医学生物学实验室标准化体系的出现与演变
Emergence and evolution of standardization systems in medical biology laboratories.
作者信息
Khattar Rita B, Nehme Maha E
机构信息
Holy Family University, Batroun, Liban-Nord, Lebanon.
出版信息
Adv Lab Med. 2024 May 1;5(3):261-267. doi: 10.1515/almed-2024-0014. eCollection 2024 Sep.
INTRODUCTION
The history of standardization relating to the activities of medical laboratories traces the development of quality system standards in the world, and their evolution.
CONTENT
In this study, we have included the key benchmarks that represent the stages of the quality system's evolution in recent decades. Accreditation of medical laboratories has become compulsory in most countries, regarding national or international standards. International acknowledgment of the effectiveness of the results delivered to the many stakeholders, particularly patients and prescribers, is conferred through the use of standards.
SUMMARY
The ISO 15189 standard represents the latest and most specific international standards for medical laboratories of all types.
OUTLOOK
More research is necessary to study if laboratory practices reflect the evolution of standards within the medical laboratory field.
引言
与医学实验室活动相关的标准化历史追溯了全球质量体系标准的发展及其演变。
内容
在本研究中，我们纳入了代表近几十年来质量体系演变阶段的关键基准。在大多数国家，依据国家或国际标准，医学实验室的认可已成为强制性要求。通过使用标准，可实现向众多利益相关者，尤其是患者和开处方者提供的结果的有效性获得国际认可。
总结
ISO 15189标准代表了各类医学实验室最新且最具体的国际标准。
展望
有必要开展更多研究，以探讨实验室实践是否反映了医学实验室领域内标准的演变。
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