ISO/TS 22583:2024
(Main)Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment
Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment
This document provides requirements and recommendations for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.
Exigences et recommandations pour les superviseurs et les opérateurs de tests biologiques effectués près du patient (POCT)
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Specification
ISO/TS 22583
Second edition
Requirements and
2024-09
recommendations for supervisors
and operators of point-of-care
testing (POCT) equipment
Exigences et recommandations pour les superviseurs et les
opérateurs de tests biologiques effectués près du patient (POCT)
Reference number
© ISO 2024
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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Personnel . 4
4.1 Supervisor.4
4.2 Operators .4
4.2.1 General .4
4.2.2 Training .5
4.2.3 Competence .5
5 Point-of-care testing (POCT) equipment selection . 6
6 Point-of-care testing (POCT) process management . 6
6.1 General .6
6.2 Pre-testing stage .6
6.2.1 General .6
6.2.2 Planning and development of the POCT service .7
6.2.3 Suitable testing environment .7
6.2.4 Availability and adequacy of test consumables .7
6.2.5 POCT equipment readiness for use .8
6.2.6 Patient consent and counselling .8
6.2.7 Verification of the patient’s identity .9
6.2.8 Sample collection requirements .9
6.2.9 Factors interfering with testing .9
6.3 Testing stage .10
6.3.1 General .10
6.3.2 Internal quality control (IQC) .10
6.3.3 External quality assessment (EQA) .10
6.3.4 Performing the test .10
6.3.5 Identification and resolution of problems .11
6.4 Post-testing stage .11
6.4.1 Result recipients .11
6.4.2 Result interpretation . 12
6.4.3 Result reporting . 12
6.4.4 Handling and disposal . 13
6.4.5 Cleaning of POCT equipment . 13
6.5 External audits of the POCT service . 13
7 Information management considerations .13
7.1 General . 13
7.2 Confidentiality and security . 13
8 Documentation and record keeping .13
8.1 Documents. 13
8.2 Records and records management .14
8.2.1 General .14
8.2.2 Requirements for managing records .14
8.2.3 Correction of records .14
8.2.4 Storage of records .14
9 Health and safety consideration . 14
9.1 General .14
9.2 Biosafety and infection control procedures . 15
9.2.1 General . 15
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9.2.2 Use of sharps . 15
9.2.3 Personal protection . 15
9.2.4 Disposal of waste . 15
9.2.5 Hazard analysis . 15
9.3 Other health and safety considerations . 15
Annex A (normative) Training and competence of operators .16
Annex B (normative) Point-of-care testing (POCT) equipment and selection of the most
appropriate test . 19
Annex C (informative) Documents and records .25
Annex D (normative) Internal quality control (ICQ) and external quality assessment (EQA) .27
Annex E (informative) Biosafety and infection control procedures .31
Bibliography .33
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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has been established has the right to be represented on that committee. International organizations,
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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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As
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