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GB/T 42060-2022 English PDF

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GB/T 42060-2022: Medical laboratories - Requirements for collection, transport, receipt, and handling of samples
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Basic data

Standard ID GB/T 42060-2022 (GB/T42060-2022)
Description (Translated English) Medical laboratories - Requirements for collection, transport, receipt, and handling of samples
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.100.01
Word Count Estimation 38,385
Date of Issue 2022-10-14
Date of Implementation 2023-05-01
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 42060-2022: Medical laboratories - Requirements for collection, transport, receipt, and handling of samples


---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.
Medical laboratories -- Requirements for collection, transport, receipt, and handling of samples ICS 11.100.01 CCSC30 National Standards of People's Republic of China medical laboratory Requirements for Sample Collection, Shipping, Reception and Processing Published on 2022-10-12 2023-05-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Foreword V Introduction VI 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Quality Management 3 5 Pre-test procedures related to patient samples3 5.1 General 3 5.2 Guidance for Laboratory Project Application 4 5.3 Implementation of the application5 5.4 Patient guidance5 5.5 Patient Identification 5 5.6 Preparation for sample collection 5 5.7 Original Sample Collection and Labeling 5 5.8 Preparation for shipment5 5.9 Sample Shipping5 5.10 Sample reception 5 5.11 Pre-inspection sample preparation 5 6 Facilities and environmental conditions5 6.1 General 5 6.2 Design 6 6.2.1 General 6 6.2.2 Security and Accessibility 6 6.2.3 Privacy and confidentiality6 6.2.4 Equipment, items and storage 6 6.3 Equipment maintenance and environmental conditions 6 6.4 Staff Facilities7 7 Equipment and items 7 7.1 General 7 7.2 Equipment reception test 7 7.3 Inspection and storage 7 7.4 Inventory management 7 7.5 Equipment maintenance and repair7 7.6 Equipment operation 8 7.7 Computer equipment 8 7.8 Equipment records8 8 Infection Prevention and Control (Biosecurity) 8 8.1 Personal protective equipment8 8.2 Hand hygiene9 8.3 Personnel Specification 9 8.4 Safe disposal9 8.5 PATIENT PROTECTION9 8.6 Cleaning and disinfection9 8.7 Special precautions 10 9 staff 10 9.1 General 10 9.2 Training and competencies 10 9.2.1 Personnel training 10 9.2.2 Competence and continuing education 10 9.3 Confidentiality and access to information11 9.4 Personnel records 11 10 INFORMATION FOR PATIENTS OR USERS11 10.1 Information to be provided by the sample receiving laboratory11 10.2 Information provided to patients 12 11 Application form 13 11.1 Application form information 13 11.2 Oral application 13 11.3 Transcription 13 12 Patient Identification 14 12.1 General 14 12.2 Routine Patient Identification 14 12.3 Emergency patient identification 14 12.4 Infant patient identification 14 13 Sample Identification 15 14 Sample Collection 15 14.1 General 15 14.2 Informed Consent 15 14.3 Description of collection activities 16 14.4 Emergency Application Processing 16 14.5 Blood sample collection 16 14.5.1 General 16 14.5.2 Blood draw sequence 16 14.5.3 Considerations for Venipuncture 16 14.5.4 Adult peripheral blood collection 17 14.5.5 Venous blood collection in children 17 14.5.6 Pediatric Peripheral Blood Collection 18 14.6 Other samples 18 15 Sample Integrity and Stability 18 15.1 Sample Integrity 18 15.2 Stability 19 15.3 Stabilization 19 16 Sample Shipping 19 16.1 General 19 16.2 Sample Shipping 19 16.3 Quality Control 20 17 Sample Receipt and Evaluation 20 17.1 General 20 17.2 Sample Acceptance or Rejection Criteria 20 17.3 Validation of sample labels 21 17.3.1 General 21 17.3.2 Non-compliance management 21 17.4 Sample receipt records 21 17.5 Sample traceability 21 17.6 Emergency samples 21 17.7 Chain of Custody 21 18 Storage of samples before inspection 22 19 Customer Satisfaction 22 20 Identification and control of nonconformities 22 20.1 Identification of Nonconformities 22 20.2 Non-compliance with records 22 21 Performance indicators 23 22 Documents and records 23 22.1 General 23 22.2 Documentation 23 22.3 Recording 23 Appendix A (Informative) Five Timepoints for Hand Hygiene25 Appendix B (Informative) Disinfectants 26 Reference 28

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. This document is equivalent to ISO /T S20658.2017 "Requirements for the collection, transportation, reception and processing of medical laboratory samples", document type The model is adjusted from ISO technical specifications to my country's national standards. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug 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 is drafted by. China National Accreditation Center for Conformity Assessment, The First Affiliated Hospital of PLA Army Medical University, Beijing Municipal Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), National Health Commission Clinical Inspection Center, Guangzhou The Second Affiliated Hospital of the University of Traditional Chinese Medicine, Shanghai Dongfang Hospital (Eastern Hospital Affiliated to Tongji University), the Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Military Medical University Affiliated Hospital, Fudan University Affiliated Cancer Hospital. The main drafters of this document. Hu Dongmei, Chen Ming, Dai Leiying, Peng Mingting, Chen Qubo, Wu Wenjuan, Li Zengshan, Xu Midie.

Introduction

The services of medical laboratories are important for both patient care and public health, and it is necessary to meet the needs of patients and those responsible for their care. needs of clinical staff. These services include test requests, patient preparation, patient identification, clinical sample collection, shipping, storage, processing and testing and results reporting, in addition to matters related to the safety and ethics of medical laboratory work. The guidance provided in this document on sample collection and handling is derived from good laboratory practice that has been applied in the pre-test process and is consistent with meet the requirements of published documents. This document is used to guide individual and institutional sample collection and submission to ensure the quality of medical laboratory services And get better public medical service effect. my country may have its own special guidelines or requirements for the activities and responsibilities of professionals and personnel in this field. Each medical laboratory or sample collection facility should determine the extent to which it complies with the relevant requirements in this document. Management should be based on patient and client User needs, available resources, and local, regional, and national mandates, etc., first determine appropriate priorities. medical laboratory Requirements for Sample Collection, Shipping, Reception and Processing

1 Scope

This document specifies requirements and good practice recommendations for sample collection, shipping, reception and handling for medical laboratory testing. This document applies to medical laboratories and other healthcare services involved in the pre-examination process, including the application of inspections for inspections Pre-procedures (eg, test requests), patient preparation and identification, sample collection, shipping, receipt, storage, and processing. This document may also apply to certain Biobank. This document does not apply to blood and blood products used for blood transfusion.

2 Normative references

There are no normative references in this document.

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 arterialpuncture Procedure for collecting arterial blood by puncturing the skin (3.13). 3.2 biobank biobank A legal entity or part thereof that conducts the preservation of biological specimens (3.3). NOTE. The composition of a biobank includes personnel, facilities and procedures (eg, management systems), service providers, and a biological sample repository. 3.3 biological specimen preservation biobanking Biological sample acquisition and storage process (3.14), including some or all of the following activities. collection of biological samples and related data and information collection, preparation, preservation, testing, analysis and distribution. Note 1.It may also include some or all of the following activities. processing, testing and analysis. Note 2.For the purpose of the application of this document, this definition only includes human sample material for diagnostic and therapeutic purposes, such as surgical pathology archives. 3.4 capilarypuncture Procedure for collecting capillary blood by puncturing the skin (3.13). 3.5 cleaning process (3.14) of removing various types of contamination, visible or invisible. [Source. GB 19781-2005, 3.5]

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