Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

MPJE Prep > USP 800 > Flashcards

USP 800 Flashcards

1
Q

who maintains the list of antineoplastics and other HDs

A

NIOSH

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

how often is the list of HD reviewed

A

every year

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

how is the risk assesement of a HD done by NIOSH

A

type of HD
dosage form
risk of exposure
packaging
manipulation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

at which points are people at risk of exposure to HD

A

receipt, dispensing, compounding, admin, patient care activities, spills, transport, waste management

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

who is responsible for ensuring proper precautions are taken at a sight for HDs

A

a designated person must ensure compliance with USP 800 and ensure all personnel who handle drugs understand the practices and precautions required

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

what designated areas are required for storage of HDs

A

receipt and unpacking
storage of HDs
non sterile HD compounding
sterile HD compounding

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

when unpacking HDs, what are the pressure requirements of that room/area

A

negative or normal pressure relative to the surrounding area

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

where can HDs not be unpackaged

A

sterile compounding areas or positive pressure

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

antineoplastic HDs storage requirements if required for manipulation (not just counting and repackaging)

A

externally ventilated
negative pressure room
12+ air changes per hr (ACPH)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

what are the storage requirements for refrigerated antineoplastic HDs

A

dedicated refrigerator
negative pressure room
12+ air exchanges per hour

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

what are the requirements of refrigerated antineoplastics that are stored in a buffer room

A

exhaust adjacent to refrigerator’s compressor and behind the fridge should be considered…

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

where must sterile and non-sterile HDs be compounded

A

within a C-PEC located in a C-SEC where the C-SEC is…
externally ventilated
physically separated (another room or area)
appropriate air exchange (ACPH)
negative pressure between a 0.01 and 0.03 inches of water column relative to all adjacent areas

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

how far must a sink for handwashing and an eye wash station be from the C-PEC

A

1 meter

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

what is the difference between the 2 allowed C-SEC engineering controls? (ISOI class 7 buffer room w ISO 7 anteroom vs. C-SCA)?

A

ISO 7 buffer and anteroom requires 30 ACPH

C-SCA requires only 12 ACPH and has shorter BUDs

refer to BUD info in 797

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

what are the C-SEC general requirements

A

externally ventilated
physically separated (another room or area)
appropriate air exchange (ACPH)
negative pressure between a 0.01 and 0.03 inches of water column relative to all adjacent areas

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

what are the C-PEC requirements

A

externally ventilated
ex) Class II or III BSC, CACI

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

what is a C-SEC

A

containment supplemental engineering controls
- ex) CSTDs (closed system drug transfer device)
- provide adjunct controls/additional level of protection during compounding or admin
- can limit aerosol generation when compounding
-

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

CACI is the abbreviation for

A

compounding aseptic contamination isolator

19
Q

can a C-STD be used in place of a C-PEC when compunding?

A

no

20
Q

if the dosage form allows, does a C-STD NEED to be used when administering a HD?

A

yes

21
Q

at what points in the process of handling HDs does PPE need to be worn

A

at every step!
receipt
storage
transport
compounding (sterile and non sterile)
administration
deactivation/decontamination, cleaning and disinfection
spill control
waste disposal

22
Q

what does PPE for HDs entail

A

chemotherapy gloves
gowns that close in the back, long sleeve, elastic or knit cuffs, seamless
head and hair covers
shoe covers
sleeve covers
face shield PLUS goggles
(another option is a full facepiece respirator)
N-95 or respirator

23
Q

when are handlers at risk of respiratory exposure to a HD?

A

attending a spill that is larger than what can be contained w a spill kit
deactivating, decontaminating, and cleaning underneath the work surface of a C-PEC
known or suspected airborne exposure to powders or vapors

24
Q

when should training occur for employees involved in any part of the HD process

A

before the employee independently handles HDs

25
Q

when does an employee complete HD training

A

when they can demonstrate effectiveness of training

26
Q

how often does personnel competency of HD handling be assessed

A

every 12 months

27
Q

if a new HD is going to be received and dealt with, what has to occur?

A

re-training

28
Q

what must be done after personnel demonstrate competency of HD handling

A

documentation of all training and competency assessments

29
Q

what must training on HDs include

A

overview of list of HDs and their risks
review of SOPs
proper PPE use
proper equipment and device use
response to know or suspected exposure
spill management
proper disposal of trace-contaminated materials

30
Q

how must HDs be packaged and received on arrival?

A

in impervious plastic
delivered directly to the HD storage area
WITH PPE, including chemotherapy gloves
spill kit accessible

31
Q

what happens if the HD shipping container appears damaged

A

seal container without opening it
contact supplier
if returned, enclose in impervious container
if not returned, dispose of as hazardous waste

32
Q

what happens if the HD shipping container is damaged, but must be opened

A

transport to C-PEC and place on a plastic-backed preparation mat
open and remove undamaged items
wipe down undamaged items
put damaged items in impervious container and label as hazardous
deactivate, decontaminate, and clean the C-PEC

33
Q

what are the steps to closing down a C-PEC

A

deactivate
decontaminate
clean
disinfection

34
Q

what are the requirements of SOPs for HDs

A

instruct on receipt, storage, labeling, compounding, packaging, transport, and disposal of HDs
prevention of accidental exposure or spills
response to exposure
spill kit use
C-PEC, C-SEC, CSTD maintenance
deactivating, decontaminating, cleaning, disinfecting

35
Q

what must be placed on the work surface of a C-PEC

A

plastic-backed preparation mat

36
Q

how often do SOPs need to be reassessed? how is this documented?

A

every 12 months by the designated person
document

37
Q

personnel who transport, compound, or administer HDs must document training according to ______ standards

A

OSHA

38
Q

CSTD stands for

A

closed-system drug-trasnfer devicde

39
Q

HEPA
- what is the abbreviation for?
- what is it?

A

high efficiency particulate air
an extended-medium, dry-type filter in a rigid frame
minimum particle efficiency = 99.97% for particles with a mass median diameter of 0.3 um

40
Q

if a room has negative pressure, where does air flow

A

into the room

41
Q

what is an anteroom

A

an ISO class 7 or cleaner room where personnel hand hygiene, garbing procedures, and other activities that generate a high particulate level occur

42
Q

what are BSCs

A

biological safety cabinets
BSCs
can be Class I, II, or III
Class II BSCs are further divided into A1, A2, B1, B2

43
Q

what is a buffer room

A

a type C-SEC under negative pressure that meets ISO Class 7 or better air quality where the C-PEC that generates and maintains an ISO Class 5 environment is physically located
activities here include preparation and staging of components and supplies used when compounding HDs

MPJE Prep (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions