EXERCISES, LESSON 1
INSTRUCTIONS: Answer the following exercises by marking the lettered response that
best answers the exercise, by completing the incomplete statement, or by writing the
answer in the space provided.
After you have completed all the exercises, turn to "Solutions to Exercises" at the end of
the lesson, and check your answers. For each exercise answered incorrectly, reread
the material referenced with the solution.
is the primary goal of blood centers.
Whole blood and blood components are regulated as both
by the FDA.
cGMP is the abbreviation for
T or F: cGMPs are only FDA recommendations, they have no legal ramifications.
The Clinical Laboratory Improvement Act of 1988 (CLIA >88) or DOD's
additional regulations for laboratories.
One or more individuals designated by, and reporting directly to, top management
with defined authority and responsibility to ensure that all quality assurance polices are
carried out in operations is called the
The cGMP regulations require adequate space and
; sanitation and
trash disposal; equipment for controlling air quality and pressure, humidity and
temperature; water systems; and
establishes personnel qualifications and similar training
requirements for laboratory staff.
should monitor the effectiveness of the training program and