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Sterile IV Compounding Processing Lecture 1-2 Theory

Total questions: 74

Worksheet time: 1hrs 9mins

Name
Class
Date
1.
Which of the following statements are false regarding the horizontal laminar flow hood? 
a)
The laminar flow hood should be located in the anteroom
b)
The laminar flow hood should be located in a Buffer zone
c)
The laminar flow hood should be located in a ISO Class 7 Environment
d)
The laminar flow hood is also considered a primary control
2.
The Buffer/Clean rooms should provide which of the following environments according to USP 797? 
a)
ISO Class 6
b)
ISO Class 7 or better
c)
ISO Class 8
d)
None of the above
3.
How often must high-risk level media fill testing be conducted by compounding personnel?
a)
at least monthly 
b)
at least annually
c)
at least semiannually
d)
at least weekly
4.
Which of the following components of the syringe must remain sterile?
a)
tip
b)
barrel 
c)
inner core of plunger
d)
only tip & inner core of plunger
5.
Which of the following drugs are used to treat cancer by substituting in or blocking the use of essential nutrients and enzymes?
a)
mitotic inhibitors
b)
alkylating agents
c)
antimetabolites
d)
none of the above
6.
Which of the following is the same as D10W 1/2NS?
a)
Dextrose 10% in Water and 0.5% Normal Saline
b)
Dextrose 10% in Water and 0.225% Normal Saline
c)
Dextrose 10% in Water and 0.45% Normal Saline
d)
Dextrose 10% in Water and 50% Normal Saline
7.

Using multiple sterile ampules to be transferred into one final sterile container

a)

immediate use risk level

b)

low risk level

c)

medium-risk level

d)

high-risk level

8.
Only a single transfer from a sterile vial utilizing sterile supplies
a)
immediate use risk level
b)
low-risk level
c)
medium-risk level
d)
high-risk level
9.
Emergency room treatments to be used within 1 hour
a)
Immediate use risk level
b)
Low-risk level
c)
Medium-risk level
d)
High-risk level
10.
Sterile ingredients measured/mixed with non-sterile devices before sterilization is performed
a)
immediate risk level
b)
low-risk level
c)
medium-risk level
d)
high-risk level
11.
How often must work surfaces in the ISO Class 7 & 8 area buffer/clean room be cleaned? 
a)
At least daily
b)
Every Shift
c)
Every 8 hours
d)
PRN
12.
A controlled room or space designated for preparing sterile pharmaceuticals.
a)
Controlled area
b)
Clean Room
c)
Sterile Room
d)
None of the above
13.
In order to maintain a controlled environment, the temperature of the drug storage refrigerators should be maintained between ____ and ____ Degrees Fahrenheit
a)
36-46
b)
36-36
c)
36-66
d)
34-54
14.
SPA is a pharmacy abbreviation meaning?
a)
Standard Procedure Association
b)
Sterile Pharmaceuticals Association
c)
Sterile Products Area
d)
None of the Above
15.
Law requires that all pharmacy personnel wear an identification tag , displaying person's name & title
a)
True
b)
False
16.
_______ deals with policies & procedures related to compounding sterile products.
a)
Process Validation
b)
USP/NF 797
c)
Quality Control
d)
Quality Assurance
17.
Measured & Documented evidence, providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
a)
Process Validation
b)
USP/NF 797
c)
Quality Control
d)
Aseptic Preparation
18.
Immediate use preparations are intended only for __________.
a)
Out patient treatment
b)
Home healthcare
c)
Non life threatening situations
d)
Emergency situations
19.
What does qhs mean?
a)
Four Times a Day
b)
Every Hour
c)
At Bedtime
d)
Quantity Sufficient
20.

Pharmacy Personnel are required to perform garbing according to the USP/NF 797 in a correct order & will be tested on this technique?

a)

True

b)

False

21.
USP/NF 797 requires that air sampling for high risk level areas be performed at least? 
a)
daily
b)
weekly
c)
monthly
d)
annually
22.
Which ISO class is the cleanest?
a)
ISO 3
b)
ISO 5
c)
ISO 8
d)
ISO 7
23.
A defined space in which the concentration of the airborne particles is controlled to meet a specified airborne particulate cleanliness class. 
a)
Controlled Area
b)
Clean Room
c)
Clean Zone
d)
All of the above
24.
Which of following is NOT a compounding example of a Low-risk Level Sterile Preparation? 
a)
A single transfer from a sterile ampule utilizing sterile supplies
b)
Measuring or mixing manually two manufactured products to prepare an admixture
c)
Measuring or mixing three manufactured products to prepare a nutritional preparation
d)
Measuring or mixing manually four manufactured products to prepare a TPN.
25.
Which of the following is a compounding example of a high-risk level sterile preparation?
a)
A. Sterile ingredients are measured and mixed in nonsterile devices before sterilization is performed
b)
B. Dissolving nonsterile bulk drug and nutrient powders to make solutions which will be terminally sterilized.
c)
C. TPN fluids prepared via automated device requiring multiple injections of nutrient components to a final sterile container. 
d)
D. Only A & B are examples of high risk level sterile preparations.
26.

Which is not an area addressed by USP 797?

a)

beyond use dates

b)

avoiding drug interactions

c)

environmental quality and control

d)

contamination risk levels

27.

Which ISO class represents the lowest airborne particulate counts?

a)

ISO Class 5

b)

ISO Class 6

c)

ISO Class 7

d)

ISO Class 8

28.

The area where hand hygiene is performed is:

a)

prior to entering the controlled environment

b)

ISO 8 area

c)

ISO 7 area

d)

ISO 5 area

29.

Which of the following would be a medium risk product?

a)

a single vial of diphenhydramine drawn up in a syringe for IM injection

b)

a large volume bag with potassium and magnesium added

c)

a Total Parenteral Nutrition (TPN) mixture

d)

A solution made from a non-sterile powder

30.

Which of the following factors determine the beyond use date (expiration date)

a)

compound's risk-level

b)

storage conditions

c)

product stability

d)

all of the above

31.

Low-risk products remain stable under refrigeration for up to how many days?

a)

3

b)

9

c)

14

d)

45

32.

Until proposed changes take place, there are _____ current compounding risk levels which may change in the future.

a)

4

b)

5

c)

6

d)

none of the above

33.

Which of the following options details the proper order of garbing?

a)

Shoe covers, hand hygiene, head/facial covers, gowning, gloving, hand sanitizing

b)

Hand hygiene, head/facial covers, shoe covers, gloving, hand sanitizing, gowning

c)

Shoe covers, head/facial covers, hand hygiene, gowning, hand sanitizing, gloving

d)

Shoe covers, hand hygiene, hand sanitizing, gowning, gloving

34.

The floors of the buffer or clean are should be cleaned

a)

before each shift

b)

daily

c)

weekly

d)

monthy

35.

Which of the following cleaning has both microbicidal and bacteriostatic properties?

a)

4% chlorhexidine gluconate

b)

3% sodium hypochlorite

c)

4% hydrogen peroxide

d)

70% isopropyl alcohol

36.

Positive air pressure in a controlled clean room will move airborne particles _______ from IV hoods.

a)

away from

b)

toward

37.

Positive air pressure creates an "air barrier" when opening the clean room door, forcing clean air _______.

a)

out of the room

b)

into the room

38.

Compounding "Risk" is defined by the likelihood of contamination based on the number of ingredients & fluid transfers during admixture.

a)

True

b)

False

39.

How often should gloves be changed?

a)

daily

b)

if damaged or after 2 hours of continued use

c)

at the end of every shift

d)

after each change in product

40.

Standards, like processes & procedures, during admixture training to ensure that compounding personal possess the knowledge, skills, & attitudes to safely perform IV admixture.

a)

Quality Control

b)

Quality Assurance

c)

Sterilization

d)

None of the above

41.

What is the process of determining whether procedures are still effective?

a)

Quality Control

b)

Sterilization

c)

Quality Assurance

d)

Risk Assessment

42.

How often should media fill testing be performed to verify the competence & skill of IV drug preparers?

a)

Monthly

b)

Bi-anually

c)

Every 3-4 months based on product risk-level

d)

Yearly

43.

How often must ISO Flow-Hoods be re-certified?

a)

Monthly

b)

Bi-anually

c)

Every 3-4 months based on usage

d)

Yearly

44.

The appropriate temperature range for the storage of drugs requiring refrigeration is between ______ and ______ Fahrenheit.

a)

22-46

b)

30-40

c)

36-46

d)

36-66

45.

If _______ are worn in a clean room they must be covered with a lab coat or gown at all times even when they are not in the clean room.

a)

gloves

b)

mask

c)

scrubs

d)

shoe covers

46.

Whenever ____ agents are stored in the same refrigerator as other drugs, they must be labeled and physically separated:

a)

chemotherapy drugs

b)

hazardous drugs

c)

cytotoxic drugs

d)

all of the above

47.

Under what conditions may an outside hospital staff member be allowed in the pharmacy?

a)

With temporary access authorization, hospital staff may gain access to all areas

b)

Outside employees are never allowed in the pharmacy

c)

all hospital staff with badges may access all areas of the hospital, including the pharmacy

d)

With temporary access authorization, hospital staff may gain access to the pharmacy as long as accompanied by a pharmacy staff escort

48.

Which of the following options details the proper order of garbing?

a)

Shoe covers, hand hygiene, head/facial covers, gowning, gloving, hand sanitizing

b)

Hand hygiene, head/facial covers, shoe covers, gloving, hand sanitizing, gowning

c)

Shoe covers, head/facial covers, hand hygiene, gowning, hand sanitizing, gloving

d)

Shoe covers, hand hygiene, hand sanitizing, gowning gloving

49.

The floors of the buffer or clean area should be cleaned

a)

before each shift

b)

daily

c)

weekly

d)

monthly

50.

Based on readings, an appropriate room temperature range for general pharmacy storage of a drug is:

a)

59-77 F

b)

68 F or cooler

c)

68-79 F

d)

86 F or cooler

51.

Pharmacy environmentally controlled areas have been constructed in a way that will:

a)

Blanket the area with dry heat at all times

b)

Create and sustain specific physical and environmental conditions

c)

Create and sustain refrigerated temperatures

d)

Ensure that all recyclable materials are gathered in a timely manner

52.

Who is responsible for the monitoring of refrigerator temperatures anywhere in the hospital where medications are stored?

a)

Environmental Services Department

b)

Pharmacy Department

c)

Nursing Department

d)

Hospital Monitoring Department

53.

Which of the following hand cleansers has both microbicidal and bacteriostatic properties?

a)

4% Chlorhexidine Gluconate

b)

3% Sodium Hypochlorite

c)

4% Hydrogen Peroxide

d)

70% Isopropyl Alcohol

54.

What two factors determine beyond use dating?

a)

Product Storage

b)

Dosage Form

c)

Compound Category (Risk Level)

d)

Route of Administration

55.

Limiting the access of personnel inside a pharmacy is one way to control the environment?

a)

True

b)

False

56.

______ is the absence of contaminants, both microbial and particulate in nature.

a)

Clean

b)

Asepsis

c)

Aesthetic

d)

None of the above

57.

The word sterile is defined as being free from contamination

a)

True

b)

False

58.

The room where Laminar flow hoods are kept

a)

Ante Area

b)

Buffer Area

c)

SPA

d)

None of the above

59.

The area where aseptic admixture is performed?

a)

Ante Area

b)

Buffer Area

c)

Clean Area

d)

Laminar Flow Hood/Bench

60.

Area where compounding drugs & supplies are gather from outside area?

a)

Ante Area

b)

Buffer Area

c)

Flow Hood/Bench

d)

None of the above

61.

Other names for Flow Hood/Bench

a)

SPA

b)

Primary Engineering Control (PEC)

c)

Isolator (Glove Box)

62.

Which ISO class allows for the greatest number of particles?

a)

ISO 3

b)

ISO 5

c)

ISO 8

d)

ISO 7

63.

Immediate use medications typically have a beyond use date (expiration) of ___________.

a)

1 hour

b)

48 hours

c)

30 hours

d)

12 hours

64.

Low-Medium Risk with 12 hour BUD medications typically have a beyond use date (expiration) of ___________.

a)

1 hour

b)

6 hours

c)

12 hours

d)

24 hours.

65.

What is the risk level of a compound with non-sterile ingredients with the goal to make a sterile product?

a)

Low Risk

b)

Medium Risk

c)

High Risk

d)

Medium Risk with 12 hour BUD

66.

An emergency drug preparation outside of an ISO 5 hood presents what risk level?

a)

Low Risk

b)

Medium Risk

c)

High Risk

d)

Immediate Use

67.

How does elevated temperature in an ISO 7 space increase compounding risk?

a)

it has no effect (negative or positive)

b)

creates a more ideal environment for bacterial growth & survival

c)

creates a less ideal environment for bacterial growth & survival

68.

One of the most effective ways to lower particulate contamination risk is to cover as many skin surfaces as possible w/ PPE

a)

True

b)

False

69.

How often should ISO 7 work surfaces be cleaned?

a)

every shift

b)

daily

c)

weekly

d)

monthly

70.

How often should ISO 7 walls and ceilings be cleaned?

a)

daily

b)

monthly

c)

weekly

d)

bi-annually

71.

How often should media fill testing be performed to verify the competence and skill of IV drug preparers?

a)

Daily

b)

Monthly

c)

Weekly

d)

Biannually (every 6 months)

e)

Yearly

72.

How often must ISO 5 hoods be recertified?

a)

weekly

b)

monthly

c)

biannually

d)

yearly

73.

A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class

a)

clean zone

b)

buffer zone

c)

cleanroom

d)

ante-area

74.

Oral and injectable antibiotics may be stored together in a hospital setting?

a)

True

b)

False