NETEC Resource Library

Select Agent Regulatory Challenges in a Patient Care Setting: Review and Recommendations

Contenu

Click for External Resource*


Click to read full article*


*The link above may share a zip file (.zip) hosted on repository.netecweb.org. Zip files will download automatically.
*All other links are external and will open in a new window. If you click an external link, you are leaving the NETEC site, and we do not maintain, review, or endorse these materials. See our terms of use.


Item Type

Publication

Terms of Use

By accessing these materials you are agreeing to our terms of use, which may be found here: Terms of Use.

Was this resource helpful?


Titre

Select Agent Regulatory Challenges in a Patient Care Setting: Review and Recommendations

Description

The Federal Select Agent Program ensures the safe and secure possession, use, and transfer of biological select agents and toxins through the select agent regulations (42 CFR §73, 7 CFR §331, and 9 CFR §121). These regulations are primarily written for interpretation by diagnostic and research laboratories, with limited text pertaining to the care of individuals infected with a select agent.

Source

Megan C. Mears, Corrie A. Ntiforo, Lauren M. Sauer, Aneesh K. Mehta, Corri B. Levine.

Date

2023-12-06

Citer ce document

Mears, M. C., C. A. Ntiforo, L. M. Sauer, A. K. Mehta, and C. B. Levine. "Select Agent Regulatory Challenges in a Patient Care Setting: Review and Recommendations." Health Secur. 2023 Dec 6; https://doi.org/10.1089/hs.2023.0073.

Résumé

The Federal Select Agent Program ensures the safe and secure possession, use, and transfer of biological select agents and toxins through the select agent regulations (42 CFR §73, 7 CFR §331, and 9 CFR §121). These regulations are primarily written for interpretation by diagnostic and research laboratories, with limited text pertaining to the care of individuals infected with a select agent. The regulations applicable to patient care settings are ambiguous, resulting in challenges with regulatory compliance. The COVID-19 pandemic called attention to these shortcomings and the need to clarify and modify the select agent regulations. In this article, we discuss 3 select agent regulation phrases regarding patient care that need clarification—specifically, the window of time to transfer, patient care setting, and conclusion of patient care—and provide recommendations for improvement. These recommendations include implementing minimum security standards to safeguard patient specimens against theft, loss, or release prior to the appropriate transfer or destruction of the material and increasing the time allowed for the transfer or destruction of specimens before entities are subject to the select agent regulations. We encourage the Federal Select Agent Program to release a policy statement clarifying the select agent regulations regarding patient care discussed herein and to lengthen the designated time to destroy or transfer agents to a registered entity. Addressing these challenges will aid in compliance with the select agent regulations in patient care settings.

Accessibilité

Read online with journal subscription.

Collection