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Chapter 10
Infection Control
© Paradigm Publishing, Inc.
1
Identifying and Controlling
the Source of Infection
• The development of the germ theory
of disease
• Microorganisms and disease
• Asepsis and sterilization
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The Development of the
Germ Theory of Disease
• The cause of infectious diseases was
not fully understood until recently.
• Disease was attributed to evil
influences.
• Knowledge of infectious disease
progressed slowly over the centuries.
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Terms to Remember
germ theory of disease
the idea that microorganisms cause
diseases
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The Development of the
Germ Theory of Disease
• Pasteur developed a heating process
to kill bacteria and mold in milk
(pasteurization).
• Pasteur proposed that disease could
be prevented by not allowing
microorganisms to enter the body.
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Terms to Remember
pasteurization
a sterilization process designed to kill
most bacteria and mold in milk and other
liquids
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The Development of the
Germ Theory of Disease
English surgeon Joseph Lister built on
Pasteur’s work:
– He knew that carbolic acid killed
bacteria, so he used it to disinfect
surgical dressings.
– He developed other antiseptic methods
for surgery.
– His sterile surgical techniques reduced
post-surgical infections and saved
thousands of lives.
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The Development of the
Germ Theory of Disease
• Robert Koch defined a series of steps
(Koch’s Postulates) that could prove that a
certain disease was caused by a certain
microorganism (1876).
• He conducted research on cattle infected
with anthrax:
– Cultured bacteria in the lab
– Infected healthy animals with it
– Found the same bacteria in the blood of the
infected animals
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Terms to Remember
bacterium
a small, single-celled microorganism that
can exist in three main forms, depending
on type: spherical (cocci), rod-shaped
(bacilli), and spiral (spirochetes)
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Microorganisms and Disease
Bacteria cause a variety of illnesses:
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Food poisoning
Strep throat
Ear infections
Rheumatic fever
Meningitis
Pneumonia
Tuberculosis
Pinkeye
Acne
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Microorganisms and Disease
• Virus – a microorganism consisting of
genetic material encased in protein
• Needs a living host in order to reproduce
• Causes many illnesses
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Colds and influenza
Mumps and measles
Chickenpox
Hepatitis
HIV
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Terms to Remember
virus
a minute infectious agent that does not
have all of the components of a cell and
thus can replicate only within a living
host cell
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Microorganisms and Disease
• Fungus – a parasite that reproduces
slowly by means of spores
• Can occur as
– Molds
– Mildews
– Mushrooms
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Terms to Remember
fungus
a single-celled organism similar to
human cells; marked by the absence of
chlorophyll, a rigid cell wall, and
reproduction by spores; feeds on living
organisms (or on dead organic material)
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Microorganisms and Disease
• Molds can be beneficial – source of
penicillin
• Can also cause conditions such as
– Athlete’s foot
– Ringworm
– Vaginal yeast infections
– More serious systemic fungal infections
in the hospital
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Microorganisms and Disease
• Protozoa – a microscopic organism
consisting of one cell or a group of
identical cells
• Live in water or inside other creatures as
parasites
• Examples include paramecia and
amoeba
• Can cause dysentery, malaria, and
sleeping sickness
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Asepsis and Sterilization
Before scientific control of harmful
microorganisms, epidemics and pandemics
killed millions of people:
– Bubonic plague killed 137 million Europeans.
– European diseases such as smallpox
decimated Native American populations.
– One quarter of delivering mothers died of
infections carried by hands and instruments of
nurses and physicians.
– Influenza epidemic of 1918 killed over 25
million people worldwide.
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Asepsis and Sterilization
• Asepsis is the absence of disease-causing
microorganisms.
• Sterilization is any process that destroys
microorganisms.
• There are several types of sterilization:
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Heat
Dry heat
Mechanical
Gas
Chemical
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Terms to Remember
asepsis
the absence of disease-causing
microorganisms
sterilization
a process that destroys the
microorganisms in a substance,
resulting in asepsis
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Asepsis and Sterilization
• Boiling kills vegetative forms, many
viruses, and fungi in about 10
minutes.
• More time is needed to kill fungus
spores and the hepatitis virus.
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Asepsis and Sterilization
• An autoclave sterilizes with heat
(270° F) and pressure (15 psi).
• Most known
organisms are
killed in about
15 minutes.
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Terms to Remember
autoclave
a device that generates heat and
pressure to sterilize
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Asepsis and Sterilization
Dry heat (such as direct flaming) kills all
organisms:
– Impractical for many substances
– Used for disposal of contaminated
objects
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Asepsis and Sterilization
• Mechanical sterilization is achieved
by means of filtration.
• It is used for heat-sensitive materials:
– Culture media
– Enzymes
– Vaccines
– Antibiotic solutions
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Asepsis and Sterilization
Gas sterilization is used for materials
subject to destruction by heat:
– Uses ethylene oxide
– Requires special equipment and
aeration
– Used only in large institutions and
manufacturing facilities
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Asepsis and Sterilization
• Chemical sterilization usually does not
produce complete sterility.
• It reduces microbial numbers to safe levels.
• Chemicals used for sterilization are known
as disinfectants.
• Commonly used topical disinfectants
include
– Iodine
– Isopropyl alcohol (IPA)
– Chlorinated bleach
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Terms to Remember
disinfectant
a chemical applied to an object or
topically to the body for sterilization
purposes, such as rubbing alcohol
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Contamination
• Prevention of contamination in the
preparation of IV products is crucial.
• Contaminated IV solution can cause
serious infection or death.
• Contamination can occur by
– Touch
– Air
– Water
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Touch
• Millions of bacteria live on the skin
and hair and under the nails.
• Touching is the most common means
of contamination and the easiest to
prevent.
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Touch
Hand washing and
use of gloves and
head coverings
minimize touch
contamination.
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Air
• Microorganisms are found in the air,
dust particles, and moisture droplets.
• Sterile materials should be prepared
in an area designed to keep
contaminants to a minimum.
• Special equipment is used to control
airflow and minimize contamination.
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Water
• Tap water contains microorganisms.
• Moisture droplets (especially from a
sneeze or cough) contain harmful
microbes.
• Sterile materials must not be exposed
to contaminated water.
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The Centers for Disease
Control and Prevention
• CDC is a federal agency that provides
guidelines and recommendations on
infection control.
• A major focus of the CDC has been to
prevent transmission of infectious diseases
in the hospital.
• CDC updates and publishes guidelines to
protect patients and healthcare workers
from infectious diseases.
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Hand Hygiene
• Hand washing and hand hygiene are
the most important practices to
prevent touch contamination.
• Hand washing involves using plain or
antiseptic soap and water.
• Hand hygiene involves using special
alcohol-based rinses, gels, or foams
that do not require water.
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Terms to Remember
hand washing
the use of plain or antiseptic soap and
water with appropriate time and
technique
hand hygiene
the use of special dry, alcohol-based
rinses, gels, or foams that do not require
water
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Hand Hygiene
• Effectiveness of hand hygiene
depends on
– Technique
– Presence of artificial fingernails and
jewelry (both can harbor
microorganisms)
• Proper hand hygiene technique is
used only about 40% of the time.
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Gloves
• CDC recommends the use of gloves
for workers in the IV area.
• Gloves are important because hand
washing alone may not prevent the
transmission of microorganisms.
• Gloves are usually made of latex or
vinyl, but because some people are
sensitive to latex, an alternative
should always be available.
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Vaccination
• CDC recommends that healthcare
workers get an annual flu shot.
• Flu shots protect the workers, their
families, and the patients.
• Flu shots are between 70% and 90%
effective.
• Only about 40% of healthcare
workers get a flu shot each year.
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USP Chapter 797 Standards
• USP developed first official and
enforceable requirements for sterile
preparation compounding (2004).
• Requirements were updated and
approved in 2008.
• USP Chapter 797 focuses on sterility
and stability.
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Terms to Remember
compounded sterile preparation
(CSP)
a sterile product that is prepared outside
the pharmaceutical manufacturer’s
facility, typically in a hospital or
compounding pharmacy
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USP Chapter 797 Standards
Standards for sterile compounding are more
stringent than for nonsterile compounding:
– Must work in a defined clean-room environment
– Additional rules for garbing
– Personnel training and testing in aseptic
techniques
– Specifications for environmental quality
– Rules for disinfection of gloves and surfaces
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Environmental Quality
and Standards
• Compounding facilities are designed
and controlled to minimize airborne
contaminants.
• 797 standards use the ISO
classification system for defining the
amount of particulate matter allowed
in room air.
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Environmental Quality
and Standards
Sterile compounding area is divided into
three main parts:
– Ante area
– Buffer area
– Direct
compounding
area (DCA)
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Terms to Remember
ante area (ante means before)
the area of the IV room used for hand
washing and donning protective
garments, among other high-particulategenerating activities
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Terms to Remember
buffer area
the area of the IV room used for the
storage of components and supplies
(such as IV bags and administration
sets) that are used for compounding
CSPs; also area for hand hygiene and
donning protective gloves
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Terms to Remember
direct compounding area (DCA)
the sterile, compounding area of the IV
room, in which the concentration of
airborne particles is controlled with a
HEPA filter providing ISO Class 5 air
quality
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Environmental Quality
and Standards
• Ante area activities
– Personnel hand washing and garbing
– Staging of components
– Order entry
– CSP labeling
• Ante area air quality should be at ISO
Class 7 or 8.
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Environmental Quality
and Standards
• Buffer area is where CSP supplies
are stored.
• Buffer area air quality should be no
more than ISO Class 7.
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Environmental Quality
and Standards
• Staging area outside the
compounding workbenches should
have an air quality of ISO Class 5.
• Compounding is performed in the
most sterile area (the DCA) under
laminar airflow workbenches (LAFW).
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Environmental Quality
and Standards
• The buffer area and the direct
compounding area together comprise the
clean room.
• Air quality is controlled with a highefficiency particulate air (HEPA) filter
system.
• The clean room is physically segregated
from the rest of the pharmacy.
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Terms to Remember
clean room
an area that includes the buffer and
staging areas and the sterile, direct
compounding area (DCA) of the IV
compounding lab
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Terms to Remember
high-efficiency particulate air (HEPA)
filter
a device used with laminar flow hoods to
filter out most particulate matter to
prepare parenteral products safely and
aseptically
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Environmental Quality
and Standards
• No food, drink, or chewing gum is
permitted in the compounding lab.
• No long-term storage is permitted in
the clean room.
• Only specific items needed for sterile
compounding can be taken into the
DCA.
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Special Equipment
• Laminar airflow workbenches (LAFW)
are crucial for maintaining air quality
in the clean room.
• Horizontal laminar airflow workbench
is used to prepare nonhazardous
CSPs.
• Vertical laminar airflow workbench is
use to prepare hazardous CSPs.
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Special Equipment
• In a horizontal LAFW, air flows from
the back of the hood, across the work
surface, and out into the room.
• Air is filtered with
a HEPA filter,
which removes
99.97% of particles
0.3 microns
or larger.
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Terms to Remember
horizontal laminar airflow workbench
(LAFW)
a special biological safety cabinet used
to prepare IV drug admixtures, nutrition
solutions, and other parenteral products
aseptically
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Special Equipment
In a vertical LAFW, air flows from the
top of the hood down through a prefilter
and a HEPA filter, onto the work
surface, and is
then circulated
through another
HEPA filter and
vented outside.
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Terms to Remember
vertical laminar airflow workbench
(LAFW)
a special biological safety cabinet used
to prepare hazardous drugs, such as
cancer chemotherapy drugs, aseptically
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Special Equipment
Safety Note
Coughing and talking should be
directed away from the hood and
workbench.
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Special Equipment
Technicians using a vertical LAFW
should wear eye protection, a mask,
and proper apparel.
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Special Equipment
• Routine cleaning of LAFWs is an
important responsibility of the IV
technician.
• The entire LAFW should be cleaned
with 70% IPA daily.
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Special Equipment
The technician should wear full
protective clothing while cleaning
LAFWs.
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Personnel Cleansing
and Garb
• Personnel must remove all outerwear
before entering the ante area.
• Cleansing process starts with hand
washing and putting on protective garb.
• Process continues with hand hygiene in the
buffer area.
• Gloves are the last step.
• For hazardous materials, extra protection
includes eye protection and double gloving.
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Contamination Risk Levels
• Risk levels are assigned to each CSP
based on the probability of microbial,
chemical, or physical contamination.
• Risk level can be
– Low
– Medium
– High
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Contamination Risk Levels
• Low-risk CSPs include sterile
products that have been handled
using aseptic techniques.
• Low-risk CSPs also include the
transfer, measuring, and mixing of
CSPs containing three or fewer
ingredients.
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Contamination Risk Levels
• Medium-risk CSPs include multiple
sterile products combined using
automated devices or transferred
from multiple sterile containers into
one final sterile container.
• Examples include TPN solutions
containing more than three
electrolytes or vitamins.
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Contamination Risk Levels
• High-risk CSPs include
– Products that have been compounded from
nonsterile ingredients
– Sterile products without preservatives
– Sterile products exposed to inferior air quality
• All high-risk CSPs must be sterilized by
using
– A 0.22 micron filter
– Autoclaving
– Dry heat
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Terms to Remember
expiration date
the date after which a manufacturer’s
product should not be used
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Training Required
to Work with CSPs
• Extensive skills and training are
necessary to practice in a clean room.
• Written tests and skill assessments
must be passed.
• The technician may be encouraged or
required to acquire additional
certifications for sterile compounding.
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Terms to Remember
infection control committee (ICC)
a committee of the hospital that provides
leadership in relation to infection control
policies
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Terms to Remember
nosocomial infection
an infection caused by bacteria found in
the hospital from any source that causes
a patient to develop an infectious
disease; also called healthcareassociated infection (HAI)
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Infection Control Committee
• Primary role is to prevent, identify,
and control nosocomial infections as
well as infections brought into the
hospital from the community.
• Committee plays a major role in
ensuring that the hospital is in
compliance with Joint Commission,
CDC, and USP Chapter 797
standards.
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Infection Control Committee
Sets infection control policy and is involved in
planning, monitoring, evaluating, updating
and educating
– Surveillance of nosocomial infections
– Antibiotic and other product evaluations
– Investigation of infection outbreaks and
infection clusters
– Development of infection control procedures
– Patient education regarding medical waste
management
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Infection Control Committee
• Hospital is also responsible for protecting
workers from contracting infectious
diseases from patients.
• ICC educates all hospital employees about
the importance of following procedures to
minimize employee exposure.
• Universal precautions are procedures
followed in all healthcare settings to
prevent infection.
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Terms to Remember
sharp
a used needle, which can be a source of
infection
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Terms to Remember
universal precautions
procedures followed in healthcare
settings to prevent infection as a result
of exposure to blood or other bodily
fluids
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