Biomedical Engineering Reference
In-Depth Information
Do Francine and Frank remain in the limited access area
and maintain the chain of custody for the controlled
substance, complying with DEA regulations. Or do they
immediately evacuate the area with all due speed, complying
with OSHA regulations?
When this scenario is presented to line personnel in a NEO
session, the responses vary widely. Many participants simply
say “Francine and Frank should get out quickly.” Some say
“They should use their good sense.” Others say “They
should ask Joe,” or “Follow Joe,” Joe being a fellow worker
in the controlled substances area, a 20-year veteran employee,
a sea lawyer.
Some participants point out that in the case of a fi re, or
even a fi re alarm, a Notice of Event (NoE) will be required,
so evacuating - breaking the chain of custody for the
controlled substance - will be covered by the NoE anyhow.
A few suggest that the relevant SOPs should be consulted -
presumably in advance of the fi re alarm.
It is important in the NEO session for the facilitator to
point out that no known organization in regulated industry
has a procedure that states “Use your good sense” or “Ask
Joe.” It is also important to explore further the point about
a NoE. What does a “Notice of Event” mean? Since some of
the new hires in the orientation session may not have
employment experience in regulated industry, they may not
know that this means that a deviation has occurred, a
deviation that may involve non-compliance with a SOP. This
will help focus the discussion of the scenario on the topic of
relevant SOPs. Clearly the facilitator of this portion of the
NEO session will have already reviewed the local procedures
that address the issues brought out in the scenario.
When the discussion focuses on the role of written
procedures, the point can be reinforced that the FDA requires
employees have direct and continuing access to relevant
