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BSI 22/30447779 DC 2022

BSI 22/30447779 DC 2022

$13.70

BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples

Published By Publication Date Number of Pages
BSI 2022 51
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PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
14 4 General requirements
4.1 General
15 4.2 Ethical conduct
4.2.1 Impartiality
4.2.2 Confidentiality
16 4.2.3 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 Advisory activities
5.3.2 Structure and authority
17 5.3.3 Facility activities
5.3.4 Risk management
5.3.5 Emergency situations
6 Resource requirements
6.1 General
6.2 Personnel
6.2.1 General
18 6.2.2 Training
6.2.3 Competence assessment
19 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
20 6.3.3 Privacy and confidentiality
6.3.4 Equipment, supplies and storage
21 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
6.4.4 Equipment maintenance and repair
22 6.4.5 Equipment operation and instructions for use
6.4.6 Adverse incident reporting
6.4.7 Computer equipment
23 6.4.8 Records
7 Process requirements
7.1 General
7.2 Test selection and requesting
24 7.3 Request information
26 7.4 Patient identification and reception
7.4.1 Transcription
7.4.2 Information for patients and users
7.4.3 Patient identification
28 7.5 Patient preparation
7.6 Sample collection
7.6.1 General
7.6.2 Informed consent before sample collection
29 7.6.3 Instructions for collection activities
7.6.4 Patient-collected samples
30 7.7 Blood sample collection
7.7.1 General
7.7.2 Order of draw
31 7.7.3 Special considerations when performing venepuncture
32 7.7.4 Adult capillary puncture
7.7.5 Paediatric blood collection
33 7.7.6 Vascular access devices (VAD)
7.7.7 Arterial puncture
34 7.8 Identification of samples
7.8.1 General
7.8.2 Handling urgent samples
35 7.9 Sample integrity and stability
7.9.1 Sample integrity
7.9.2 Stability
36 7.9.3 Stabilization of samples
7.10 Package and transport of samples
7.10.1 General
7.10.2 Sample transport
37 7.10.3 Quality and safety monitoring
7.11 Infection prevention and control (biosafety)
7.11.1 Personal protective equipment
7.11.2 Hand hygiene
38 7.11.3 Personnel practices
7.11.4 Safe disposal
7.11.5 Patient protection
7.11.6 Cleaning and disinfection
39 7.11.7 Special precautions
8 Management system requirements
8.1 General requirements
8.2 Evaluation of pre-examination processes
8.2.1 Quality indicators
40 8.3 Facility user and personnel feedback
8.4 Customer satisfaction
41 Annex€A (informative) Your five moments for hand hygiene
42 Annex€B (informative) Disinfectants
44 Annex€C (informative) The pre-examination process
45 Annex€D (normative) Sample types other than blood
49 Bibliography

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BSI 22/30447779 DC 2022
$13.70