ISO/TS 20658:2017

Medical laboratories — Requirements for collection, transport, receipt, and handling of samples

ISO/TS 20658:2017 specifies requirements and good practice recommendations for the collection, transport, receipt and handling of samples intended for medical laboratory examinations. ISO/TS 20658:2017 is applicable to medical laboratories and other medical services involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection, transport, receipt and storage. It may also be applicable to some biobanks. ISO/TS 20658:2017 does not apply to blood and blood products intended for transfusion.

Laboratoires de biologie médicale — Exigences pour le prélèvement, le transport, la réception et la manipulation des échantillons

Medicinski laboratoriji - Zahteve za odvzem, transport, prejem in ravnanje z vzorci

Ta dokument določa zahteve in priporočila glede dobrih praks za zbiranje, transport, prejemanje vzorcev, predvidenih za medicinske laboratorijske preiskave, in ravnanje z njimi.
Ta dokument se uporablja za medicinske laboratorije in druge zdravstvene storitve, vključene v laboratorijske predpreiskovalne procese, ki vključujejo zahteve za preiskavo, pripravo in identifikacijo bolnika, jemanje vzorcev, transport, prejem in shranjevanje vzorcev. Lahko se uporablja tudi za nekatere biobanke.
Ta dokument se ne nanaša na kri in krvne proizvode, predvidene za transfuzijo.

General Information

• Status: Withdrawn
• Publication Date: 01-Nov-2017
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
• Drafting Committee: ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 19-May-2023
• Ref Project: SIST-TS ISO/TS 20658:2018 - Medical laboratories - Requirements for collection, transport, receipt, and handling of samples

Relations

• Revised: ISO 20658:2023 - Requirements for the collection and transport of samples for medical laboratory examinations
• Effective Date: 23-Apr-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS ISO/TS 20658:2018
01-maj-2018
Medicinski laboratoriji - Zahteve za odvzem, transport, prejem in ravnanje z vzorci
Medical laboratories - Requirements for collection, transport, receipt, and handling of
samples
Laboratoires de biologie médicale - Exigences pour le prélèvement, le transport, la
réception et la manipulation des échantillons
Ta slovenski standard je istoveten z: ISO/TS 20658:2017
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST-TS ISO/TS 20658:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS ISO/TS 20658:2018

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SIST-TS ISO/TS 20658:2018
TECHNICAL ISO/TS
SPECIFICATION 20658
First edition
2017-10
Medical laboratories — Requirements
for collection, transport, receipt, and
handling of samples
Laboratoires de biologie médicale — Exigences pour le prélèvement,
le transport, la réception et la manipulation des échantillons
Reference number
ISO/TS 20658:2017(E)
©
ISO 2017

---------------------- Page: 3 ----------------------

SIST-TS ISO/TS 20658:2018
ISO/TS 20658:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 4 ----------------------

SIST-TS ISO/TS 20658:2018
ISO/TS 20658:2017(E)

Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality management . 3
5 Pre-examination processes relating to patient samples. 4
5.1 General . 4
5.2 Laboratory test is ordered . 5
5.3 Sample request generation process . 5
5.4 Process for providing instructions to patients . 5
5.5 Patient identification process . 5
5.6 Preparation for sample collection process . 5
5.7 Primary sample collection and labelling process . 5
5.8 Preparation for transportation process . 5
5.9 Sample transport process . 5
5.10 Sample receipt process . 5
5.11 Process for preparing sample for examination . 5
6 Infrastructure and environmental conditions . 6
6.1 General . 6
6.2 Design . 6
6.2.1 General. 6
6.2.2 Safety and accessibility . 6
6.2.3 Privacy and confidentiality . 7
6.2.4 Equipment, supplies and storage . 7
6.3 Facility maintenance and environmental conditions . 7
6.4 Personnel facilities . 7
7 Equipment and supplies . 7
7.1 General . 7
7.2 Equipment acceptance testing . 7
7.3 Inspection and storage . 8
7.4 Inventory management . 8
7.5 Equipment maintenance and repair . 8
7.6 Equipment operation . 8
7.7 Computer equipment . 9
7.8 Equipment records . 9
8 Infection prevention and control (biosafety) .10
8.1 Personal protective equipment.10
8.2 Hand hygiene .10
8.3 Personnel practices .10
8.4 Safe disposal .10
8.5 Patient protection .11
8.6 Cleaning and disinfection . .11
8.7 Special precautions .11
9 Personnel .11
9.1 General .11
9.2 Training and competence .11
9.2.1 Personnel training .11
9.2.2 Competence and continuing education .12
9.3 Confidentiality and access to information .12
9.4 Personnel records.12
© ISO 2017 – All rights reserved iii

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SIST-TS ISO/TS 20658:2018
ISO/TS 20658:2017(E)

10 Information for patients and users of services .13
10.1 Information to be provided by laboratories that will receive the samples .13
10.2 Information for patients .14
11 Request form .15
11.1 Request form information .15
11.2 Verbal requests .16
11.3 Transcription .16
12 Patient identification .16
12.1 General .16
12.2 Routine patient identification .16
12.3 Patient identification in medical emergency situations .17
12.4 Patient identification of babies and young children .17
13 Identification of samples .17
14 Sample collection .18
14.1 General .18
14.2 Informed consent .18
14.3 Instructions for collection activities .19
14.4 Handling urgent requests .19
14.5 Blood sample collection .19
14.5.1 General.19
14.5.2 Order of draw.20
14.5.3 Special considerations when performing venipuncture .20
14.5.4 Adult capillary puncture .20
14.5.5 Paediatric venipuncture .21
14.5.6 Paediatric capillary puncture .21
14.6 Other samples .22
15 Sample integrity and stability .22
15.1 Sample integrity .22
15.2 Stability .23
15.3 Stabilization .23
16 Transport of samples .23
16.1 General .23
16.2 Sample transport .24
16.3 Quality monitoring .24
17 Sample receipt and assessment .24
17.1 General .24
17.2 Criteria for sample acceptance or rejection .24
17.3 Sample label confirmation .25
17.3.1 General.25
17.3.2 Managing nonconformities .25
17.4 Records of sample receipt .26
17.5 Sample tracking .26
17.6 Urgent samples .26
17.7 Chain of Custody .26
18 Sample storage prior to examination .26
19 Customer satisfaction .27
20 Identification and control of nonconformities.27
20.1 Identification of nonconformities .27
20.2 Records of nonconformities.27
21 Performance indicators .28
22 Documents and records .28
22.1 General .28
iv © ISO 2017 – All rights reserved

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SIST-TS ISO/TS 20658:2018
ISO/TS 20658:2017(E)

22.2 Documents .29
22.3 Records .29
Annex A (informative) Your five moments for hand hygiene .30
Annex B (informative) Disinfectants .31
Bibliography .33
© ISO 2017 – All rights reserved v

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SIST-TS ISO/TS 20658:2018
ISO/TS 20658:2017(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 voluntary nature of standards, 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.
This document was prepared by Technical Committee ISO/TC 212, Clinical Laboratory testing and in
vitro diagnostic test systems.
vi © ISO 2017 – All rights reserved

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SIST-TS ISO/TS 20658:2018
ISO/TS 20658:2017(E)

Introduction
Medical laboratory services are essential to patient care and public health and therefore, have to
be available to meet the needs of all patients and the clinical personnel responsible for the care of
those patients. Such services are required to be performed according to documented policies and
procedures for examination requests, patient preparation, patient identification, collection of samples,
transportation of samples, sample storage, processing, examination of samples and reporting results,
in addition to the considerations of safety and ethics in medical laboratory work.
This document provides guidance from a number of sources that are incorporated into a set of good
laboratory practices encompassing the pre-examination processes, in a way that meets published
requirements for sample collection and handling. This document is intended to be used by individuals
and organizations engaged in the collection of samples for submission to medical laboratories for
examination, for the purpose of ensuring the quality of laboratory services and to achieve better health
outcomes for the public.
It is acknowledged that a country could have its own specific guidance or requirements applicable to
professional personnel, their activities and their responsibilities in this domain.
Each laboratory or sample collection organization should determine its level of adherence to the good
laboratory practices described in this document. Management should take the first step by setting
appropriate priorities based on patient and customer needs, the resources available, as well as local,
regional and national mandates.
This document was developed based on the Canadian Standard CSA Z316.7−12.
© ISO 2017 – All rights reserved vii

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SIST-TS ISO/TS 20658:2018

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SIST-TS ISO/TS 20658:2018
TECHNICAL SPECIFICATION ISO/TS 20658:2017(E)
Medical laboratories — Requirements for collection,
transport, receipt, and handling of samples
1 Scope
This document specifies requirements and good practice recommendations for the collection, transport,
receipt and handling of samples intended for medical laboratory examinations.
This document is applicable to medical laboratories and other medical services involved in laboratory
pre-examination processes that include the examination request, patient preparation and identification,
sample collection, transport, receipt and storage. It may also be applicable to some biobanks.
This document does not apply to blood and blood products intended for transfusion.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
3.1
arterial puncture
procedure (3.13) that involves the collection of blood from arteries by puncturing the skin
3.2
biobank
entity that performs biobanking (3.3)
Note 1 to entry: A biobank encompasses staff, facilities and procedures (e.g. management systems) and includes
service providers, as well as repositories of biological materials.
3.3
biobanking
process (3.14) of receiving, collecting, storing and distributing biological materials from human, animal,
plant and microorganisms, as well as related information and data, for the purpose of research and
development
Note 1 to entry: Some or all of the following activities may also be included: processing, testing and analysing.
Note 2 to entry: For the purpose of this document, this definition only includes human materials procured solely
for diagnostic and treatment purposes, e.g. surgical pathology archives.
3.4
capillary puncture
procedure (3.13) that involves the collection of blood from capillaries by puncturing the skin
3.5
cleaning
process (3.14) to remove any type of contamination, visible or not
[SOURCE: ISO 15190:2003, 3.5]
© ISO 2017 – All rights reserved 1

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SIST-TS ISO/TS 20658:2018
ISO/TS 20658:2017(E)

3.6
decontamination
procedure (3.13) that eliminates or reduces microbial or toxic agents to a safe level with respect to the
transmission of infection or other adverse effects
[SOURCE: ISO 15190:2003, 3.7]
3.7
disinfection
process (3.14) of reducing the number of microorganisms, but not usually bacterial spores, without
necessarily killing or removing all organisms
[SOURCE: ISO 15190:2003, 3.9]
3.8
examination processes
analytical phase
set of operations having the object of determining the value or characteristics of a property
Note 1 to entry: Laboratory examinations are also often called assays or tests.
[SOURCE: ISO 15189:2012, 3.7, modified — Notes to entry 2 and 3 have been omitted.
...

TECHNICAL ISO/TS
SPECIFICATION 20658
First edition
2017-10
Medical laboratories — Requirements
for collection, transport, receipt, and
handling of samples
Laboratoires de biologie médicale — Exigences pour le prélèvement,
le transport, la réception et la manipulation des échantillons
Reference number
ISO/TS 20658:2017(E)
©
ISO 2017

---------------------- Page: 1 ----------------------
ISO/TS 20658:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 20658:2017(E)

Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality management . 3
5 Pre-examination processes relating to patient samples. 4
5.1 General . 4
5.2 Laboratory test is ordered . 5
5.3 Sample request generation process . 5
5.4 Process for providing instructions to patients . 5
5.5 Patient identification process . 5
5.6 Preparation for sample collection process . 5
5.7 Primary sample collection and labelling process . 5
5.8 Preparation for transportation process . 5
5.9 Sample transport process . 5
5.10 Sample receipt process . 5
5.11 Process for preparing sample for examination . 5
6 Infrastructure and environmental conditions . 6
6.1 General . 6
6.2 Design . 6
6.2.1 General. 6
6.2.2 Safety and accessibility . 6
6.2.3 Privacy and confidentiality . 7
6.2.4 Equipment, supplies and storage . 7
6.3 Facility maintenance and environmental conditions . 7
6.4 Personnel facilities . 7
7 Equipment and supplies . 7
7.1 General . 7
7.2 Equipment acceptance testing . 7
7.3 Inspection and storage . 8
7.4 Inventory management . 8
7.5 Equipment maintenance and repair . 8
7.6 Equipment operation . 8
7.7 Computer equipment . 9
7.8 Equipment records . 9
8 Infection prevention and control (biosafety) .10
8.1 Personal protective equipment.10
8.2 Hand hygiene .10
8.3 Personnel practices .10
8.4 Safe disposal .10
8.5 Patient protection .11
8.6 Cleaning and disinfection . .11
8.7 Special precautions .11
9 Personnel .11
9.1 General .11
9.2 Training and competence .11
9.2.1 Personnel training .11
9.2.2 Competence and continuing education .12
9.3 Confidentiality and access to information .12
9.4 Personnel records.12
© ISO 2017 – All rights reserved iii

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ISO/TS 20658:2017(E)

10 Information for patients and users of services .13
10.1 Information to be provided by laboratories that will receive the samples .13
10.2 Information for patients .14
11 Request form .15
11.1 Request form information .15
11.2 Verbal requests .16
11.3 Transcription .16
12 Patient identification .16
12.1 General .16
12.2 Routine patient identification .16
12.3 Patient identification in medical emergency situations .17
12.4 Patient identification of babies and young children .17
13 Identification of samples .17
14 Sample collection .18
14.1 General .18
14.2 Informed consent .18
14.3 Instructions for collection activities .19
14.4 Handling urgent requests .19
14.5 Blood sample collection .19
14.5.1 General.19
14.5.2 Order of draw.20
14.5.3 Special considerations when performing venipuncture .20
14.5.4 Adult capillary puncture .20
14.5.5 Paediatric venipuncture .21
14.5.6 Paediatric capillary puncture .21
14.6 Other samples .22
15 Sample integrity and stability .22
15.1 Sample integrity .22
15.2 Stability .23
15.3 Stabilization .23
16 Transport of samples .23
16.1 General .23
16.2 Sample transport .24
16.3 Quality monitoring .24
17 Sample receipt and assessment .24
17.1 General .24
17.2 Criteria for sample acceptance or rejection .24
17.3 Sample label confirmation .25
17.3.1 General.25
17.3.2 Managing nonconformities .25
17.4 Records of sample receipt .26
17.5 Sample tracking .26
17.6 Urgent samples .26
17.7 Chain of Custody .26
18 Sample storage prior to examination .26
19 Customer satisfaction .27
20 Identification and control of nonconformities.27
20.1 Identification of nonconformities .27
20.2 Records of nonconformities.27
21 Performance indicators .28
22 Documents and records .28
22.1 General .28
iv © ISO 2017 – All rights reserved

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ISO/TS 20658:2017(E)

22.2 Documents .29
22.3 Records .29
Annex A (informative) Your five moments for hand hygiene .30
Annex B (informative) Disinfectants .31
Bibliography .33
© ISO 2017 – All rights reserved v

---------------------- Page: 5 ----------------------
ISO/TS 20658:2017(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 voluntary nature of standards, 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.
This document was prepared by Technical Committee ISO/TC 212, Clinical Laboratory testing and in
vitro diagnostic test systems.
vi © ISO 2017 – All rights reserved

---------------------- Page: 6 ----------------------
ISO/TS 20658:2017(E)

Introduction
Medical laboratory services are essential to patient care and public health and therefore, have to
be available to meet the needs of all patients and the clinical personnel responsible for the care of
those patients. Such services are required to be performed according to documented policies and
procedures for examination requests, patient preparation, patient identification, collection of samples,
transportation of samples, sample storage, processing, examination of samples and reporting results,
in addition to the considerations of safety and ethics in medical laboratory work.
This document provides guidance from a number of sources that are incorporated into a set of good
laboratory practices encompassing the pre-examination processes, in a way that meets published
requirements for sample collection and handling. This document is intended to be used by individuals
and organizations engaged in the collection of samples for submission to medical laboratories for
examination, for the purpose of ensuring the quality of laboratory services and to achieve better health
outcomes for the public.
It is acknowledged that a country could have its own specific guidance or requirements applicable to
professional personnel, their activities and their responsibilities in this domain.
Each laboratory or sample collection organization should determine its level of adherence to the good
laboratory practices described in this document. Management should take the first step by setting
appropriate priorities based on patient and customer needs, the resources available, as well as local,
regional and national mandates.
This document was developed based on the Canadian Standard CSA Z316.7−12.
© ISO 2017 – All rights reserved vii

---------------------- Page: 7 ----------------------
TECHNICAL SPECIFICATION ISO/TS 20658:2017(E)
Medical laboratories — Requirements for collection,
transport, receipt, and handling of samples
1 Scope
This document specifies requirements and good practice recommendations for the collection, transport,
receipt and handling of samples intended for medical laboratory examinations.
This document is applicable to medical laboratories and other medical services involved in laboratory
pre-examination processes that include the examination request, patient preparation and identification,
sample collection, transport, receipt and storage. It may also be applicable to some biobanks.
This document does not apply to blood and blood products intended for transfusion.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
3.1
arterial puncture
procedure (3.13) that involves the collection of blood from arteries by puncturing the skin
3.2
biobank
entity that performs biobanking (3.3)
Note 1 to entry: A biobank encompasses staff, facilities and procedures (e.g. management systems) and includes
service providers, as well as repositories of biological materials.
3.3
biobanking
process (3.14) of receiving, collecting, storing and distributing biological materials from human, animal,
plant and microorganisms, as well as related information and data, for the purpose of research and
development
Note 1 to entry: Some or all of the following activities may also be included: processing, testing and analysing.
Note 2 to entry: For the purpose of this document, this definition only includes human materials procured solely
for diagnostic and treatment purposes, e.g. surgical pathology archives.
3.4
capillary puncture
procedure (3.13) that involves the collection of blood from capillaries by puncturing the skin
3.5
cleaning
process (3.14) to remove any type of contamination, visible or not
[SOURCE: ISO 15190:2003, 3.5]
© ISO 2017 – All rights reserved 1

---------------------- Page: 8 ----------------------
ISO/TS 20658:2017(E)

3.6
decontamination
procedure (3.13) that eliminates or reduces microbial or toxic agents to a safe level with respect to the
transmission of infection or other adverse effects
[SOURCE: ISO 15190:2003, 3.7]
3.7
disinfection
process (3.14) of reducing the number of microorganisms, but not usually bacterial spores, without
necessarily killing or removing all organisms
[SOURCE: ISO 15190:2003, 3.9]
3.8
examination processes
analytical phase
set of operations having the object of determining the value or characteristics of a property
Note 1 to entry: Laboratory examinations are also often called assays or tests.
[SOURCE: ISO 15189:2012, 3.7, modified — Notes to entry 2 and 3 have been omitted.]
3.9
hand hygiene
general term referring to any action of hand cleansing
[SOURCE: WHO Guidelines on Hand Hygiene in Health Care, 2009]
3.10
medical laboratory
clinical laboratory
laboratory for the biological, microbiological, immunological, chemical, immunohaematological,
haematological, biophysical, cytological, pathological, genetic or other examination of materials
derived from the human body for the purpose of providing information for the diagnosis, management,
prevention and treatment of disease in, or assessment of the health of, human beings, and which may
provide a consultant advisory service covering all aspects of laboratory investigation including the
interpretation of results and advice on further appropriate investigation
Note 1 to entry: These examinations also include procedures for determining, measuring or otherwise describing
the presence or absence of various substances or microorganisms.
[SOURCE: ISO 15189:2012, 3.11]
3.11
post-examination processes
post-analytical phase
processes (3.14) following the examination, including review of results, retention and storage of clinical
mater
...