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

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.

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]