisory services 44.8 Resolution of complaints 44.9 Identification and control of nonconf

18、ormities 44.10 Corrective action . 54.11 Preventive action . 54.12 Continual improvement 54.13 Quality and technical records . 54.14 Internal audits . 64.15 Management review . 65 Technical requirements 65.1 Personnel . 65.2 Accommodation and environmental conditions . 85.3 Equipment . 85.4 Pre-exam

19、ination procedures 85.5 Examination procedures 85.6 Assuring the quality of examination procedures 95.7 Post-examination procedure . 95.8 Reporting of results . 10Bibliography .11 ISO 2016 All rights reserved iiiContents PageBS EN ISO 22870:2016ISO 22870:2016(E)ForewordISO (the International Organiz

20、ation 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

21、 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.Th

22、e 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 e

23、ditorial 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 r

24、ights 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 ex

25、planation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee re

26、sponsible for this document is ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the first edition (ISO 22870:2006), of which it constitutes a minor revision.The changes compared to the previous edition are as follows: inclusion of

27、cross-references to the applicable clauses in ISO 15189:2012.iv ISO 2016 All rights reservedBS EN ISO 22870:2016ISO 22870:2016(E)IntroductionTraditional examinations of a patients body fluids, excreta and tissues are carried out generally in the controlled and regulated environment of a recognized m

28、edical laboratory. The introduction of quality management systems and accreditation of these laboratories are gaining increasing interest.Advances in technology have resulted in compact, easy-to-use in vitro diagnostic (IVD) medical devices that make it possible to carry out some examinations at, or

29、 close to, the location of the patient. Point-of-care/near-patient testing may benefit the patient as well as healthcare facilities.Risk to the patient and to the facility can be managed by a well-designed, fully implemented quality management system that facilitates evaluation of new or alternative

30、 POCT instruments and systems, evaluation and approval of end-user proposals and protocols, purchase, installation and maintenance of equipment, maintenance of consumable supplies and reagents, training, certification and recertification of POCT system operators, and quality control and quality assu

31、rance.Bodies that recognize the competence of POCT facilities may use this document as the basis for their activities. If a healthcare facility seeks accreditation for a part or all of its activities, it should select an accreditation body that operates in a manner which takes into account the speci

32、al requirements of POCT. ISO 2016 All rights reserved vBS EN ISO 22870:2016BS EN ISO 22870:2016Point-of-care testing (POCT) Requirements for quality and competence1 ScopeThis document gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 1

33、5189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.Patien

34、t self-testing in a home or community setting is excluded, but elements of this document can be applicable.NOTE Local, regional and national regulations are to be taken into consideration.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of thei

35、r 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 15189:2012, Medical laboratories Requirements for quality and competence3 Terms and

36、definitionsFor 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: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www

37、.iso.org/obp 3.1point-of-care testingPOCTnear-patient testingtesting that is performed near or at the site of a patient with the result leading to possible change in the care of the patient4 Management requirements4.1 Organization and management4.1.1 ISO 15189:2012, 4.1.1.2, 4.1.1.3 and the followin

38、g apply.The management of laboratory services shall plan and develop the processes needed for POCT.The following shall be considered, as appropriate:a) quality objectives and requirements for POCT;INTERNATIONAL STANDARD ISO 22870:2016(E) ISO 2016 All rights reserved 1BS EN ISO 22870:2016ISO 22870:20

39、16(E)b) the need to establish processes and documents, and provide resources specific to POCT;c) required verification, validation, and monitoring of activities specific to POCT;d) records to provide evidence that POCT processes and procedures meet requirements.The governing body of the organization

40、 shall be ultimately responsible for ensuring that appropriate measures are in place to monitor the accuracy and quality of POCT conducted within the healthcare organization.4.1.2 ISO 15189:2012, 4.1.2.2, and the following subclauses apply.4.1.2.1 A health professional grouping (e.g. Medical Advisor

41、y Committee) shall be responsible to the governing body for defining the scope of POCT to be made available. This shall take into consideration the clinical need for POCT, its financial implications, technical feasibility and the ability of the organization to fulfil the need.4.1.2.2 The laboratory

42、director or designate shall appoint a multidisciplinary POCT management group with representation from the laboratory, administration and clinical programmes including nursing to advise on the provision of POCT.4.1.2.3 The management group shall ensure that responsibilities and authorities are defin

43、ed and communicated within the organization.4.1.2.4 The management group shall assist in evaluating and selecting POCT devices and systems. Performance criteria for POCT devices should include consideration of trueness, precision, detection limits, use limits and interferences. Practicability should

44、 also be considered.4.1.2.5 The management group shall consider all proposals to introduce any product, device or system for POCT.4.1.3 ISO 15189:2012, 4.1.1.1 applies.4.2 Quality management system4.2.1 ISO 15189:2012, 4.1.2.3, 4.1.2.4, 4.1.2.6 and the following apply.4.2.2 The management of laborat

45、ory services shall establish, document, implement and maintain a quality management system and continually improve its effectiveness.4.2.2.1 The management of laboratory services shalla) identify the processes needed for the quality management system for POCT throughout the organization,b) determine

46、 the sequence and interaction of these processes,c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,e) mon

47、itor, measure and analyse these processes,f) implement actions necessary to achieve planned results and continual improvement of these processes, and2 ISO 2016 All rights reservedBS EN ISO 22870:2016ISO 22870:2016(E)g) appoint a person with appropriate training and experience as quality manager resp

48、onsible for POCT quality, which includes review of the requirements related to POCT.These processes shall be managed by the organization in accordance with the requirements of this document.Processes needed for the quality management system referred to above should include processes for management a

49、ctivities, provision of resources, service provisions and measurement provisions.4.2.2.2 The management of laboratory services shall plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of POCT to the quality system.4.2.3 The quality management system documentation shall includea) documented statements of a quality policy and quality objectives,b) quality manual,c) documented procedures required by this document,d) documents needed by the organization to ensure the effective plan