Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)

This document gives specific requirements applicable to point-of-care testing and is intended to be
used in conjunction with ISO 15189. 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.
Patient 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.

Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an Qualität und Kompetenz (ISO 22870:2016)

Dieses Dokument legt besondere Anforderungen fest, die für patientennahe Untersuchungen gelten, und ist zur Anwendung im Zusammenhang mit ISO 15189 vorgesehen. Die Anforderungen dieses Dokumentes gelten, wenn POCT in einem Krankenhaus oder einer Klinik erfolgen, und dürfen auch in einer Pflegeorganisation angewendet werden, die ambulante Patientenversorgung durchführt. Dieses Dokument kann für transkutane Messungen, die Analyse der Ausatemluft und die In vivo Überwachung physiologischer Parameter angewendet werden.
Die Selbstuntersuchung von Patienten in deren Heim oder in einer Gemeinschaftseinrichtung fällt nicht unter dieses Dokument, aber bestimmte seiner Elemente können dafür gelten.
ANMERKUNG    Örtliche, regionale und nationale Bestimmungen sind zu berücksichtigen.

Analyse de biologie délocalisée (ADBD) - Exigences en matière de qualité et de compétences (ISO 22870:2016)

ISO 22870:2016 fournit des exigences spécifiques des examens de biologie médicale délocalisée et est destiné à être utilisé conjointement avec l'ISO 15189. Les exigences du présent document s'appliquent lorsque les EBMD sont réalisées dans un hôpital ou une clinique et par un organisme de santé prodiguant des soins ambulatoires. Le présent document peut s'appliquer à des mesurages transcutanés, à l'analyse de l'air expiré et à la surveillance in vivo de paramètres physiologiques.
L'auto-test par les patients à domicile ou dans un dispensaire est exclu- mais certains éléments du présent document peuvent s'appliquer.

Testiranje ob pacientu (POCT) - Zahteve za kakovost in kompetentnost (ISO 22870:2016)

Ta dokument podaja posebne zahteve, ki se uporabljajo za preskušanje ob preiskovancu (POCT), in se uporablja skupaj s standardom ISO 15189. Zahteve tega dokumenta se uporabljajo, kadar se preskušanje ob preiskovancu izvaja v bolnišnici, kliniki ali zdravstveni organizaciji, ki zagotavlja ambulantno nego. Ta dokument se lahko uporablja za transkutane meritve, analizo izdihnjenega zraka ter spremljanje fizioloških parametrov in vivo.
Preskušanje, ki ga bolnik izvaja sam doma ali v skupnem okolju, ni vključeno, vendar se lahko uporabijo nekateri deli tega dokumenta.
OPOMBA: Treba je upoštevati lokalne, regionalne in nacionalne predpise.

General Information

Status
Published
Public Enquiry End Date
09-Sep-2016
Publication Date
10-Jan-2017
Technical Committee
Current Stage
6100 - Translation of adopted SIST standards (Adopted Project)
Start Date
06-Nov-2019
Due Date
04-Nov-2020
Completion Date
28-May-2020

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SLOVENSKI STANDARD
SIST EN ISO 22870:2017
01-februar-2017
1DGRPHãþD
SIST EN ISO 22870:2006
Testiranje ob pacientu (POCT) - Zahteve za kakovost in kompetentnost (ISO
22870:2016)
Point-of-care testing (POCT) - Requirements for quality and competence (ISO
22870:2016)
Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an
Qualität und Kompetenz (ISO 22870:2016)
Analyse de biologie délocalisée (ADBD) - Exigences en matière de qualité et de
compétences (ISO 22870:2016)
Ta slovenski standard je istoveten z: EN ISO 22870:2016
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST EN ISO 22870:2017 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 22870:2017
---------------------- Page: 2 ----------------------
SIST EN ISO 22870:2017
EN ISO 22870
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 03.120.10; 11.100.01 Supersedes EN ISO 22870:2006
English Version
Point-of-care testing (POCT) - Requirements for quality
and competence (ISO 22870:2016)

Examens de biologie médicale délocalisée (EBMD) - Patientennahe Untersuchungen (point-of-care testing,

Exigences concernant la qualité et la compétence (ISO POCT) - Anforderungen an Qualität und Kompetenz

22870:2016) (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 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, 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 FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR 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 Ref. No. EN ISO 22870:2016 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 22870:2017
EN ISO 22870:2016 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 22870:2017
EN ISO 22870:2016 (E)
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 secretariat 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 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 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, Belgium, 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, Switzerland,

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.

---------------------- Page: 5 ----------------------
SIST EN ISO 22870:2017
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SIST EN ISO 22870:2017
INTERNATIONAL ISO
STANDARD 22870
Second edition
2016-11-01
Point-of-care testing (POCT) —
Requirements for quality and
competence
Examens de biologie médicale délocalisée (EBMD) — Exigences
concernant la qualité et la compétence
Reference number
ISO 22870:2016(E)
ISO 2016
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SIST EN ISO 22870:2017
ISO 22870:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless 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 address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 22870:2017
ISO 22870:2016(E)
Contents Page

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

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

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

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

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

4 Management requirements ....................................................................................................................................................................... 1

4.1 Organization and management ................................................................................................................................................ 1

4.2 Quality management system ....................................................................................................................................................... 2

4.3 Document control ................................................................................................................................................................................. 4

4.4 Service agreements ............................................................................................................................................................................. 4

4.5 Examination by referral laboratories .................................................................................................................................. 4

4.6 External services and supplies .................................................................................................................................................. 4

4.7 Advisory services .................................................................................................................................................................................. 4

4.8 Resolution of complaints ................................................................................................................................................................ 4

4.9 Identification and control of nonconformities ............................................................................................................ 4

4.10 Corrective action ................................................................................................................................................................................... 5

4.11 Preventive action ................................................................................................................................................................................... 5

4.12 Continual improvement .................................................................................................................................................................. 5

4.13 Quality and technical records ..................................................................................................................................................... 5

4.14 Internal audits ......................................................................................................................................................................................... 6

4.15 Management review ........................................................................................................................................................................... 6

5 Technical requirements ................................................................................................................................................................................ 6

5.1 Personnel ..................................................................................................................................................................................................... 6

5.2 Accommodation and environmental conditions ....................................................................................................... 8

5.3 Equipment ................................................................................................................................................................................................... 8

5.4 Pre-examination procedures ...................................................................................................................................................... 8

5.5 Examination procedures ................................................................................................................................................................ 8

5.6 Assuring the quality of examination procedures ...................................................................................................... 9

5.7 Post-examination procedure ......... .............................................................................................................................................. 9

5.8 Reporting of results .........................................................................................................................................................................10

Bibliography .............................................................................................................................................................................................................................11

© ISO 2016 – All rights reserved iii
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SIST EN ISO 22870:2017
ISO 22870:2016(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 on 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 the following URL: www.iso.org/iso/foreword.html.

The committee responsible 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 cross-references to the applicable clauses in ISO 15189:2012.
iv © ISO 2016 – All rights reserved
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SIST EN ISO 22870:2017
ISO 22870:2016(E)
Introduction

Traditional examinations of a patient’s body fluids, excreta and tissues are carried out generally in the

controlled and regulated environment of a recognized medical 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 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 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 assurance.

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 special requirements of POCT.

© ISO 2016 – All rights reserved v
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SIST EN ISO 22870:2017
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SIST EN ISO 22870:2017
INTERNATIONAL STANDARD ISO 22870:2016(E)
Point-of-care testing (POCT) — Requirements for quality
and competence
1 Scope

This document gives specific requirements applicable to point-of-care testing and is intended to be

used in conjunction with ISO 15189. 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.

Patient 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 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 15189:2012, Medical laboratories —Requirements for quality and competence
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:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
point-of-care testing
POCT
near-patient testing

testing that is performed near or at the site of a patient with the result leading to possible change in the

care of the patient
4 Management requirements
4.1 Organization and management
4.1.1 ISO 15189:2012, 4.1.1.2, 4.1.1.3 and the following 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;
© ISO 2016 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 22870:2017
ISO 22870:2016(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 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 Advisory 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 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 defined 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 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 system
4.2.1 ISO 15189:2012, 4.1.2.3, 4.1.2.4, 4.1.2
...

SLOVENSKI SIST EN ISO 22870
STANDARD februar 2017
Testiranje ob pacientu (POCT) – Zahteve za kakovost in kompetentnost (ISO
22870:2016)
Point-of-care testing (POCT) – Requirements for quality and competence (ISO
22870:2016)
Patientennahe Untersuchungen (point-of-care testing, POCT) – Anforderungen an
Qualität und Kompetenz (ISO 22870:2016)
Examens de biologie médicale délocalisée (EBMD) – Exigences concernant la
qualité et la compétence (ISO 22870:2016)
Referenčna oznaka
ICS 03.120.10; 11.100.01 SIST EN ISO 22870 : 2017 (sl)
Nadaljevanje na strani II in od 1 do 21

© 2020-06: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 22870 : 2017
NACIONALNI UVOD

Standard SIST EN ISO 22870 (sl), Testiranje ob pacientu (POCT) – Zahteve za kakovost in

kompetentnost (ISO 22870:2016), 2017, ima status slovenskega standarda in je enakovreden

evropskemu standardu EN ISO 22870 (en), Point-of-care testing (POCT) – Requirements for quality

and competence (ISO 22870:2016), 2016.
Ta standard nadomešča SIST EN ISO 22870:2006.
NACIONALNI PREDGOVOR

Evropski standard EN ISO 22870:2016 je pripravil tehnični odbor Evropskega komiteja za

standardizacijo CEN/TC 140 Diagnostični sistemi in vitro (In vitro diagnostic systems). Slovenski

standard SIST EN ISO 22870:2017 je prevod evropskega standarda EN ISO 22870:2016. V primeru

spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem

izmed treh uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ

Varovanje zdravja.

Odločitev za izdajo tega standarda je dne 20. decembra 2016 sprejel SIST/TC VAZ Varovanje zdravja.

ZVEZE S STANDARDI

S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi

standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:

SIST EN ISO 15189:2013 Medicinski laboratoriji – Zahteve za kakovost in kompetentnost

OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 22870:2016
PREDHODNA IZDAJA
– standard SIST EN ISO 22870:2006
OPOMBE

– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO 22870:2017

to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN ISO 22870:2016 in je objavljen z dovoljenjem

Upravni center
CEN-CENELEC
Avenue Marnix 17
B-1000 Bruselj

This national document is identical with EN ISO 22870:2016 and is published with the

permission of
CEN-CENELEC
Management Centre
Avenue Marnix 17
B-1000 Brussels
---------------------- Page: 2 ----------------------
EVROPSKI STANDARD EN ISO 22870
EUROPEAN STANDARD
NORME EUROPÉENNE
november 2016
EUROPÄISCHE NORM
ICS 03.120.10; 11.100.01 Nadomešča EN ISO 22870:2006
Slovenska izdaja
Testiranje ob pacientu (POCT) – Zahteve za kakovost in kompetentnost
(ISO 22870:2016)

Point-of-care testing (POCT) – Examens de biologie médicale Patientennahe Untersuchungen

Requirements for quality and délocalisée (EBMD) – (point-of-care testing, POCT) –

competence (ISO 22870:2016) Exigences concernant la qualité Anforderungen an Qualität und

et la compétence (ISO Kompetenz (ISO 22870:2016)
22870:2016)
Ta evropski standard je CEN sprejel 14. oktobra 2016.

Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerimi je predpisano, da mora biti ta

evropski standard brez kakršnih koli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh

nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko dobijo pri Upravnem centru

CEN-CENELEC ali pri katerem koli članu CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih jezikih, ki

jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru CEN-CENELEC,

veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske,

Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske,

Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške, Poljske,

Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.

CEN
Evropski komite za standardizacijo
European committee for standardization
Comité européen de normalisation
Europäisches komitee für normung
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj

© 2016 CEN Lastnice avtorskih pravic so vse države članice CEN. Ref. oznaka EN ISO 22870:2016 E

---------------------- Page: 3 ----------------------
SIST EN ISO 22870 : 2017

VSEBINA Stran CONTENTS Page

Evropski predgovor ........................................... 3 European foreword ............................................ 3

Predgovor ......................................................... 4 Foreword ........................................................... 4

Uvod ................................................................. 5 Introduction ........................................................ 5

1 Področje uporabe ........................................ 6 1 Scope ........................................................... 6

2 Zveza z drugimi standardi ........................... 6 2 Normative references ................................... 6

3 Izrazi in definicije ......................................... 6 3 Terms and definitions ................................... 6

4 Zahteve za vodenje ..................................... 7 4 Management requirements .......................... 7

4.1 Organizacija in vodenje ............................ 7 4.1 Organization and management ................. 7

4.2 Sistem vodenja kakovosti ......................... 8 4.2 Quality management system .................... 8

4.3 Obvladovanje dokumentov ..................... 10 4.3 Document control .................................... 10

4.4 Storitvene pogodbe ................................ 10 4.4 Service agreements ................................ 10

4.5 Preiskava, ki jo opravijo prejemni 4.5 Examination by referral laboratories ....... 10

laboratoriji ..................................................... 10

4.6 Zunanje storitve in nabava materialnih 4.6 External services and supplies ................ 10

sredstev ....................................................... 10

4.7 Svetovanje .............................................. 10 4.7 Advisory services .................................... 10

4.8 Reševanje pritožb ................................... 10 4.8 Resolution of complaints ......................... 10

4.9 Identifikacija in obvladovanje 4.9 Identification and control of

neskladnosti ................................................ 10 nonconformities ........................................... 10

4.10 Korektivni ukrepi ................................... 11 4.10 Corrective action ................................... 11

4.11 Preventivni ukrepi ................................. 12 4.11 Preventive action ................................... 12

4.12 Nenehno izboljševanje ......................... 12 4.12 Continual improvement ......................... 12

4.13 Zapisi o kakovosti in strokovni zapisi ... 12 4.13 Quality and technical records ................ 12

4.14 Notranje presoje ................................... 13 4.14 Internal audits ........................................ 13

4.15 Vodstveni pregled ................................. 13 4.15 Management review .............................. 13

5 Tehnične zahteve ...................................... 14 5 Technical requirements .............................. 14

5.1 Osebje .................................................... 14 5.1 Personnel ................................................ 14

5.2 Prostori in okoljske razmere ................... 15 5.2 Accommodation and environmental

conditions ..................................................... 15

5.3 Oprema ................................................... 16 5.3 Equipment ............................................... 16

5.4 Predpreiskovalni postopki ...................... 16 5.4 Pre-examination procedures ................... 16

5.5 Preiskovalni postopki .............................. 17 5.5 Examination procedures ......................... 17

5.6 Zagotavljanje kakovosti preiskovalnih 5.6 Assuring the quality of examination

postopkov .................................................... 17 procedures ................................................... 17

5.7 Popreiskovalni postopki .......................... 18 5.7 Post-examination procedure ................... 18

5.8 Poročanje o rezultatih ............................. 19 5.8 Reporting of results ................................. 19

Literatura ........................................................ 20 Bibliography .................................................... 20

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SIST EN ISO 22870 : 2017
Evropski predgovor European foreword

Ta dokument (EN ISO 22870:2016) je pripravil This document (EN ISO 22870:2016) has been

tehnični odbor ISO/TC 212 "Preskušanje kliničnih prepared by Technical Committee ISO/TC 212

laboratorijev ter diagnostični sistemi in vitro" v "Clinical laboratory testing and in vitro diagnostic

sodelovanju s tehničnim odborom CEN/TC 140 test systems" in collaboration with Technical

"Diagnostični medicinski pripomočki in vitro", Committee CEN/TC 140 "In vitro diagnostic

katerega sekretariat vodi DIN. medical devices" the secretariat of which is held
by DIN.

Ta evropski standard mora dobiti status This European Standard shall be given the status

nacionalnega standarda bodisi z objavo of a national standard, either by publication of an

istovetnega besedila ali z razglasitvijo najpozneje identical text or by endorsement, at the latest by

maja 2017, nasprotujoče nacionalne standarde May 2017, and conflicting national standards shall

pa je treba razveljaviti najpozneje novembra be withdrawn at the latest by November 2019.

2019.

Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of

elementov tega dokumenta predmet patentnih the elements of this document may be the subject

pravic. CEN (in/ali CENELEC) ne prevzema of patent rights. CEN [and/or CENELEC] shall not

odgovornosti za identifikacijo posameznih ali be held responsible for identifying any or all such

vseh takih patentnih pravic. patent rights.

Ta dokument nadomešča EN ISO 22870:2006. This document supersedes EN ISO 22870:2006.

Ta dokument je bil pripravljen v okviru mandata, This document has been prepared under a

ki sta ga Evropska komisija in Evropsko združenje mandate given to CEN by the European

za prosto trgovino dodelila CEN, ter podpira Commission and the European Free Trade

bistvene zahteve Uredbe (ES) 765/2008. Association, and supports essential requirements

of EC Regulation 765/2008.
V skladu z notranjimi predpisi CEN-CENELEC According to the CEN-CENELEC Internal

morajo ta evropski standard obvezno uvesti Regulations, the national standards organizations

nacionalne organizacije za standardizacijo of the following countries are bound to implement

naslednjih držav: Avstrije, Belgije, Bolgarije, this European Standard: Austria, Belgium,

Cipra, Češke republike, Danske, Estonije, Finske, Bulgaria, Croatia, Cyprus, Czech Republic,

Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Denmark, Estonia, Finland, Former Yugoslav

Latvije, Litve, Luksemburga, Madžarske, Malte, Republic of Macedonia, France, Germany,

Nekdanje jugoslovanske republike Makedonije, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Nemčije, Nizozemske, Norveške, Poljske, Lithuania, Luxembourg, Malta, Netherlands,

Portugalske, Romunije, Slovaške, Slovenije, Norway, Poland, Portugal, Romania, Slovakia,

Španije, Švedske, Švice, Turčije in Združenega Slovenia, Spain, Sweden, Switzerland, Turkey

kraljestva. and the United Kingdom.
Razglasitvena objava Endorsement notice

Besedilo standarda ISO 22870:2016 je CEN The text of ISO 22870:2016 has been approved

odobril brez sprememb kot evropski standard EN by CEN as EN ISO 22870:2016 without any

ISO 22870:2016. modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 22870 : 2017
Predgovor Foreword
ISO (Mednarodna organizacija za ISO (the International Organization for

standardizacijo) je svetovna zveza nacionalnih Standardization) is a worldwide federation of

organov za standarde (članov ISO). Mednarodne national standards bodies (ISO member bodies).

standarde ponavadi pripravljajo tehnični odbori The work of preparing International Standards is

ISO. Vsak član, ki želi delovati na določenem normally carried out through ISO technical

področju, za katero je bil ustanovljen tehnični committees. Each member body interested in a

odbor, ima pravico biti zastopan v tem odboru. Pri subject for which a technical committee has been

delu sodelujejo tudi mednarodne vladne in established has the right to be represented on that

nevladne organizacije, povezane z ISO. V vseh committee. International organizations,

zadevah, ki so povezane s standardizacijo na governmental and non-governmental, in liaison

področju elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO

Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International

Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.

Postopki, uporabljeni pri pripravi tega The procedures used to develop this document

dokumenta, in predvideni postopki za njegovo and those intended for its further maintenance are

vzdrževanje so opisani v Direktivah ISO/IEC, 1. described in the ISO/IEC Directives, Part 1. In

del. Posebna pozornost naj se nameni različnim particular the different approval criteria needed for

kriterijem odobritve, potrebnim za različne vrste the different types of ISO documents should be

dokumentov ISO. Ta dokument je bil pripravljen noted. This document was drafted in accordance

v skladu z uredniškimi pravili Direktiv ISO/IEC, 2. with the editorial rules of the ISO/IEC Directives,

del (glej www.iso.org/directives). Part 2 (see www.iso.org/directives).

Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of

elementov tega dokumenta predmet patentnih the elements of this document may be the subject

pravic. ISO ne prevzema odgovornosti za of patent rights. ISO shall not be held responsible

identifikacijo posameznih ali vseh takih patentnih for identifying any or all such patent rights. Details

pravic. Podrobnosti o morebitnih patentnih of any patent rights identified during the

pravicah, identificiranih med pripravo tega development of the document will be in the

dokumenta, bodo navedene v uvodu in/ali na Introduction and/or on the ISO list of patent

seznamu ISO s prejetimi patentnimi izjavami declarations received (see www.iso.org/patents).

(glej www.iso.org/patents).

Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is

dokumentu, so informacije za uporabnike in ne information given for the convenience of users

pomenijo podpore blagovni znamki. and does not constitute an endorsement.

Za razlago pomena specifičnih terminov in For an explanation on the meaning of ISO specific

izrazov ISO, povezanih z ugotavljanjem terms and expressions related to conformity

skladnosti, ter informacije o tem, kako ISO assessment, as well as information about ISO’s

upošteva načela Svetovne trgovinske adherence to the World Trade Organization

organizacije (WTO) o tehničnih ovirah pri (WTO) principles in the Technical Barriers to

trgovanju (TBT), glej naslednjo povezavo: Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html. www.iso.org/iso/foreword.html.

Odbor, ki je pristojen za ta dokument, je tehnični The committee responsible for this document is

odbor ISO/TC 212, Preskušanje kliničnih ISO/TC 212, Clinical laboratory testing and in vitro

laboratorijev ter diagnostični sistemi in vitro. diagnostic test systems.

Ta druga izdaja razveljavlja in nadomešča prvo This second edition cancels and replaces the first

izdajo (ISO 22870:2006) ter vključuje manjše edition (ISO 22870:2006), of which it constitutes a

popravke. minor revision.

Spremembe v primerjavi s predhodno izdajo so The changes compared to the previous edition

naslednje: are as follows:
 vključitev sklicevanj na ustrezne točke  inclusion of cross-references to the
standarda ISO 15189:2012. applicable clauses in ISO 15189:2012.
---------------------- Page: 6 ----------------------
SIST EN ISO 22870 : 2017
Uvod Introduction

Tradicionalne preiskave telesnih tekočin, izločkov Traditional examinations of a patient’s body fluids,

ter tkiv pacientov se ponavadi opravljajo v excreta and tissues are carried out generally in

nadzorovanem in predpisanem okolju priznanega the controlled and regulated environment of a

medicinskega laboratorija. Zanimanje za uvajanje recognized medical laboratory. The introduction

sistemov vodenja kakovosti in akreditacije takih of quality management systems and accreditation

laboratorijev je vse večje. of these laboratories are gaining increasing
interest.

S tehnološkim napredkom so nastali kompaktni Advances in technology have resulted in

diagnostični medicinski pripomočki in vitro (IVD), compact, easy-to-use in vitro diagnostic (IVD)

preprosti za uporabo, s katerimi je mogoče medical devices that make it possible to carry out

nekatere preiskave opraviti na lokaciji pacienta ali some examinations at, or close to, the location of

blizu nje. Testiranje ob pacientu/v bližini pacienta the patient. Point-of-care/near-patient testing may

lahko koristi pacientom in zdravstvenim benefit the patient as well as healthcare facilities.

ustanovam.

Tveganje za pacienta in ustanovo je mogoče Risk to the patient and to the facility can be

obvladovati z dobro zasnovanim sistemom managed by a well-designed, fully implemented

vodenja kakovosti, ki se izvaja v celoti in quality management system that facilitates

omogoča:
 vrednotenje novih ali alternativnih  evaluation of new or alternative POCT
instrumentov in sistemov POCT, instruments and systems,
 vrednotenje in odobritev predlogov ter  evaluation and approval of end-user
protokolov končnih uporabnikov, proposals and protocols,

 nabavo, namestitev in vzdrževanje opreme,  purchase, installation and maintenance of

equipment,
 vzdrževanje potrošnega materiala in  maintenance of consumable supplies and
reagentov, reagents,

 usposabljanje, certificiranje in ponovno  training, certification and recertification of

certificiranje operaterjev sistemov za POCT POCT system operators, and
ter
 kontrolo kakovosti in zagotavljanje  quality control and quality assurance.
kakovosti.

Organi, ki priznavajo kompetentnost ustanov, ki Bodies that recognize the competence of POCT

izvajajo POCT, lahko ta dokument uporabljajo kot facilities may use this document as the basis for

podlago za svoje dejavnosti. Če zdravstvena their activities. If a healthcare facility seeks

ustanova želi pridobiti akreditacijo za del svojih accreditation for a part or all of its activities, it

dejavnosti ali vse dejavnosti, naj izbere should select an accreditation body that operates

akreditacijski organ, ki pri delovanju upošteva in a manner which takes into account the special

posebne zahteve za POCT. requirements of POCT.
---------------------- Page: 7 ----------------------
SIST EN ISO 22870 : 2017
Testiranje ob pacientu (POCT) – Point-of-care testing (POCT) —
Zahteve za kakovost in Requirements for quality and
kompetentnost competence
1 Področje uporabe 1 Scope

Ta dokument podaja posebne zahteve, ki se This document gives specific requirements

uporabljajo za testiranje ob pacientu (POCT), in applicable to point-of-care testing and is intended

se uporablja skupaj s standardom ISO 15189. to be used in conjunction with ISO 15189. The

Zahteve tega dokumenta se uporabljajo, kadar se requirements of this document apply when POCT

POCT izvaja v bolnišnici, kliniki ali zdravstveni is carried out in a hospital, clinic and by a

organizaciji, ki zagotavljajo ambulantno oskrbo. healthcare organization providing ambulatory

Ta dokument se lahko uporablja za transkutane care. This document can be applied to

meritve, analizo izdihanega zraka ter spremljanje transcutaneous measurements, the analysis of

fizioloških parametrov in vivo. expired air, and in vivo monitoring of physiological

parameters.

Testiranje, ki ga pacient izvaja sam doma ali v Patient self-testing in a home or community

skupnostih, ni vključeno, vendar so lahko nekateri setting is excluded, but elements of this document

deli tega dokumenta uporabni. can be applicable.

OPOMBA: Upoštevati je treba lokalne, regionalne in NOTE Local, regional and national regulations are

nacionalne predpise. to be taken into consideration.
2 Zveza z drugimi standardi 2 Normative references

Naslednji dokumenti se sklicujejo na besedilo na The following documents are referred to in the text

takšen način, da njihov del ali celotna vsebina in such a way that some or all of their content

predstavljajo zahteve tega dokumenta. Pri constitutes requirements of this document. For

datiranih sklicevanjih se uporablja le navedena dated references, only the edition cited applies.

izdaja. Pri nedatiranih sklicevanjih se uporablja For undated references, the latest edition of the

zadnja izdaja referenčnega dokumenta (vključno referenced document (including any

z vsemi dopolnili). amendments) applies.
ISO 15189:2012 Medicinski laboratoriji – ISO 15189:2012, Medical laboratories —
Zahteve za kakovost in Requirements for quality and
kompetentnost competence
3 Izrazi in definicije 3 Terms and definitions

V tem dokumentu se uporabljajo naslednji izrazi For the purposes of this document, the following

in definicije. terms and definitions apply.

ISO in IEC hranita terminološke zbirke podatkov ISO and IEC maintain terminological databases

za uporabo v standardizaciji na naslednjih for use in standardization at the following

naslovih: addresses:
 IEC Electropedia: na voljo na spletnem  IEC Electropedia: available at
mestu http://www.electropedia.org/ http://www.electropedia.org/

 brskanje po spletni strani ISO: na voljo na  ISO Online browsing platform: available at

spletnem mestu http://www.iso.org/obp http://www.iso.org/obp
3.1 3.1
testiranje ob pacientu point-of-care testing
POCT POCT
testiranje v bližini pacienta near-patient testing

testiranje, ki se izvaja v bližini pacienta ali ob testing that is performed near or at the site of a

pacientu in katerega rezultat privede do patient with the result leading to possible change

morebitne spremembe pri oskrbi pacienta in the care of the patient
---------------------- Page: 8 ----------------------
SIST EN ISO 22870 : 2017
4 Zahteve za vodenje 4 Management requirements
4.1 Organizacija in vodenje 4.1 Organization and management

4.1.1 Uporabljata se točki 4.1.1.2 in 4.1.1.3 4.1.1 ISO 15189:2012, 4.1.1.2, 4.1.1.3 and the

standarda ISO 15189:2012 ter naslednje. following apply.

Vodstvo laboratorija mora planirati in razvijati The management of laboratory services shall

procese, potrebne za POCT. plan and develop the processes needed for
POCT.

Upoštevati je treba naslednje, kot je ustrezno: The following shall be considered, as

appropriate:

a) cilje kakovosti in zahteve za POCT; a) quality objectives and requirements for

POCT;
b) potrebo po vzpostavitvi procesov in b) the need to establish processes and

dokumentov ter po priskrbi virov, specifičnih documents, and provide resources specific

za POCT; to POCT;
c) zahtevano overjanje, validacijo in c) required verification, validation, and

spremljanje aktivnosti, specifičnih za monitoring of activities specific to POCT;

POCT;
d) zapise za dokazovanje, da procesi in d) records to provide evidence that POCT
postopki POCT izpolnjujejo zahteve. processes and procedures meet
requirements.

Vodstvo organizacije mora biti končno The governing body of the organization shall be

odgovorno za zagotavljanje, da so vzpostavljeni ultimately responsible for ensuring that

ustrezni ukrepi za spremljanje točnosti in appropriate measures are in place to monitor the

kakovosti POCT, ki se opravlja v zdravstveni accuracy and quality of POCT conducted within

organizaciji. the healthcare organization.

4.1.2 Uporablja se točka 4.1.2.2 standarda ISO 4.1.2 ISO 15189:2012, 4.1.2.2, and the following

15189:2012 in naslednje podtočke. subclauses apply.

4.1.2.1 Vodstvo imenuje skupino zdravstvenih 4.1.2.1 A health professional grouping (e.g.

delavcev (npr. medicinski svetovalni odbor), ki Medical Advisory Committee) shall be

mora biti odgovorna za določitev obsega POCT. responsible to the governing body for defining the

Pri tem mora upoštevati klinično potrebo po scope of POCT to be made available. This shall

POCT, njegove finančne posledice, tehnično take into consideration the clinical need for POCT,

izvedljivost in sposobnost organizacije za its financial implications, technical feasibility and

izpolnjevanje potrebe. the ability of the organization to fulfil the need.

4.1.2.2 Vodja laboratorija ali od njega 4.1.2.2 The laboratory director or designate shall

pooblaščena oseba mora imenovati appoint a multidisciplinary POCT management

multidisciplinarno skupino za vodenje POCT, group with representation from the laboratory,

katere člani zastopajo laboratorij, upravo in administration and clinical programmes including

klinična področja, vključno z zdravstveno nego, nursing to advise on the provision of POCT.

za svetovanje o izvajanju POCT.

4.1.2.3 Skupina za vodenje mora zagotoviti, da 4.1.2.3 The management group shall ensure that

so odgovornosti in pooblastila določeni ter da je responsibilities and authorities are defined and

osebje organizacije s tem seznanjeno. communicated within the organization.

4.1.2.4 Skupina za vodenje mora pomagati pri 4.1.2.4 The management group shall assist in

vrednotenju ter izbiri pripomočkov in sistemov za evaluating and selecting POCT devices and

POCT. Merila za delovanje pripomočkov za systems. Performance criteria for POCT devices

POCT naj vključujejo upoštevanje pravilnosti, should include consideration of trueness,

---------------------- Page: 9 ----------------------
SIST EN ISO 22870 : 2017

natančnosti, meje detekcije, omejitev pri uporabi precision, detection limits, use limits and

in interference. Upoštevala naj bi se tudi interferences. Practicability should also be

praktičnost uporabe. considered.

4.1.2.5 Skupina za vodenje mora obravnavati 4.1.2.5 The management group shall consider all

vse predloge za uvedbo posameznega proposals to introduce any product, device or
proizvoda, pripomočka ali sistema za POCT. system for POCT.

4.1.3 Uporablja se točka 4.1.1.1 standarda ISO 4.1.3 ISO 15189:2012, 4.1.1.1 applies.

15189:2012.
4.2 Sistem vodenja kakovosti 4.2 Quality management system

4.2.1 Uporabljajo se točke 4.1.2.3, 4.1.2.4 in 4.2.1 ISO 15189:2012, 4.1.2.3, 4.1.2.4, 4.1.2.6

4.1.2.6 standarda ISO 15189:2012 ter and the following apply.
naslednje.

4.2.2 Vodstvo laboratorija mora vzpostaviti, 4.2.2 The management of laboratory services

dokumentirati, izvajati in vzdrževati sistem shall establish, document, implement and

vodenja kakovosti ter nenehno izboljševati maintain a quality management system and

njegovo uspešnost. continually improve its effectiveness.

4.2.2.1 Vodstvo laboratorija mora: 4.2.2.1 The management of laboratory services

shall

a) identificirati procese, potrebne za sistem a) identify the processes needed for the quality

vodenja kakovosti POCT v celotni management system for POCT throughout
organizaciji, the organization,

b) določiti zaporedje in medsebojne vplive teh b) determine the sequence and interaction of

procesov, these processes,

c) določiti kriterije in metode, potrebne za c) determine criteria and methods needed to

zagotovitev uspešnega delovanja in tudi ensure that both the operation and control of

uspešnega obvladovanja teh procesov, these processes are effective,

d) zagotoviti, da so na voljo viri in informacije, d) ensure the availability of resources and

potrebni za podporo delovanja in za information necessary to support the
nadzorovanje teh procesov, operation and monitoring of these
processes,

e) nadzorovati, meriti in analizirati te procese, e) monitor, measure and analyse these

processes,

f) izvajati ukrepe, potrebne za doseganje f) implement actions necessary to achieve

planiranih rezultatov in za nenehno planned results and continual improvement
izboljševanje teh procesov, ter of these processes, and
g) imenovati osebo z ustrezno g) appoint a person with appropriate training
usposobljenostjo in izkušnjami za vodjo and experience as quality manager

kakovosti, ki je odgovoren za kakovost responsible for POCT quality, which includes

POCT, kar vključuje pregledovanje zahtev v review of the requirements related to POCT.

zvezi s POCT.

Organizacija mora voditi te procese v skladu z These processes shall be managed by the

...

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