GB/T 22576.4-2021Medical laboratories—Requirements for quality and competence—Part 4: Requirements in the field of clinical chemistry examination (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" Drafting.

This document is part 4 of GB/T 22576 "Requirements for the Quality and Capability of Medical Laboratories". This document and GB/T 22576.1 Cooperate and use together.

GB/T 22576 has released the following parts.

---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 in the field of clinical chemistry testing;

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

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

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

Introduction

The services of medical laboratories are necessary for patient healthcare, so it is necessary to satisfy all patients and clinical personnel responsible for patient healthcare.

The needs of the staff. These services include application acceptance, patient preparation, patient identification, sample collection, transportation, storage, clinical sample processing and inspection And the interpretation of the results, reports and recommendations; in addition, the safety and ethical issues of medical laboratory work must also be considered.

As long as national laws and regulations and relevant standards require permission, it is expected that the services of medical laboratories include diagnosis and patient management, as well as Examination of patients in consultations and active participation in disease prevention. Each laboratory should provide its professionals with appropriate educational and scientific research opportunity.

GB/T 22576 stipulates the capabilities and quality of medical laboratories in all disciplines in the currently recognized medical laboratory service field. The requirements are to be composed 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 in the field of clinical hematology testing. The purpose is to regulate the quality and capacity of medical laboratories for clinical hematology Specific requirements in the inspection field.

---Part 3: Requirements in the field of urine testing. The purpose is to regulate the quality and capacity of medical laboratories in the field of clinical urine testing Specific requirements.

---Part 4: Requirements in the field of clinical chemistry testing. The purpose is to regulate the quality and capability of medical laboratories for clinical chemistry testing The specific requirements of the field.

---Part 5: Requirements in the field of clinical immunology testing. The purpose is to regulate the quality and capacity of medical laboratories for clinical immunology Specific requirements in the inspection field.

---Part 6: Requirements in the field of clinical microbiology testing. The purpose is to stipulate that the quality and capacity of medical laboratories are important for clinical microbiology. Specific requirements in the field of physical inspection.

---Part 7: Requirements in the field of blood transfusion medicine. The purpose is to stipulate that the quality and capacity of medical laboratories are important for the field of blood transfusion medicine. Body requirements.

---Part 8: Requirements for laboratory information systems. The purpose is to regulate the quality and capability of medical laboratories to the laboratory information system Specific requirements.

---Part 9: Requirements in the field of molecular diagnostics. The purpose is to stipulate that the quality and capabilities of medical laboratories are important for the field of molecular diagnostics. Body requirements.

---Part 10: Requirements in the field of cytopathological examination. The purpose is to regulate the quality and capacity of medical laboratories for cytopathology Check the specific requirements of the field.

---Part 11: Requirements in the field of histopathology examination. The purpose is to regulate the quality and capacity of medical laboratories for histopathology Check the specific requirements of the field.

The numbers and names of the chapters and articles of this document adopt the chapter and article numbers and names of GB/T 22576.1, which are relevant in the field of clinical chemistry testing. The specific requirements are given after the corresponding clauses.

1 Scope

This document specifies the requirements for the quality and competence of medical laboratories in the field of clinical chemistry testing.

This document applies to medical laboratories that carry out clinical chemistry tests, as well as medical laboratories that carry out clinical immunological quantitative tests.

2 Normative references

The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 21415 Metrology traceability for measurement of calibrator and control substance assignment in biological samples of in vitro diagnostic medical devices Origin

GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories Part 1: General requirements

WS/T 403 Analytical Quality Index of Routine Items of Clinical Biochemistry Test

WS/T 407 Guidelines for the Comparability Verification of Quantitative Test Results in Medical Institutions

3 Terms and definitions

The terms and definitions defined in GB/T 22576.1-2018 apply to this document.

4 Management requirements