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临床生物化学实验室的外部质量评估实践:有何必要性?

External Quality Assessment Practices in Clinical Biochemistry Laboratory: What is the need ?

机构信息

Department of Biochemistry, BP Koirala Institute of Health Sciences, Dharan, Nepal.

Department of Biochemistry, KIST Medical College and Teaching Hospital, Lalitpur, Nepal.

出版信息

Kathmandu Univ Med J (KUMJ). 2020;18(69):86-92.

PMID:33582695
Abstract

Health Care services is considered as an amalgamation between the doctor undergoing the examination and laboratory personnel behind the proper diagnosis of the patient. It has evolved to a large extent from a simple process of examination to handling the prescription to the patient. During this evolution, there has been a remarkable development in the field of laboratory diagnosis. A good laboratory is abided by the rule of quality services including quality control; both internal and external. External quality assessment program contributes to the long term accuracy of the analytical method used by the laboratory. It determines the number of quality element of the practicing laboratory and helps in the upliftment of the status of the laboratory to laboratory accreditation and certification. This review article is intended to review the importance of the external quality assessment program over internalquality control, its need in the laboratory and the current practices in externalquality assessment. Medline search was done for the articles published in English language from 1945 to 2018. Keywords employed to search the articles were external quality assessment, EQA programs, quality assurance, and quality control in clinical biochemistry, respectively. We searched for any articles with the details of external quality assessment tools that were original articles, review, editorial and the official website of the EQAS program. The unavailable articles were searched through research gate and the authors were requested for full text. A total of 5 full text original research article were found and rest of the articles like review article, editorial, national policy were studied in detail. Standard textbooks for clinical chemistry and chapters for EQA under quality assurance was reread in detail. Studies and policy makers have depicted that External Quality Assessment scheme (EQAS) as an integral component for the efficient and high quality laboratory operation. The western countries haizve their own laboratory accreditation body which conducts the EQAS program and offers participation to other clinical laboratories. Countries in South East Asia have shown to be burgeoning in the field of EQA program with establishment of their own laboratory accreditation bodies and incorporating the non-accredited laboratories in EQA programs.

摘要

医疗保健服务被认为是医生进行检查和实验室人员对患者进行正确诊断的结合。它已经从一个简单的检查过程演变成了一个为患者处理处方的过程。在这个演变过程中,实验室诊断领域取得了显著的发展。一个好的实验室遵守质量服务规则,包括质量控制;内部和外部的。外部质量评估计划有助于实验室使用的分析方法的长期准确性。它确定了实践实验室的质量要素数量,并有助于提高实验室的地位,使其获得实验室认证和认可。本文旨在回顾外部质量评估计划相对于内部质量控制的重要性,实验室对其的需求以及外部质量评估的当前实践。在 1945 年至 2018 年期间,以英文发表的文章进行了 Medline 搜索。用于搜索文章的关键字是外部质量评估、EQA 计划、临床生物化学中的质量保证和质量控制。我们搜索了有关外部质量评估工具的详细信息的文章,这些文章是原始文章、评论、社论和 EQAS 计划的官方网站。无法获取的文章通过 research gate 进行搜索,并请求作者提供全文。共发现 5 篇全文原始研究文章,详细研究了其余评论文章、社论、国家政策等文章。重新详细阅读了临床化学标准教科书和质量保证章节下的 EQA。研究人员和政策制定者将外部质量评估计划(EQAS)描述为高效和高质量实验室运作的一个组成部分。西方国家有自己的实验室认证机构,该机构开展 EQAS 计划,并为其他临床实验室提供参与机会。东南亚国家在 EQA 计划方面表现出强劲的发展势头,建立了自己的实验室认证机构,并将非认证实验室纳入 EQA 计划。

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