Standard
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AS ISO 20658:2023
[Current]Requirements for the collection and transport of samples for medical laboratory examinations
AS ISO 20658:2023 identically adopts ISO 20658:2023, which specifies requirements and good practice recommendations for the collection and transport of samples intended for medical laboratory examinations
Published: 22/12/2023
Pages: 41
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General
4.2 Ethical conduct
4.2.1 General
4.2.2 Impartiality
4.2.3 Confidentiality
4.2.3.1 Management of information
4.2.3.2 Release and disclosure of information
4.2.3.3 Personnel responsibility
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
5.3.2 Structure and authority
5.3.2.1 Structure
5.3.2.2 Authority
5.3.3 Advisory services
5.3.4 Risk management
5.3.5 Emergency situations
6 Resource requirements
6.1 General
6.2 Personnel
6.2.1 General
6.2.2 Training
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
6.3.3 Privacy and confidentiality
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
6.4.4 Equipment maintenance and repair
6.4.4.1
6.4.4.2
6.4.4.3
6.4.4.4
6.4.4.5
6.4.5 Equipment operation and instructions for use
6.4.5.1
6.4.5.2
6.4.5.3
6.4.5.4
6.4.6 Adverse incident reporting
6.4.7 Computer equipment
6.4.8 Records
7 Process requirements
7.1 General
7.2 Test selection and requesting
7.3 Request information
7.3.1 General
7.3.2 Request to perform sample collection for subsequent laboratory examination
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
7.4.3.1 General
7.4.3.2 Routine patient identification
7.4.3.3 Patient identification in a medical emergency situation
7.4.3.4 Patient identification of babies and young children
7.5 Patient preparation
7.6 Sample collection
7.6.1 General
7.6.2 Informed consent before sample collection
7.6.3 Instructions for collection activities
7.6.4 Patient-collected samples
7.7 Blood sample collection
7.7.1 General
7.7.2 Order of draw
7.7.3 Special considerations when performing venepuncture
7.7.4 Adult capillary puncture
7.7.5 Paediatric blood collection
7.7.5.1 General
7.7.5.2 Patient preparation
7.7.5.3 Collection technique
7.7.5.4 Paediatric capillary puncture
7.7.6 Vascular access devices (VAD)
7.7.7 Arterial puncture
7.7.7.1 General
7.7.7.2 Special considerations when performing arterial blood sampling
7.7.7.3 Considerations when performing arterial blood sampling for blood gas analysis
7.8 Identification of samples
7.8.1 General
7.8.2 Handling urgent samples
7.9 Sample integrity and stability
7.9.1 Sample integrity
7.9.2 Stability
7.9.3 Stabilization of samples
7.10 Package and transport of samples
7.10.1 General
7.10.2 Sample transport
7.10.2.1 General
7.10.2.2 Pneumatic tube systems (PTS)
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
7.11.3 Personnel practices
7.11.4 Safe disposal
7.11.5 Patient protection
7.11.6 Cleaning and disinfection
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
8.3 Facility user and personnel feedback
8.4 Customer satisfaction
Annex A
Annex B
B.1 General
Annex C
Annex D
D.1 General
D.2 Respiratory tract samples
D.2.1 General
D.2.2 Swabs
D.3 Faecal samples
D.4 Urine samples
D.4.1 General
D.4.2 Midstream urine samples
D.4.3 Timed urine collections
D.5 Samples for fertility testing (semen)
D.6 Cerebrospinal fluids
D.7 Other body fluids
D.8 Biopsies and other tissue samples
D.9 Samples for cytology
D.10 Samples for microbiology
D.11 Samples for transfusion medicine (immunohaematology)
D.12 Samples for haematology coagulation studies
Bibliography
Cited references in this standard