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卫生实验室许可:政策和最佳实践分析

Markus Huber¹, Madina Andreyeva², Lance D Presser³

¹Bio-risk Management and Biosafety, WHO Health Emergencies Programme, World Health Organization, Avenue Appia 20, 1211Geneva, Switzerland.

Bulletin of the World Health Organization

|June 13, 2025

概括

世界各地的政府通过各种许可法规来监管卫生实验室,通常涉及注册和许可步骤. 采用国际质量标准,如ISO 15189,对于强大的实验室监督和全球卫生安全至关重要.

科学领域:

公共卫生公共卫生
卫生政策卫生政策
实验室科学实验室科学

背景情况:

卫生实验室监管对于质量保证和公共卫生至关重要.
在不同的医疗保健系统中,对健康实验室许可的国际方法有很大差异.

研究的目的:

在全球范围内分析和比较健康实验室许可法规.
了解全球18个国家的不同监管方法.

主要方法:

对18个不同国家的健康实验室许可立法进行比较审查.
专注于立法方法,认证,认证,质量保证,生物安全和生物安全.

主要成果:

卫生实验室许可立法通常包括行政法和实体法.
确定了三个主要的立法方法:独立法案,一般法案和基于健康保险合同的法律.
许可程序通常涉及注册和许可,有效期为1-5年或永久许可.

结论:

国家能力和优先事项塑造了各种健康实验室许可框架.
整合质量标准,如ISO 15189,对于有效的实验室监督至关重要.
强有力的许可框架增强了国内系统,并为全球卫生安全做出了贡献.

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