在患者护理环境中选择代理人的监管挑战:审查和建议
Megan C Mears1, Corrie A Ntiforo2, Lauren M Sauer3
1Megan C. Mears, PhD, MPH, is a Graduate Student, School of Public and Population Health and Department of Pathology; University of Texas Medical Branch, Galveston, TX.
Health security
|December 6, 2023
概括
联邦选择代理程序规定需要对患者护理设置进行澄清. 建议包括更新的安全标准和延长处理生物选择剂和毒素的时间表.
科学领域:
- 公共卫生 公共卫生
- 监管科学 监管科学
- 传染病控制和控制传染病
背景情况:
- 联邦精选剂计划 (FSAP) 监管生物精选剂和毒素的安全和保障.
- 目前的FSAP法规主要针对实验室,对患者护理环境缺乏明确性.
- 患者护理法规中的模糊性带来了合规性挑战,COVID-19大流行凸显了这一点.
研究的目的:
- 识别和解决关于患者护理的FSAP法规中的模两可.
- 为改善医疗保健机构的监管清晰度和合规性提出具体建议.
- 提高临床环境中生物选择剂和毒素的安全处理和安全性.
主要方法:
- 分析与患者护理相关的特定代理商法规中的关键词.
- 确定需要澄清的特定领域:"转移时间窗口"",患者护理环境"和"患者护理结论".
- 制定监管修改和政策澄清的建议.
主要成果:
- 精选代理商法规中的三个关键短语需要澄清,以便有效的患者护理应用.
- 提议的改进包括患者标本的最低安全标准和延长的转移/销毁时间表.
- 需要提高清晰度,以防止生物制剂的盗窃,丢失或释放.
结论:
- 澄清患者护理的FSAP法规对于监管合规至关重要.
- 为医疗保健机构推政策声明和延长代理管理时间表.
- 解决这些监管缺口将改善在患者护理中的生物选择剂和毒素的安全管理.
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