Clinical laboratories, the Select Agent Program, and biological surety (biosurety)

被引:12
作者
Pastel, Ross H. [1 ]
Demmin, Gretchen [1 ]
Severson, Grant [1 ]
Torres-Cruz, Rafael [1 ]
Trevino, Jorge [1 ]
Kelly, John [1 ]
Arrison, Jay [1 ]
Christman, Joy [1 ]
机构
[1] USA, Med Res Inst Infect Dis, Ft Detrick, MD 21702 USA
关键词
D O I
10.1016/j.cll.2006.03.004
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
The threat of bioterrorism has led to increased concerns over the availability of biological select agents and toxins (BSAT). Congress has implemented several public laws that have led to the development of federal regulations by the Centers for Disease Control and Prevention (CDC) and the US Department of Agriculture. The CDC regulation 42 CFR 73 has a direct impact on all clinical laboratories that may at some time identify BSAT in a clinical specimen. The Department of Defense has imposed a more stringent layer of regulation called biological surety (biosurety) on top of the requirements of 42 CFR 73 for military laboratories that possess BSAT. However, 42 CFR 73 falls into the framework of biosurety. Both sets of regulations have four pillars (safety, physical security, agent accountability, and personnel reliability) that are built on a foundation of training and covered by a roof of management (operations and plans).
引用
收藏
页码:299 / +
页数:15
相关论文
共 15 条
[1]  
[Anonymous], 2001, Uniting and Strengthening America by Providing Appropriate ToolsRequired to Intercept and Obstruct Terrorism (USA PATRIOTACT) Act of 2001
[2]  
[Anonymous], 2002, FED REGISTER, V240, P76907
[3]  
[Anonymous], 1999, Biosafety in Microbiological and Biomedical Laboratories
[4]   Implementation of biosurety systems in a Department of Defense medical research laboratory [J].
Carr, K ;
Henchal, EA ;
Wilhelmsen, C ;
Carr, B .
BIOSECURITY AND BIOTERRORISM-BIODEFENSE STRATEGY PRACTICE AND SCIENCE, 2004, 2 (01) :7-16
[5]   Biological warfare - A historical perspective [J].
Christopher, GW ;
Cieslak, TJ ;
Pavlin, JA ;
Eitzen, EM .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1997, 278 (05) :412-417
[6]  
*DEP ARM, 1993, 38569 DEP ARM
[7]  
HARRIS HL, 2006, TROUBLED PAST INCLUD
[8]  
SALERNO RM, 2006, BALANCING SECURITY R
[9]  
*SAND NAT LAB, 2006, SAND20052348P
[10]  
U.S. Department of Agriculture, 2005, FED REG, V70, P13241