SIST-TS ISO/TS 20658:2018

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

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 2017
© ISO 2017, Published in Switzerland
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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
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 .
...