What are the implications of having our site visit be “BSL1” versus “BSL2”?
Practically any clinical site that handles body fluids should be able to provide Biosafety Level 2 (BSL2) containment using routine medical precautions, procedures and equipment. BSL2 controls offer additional protection to the agent, the site workers, and the environment. Compared to BSL1, the biggest differences are more attention to proper signage, decontamination, transport, and disposal of the gene transfer product. Also, many (but not all) BSL2 products require the use of a certified biologiacal safety cabinet (BSC, sometimes referred to as a “hood”) to prepare the prodct, so this can be a challenge if the site does not already have a BSC.
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