GB/T 22576.1-2026Medical laboratories - Requirements for quality and competence - Part 1: General requirements (English PDF)

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 Part 1 of GB/T 22576, "Requirements for Quality and Competence of Medical Laboratories". GB/T 22576 has been published.

The following section.

---Part 1: General Requirements;

---Part 2: Requirements in the field of clinical hematology testing;

---Part 3: Requirements in the field of urine testing;

---Part 4: Requirements for the Clinical Chemistry Testing Field;

---Part 5: Requirements in the field of clinical immunology testing;

---Part 6: Requirements in the field of clinical microbiology testing;

---Part 7: Requirements in the field of transfusion medicine.

This document supersedes GB/T 22576.1-2018 "Requirements for Quality and Competence of Medical Laboratories Part 1: General Requirements", and is consistent with...

Compared with GB/T 22576.1-2018, apart from structural adjustments and editorial changes, the main technical changes are as follows.

---Risk management requirements have been added (see 5.6, 8.5);

---Added additional requirements for point-of-care testing (POCT) (formerly ISO 22870) (see Appendix A).

This document adopts ISO 15189:2022 "Requirements for quality and competence of medical laboratories".

The following minimal editorial changes have been made to this document.

---To harmonize with existing standards, the standard name has been changed to "Requirements for Quality and Competence of Medical Laboratories Part 1: General Requirements" beg".

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).

Introduction

Medical laboratories are crucial to patient care, and their activities must be conducted within ethical and regulatory frameworks, clearly defining the responsibilities of medical personnel towards patients.

Responsibility. These activities should be carried out promptly to meet the needs of all patients and those responsible for their healthcare, including. arranging test requests, patient preparation...

Preparation, patient identification, sample collection and transportation, patient sample processing, selection of tests appropriate for the intended use, sample testing, sample storage, and post-processing.

Follow-up explanations, reports, and recommendations. This may also include providing patients with results, arranging emergency testing, and notifying them of critical outcomes.

GB/T 22576 specifies the competence and quality requirements of medical laboratories in all disciplines within the currently recognized areas of medical laboratory services.

The requirements are proposed to consist of 11 parts.

---Part 1: General Requirements. The purpose is to specify general requirements for the quality and competence of medical laboratories.

---Part 2: Requirements for Clinical Hematology Laboratory Testing. The purpose is to define the quality and competence requirements of medical laboratories in clinical hematology.

Specific requirements in the field of inspection.

---Part 3: Requirements in the Field of Urine Testing. The purpose is to define the quality and competence requirements of medical laboratories in the field of clinical urine testing.

Specific requirements.

---Part 4: Requirements for Clinical Chemistry Testing. The purpose is to define the quality and competence requirements of medical laboratories for clinical chemistry testing.

Specific requirements of the field.

---Part 5: Requirements for Clinical Immunology Testing. The purpose is to define the quality and competence requirements of medical laboratories in clinical immunology.

Specific requirements in the field of inspection.

---Part 6: Requirements for Clinical Microbiology Testing. The purpose is to define the quality and competence requirements of medical laboratories in clinical microbiology testing.

Specific requirements in the field of physical testing.

---Part 7: Requirements for Transfusion Medicine. The purpose is to specify the quality and competence requirements of medical laboratories in the field of transfusion medicine.

Physical requirements.

---Part 8: Requirements for Laboratory Information Systems. The purpose is to specify the requirements for laboratory information systems in medical laboratories regarding quality and competence.

Specific requirements.

---Part 9: Requirements for the Molecular Diagnostics Field. The purpose is to specify the quality and competence requirements of medical laboratories in the field of molecular diagnostics.

Physical requirements.

---Part 10: Requirements in the Field of Cytopathology. The purpose is to specify the quality and competence requirements of medical laboratories in cytopathology.

Specific requirements for the inspection area.

---Part 11: Requirements in the Field of Histopathological Examination. The purpose is to specify the quality and competence requirements of medical laboratories in histopathology.

Specific requirements for the inspection area.

The purpose of this document is to improve patient health and laboratory user satisfaction by building confidence in the quality and competence of medical laboratories.

Satisfaction level.

This document outlines the requirements for medical laboratories to plan and implement measures to address risks and improve opportunities. The advantages of this approach include. [].

The effectiveness of a high-level management system reduces the probability of invalid results and minimizes potential harm to patients, laboratory staff, the public, and the environment.

The requirements for risk management are consistent with the principles of ISO 22367.

Laboratory safety requirements are consistent with the principles of ISO 15190.

Sample collection and transport requirements are consistent with ISO 20658.

The structure of this document is based on GB/T 27025-2019.

While this document is intended for use in currently recognized medical laboratory disciplines, it can also be effectively applied to other medical services, such as diagnostic imaging.

Interruption, respiratory therapy, physiology, blood bank and transfusion.

Using this document facilitates collaboration between medical laboratories and other healthcare service sectors, promotes information exchange, and simplifies methods and procedures.

Consistency.

Medical laboratories that meet the requirements of this document can promote the comparability of patient test results between medical laboratories in different countries or regions.

When seeking accreditation, laboratories should choose an accreditation body that complies with ISO/IEC 17011 and takes into account the specific requirements of medical laboratories.

A comparison of this document with GB/T 19001-2016 and GB/T 27025-2019 is shown in Appendix B. This document also compares with GB/T 22576.1-See Appendix C for a comparison of 2018.

Requirements for the quality and competence of medical laboratories Part 1: General Requirements

1 Scope

This document specifies the requirements for the quality and competence of medical laboratories.

This document applies to medical laboratories establishing management systems and assessing their own capabilities, and is also applicable to laboratory users, regulatory agencies, and accreditation bodies.

The institution confirms or recognizes the capabilities of the medical laboratory.

This document also applies to point-of-care testing.

Note. International, national, or regional regulations or requirements may also apply to specific content in this document.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB/T 27000-2023 Conformity assessment vocabulary and general principles (ISO/IEC 17000:2020, IDT) GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017, IDT) ISO/IEC Guide 99.2007 International Metrology Terminology. Basic and General Concepts and Related Terms (VIM) principles) Note. GB/T 27000-2023 Conformity assessment vocabulary and general principles (ISO/IEC 17000:2020).

3 Terms and Definitions

The terms and definitions defined in ISO/IEC Guide 99 and ISO/IEC 17000, as well as the following terms and definitions, apply to this document.

The addresses of the terminology databases maintained by ISO and IEC for standardization are as follows.

bias

Measurement bias

Estimated value of systematic measurement error.

Note. This definition applies only to quantitative measurements.

[Source. ISO/IEC Guide 99.2007, 2.18, modified] 3.2 reference interval A specific range of values taken from the distribution of biological reference populations.