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GB/T 29790-2020: (Instant inspection quality and ability requirements)
Status: Valid GB/T 29790: Evolution and historical versions
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| GB/T 29790-2020 | English | 229 |
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(Instant inspection quality and ability requirements)
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GB/T 29790-2020
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| GB/T 29790-2013 | English | 479 |
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Point-of-care testing (POCT) -- Requirements for quality and competence
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GB/T 29790-2013
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PDF similar to GB/T 29790-2020
Basic data | Standard ID | GB/T 29790-2020 (GB/T29790-2020) | | Description (Translated English) | (Instant inspection quality and ability requirements) | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 12,193 | | Date of Issue | 2020-11-19 | | Date of Implementation | 2021-12-01 | | Older Standard (superseded by this standard) | GB/T 29790-2013 | | Regulation (derived from) | National Standard Announcement No. 26 of 2020 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 29790-2020: (Instant inspection quality and ability requirements)---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.
(Instant inspection quality and ability requirements)
ICS 03.120.10;11.100
C30
National Standards of People's Republic of China
Replace GB/T 29790-2013
Instant inspection of quality and capability requirements
(ISO 22870.2016, IDT)
2020-11-19 released
2021-12-01 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Preface Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Management requirements 1
4.1 Organization and Management 1
4.2 Quality Management System 2
4.3 Document Control 3
4.4 Service Agreement 3
4.5 Inspection by commissioned laboratory 3
4.6 External services and supplies 3
4.7 Consulting Service 3
4.8 Resolution of complaints 3
4.9 Identification and control of nonconformities 3
4.10 Corrective action 3
4.11 Preventive measures 4
4.12 Continuous improvement 4
4.13 Quality and technical records 4
4.14 Internal audit 4
4.15 Management Review 4
5 Technical requirements 5
5.1 Personnel 5
5.2 Facilities and environmental conditions 6
5.3 Laboratory equipment 6
5.4 Pre-inspection process 6
5.5 Inspection process 6
5.6 Quality Assurance During Inspection 6
5.7 Post-inspection process 7
5.8 Results report 7
Reference 8
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 29790-2013 "Requirements for Instant Testing Quality and Capability". Compared with GB/T 29790-2013, the main
The main technical changes are as follows.
---Modify the "Immediate Inspection" in the standard to "Immediate Inspection";
---Modified some terms in the standard, changed "laboratory leader" to "laboratory director", "detection limit" to "detection limit", "medical care
"Provider" is replaced by "medical personnel", etc.;
--- Deleted the "GB/T 22576-2008 5.1.3 and the following content applies" requirements (see 5.1.2, the.2013 edition of 5.1.2);
--- Deleted 5.1.3, 5.6.4, 5.6.7 (see 5.1.3, 5.6.4, 5.6.7 of the.2013 version);
--- Modified b) and d) in 5.1.4, and added "certification" related content (see 5.1.4, 5.1.5 of the.2013 edition);
---Modified 5.4 "pre-inspection procedure", changed to "pre-inspection process" (see 5.4,.2013 edition of 5.4);
---Modified 5.5 "inspection procedure", changed to "inspection process" (see 5.5, the.2013 edition of 5.5);
---Modified 5.6 "Quality Assurance of Inspection Procedures" and changed to "Quality Assurance of Inspection Processes" (see 5.6,.2013 edition of 5.6);
--- Modified 5.7 "procedure after inspection", changed to "process after inspection" (see 5.7, 5.7 in the.2013 edition).
The use of the translation method in this standard is equivalent to the adoption of ISO 22870.2016 "Requirements for immediate inspection quality and ability."
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. Beijing Institute of Medical Device Inspection, China National Accreditation Center for Conformity Assessment, No.
Second Medical Center, Beijing Tiantan Hospital Affiliated to Capital Medical University, First Affiliated Hospital of Zhejiang University School of Medicine.
The main drafters of this standard. Song Wei, Hu Dongmei, Deng Xinli, Zhang Guojun, Yang Daqian.
The previous versions of the standard replaced by this standard are as follows.
---GB/T 29790-2013.
Introduction
Traditional testing of patient fluids, excreta and tissue samples is usually in a regulated and controlled environment of a recognized medical laboratory
In progress. There is growing interest in these laboratories to introduce quality management systems and gain accreditation.
Technological advancements have led to the emergence of various in vitro diagnostic (IVD) medical devices that are compact in design and convenient to use.
It is possible to conduct inspections at or near the location. Immediate/proximity testing is beneficial to patients and medical institutions.
The risks that immediate inspection brings to patients and institutions can be controlled by a well-designed and fully implemented quality management system, which can
promote.
--- Evaluation of new or alternative POCT equipment and systems;
---Evaluation and approval of end user proposals and plans;
--- Equipment purchase, installation and maintenance;
---Maintenance of consumables and reagents;
---POCT system operator training, certification and renewal;
---Quality control and quality assurance.
Organizations that recognize the capabilities of POCT laboratories can use this standard as the basis for their activities. Seeking for some or all of its activities
An accredited medical institution should choose an accredited institution that operates in accordance with the specific requirements of POCT.
Instant inspection of quality and capability requirements
1 Scope
This standard specifies special requirements applicable to point-of-care inspection (POCT) and is used in conjunction with GB/T 22576.1-2018.This standard
The requirements apply to real-time inspections in hospitals, clinics or medical institutions that provide mobile medical services. This standard can be applied to
Skin measurement, breath analysis and in vivo monitoring of physiological parameters.
This standard does not include patient self-tests at home or in the community, but the elements of this standard are applicable.
Note. Local, regional and national regulations need to be considered.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories Part 1.General requirements (ISO 15189.2012,
IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Point-of-care testing; POCT
Near-patient testing
Tests performed near or at the patient’s location, the results of which may lead to changes in the patient’s treatment.
4 Management requirements
4.1 Organization and management
4.1.1 GB/T 22576.1-2018 4.1.1.2, 4.1.1.3 and the following clauses apply.
The management of laboratory services should plan and formulate the processes required for POCT.
When applicable, the following should be considered.
a) POCT's quality objectives and requirements;
b) Need to establish POCT-specific processes and documents, and provide resources;
c) Specific verification, confirmation and supervision activities required by POCT;
d) Provide records proving that the POCT process and procedures meet the requirements.
The manager of the organization is ultimately responsible for ensuring that appropriate measures are in place to monitor the accuracy and quality of the POCT running in the medical institution.
4.1.2 The clauses 4.1.2.2 and below in GB/T 22576.1-2018 apply.
4.1.2.1 A medical professional body (such as a medical advisory committee) should be accountable to the manager and determine the scope of POCT that can be provided. This test
Taking into account the clinical needs, financial matters, technical feasibility of POCT, and the organization's ability to meet the needs.
4.1.2.2 The laboratory director or his designated personnel shall designate a multidisciplinary POCT management team, with personnel from the laboratory, management
Bed, nursing, and advice on the implementation of POCT.
4.1.2.3 The management team shall ensure that responsibilities and authorities are defined and communicated within the organization.
4.1.2.4 The management team shall assist in the evaluation and selection of POCT equipment and systems. POCT equipment should consider its practicality, and its performance requirements should include
Including accuracy, precision, detection limit, limitation and interference.
4.1.2.5 The management team shall consider all recommendations regarding the introduction of POCT products, equipment or systems.
4.1.3 4.1.1.1 of GB/T 22576.1-2018 applies.
4.2 Quality Management System
4.2.1 The provisions of 4.1.2.3, 4.1.2.4, 4.1.2.6 and the following in GB/T 22576.1-2018 apply.
4.2.2 The management of laboratory services shall establish, document, implement and maintain a quality management system and continuously improve its effectiveness.
4.2.2.1 The management of laboratory services shall.
a) Identify the processes required for the POCT quality management system throughout the organization;
b) Determine the sequence and relationship of these processes;
c) Determine the required standards and methods to ensure the effective operation and control of these processes;
d) Ensure the availability of resources and information necessary to support the operation and supervision of these processes;
e) monitoring, measuring and analyzing these processes;
f) Implement the necessary measures to achieve the expected results and continuous improvement of these processes;
g) Designate a person who has received appropriate training and experience as the quality supervisor to be responsible for the quality of POCT, including reviewing POCT phases
Related requirements.
The organization shall manage these processes in accordance with the requirements of this standard.
The processes necessary for the above-mentioned quality management system should include management activities, resource provision, service configuration and measurement implementation.
4.2.2.2 The management of laboratory services shall plan and implement the necessary supervision, measurement, analysis and improvement processes to prove POCT and quality
System compliance.
4.2.3 The quality management system documents shall include.
a) Documented statement of quality policy and quality objectives;
b) Quality manual;
c) Documented procedures required by this standard;
d) Documents required by the organization to ensure effective planning, operation and process control;
e) Records required by this standard.
Note. In this standard, the term "documented procedures" refers to procedures for formulation, documentation, implementation and maintenance.
The content of the quality management system documents of different organizations may be different due to the following reasons.
---The size of the organization and the type of activities;
---The complexity of the process and its interaction;
---The ability of personnel.
Documents can be in any form or type of medium, and can be maintained within the prescribed storage time according to local, regional or national requirements.
Care and retrieval.
4.2.4 4.1.2.3, 4.1.2.4 and the following clauses in GB/T 22576.1-2018 apply.
The laboratory director or suitably qualified designated person shall ensure.
a) Establish and measurable POCT quality goals;
b) Plan the quality management system to meet the requirements of service and quality objectives;
c) When planning and changing the quality management system, the laboratory management shall ensure that its integrity is maintained.
4.2.5 The provisions of 4.2.2 and the following in GB/T 22576.1-2018 apply.
The organization shall develop and maintain a quality manual, which includes.
a) The scope of the quality management system;
b) Documented procedures established for the quality management system, or its source;
c) Description of the interaction between the processes of the quality management system.
4.3 Document control
4.3 in GB/T 22576.1-2018 applies.
4.4 Service Agreement
4.4 in GB/T 22576.1-2018 applies.
4.5 Inspection by commissioned laboratory
This clause does not apply to this standard.
4.6 External services and supplies
4.6 of GB/T 22576.1-2018 applies.
4.7 Consulting Service
4.7 of GB/T 22576.1-2018 applies.
4.8 Resolution of complaints
4.8 of GB/T 22576.1-2018 applies.
4.9 Identification and control of nonconformities
4.9.1 GB/T 22576.1-2018 4.9 and the following clauses apply.
4.9.2 The organization shall ensure that POCTs that do not meet the requirements are identified and controlled to prevent unintended applications. Should be in a documented procedure
Clearly stipulate the responsibility and authority for controlling and handling non-conforming POCT.
The organization shall adopt one or more of the following methods to deal with non-conformance to POCT.
a) Take measures to eliminate nonconformities that have been found;
b) Authorize its use, release and acceptance;
c) Take measures to limit its initial intended use or application.
A record of the nature of the nonconformity and subsequent measures should be kept.
4.9.3 The organization shall determine, collect and analyze appropriate data to evaluate the effectiveness of the continuous improvement of the quality management system. The data shall include
Monitoring, measurement and other relevant source data.
4.9.4 Data analysis should provide the following relevant information.
a) Medical staff/patient/client satisfaction (see 4.12);
b) Compliance with POCT requirements (see 4.2);
c) The characteristics and trends of POCT, including the timing of preventive measures;
d) Supplier.
4.10 Corrective actions
4.10.1 The provisions of 4.10 and below in GB/T 22576.1-2018 apply.
4.10.2 The organization shall take measures to eliminate the causes of nonconformities to prevent their recurrence. Corrective actions should be related to the impact of
Adapt to the sound.
4.10.3 A documented procedure shall be established to specify the following requirements.
a) Review non-conformities (including complaints from medical staff/patients/customers);
b) Determine the reason for the nonconformity;
c) Evaluate the necessity of measures taken to ensure that non-conformities no longer occur;
d) Determine and implement the required measures;
e) Records of the results of measures taken;
f) Review the corrective actions taken.
4.11 Preventive measures
4.11.1 GB/T 22576.1-2018 4.11 and the following clauses apply.
4.11.2 The organization shall determine measures to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive measures should be commensurate with the impact of potential problems
adapt.
4.11.3 A documented procedure shall be established to specify the following requirements.
a) Identify potential non-conformities and their causes;
b) Evaluate the necessity of measures taken to prevent the occurrence of nonconformities;
c) Determine and implement the required measures;
d) Records of the results of measures taken;
e) Review the preventive measures taken.
4.12 Continuous improvement
4.12.1 GB/T 22576.1-2018 4.12, 4.14.6, 4.14.7 and the following provisions apply.
4.12.2 The quality assurance plan shall regularly review the relevant benefits of POCT, the application method of supervision and testing, and conduct audits to confirm record protection.
Save and review the critical value report.
4.13 Quality and technical records
4.13.1 GB/T 22576.1-2018 4.13 and the following clauses apply.
4.13.2 Records shall be established and maintained to provide evidence of compliance and effective operation of the quality management system. Records should be clear and easy to identify
And retrieval. Documented procedures should be established to specify the control required for the identification, storage, protection, retrieval, preservation time and disposal of records.
4.14 Internal audit
4.14.1, 4.14.5 and the following clauses in GB/T 22576.1-2018 apply.
a) The laboratory director or designated personnel with appropriate qualifications and the multidisciplinary POCT management team shall receive and review the quality assurance plan
report.
b) The modification suggestions made during the audit, if approved, should be incorporated into the POCT policies, processes and procedures.
4.15 Management review
4.15.1 GB/T 22576.1-2018 4.15 and the following clauses apply.
4.15.2 The laboratory director or designated personnel with appropriate qualifications shall conduct periodic management reviews, including.
---Cost-benefit analysis and evaluation of clinical needs;
---The clinical effectiveness and cost efficiency of POCT activities;
---Identify the timing of improvement.
Note. See [7] in the references.
4.15.3 The management review input shall include the following information.
a) Audit results;
b) Feedback from medical staff/patients/customers;
c) Process performance and service compliance;
d) The status of preventive and corrective measures;
e) Follow-up measures for the previous management review;
f) Changes that may affect the quality management system;
g) Suggestions for improvement.
4.15.4 The laboratory director or designated personnel with appropriate qualifications shall modify the policies, processes or procedures based on the results of the management review.
5 Technical requirements
5.1 Personnel
4.1.1.4, 5.1 and the following clauses in GB/T 22576.1-2018 apply.
5.1.1 The organization shall determine and provide the required human resources to.
a) Implement and maintain the POCT quality management system and continuously improve its effectiveness;
b) Ensure that all personnel involved in POCT services, projects and departments are provided with the required training;
c) Improve medical staff/patient/customer satisfaction by meeting customer requirements.
5.1.2 The laboratory director or other suitably qualified personnel shall be responsible for.
a) Obtain, evaluate and select all POCT equipment, reagents and systems, including quality control materials;
b) Develop documented quality policies and programs for all POCT operations and related quality control and quality assurance.
A suitable laboratory expert can be appointed to take full charge of the POCT work.
5.1.3 GB/T 22576.1-2018 4.1.2.5 and the following content apply.
The management team should assign responsibilities and assign personnel to operate POCT. The responsibilities and responsibilities of each group of personnel should be specified in the operating procedures.
5.1.4 The 5.1.2, 5.1.6, 5.1.8 and the following in GB/T 22576.1-2018 apply.
The laboratory director or other suitably qualified personnel can appoint a suitably trained and experienced person to manage training and competence
Evaluation.
a) The supervisor should develop, implement and maintain an appropriate theoretical and practical training plan for all POCT personnel.
The supervisor can appoint a suitable technical expert or technician to be responsible for training a specific POCT equipment/system.
b) Only personnel who have completed training and have proven their ability should operate POCT, and their training/assessment (or certification) should be saved,
And retraining/reassessment (or recertification) records.
c) The content of the training plan and the knowledge/skill level assessment process should be documented.
Knowledge/skills requirements include. proof of the ability to understand the correct use of equipment, measurement system (chemical and sensor) principles, and concerns
The pre-analysis link includes.
---Sample collection;
---Clinical application and limitations;
---Professional skills of analysis procedures;
---Storage of reagents;
---Quality control and quality assurance;
---Technical limitations of the equipment;
---Response to results that exceed a predetermined value;
---Infection control operations;
--- Correct records and maintenance of results.
d) The management team should develop a retraining/recertification cycle and continuing education plan;
e) As part of the quality assurance plan, the work of POCT operators should be supervised.
5.2 Facilities and environmental conditions
5.2.1 The clauses 5.2 and below in GB/T 22576.1-2018 apply.
5.2.2 The place where POCT is carried out and the equipment used should comply with applicable national regulations or regional and local requirements.
5.2.3 The organization shall specify and manage the required working environment to achieve good working conditions, while complying with the requirements of POCT and equipment manufacturing
Manufacturer’s recommendations.
5.3 Laboratory equipment
5.3.1 The clauses 5.3, 5.9.2, 5.10 and the following in GB/T 22576.1-2018 apply.
5.3.2 The laboratory director or designated personnel with appropriate qualifications shall be responsible for the selection criteria and procurement of equipment, consumables and reagents.
a) A detailed list of all POCT equipment should be kept, including serial number, unique identification, manufacturer/supplier, date of purchase and use
History (including date of suspension);
b) Reagents, kits and equipment should be verified before routine use;
c) There should be written procedures for the maintenance and operation of POCT equipment;
d) If the POCT equipment or system does not meet the key requirements or has safety issues, the management team should recommend to stop;
e) Records of purchased POCT consumables and reagents should be kept to facilitate tracking and verification of specific tests;
f) Regular and irregular maintenance of equipment should be monitored and recorded.
5.4 Pre-inspection process
5.4.1 5.4.1, 5.4.4.2.and the following clauses in GB/T 22576.1-2018 apply.
5.4.2 The organization shall ensure that the identification of samples and their records can be traced back to the patient.
5.4.3 When samples taken from patients for POCT are controlled by the organization or used for them, the organization should take care of it. The organization shall identify and protect
Samples for analysis. If the sample is lost, damaged or found to be unsuitable for use, it should be reported to the responsible medical staff and kept
recording.
5.5 Inspection process
5.5.1 The clauses 5.5 and below in GB/T 22576.1-2018 apply.
5.5.2 All users should have access to the procedure manual for each POCT system.
5.5.3 After the document review, the manufacturer's recommendations regarding the minimum requirements for quality control of a specific equipment system can be accepted.
5.5.4 In the case of approval by the regulatory authority, the quality control data generated by the instrument should be accepted.
5.6 Quality assurance during inspection
5.6.1 GB/T 22576.1-2018 5.6 and the following clauses apply.
5.6.2 The quality supervisor shall be responsible for designing, implementing and operating quality control to ensure that POCT meets the quality standards of the central laboratory. Should be established
And publish the relationship between laboratory and POCT data, or get it when needed.
5.6.3 The quality supervisor may appoint a suitably qualified person to be responsible for the quality control of a particular POCT equipment/system. Duty
After the assignment, the quality supervisor shall still be responsible to the laboratory director or designated personnel for the quality of all POCT inspections.
5.6.4 When applicable, participate in the room quality assessment (EQA) (see GB/T 27043) upon request. In the absence of an EQA plan,
The laboratory director or his designated personnel should establish an indoor quality evaluation plan, including the distribution of samples or repeated testing in the laboratory.
5.6.5 The laboratory director or his designated personnel and the multidisciplinary POCT management team shall accept and review the external or internal quality evaluation data, and evaluate
The revision suggestions put forward by the review should be incorporated into the POCT policy, process and procedures.
5.6.6 The laboratory director shall confirm the following service process.
a) The quality control plan should verify the accuracy and precision of the instrument, including linearity when applicable;
b) Pack patient samples or other acceptable quality control materials to verify the performance of the POCT system used in multiple locations;
c) The frequency of indoor quality control for each piece of equipment should be specified;
d) Corrective actions taken for out-of-control results should be recorded;
e) The measures taken to the results of non-conformity quality control shall be recorded;
f) The quality control results should be recorded and reviewed regularly by the quality supervisor or its designated personnel;
g) The process control of consumables and reagents should be recorded and monitored;
h) If permitted, self-tests performed by inp...
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