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GB/T 42060-2022Medical laboratories - Requirements for collection, transport, receipt, and handling of samples (English PDF)

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

October 14, 2022

Implementation date

May 1, 2023

Scope

GB/T 42060-2022 (Medical laboratories - Requirements for collection, transport, receipt, and handling of samples) is available as an English-translated PDF.

GB/T 42060-2022 is the Chinese standard "Medical laboratories - Requirements for collection, transport, receipt, and handling of samples". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — GB/T 42060-2022

National Standard of the People's Republic of China

ICS: 11.100.01
Classification: C 30

Issued by: State Administration for Market Regulation, China National Standardization Administration

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Quality Management
5 Pre-test procedures related to patient samples
5.1 General
5.2 Guidance for Laboratory Project Application
5.3 Implementation of the application
5.4 Patient guidance
5.5 Patient Identification
5.6 Preparation for sample collection
5.7 Original Sample Collection and Labeling
5.8 Preparation for shipment
5.9 Sample Shipping
5.10 Sample reception
5.11 Pre-inspection sample preparation
6 Facilities and environmental conditions
6.1 General
6.2 Design
6.2.1 General
6.2.2 Security and Accessibility
6.2.3 Privacy and confidentiality
6.2.4 Equipment, items and storage
6.3 Equipment maintenance and environmental conditions
6.4 Staff Facilities
7 Equipment and items
7.1 General
7.2 Equipment reception test
7.3 Inspection and storage
7.4 Inventory management
7.5 Equipment maintenance and repair
7.6 Equipment operation
7.7 Computer equipment
7.8 Equipment records
8 Infection Prevention and Control (Biosecurity)
8.1 Personal protective equipment
8.2 Hand hygiene
8.3 Personnel Specification
8.4 Safe disposal
8.5 PATIENT PROTECTION
8.6 Cleaning and disinfection
8.7 Special precautions
9 staff
9.1 General
9.2 Training and competencies
9.2.1 Personnel training
9.2.2 Competence and continuing education
9.3 Confidentiality and access to information
9.4 Personnel records
10 INFORMATION FOR PATIENTS OR USERS
10.1 Information to be provided by the sample receiving laboratory
10.2 Information provided to patients
11 Application form
11.1 Application form information
11.2 Oral application
11.3 Transcription
12 Patient Identification
12.1 General
12.2 Routine Patient Identification
12.3 Emergency patient identification
12.4 Infant patient identification
13 Sample Identification
14 Sample Collection
14.1 General
14.2 Informed Consent
14.3 Description of collection activities
14.4 Emergency Application Processing
14.5 Blood sample collection
14.5.1 General
14.5.2 Blood draw sequence
14.5.3 Considerations for Venipuncture
14.5.4 Adult peripheral blood collection
14.5.5 Venous blood collection in children
14.5.6 Pediatric Peripheral Blood Collection
14.6 Other samples
15 Sample Integrity and Stability
15.1 Sample Integrity
15.2 Stability
15.3 Stabilization
16 Sample Shipping
16.1 General
16.2 Sample Shipping
16.3 Quality Control
17 Sample Receipt and Evaluation
17.1 General
17.2 Sample Acceptance or Rejection Criteria
17.3 Validation of sample labels

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

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]

GB/T 16886.9 | GB/T 42062 | GB/T 42061 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 64 pages — is available in the English PDF.

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