ANSWERS EXAM PREPARATION GUIDE
MASTER TEST BANK COMPLETE PASS
SUPPORT
●● Category 1 CSP
Answer: A CSP assigned a BUD of 12 hours or less at controlled room
temperature or 24 hours or less refrigerated.
●● Category 2 CSP
Answer: A CSP assigned in a BUD of greater than 12 hours room
temperature or greater than 24 hours refrigerated.
●● Immediate use CSP
Answer: Administration begins within 4 hrs following the start of the
preparation. Must not involve more that 3 sterile products.
●● Glove Fingertip Sampling
Answer: One plate per hand, TSA to support bacterial and fungal
growth, label each device, do not spray hands with IPA, Incubate 30-35
for 48 H and 20-25 for 5 days, record CFU, Determine if CFU action
level is exceeded by counting the total number of CFU from both hands
,●● Media Fill Testing Procedure
Answer: Simulate compounding activities if sterile to sterile use
soybean-casein digest media, if non sterile use commerically available
nonsterile soybean-casein digest powder to make a 3% non-sterile
solution. Preparer at least 1 container as a positive control.
Once compounding simulations are completed perform gloved fingertip
and thumb sampling on each hand and surface sample of DCA inside the
PEC. Take samples prior to disinfecting.
Incubate 20-25 and 30-35 for a minimum of 7 days at each temperature.
Failure is indicated by visible turbidity or other growth in one more
containers on or before 14 days.
●● Action Level for Gloved fingertip and thumb sampling
Answer: After Garbing greater than 0 CFU
After media-fill testing greater than 3 CFU
Action levels based on total CFU count from both hands
●● Compounder - ongoing training and competency
Answer: Training and Competency in compounding sterile principles - at
least every 12 months
,Garbing Competency - Category 1 and 2 at least every 6 months,
Category 3 every months
Media Fill with Post GFT and Surface sampling - Category 1 and 2 at
least every 6 months, Category 3 at least every 3 months
●● Designated Persons - ongoing training and competency
Answer: Training and Competency in compounding sterile principles - at
least every 12 months unless compounding
Garbing Competency - At least every 12 months unless compounding
Media Fill with Post GFT and Surface sampling -at least every 12
months unless compounding
●● Personnel who restock or clean and disinfect the sterile
compounding area- ongoing training and competency
Answer: Defined by facilities SOP
●● Handwashing procedures
Answer: Clean under fingernails under warm running water using nail
cleaner
Wash hands and forearms up to elbows for 30 s.
Dry hands and forearms up to elbows completely with low-lint
disposable towels.
, Apply an alcohol-based hand rub to dry skin
Apply product to one hand and rub hands together
Allow hands to dry before donning sterile gloves
●● Minimum Garb requirements in category 2 and 3
Answer: Low Lint garment with sleves
Low Lint shoe covers
Low Lint cover for head and facial hair
Low Lint face mask
Sterile powder free gloves
If using a RABS disposable gloves should be worn inside the RABS
sleeves.
●● Additional garbing requirements for category 3