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BS ISO 20658:2023

BS ISO 20658:2023

$198.66

Requirements for the collection and transport of samples for medical laboratory examinations

Published By Publication Date Number of Pages
BSI 2023 52
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PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 General requirements
4.1 General
13 4.2 Ethical conduct
4.2.1 General
4.2.2 Impartiality
4.2.3 Confidentiality
14 4.2.4 Requirements regarding patients, facility personnel and others
5 Structural requirements
5.1 Legal entity
5.2 Facility manager
5.2.1 Facility manager competence
5.2.2 Delegation of duties
5.3 Facility responsibilities and activities
5.3.1 Facility activities
15 5.3.2 Structure and authority
5.3.3 Advisory services
5.3.4 Risk management
5.3.5 Emergency situations
6 Resource requirements
6.1 General
16 6.2 Personnel
6.2.1 General
6.2.2 Training
17 6.2.3 Competence assessment
6.2.4 Continuing education and/or continuing professional development
6.2.5 Personnel records
6.3 Facilities and environmental conditions
6.3.1 General
6.3.2 Design
18 6.3.3 Privacy and confidentiality
19 6.3.4 Equipment, supplies and storage
6.3.5 Facility maintenance
6.3.6 Personnel facilities
6.4 Equipment, reagents, and consumables
6.4.1 General
6.4.2 Verification and storage
6.4.3 Inventory management
20 6.4.4 Equipment maintenance and repair
6.4.5 Equipment operation and instructions for use
6.4.6 Adverse incident reporting
21 6.4.7 Computer equipment
6.4.8 Records
7 Process requirements
7.1 General
7.2 Test selection and requesting
22 7.3 Request information
7.3.1 General
23 7.3.2 Request to perform sample collection for subsequent laboratory examination
24 7.3.3 Oral requests
7.3.4 Handling urgent requests
7.4 Patient identification and reception
7.4.1 Transcription
7.4.2 Information for patients and users
7.4.3 Patient identification
26 7.5 Patient preparation
7.6 Sample collection
7.6.1 General
27 7.6.2 Informed consent before sample collection
7.6.3 Instructions for collection activities
28 7.6.4 Patient-collected samples
7.7 Blood sample collection
7.7.1 General
7.7.2 Order of draw
29 7.7.3 Special considerations when performing venepuncture
30 7.7.4 Adult capillary puncture
7.7.5 Paediatric blood collection
31 7.7.6 Vascular access devices (VAD)
32 7.7.7 Arterial puncture
7.8 Identification of samples
7.8.1 General
33 7.8.2 Handling urgent samples
7.9 Sample integrity and stability
7.9.1 Sample integrity
34 7.9.2 Stability
7.9.3 Stabilization of samples
7.10 Package and transport of samples
7.10.1 General
35 7.10.2 Sample transport
36 7.10.3 Quality and safety monitoring
7.11 Infection prevention and control (biosafety)
7.11.1 Personal protective equipment (PPE)
7.11.2 Hand hygiene
37 7.11.3 Personnel practices
7.11.4 Safe disposal
7.11.5 Patient protection
7.11.6 Cleaning and disinfection
38 7.11.7 Special precautions
8 Management system requirements
8.1 General requirements
8.2 Evaluation of pre-examination processes
8.2.1 General
8.2.2 Quality indicators
39 8.3 Facility user and personnel feedback
8.4 Customer satisfaction
40 Annex A (normative) Your five moments for hand hygiene
41 Annex B (informative) Disinfectants
43 Annex C (informative) Pre-examination process
44 Annex D (normative) Sample types other than blood
48 Bibliography

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BS ISO 20658:2023
$198.66