Technical Specification
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SA TS ISO 22583:2021
[Superseded]Guidance for supervisors and operators of point-of-care testing (POCT) devices
Identically adopts ISO/TS 22583:2019, which gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document. KEYWORDS: POCT testing devices supervisors operators
Published: 12/02/2021
Pages: 35
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 Personnel
4.1 Supervisor
4.2 Operators
4.2.1 General
4.2.2 Training
4.2.3 Competence
5 Point-of-care testing equipment selection
6 Point-of-care testing process management
6.1 General
6.2 Pre-testing stage
6.2.1 General
6.2.2 Planning and development of the POCT service
6.2.3 Suitable testing environment
6.2.4 Availability and adequacy of test consumables
6.2.4.1 General
6.2.4.2 Collection devices
6.2.5 POCT equipment readiness for use
6.2.5.1 General
6.2.5.2 Validation of POCT equipment
6.2.5.3 Verification of POCT equipment
6.2.5.4 Calibration of POCT equipment
6.2.5.5 Preventive maintenance of POCT equipment
6.2.6 Patient consent and counselling
6.2.6.1 General
6.2.6.2 Patient consent
6.2.6.3 Patient counselling
6.2.7 Verification of the Patient’s identity
6.2.8 Sample collection requirements
6.2.9 Factors interfering with testing
6.3 Testing stage
6.3.1 General
6.3.2 Internal quality control
6.3.3 External quality assessment
6.3.4 Performing the test
6.3.4.1 General
6.3.4.2 Performing the test in the presence of the patient
6.3.4.3 Processing one sample at a time
6.3.4.4 Sample identification
6.3.4.5 Reading the result
6.3.5 Identification and resolution of problems
6.4 Post-testing stage
6.4.1 Result recipients
6.4.2 Result interpretation
6.4.3 Result reporting
6.4.3.1 General
6.4.3.2 Results which pose significant risk to patients and need immediate action
6.4.4 Handling and disposal
6.4.5 Cleaning of POCT equipment
6.5 External audits of the POCT service
7 Information management considerations
7.1 General
7.2 Confidentiality and security
8 Documentation and record keeping
8.1 Documents
8.2 Records and Records management
8.2.1 General
8.2.2 Requirements for managing records
8.2.3 Correction of records
8.2.4 Storage of records
9 Health and safety consideration
9.1 General
9.2 Infection prevention and control (biosafety)
9.2.1 General
9.2.2 Use of sharps
9.2.3 Personal protection
9.2.4 Disposal of waste
9.2.5 Hazard analysis
9.3 Other health and safety considerations
Annex A
A.1 General
A.2 Training:
A.3 Competence assessment
Annex B
B.1 Fit-for-purpose assessment of POCT equipment
B.1.1 General
B.1.2 Analytical performance
B.1.2.1 General
B.1.2.2 Equipment characteristics
B.1.3 Applying the important equipment characteristics
B.2 Validation and/or verification of methods and equipment
B.2.1 General
B.2.2 Validation of POCT equipment and tests
B.2.3 Verification of POCT equipment and tests
B.3 Calibration of POCT equipment
B.4 POCT equipment and in Vitro diagnostics (IVD) regulation
Annex C
C.1 Documents
C.2 Records
Annex D
D.1 General
D.2 Internal quality control
D.2.1 General
D.2.2 Quality control process
D.2.3 Quantitative IQC
D.2.4 Quantitative IQC ranges
D.2.5 Qualitative IQC
D.2.6 Qualitative IQC ranges
D.2.7 Other Quality checks
D.2.7.1 General
D.2.7.2 Lateral flow immunochromatographic POCT
D.2.8 Electronic QC
D.2.9 Corrective Action
D.3 External quality assessment
Annex E
E.1 Personal protective equipment
E.2 Hand hygiene
E.3 Personnel practices
E.4 Safe disposal
E.5 Patient protection
E.6 Cleaning and disinfection
E.7 Special precautions
Bibliography
Cited references in this standard