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GBZ43281-2023: Guidance for supervisors and operators of point-of-care testing (POCT) devices
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/Z 43281-2023 | English | 564 |
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Guidance for supervisors and operators of point-of-care testing (POCT) devices
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GB/Z 43281-2023
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Basic data | Standard ID | GB/Z 43281-2023 (GB/Z43281-2023) | | Description (Translated English) | Guidance for supervisors and operators of point-of-care testing (POCT) devices | | Sector / Industry | National Standard | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.100.01, 03.100.30 | | Word Count Estimation | 31,322 | | Date of Issue | 2023-11-27 | | Date of Implementation | 2024-06-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GBZ43281-2023: Guidance for supervisors and operators of point-of-care testing (POCT) devices---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
GB /Z 43281-2023: Guidelines for supervisors and operators of point-of-care testing (POCT) equipment
ICS 11:100:01;03:100:30
CCSC30
National Standardization Guiding Technical Documents of the People's Republic of China
Point-of-care Testing (POCT) Equipment Supervisor and
Operator's Guide
testing(POCT)devices
Published on 2023-11-27
2024-06-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Table of contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 people 3
4:1 Supervisor 3
4:2 Operator 4
4:2:1 General 4
4:2:2 Training 4
4:2:3 Capabilities 4
5 Selection of POCT equipment 5
6 POCT process management 5
6:1 Overview 5
6:2 Pre-inspection phase 5
6:2:1 Overview 5
6:2:2 Planning and implementation of POCT services 5
6:2:3 Suitable inspection environment 6
6:2:4 Preparation for inspection of consumables 6
6:2:5 POCT equipment preparation 6
6:2:6 Patient consent and consultation 7
6:2:7 Verify patient identity 7
6:2:8 Sample collection requirements 7
6:2:9 Check for interference factors 8
6:3 Inspection phase 8
6:3:1 Overview 8
6:3:2 Internal quality control 8
6:3:3 External quality evaluation 8
6:3:4 Inspection 8
6:3:5 Identify and solve problems 9
6:4 Post-inspection phase 9
6:4:1 Result reception 9
6:4:2 Interpretation of results 9
6:4:3 Results reporting10
6:4:4 Handling and disposal10
6:4:5 Cleaning of POCT equipment 10
6:5 External audit of POCT services10
7 Information Management10
7:1 Overview10
7:2 Confidentiality and Security11
8 Documentation and Records11
8:1 Document 11
8:2 Records and records management11
8:2:1 Overview 11
8:2:2 Records management requirements 11
8:2:3 Recording corrections11
8:2:4 Record storage 11
9 Health and Safety12
9:1 General 12
9:2 Infection prevention and control (biosafety) 12
9:2:1 Overview 12
9:2:2 Use of sharp tools 12
9:2:3 Personal protection12
9:2:4 Waste disposal12
9:2:5 Hazard analysis 12
9:3 Other health and safety12
Appendix A (Normative) Operator Training and Competence13
Appendix B (Normative) Selection of POCT equipment and optimal testing 15
Appendix C (Informative) Documents and Records 19
Appendix D (normative) Internal quality control and external quality evaluation 20
Appendix E (Informative) Infection Prevention and Control (Biosafety) 23
Reference 25
Foreword
This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents"
Drafting:
This document is equivalent to ISO /T S22583:2019 "Guidelines for Point-of-Care Testing (POCT) Equipment Supervisors and Operators": The document type is:
ISO 's technical specifications were adjusted into my country's national standardization guiding technical documents:
Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:
This document is proposed by the National Medical Products Administration:
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136):
This document was drafted by: Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protective Equipment Inspection and Research Center), Shanghai Clinical
Bed Testing Center, Beijing Tiantan Hospital Affiliated to Capital Medical University, China National Accreditation Center for Conformity Assessment, Fuwai Hospital of the Chinese Academy of Medical Sciences,
The First Medical Center of the Chinese People's Liberation Army General Hospital, Guilin Unitech Medical Electronics Co:, Ltd:, Guangzhou Wondfo Biotechnology Co:, Ltd:
company:
The main drafters of this document: Song Wei, Ouou Zhu, Zhang Guojun, Zhou Jie, Zhou Zhou, Li Mianyang, Li Qiuping, and Sun Yaling:
Introduction
Due to the ease of use and immediacy of point-of-care testing (POCT), POCT equipment is widely used in patient health as a decision-making tool
related areas such as management or care needs: Simple and easy-to-use POCT equipment promotes the continuous development of POCT: Traditionally, the patient's physical
Fluid, excreta, and tissue examinations are performed in the controlled and supervised environment of medical laboratories, and POCT is increasingly performed globally
Conducted outside the traditional laboratory environment, such as pharmacies, clinics, nursing homes, emergency rescue sites, communities, shopping malls, etc:, and by people without
Medical laboratory support operators:
POCT results can be used for patient admission, transfer, and guidance of patient health management, and may also have significant civil and/or legal impacts:
effects, such as suspension or termination of employment, Family Court decisions, or revocation of bail or parole, so the equipment operates properly and produces the correct results, and
It is essential that operators are trained and competent, which requires supervisors to provide a quality inspection system and provide operators with
writer:
This document provides guidance for supervisors and operators performing POCT services to evaluate the POCT services, inspections and
Suitability of equipment selection, as well as technical performance and results interpretation requirements to ensure reliability of results, quality of results, and interpretation of results
Suitable for intended use:
Point-of-care Testing (POCT) Equipment Supervisor and
Operator's Guide
1 Scope
This document provides guidance for supervisors and operators performing point-of-care testing without medical laboratory training, supervision, or support:
Guidance on (POCT) services, including key points to consider in providing safe and reliable POCT results:
This document does not cover self-test products:
2 Normative reference documents
This document has no normative references:
3 Terms and definitions
The following terms and definitions apply to this document:
Terminology databases for standardization maintained by ISO and IEC at the following address:
---ISO online browsing platform: http://www:iso:org/obp;
3:1
analyteanalyte
An item that is measured, tested, or calculated:
Examples: glucose, troponin, cocaine, HIV antibodies:
3:2
reference rangereferencerange
normal rangenormalrange
normal valuenormalvalue
A defined interval of a distribution of values taken from a biological biological reference population:
Note 1: The reference interval consists of the values or ranges expected for the analyte (3:1) in "healthy persons": They are sometimes called "normal" values: Although the "normal" range can be said to
It indicates the health status of the patient (3:10), but it needs to be considered that the result is within the "normal" range and does not necessarily mean that the patient (3:10) is healthy:
Results in the "normal" range do not necessarily mean that the patient (3:10) is unhealthy: Also note that the "normal range" may vary from device to device (3:6) and
There are differences among different groups of people:
Note 2: In some cases, such as the normal value of drug testing is negative or not detected:
[Source: GB/T 22576:1-2018, 3:4, with modifications]
3:3
clinicalhandover clinicalhandover
patient handover patienthandover
Handover
The temporary or permanent transfer of some or all of the professional care duties and responsibilities for a patient (3:10) to another person or professional body:
Note 1: The handover of all or part of the treatment of a patient (3:10) between medical staff or between different locations is a high-risk situation, and errors in clinical handover can lead to
The main source of harm to patients (3:10), such mistakes can be avoided:
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