Download Anaphylaxis policy/procedure

South West Nova District Health Authority
Shared Competency
TITLE: Immunization
NUMBER: 0-022
Effective Date:
Page (1 of 43)
August 2014
Applies To: Nursing
POLICY APPLICABLE:
Shared Competency Procedures
Immunization Policy
Immunization Procedure
Immunization Anaphylaxis Protocol
100.205
100.240
100.240.1
100.241
PROGRAM OBJECTIVES:
Theory Objectives
Following completion of the theory component of the learning module, the learner will be able
to:
1. Identify concepts and principles of immunity and the prevention of vaccine preventable
disease
a) Understand the function of the immune system and the concept of immunity
2. Identify the information health care personnel should be aware of when providing
immunization.
a) Aware of and can respond appropriately to vaccine related myths posed by
patients/families/staff using an evidenced-based approach
b) Appropriately refer to expert professionals/resources when required to
address the immunization needs of certain populations
c) Anticipates, identifies, and manages adverse events following immunization
3. Identify the need to have a physician order to administer the immunization agent, as
well as, an order to implement the Immunization Anaphylaxis Protocol in the event a
patient has an anaphylaxis reaction.
4. Recognize the need to prepare medications for an anaphylactic reaction.
5. Locate Immunization Anaphylaxis Protocol and manage anaphylaxis
a) Identify the symptoms of anaphylactic reactions
b) Know the step-by-step response to anaphylaxis
c) Understand appropriate treatment utilized in the management of anaphylaxis
d) Know the requirements for documentation and reporting of adverse events
following immunization
6. Locate the proper procedure for administration of immunization agents.
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7. Demonstrate comprehensive knowledge of the Administration of immunizing agents
and immunization practice
a) Prepare and administer immunization agents correctly
b) Understand the requirements for implementing the Canadian National guidelines
when storing, handling or transporting vaccines (Medication Cold Chain and Safe
Medication Storage)
c) Document information relevant to each immunization.
8. Identify the seven “Rights” of Immunization.
9. Identify the legal and ethical aspects of immunization
a) Current legal requirements for informed consent
b) Data protection
c) Documentation
d) Professional accountability
Clinical Objectives
Upon successful completion of the clinical component and of the learner module, the learner
will be able to:
Properly implement the procedure according to the Policy and Procedure guidelines of the
SWNDHA, Nursing Program, required for Immunization.
CRITERIA FOR CERTIFICATION:
Applicable to all RN’s in designated areas as indicated by the Nursing Program competency
table;
1. Achievement of a minimum of 80% on the written quiz for the theory component of the
learning module.
2. Successfully complete all the provincial on-line tutorials prior to clinical component.
3. Successful completion of the clinical component for immunization as determined by
the *designated supervisor authorized to provide supervision and approval for
certification.
CRITERIA FOR MAINTENANCE:
1. Consistently performs procedure.
2. Competency in performing procedure is reviewed by nursing management
periodically.
3. The individual expresses confidence in their competence in performing the procedure.
Designated Supervisor/s authorized to provide supervision and approval for certification:
Each Nursing Unit will delegate unit specific Designated Supervisors.
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The role of the Designated Supervisor is to ensure that the procedure act is performed within
the established standards. The standards are outlined within the clinical component
evaluation list.
The Designated Supervisor certifies that the learner has demonstrated the ability to perform
the procedure/act without further direct supervision.
Prepared by Linda McCarthy, R.N. September 1990 Revised by McCarthy, R.N.
September 1991
Reviewed by Anne Morton, R.N. October 1993, August 1996
Revised by McCarthy Wilson R.N., James, R.N., MacLachlan R.N., November 2002
Reviewed by Ruth Davis, DOH
Revised by M. Lowe RN, L. Wilson RN, K. Boudreau RN.
Revised by D. Theriault R.N. 2014
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SWNDHA – NURSING PROGRAM
COMPETENCY PROCEDURE LEARNING MODULE
PART I – THEORY COMPONENT
DEFINITIONS:
Active immunity:
The production of antibodies against a specific disease by the immune system. Active
immunity can be acquired in two ways, either by contracting the disease or through
vaccination. Active immunity is usually permanent, meaning an individual is protected from
the disease for the duration of their lives.
Additives:
Substances may be added to vaccines for two different purposes:
1. To support the growth and purification of specific immunogens and/or the
inactivation of toxins. These include antibiotics added to prevent contamination
during viral cell culture; substances needed for the growth of viruses, such as egg
or yeast proteins, glycerol, serum, amino acids and enzymes; and formaldehyde
used to inactivate viruses and protein toxins. Most of these reagents are removed
in subsequent manufacturing steps, but minute “trace” amounts may remain in the
final product.
2. To confirm to product quality or stability standards. Compounds may be
added to vaccines for a variety of manufacture-related issues: controlling
acidity (pH); stabilizing immunogens through necessary steps in the manufacturing
process. Examples of such additives include but are not limited to: potassium or
sodium salts, lactose, polysorbate 20 or 80.
Adjuvant:
A substance added to a vaccine to enhance the immune response by degree and/or duration,
making it possible to reduce the amount of immunogen per dose or the total number of doses
needed to achieve immunity.
Adverse Event Following Immunization (AEFI):
An adverse event temporally associated with immunization that may or may not have been
caused by the biological or the immunization process.
Allergy:
A condition in which the body has an exaggerated response to a substance (e.g. food or
drug). Also known as hypersensitivity.
Anaphylaxis:
An immediate and severe allergic reaction to a substance (e.g. food or drugs). Symptoms of
anaphylaxis include breathing difficulties, loss of consciousness and a drop in blood
pressure. This condition can be fatal and requires immediate medical attention.
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Antibody:
A protein (an immune globulin molecule) produced by an organism in response to stimulation
by an antigen. An antibody combines only with the specific antigen that induces its synthesis.
Herd Immunity (Community Immunity):
Having a large percentage of the population vaccinated in order to prevent the spread of
certain infectious diseases. Even individuals not vaccinated (such as newborns and those
with chronic illnesses) are offered some protection because the disease has little opportunity
to spread within the community.
Immune globulin:
A protein found in the blood that fights infection. Also known as gamma globulin.
Immunity:
Protection against a disease. There are two types of immunity, passive and active. Immunity
is indicated by the presence of antibodies in the blood and can usually be determined with a
laboratory test. See active and passive immunity.
Immunization:
The process by which a person or animal becomes protected against a disease. This term is
often used interchangeably with vaccination or inoculation.
Immunosuppression:
When the immune system is unable to protect the body from disease. This condition can be
caused by disease (like HIV infection or cancer) or by certain drugs (like those used in
chemotherapy). Individuals whose immune systems are compromised should not receive
live, attenuated vaccines.
Inactive vaccine:
A vaccine made from viruses and bacteria that have been killed through physical or chemical
processes. These killed organisms cannot cause disease.
Live vaccine:
A vaccine in which a live virus is weakened through chemical or physical processes in order
to produce an immune response without causing the severe effects of the disease.
Attenuated vaccines currently licensed in the United States include measles, mumps, rubella,
polio, yellow fever and varicella. Also known as an attenuated vaccine.
Passive immunity:
Protection against disease through antibodies produced by another human being or animal.
Passive immunity is effective, but protection is generally limited and diminishes over time
(usually a few weeks or months). For example, maternal antibodies are passed to the infant
prior to birth. These antibodies temporarily protect the baby for the first 4-6 months of life.
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Preservatives:
Chemicals (example: thimerosal, phenol) added to multi-dose, killed or subunit vaccines in
order to prevent serious secondary infections as a result of bacterial or fungal contamination.
Temporal association:
Two or more events that occur around the same time but are unrelated, chance occurrences.
Vaccine:
Is an antigenic preparation which, when introduced into an organism, induces the production
of antibodies capable of fighting off infection of that organism by a given microorganism.
Waning Immunity:
The loss of protective antibodies over time.
A complete glossary of vaccine terms and acronyms may be found at the following link:
http://www.cdc.gov/vaccines/about/terms/glossary.htm
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SWNDHA – NURSING PROGRAM
COMPETENCY PROCEDURE LEARNING MODULE
PART I – THEORY COMPONENT
I.
CONCEPTS AND PRINCIPLES OF IMMUNITY AND THE PREVENTION OF
VACCINE PREVENTABLE DISEASE
Objective:
Understand the function of the immune system and the concept of immunity
An understanding of the immune system is necessary if one is to understand how vaccines
work and why immunization is so important in the prevention of disease. The following
overview provides a general description of the immune system. Additional readings are noted
for those who work extensively with vaccines and require more information.
Immunity may be simply defined as the body’s resistance to disease. When the body is
exposed to a foreign substance or antigen, the immune system mounts a defense. There are
two divisions of the immune system involved in this defense: the innate (nonspecific) system
and the acquired (specific) system. The latter is the one activated by vaccines. This activation
of the immune system through the use of vaccines composed of inactivated or weakened
viruses or bacteria is called immunization.
Immune System Components
There are two components to the immune system: The innate or nonspecific and the
acquired or specific.
 The innate or nonspecific division of the immune system can be described as a
generic or “all purpose” response.
The innate system does its job without having to recognize the type of antigen or
remember it from a previous encounter. The skin and mucous membranes are the
first-line barriers of the innate system, while other processes such as fever and
inflammation come into play once the antigen has entered the body. One’s general
health and well-being has a strong influence on how well this system is able to cope
with exposure to an antigen. While it is described as a distinct entity from the acquired
system below, it is important to remember that one system cannot function without the
other.
 The acquired or specific division of the immune system is the “specialist” response. It
remembers a previous exposure and has acquired the ability to respond quickly and
decisively when the same antigen is encountered again.
In order to acquire this ability, the body must have been successful in overcoming the
antigen on a previous occasion. The inactivated or weakened organisms used in
vaccines provide the opportunity for the body to acquire this ability without having to
experience the detrimental effects of the disease.
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Types of Immunity
Immunity can also be categorized by whether it is naturally or artificially acquired.
 Natural immunity is best described as that which would happen in nature without any
intervention. Recovering from measles will provide natural immunity to the disease
while being immunized against measles provides artificial immunity.
 The word “artificial” usually denotes medical intervention of some type.
Immunity can be further categorized by whether it is active or passive.
 Active immunity refers to protection that is long term while passive immunity is short
term. The body produces its own immunity (cell mediated and/or humoral) in active
immunity, but this takes time.
 Passive immunity on the other hand refers to “borrowed” immunity or the transfer of
antibodies formed in another organism to a given individual such as that transferred
from a mother to her baby or through the use of immune globulins (e.g. rabies immune
globulin). Passive immunity provides effective protection but this protection disappears
with time, usually within a few weeks or months.
Examples of the above include:
 Measles disease – naturally acquired active immunity.
 Measles vaccine – artificially acquired active immunity.
 Placental transfer of antibodies – naturally acquired passive immunity. (Note that the
antibodies for some diseases like pertussis do not transfer very well to the baby.)
 Immune globulin products (e.g. hepatitis b immune globulin) – artificially acquired
passive immunity.
II. CLIENT ASSESSMENT IN IMMUNIZATION PRACTICE
Objectives:
1. Aware of and can respond appropriately to vaccine related myths posed by
patients/families/staff
2. Appropriately refers to expert professionals/resources when required to address the
immunization needs of certain populations
3. Anticipates, identifies, and manages adverse events following immunization
Vaccine Myths
Vaccines have been blamed for a number of illnesses that we do not know the cause of.
While the claims have been refuted, they point to the critical need for healthcare
professionals to have up-to-date information about the risks and benefits of vaccines. Please
see resources/links below.
Please refer to the product monograph/product insert, Public Health Agency of Canada at
http://www.phac-aspc.gc.ca/im/q_a_thimerosal-eng.php and the Canadian Coalition for
Immunization Awareness and Promotion at http://www.immunize.cpha.ca/en/publicationsresources/questions.aspx and the Canadian Health Services Research Foundation at
http://www.chsrf.ca/mythbusters/html/myth24_e.php for more information.
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Nursing Assessment in Immunization Practice
Vaccines are intended to produce active immunity to specific antigens.
An adverse reaction is an untoward effect caused by a vaccine that is extraneous to the
vaccine’s primary purpose of production of immunity. Adverse reactions are also called
vaccine “side effect”, and is an expected or anticipated response following immunization,
such as a sore arm, mild fever, or redness at the injections site. A vaccine adverse event
refers to any adverse event that occurs following vaccination. An adverse event could be a
true vaccine reaction or just a coincidental event, with further research needed to distinguish
between them.
Vaccine adverse events fall into three general categories: local, systemic, and allergic.
1. Local reactions are generally the least severe and most frequent. Allergic reactions
are the more severe and least frequent. The most common type of adverse reactions
is local reactions, such as pain, swelling, and redness at the site of injection. These
are most common with inactivated vaccines, usually occur within a few hours of the
injection and are usually mild and self-limited.
2. Systemic adverse reactions are more generalized events and include fever, malaise,
myalgias (muscle pain), headache, loss of appetite, and others. These symptoms are
common and non-specific; they may occur because of the vaccine, or may be caused
by something unrelated to the vaccine. These are not common in inactivated
vaccines, but may occur following receipt of live attenuated vaccines. Systemic
adverse reactions following live vaccines are usually mild, and occur a week or two
after the vaccine was given.
3. A third type of vaccine adverse reaction is a severe (anaphylactic) allergic reaction.
The allergic reaction may be caused by the vaccine antigen itself or some other
component of the vaccine.
The risk associated with any adverse event is minimized by screening recipients of vaccines.
In particular, close attention should be made for those individuals at increased risk for
contraindications or precautions in immunization.
Contraindications:
A contraindication is a condition that increases the chance of a serious adverse event.
Vaccines should not be given when a contraindication exists.
There are three contraindications:
1. Anaphylaxis to a component of the vaccine (can occur with any vaccine)
2. Significant immunosuppression (live vaccines only)
3. Pregnancy (live vaccines only)
Precautions:
A precaution is a condition that may increase the chance of an adverse reaction following
immunization or that may compromise the ability of the vaccine to produce immunity.
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Check with ordering physician when a precaution is present to determine if the
immunization should be deferred.
Please refer to specific product monograph/product insert for any contraindications or
precautions for administration.
1) Allergy
A severe (anaphylactic) allergic reaction following a dose of a vaccine will almost
always contraindicate a subsequent dose of that vaccine. Persons may be allergic to the
vaccine antigen, the animal protein, the antibiotics, the preservatives, the latex in rubber
stoppers or the stabilizers.
**Refer to product monograph/product insert for a list of any allergy precautions and
to determine if the product is latex free.**
The most common animal protein allergen is egg protein found in vaccines prepared using
embronated chick eggs (e.g., yellow fever & influenza). Ordinarily, persons who are able to
eat eggs or egg products can receive vaccines that contain egg; persons with a history of
anaphylactic allergy to eggs or egg proteins should not. Persons with an egg allergy who
are at higher risk for a severe allergic reaction, defined by CSACI as previous respiratory or
cardiovascular reaction, generalized hives or those with poorly controlled asthma should only
be vaccinated if recommended by an allergist. Asking persons whether they can eat eggs
without adverse effects is a reasonable way to screen for those at risk.
The MMR vaccine viruses most widely used in Canada and one of the rabies vaccines
(RabAvert®) are grown in chick embryo cell culture. The final vaccine products may contain
trace quantities of egg proteins, but the amount is not felt to be enough to cause an allergic
reaction, especially for MMR. Egg allergy is no longer a contraindication to immunization with
MMR; however it contains trace amounts of neomycin and gelatin; and so people who have
experienced anaphylactic reactions to neomycin or who have a documented gelatin allergy
should not receive MMR.
2) Immunosuppression
Immunosuppression is the prevention or diminution of the organism’s immune
response to an antigen. Live vaccines can cause severe or fatal reactions in
immunosuppressed persons due to uncontrolled replication of the vaccine virus; and they
should not be given live vaccines for this reason. Inactivated vaccines cannot replicate so
they are safe to use; however the response to the vaccine may be decreased. Refer to
product monograph/product insert for precautions with immunosuppression.
3) Illness
There is no evidence that a concurrent acute febrile illness reduces vaccine efficacy or
increases vaccine adverse events. The concern is that an adverse reaction (particularly
fever) following vaccination could complicate the management of a severely ill person. If a
person has a moderate or severe acute illness, vaccination with both live and inactivated
vaccines should be delayed until the illness has improved.
4) Pregnancy
The concern about vaccinating pregnant women is with infection of the fetus and is
theoretical. Only smallpox (vaccinia) vaccine has been shown to cause fetal injury. However,
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since the theoretical possibility exists, live vaccines should not be given to women known to
be pregnant. Since inactivated vaccines cannot replicate, they cannot cause fetal infection.
Inactivated vaccines should be administered to pregnant women for whom they are indicated.
5) Recent Administration of Blood Components and Manufactured Blood Products
with Antibodies (Immune Globulin)
Passive immunization with products of human origin can interfere with immune
response to live vaccines; the recommended interval varies depending on the product.
Studies have found no evidence that Ig administration interferes with the response to
inactivated vaccines, toxoids, or the live vaccines for yellow fever or polio. See the Canadian
Immunization Guide Green Edition for interval between Ig or blood components/ blood
products and MMR or Varicella vaccines.
6) Recent Administration of Live Virus Vaccine
If not given in the same visit as other live virus vaccines, administration of two live
vaccines should be separated by at least 4 weeks
7) Severe Bleeding Disorder
Should receive all recommended immunizations according to schedule. Route
preferred is subcutaneous, however if given IM, should be given following anti-haemophilia
therapy or correction of the bleeding disorder.
Individuals with a bleeding disorder or who are receiving anticoagulant therapy may
develop hematomas in IM injection sites. Prior to administration of IM vaccines the patient or
family should be instructed about the risk of hematoma formation from the injection.
Additionally, a physician familiar with the patient's bleeding disorder or therapy should be
consulted regarding the safety of administration by this route. If the patient periodically
receives hemophilia replacement factor or other similar therapy, IM vaccine administration
should ideally be scheduled shortly after replacement therapy.
A 23-gauge or finer needle should be used and firm pressure applied to the site for at
least 5 minutes. The site should not be rubbed or massaged.
Assessment Questions
Every person who administers vaccines should screen every patient for contraindications and
precautions before giving the vaccine dose. Effective screening is not difficult or complicated
and can be accomplished with just a few questions. Questions should be tailored to the
population, and asked in a respectful, compassionate manner.
1.
2.
How are you today?
The first question screens for concurrent moderate or acute illness.
Allergies to food or medications?
A severe allergic reaction to a vaccine component is a contraindication to immunization,
so this question must always be asked. It may be more time-efficient to inquire about
allergies in a generic way, as most people will not be familiar with minor components of
the vaccine, but they should know if they have had an allergic reaction that was severe
enough to require medical attention.
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3.
4.
5.
6.
Any problem after last vaccines/shots?
This open-ended question explores for allergic reactions to a previous doses. Also
screen for previous vasovagal (fainting episode).
Problems with immune system?
This question will help identify persons with immunodeficiency who generally should not
receive live attenuated vaccines.
Blood components or manufactured blood products in last year?
This question helps to identify precautions for live attenuated MMR and varicella
vaccines, which should not be given to persons who have received passive antibodies
in the last few months. The question may also expose unreported illnesses that might
not have been revealed in earlier questions.
Pregnant?
This question should be asked of all adolescent and adult women. MMR, and varicella
should not be given to women known to be pregnant, or for 4 weeks prior to pregnancy.
Any woman who could become pregnant should be informed of the theoretical
possibility of a teratogenic effect and be told to avoid pregnancy for 1 month after
administration of the vaccine. Pregnancy testing is not required prior to immunization.
III. MANAGEMENT OF ANAPHYLAXIS
Objectives
1. Identify the symptoms of anaphylactic reactions
2. Know the step-by-step response to anaphylaxis
3. Understand appropriate treatment utilized in the management of anaphylaxis
4. Know the requirements for documentation and reporting of adverse events following
immunization
Assessment
Reactions are rare with vaccines (0.4-1.8 reports per 1,000,000 doses). However, clinicians
who immunize should always assess for contraindications, including allergies to a component
of the vaccine. Some potential allergens may include: neomycin, gelatin, sorbitol, egg protein,
and thimerosal. If your patient states they have a latex allergy, check product
monograph/product insert to verify product is latex free.
Anaphylaxis represents the most severe of allergic reactions, due to rapid IgE mediated
response, occurring after re-exposure to an allergen & sudden systemic release of mast cells
and basophil mediators. This can cause a varied clinical presentation, however respiratory
compromise and cardiovascular collapse cause concern because of acute life-threatening
potential.
The signs and symptoms of anaphylaxis usually begin within 30 minutes after an injection.
However, the most severe reactions occur when symptoms develop in the first 15 minutes.
The clinical signs often involve multiple body systems (skin, respiration, circulation). The
symptoms of anaphylaxis are varied and may progress to shock and cardiovascular collapse
characterized by, among other things, a delayed loss of consciousness. The increased
vascular permeability may allow transfer of 50% of intravascular fluid into the extravascular
space within 10 minutes.
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It is important to recognize the first signs and symptoms of anaphylaxis quickly so that
treatment can be administered without delay.
Cardinal Signs
 Itchy, uticarial rash (in over 90% of cases)
 Progressive, painless swelling (angioedema) about the face and mouth, which may be
preceded by itchiness, tearing, nasal congestion, or facial flushing
 Respiratory symptoms, including sneezing, coughing, wheezing, labored breathing,
and upper airway swelling (indicated by hoarseness and/or difficulty swallowing)
possibly causing airway obstruction.
 Hypotension, which generally develops later in the reaction and can progress to shock
and collapse.
Table 2: Signs and symptoms of anaphylaxis according to clinical progression and
severity of attack (Source: NS Immunization Manual, 2008)
Clinical Progression
Mild, early warning signs (015-30 minutes, rarely greater
than 1 hr)
Life-threatening symptoms
Signs and Symptoms
Itching of the skin, rash and
swelling around injection site,
dizziness, general feeling of
warmth.
Painless swelling in part of
the body (face or mouth),
flushing, itching skin, nasal
congestion, sneezing, tears.
Hoarseness, feeling sick,
vomiting, swelling
in the throat, difficulty
breathing,
abdominal pain.
Wheezing, noisy, difficult
breathing, circulatory
collapse, low blood pressure,
irregular, weak pulse
Severity of Attack
Mild
Mild to moderate
Moderate to severe
Severe
Anaphylaxis versus a Vasovagal Response
It is important to distinguish between anaphylaxis & fainting (vasovagal syncope), anxiety
attacks & breath holding.
The most important differences include:
1. Anaphylaxis has obstructive respiratory signs and symptoms
2. Progressive & painless swelling of face/mouth
3. Airway swelling/obstruction(coughing, hoarseness)
4. Facial flushing, tingling
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Vasovagal reaction or vasovagal syncope (faint) is an abnormal response of the autonomous
nervous system to a significant emotional component, to a physical or psychological stress. It
is a fairly common and mild reaction to immunization, particularly in adolescents and young
adults. It is sometimes observed before immunization, but usually occurs a few seconds to a
few minutes after an injection. Rapidity of onset is the key distinguishing element of this
reaction. The principal symptoms are a fainting sensation, dizziness, hypotension, pallor,
bradycardia (slow and weak, but regular pulse), clammy skin, diaphoresis, nausea and
vomiting, as well as loss of consciousness in some cases, with fainting, the subject changes
from a normal to an unconscious state in seconds. Fainting is sometimes accompanied by
brief tonic or clonic activity (jerky limb movements), but this generally require no treatment or
investigation.
The greatest risk for someone who faints is injury from a fall. It is possible to reduce the risk
of fainting by taking measures to lessen stress in the vaccine recipient; for example, having
the subject sit for the injection and providing a comfortable room temperature. Before the
injection, clients should be asked if they have a tendency to faint; if so, they should be asked
to lie down.
Patients who experience a fainting sensation should be asked to remain seated and place
their head between their legs or lie on their back, legs elevated above the head. Place a
damp, cold cloth on their face. At all times the client should be reassured.
Vasovagal syncope does not manifest as an obstructive airway, however, vasovagal may
exhibit as:
1. Numbness, weakness, tingling of extremities
2. Pallor, sweating, nausea, vomiting
3. May have musculoskeletal components: such as brief, clonic seizure activity
4. Deceased heart rate
TREATMENT OF ANAPHYLAXIS (See Anaphylaxis Protocol I-241)
The recommended first line treatment of anaphylaxis is the timely administration of
epinephrine. The optimal route and site of administration (if no IV access) is intramuscular
(IM) injection in the lateral aspect of the thigh (vastus lateralis muscle). The IM epinephrine
injection into the thigh have been reported to provide a more rapid absorption and higher
plasma epinephrine levels in both children and adults than intramuscular or subcutaneous
injections administered into the arm.
Subcutaneous administration is no longer recommended.
The epinephrine dose should be carefully determined. Calculations based on body weight
are preferred when the weight is known. Excessive doses of epinephrine can add to patients’
distress by causing palpitations, tachycardia, flushing and headache.
Although unpleasant, such side effects pose little danger. Cardiac dysrhythmias may occur in
older adults, but are rare in otherwise healthy individuals.
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Give 0.01 ml/kg body weight of aqueous epinephrine 1:1000 IM. Repeat at 5 min intervals as
needed, to a maximum of three doses. Adult Dose: 0.5mg (0.5ml) epinephrine (1:1000).
AGE
2 - 6 months*
12 months
18 months - 4 years
5 years
6 – 9 years
10 – 13 years
14 years and older
EPINEPHRINE 1:1,000
0.07 mL
0.1 mL
0.15 mL
0.2 mL
0.3 mL
0.4 mL
0.5 mL
*Doses for children between the ages shown above should be approximated, the volume
being intermediate between the values shown or increased to the next larger dose.
The use of diphenhydramine (Benadryl®) is recommended as an adjunct to epinephrine
when the person is not responding well to epinephrine and when transfer to an acute care
facility cannot be done within 30 minutes, for example, in a non-hospital setting. The use of
diphenhydramine is considered second line therapy and should never be administered alone
or before epinephrine in the treatment of anaphylaxis.
Action: Give ONE dose of diphenhydramine (Benadryl®).
Adult Dose: 50mg diphenhydramine po or IM
AGE
Less than 2 years
2 – 4 years
5 – 11 years
12 years and older
BENADRYL®
Injected (50mg/mL)
0.25mL
0.5mL
0.5mL – 1 mL
1 mL
IV. ADMINISTRATION OF IMMUNIZING AGENTS AND IMMUNIZATION PRACTICE
Objectives
1. Prepares and administers immunization agents correctly
2. Understand the requirements for implementing the Canadian National guidelines when
storing, handling or transporting vaccines (Medication Cold Chain and Safe Medication
Storage)
3. Documents information relevant to each immunization.
Patient Preparation
All patients must be screened for contraindications and precautions prior to administration of
vaccine. Refer to vaccine product monograph and see page 8-9 for screening questions prior
to immunization.
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Communication
Patients and families are exposed through the media to information about vaccines, some of
which is inaccurate or misleading. Health care providers must be prepared to discuss the
benefits and risks of vaccines using “Vaccine Information Sheet” available through the local
Public Health office or the Health Promotion and Protection website at
http://www.gov.ns.ca/hpp/cdpc/vaccine-publications.asp or other reliable resources.
Establishing an open dialogue provides a safe, trust-building environment in which individuals
can freely evaluate information, discuss vaccine concerns and make informed decisions
regarding immunization.
Equipment
Syringe Selection
A separate needle and syringe should be used for each injection. A parenteral vaccine may
be delivered in either a 1 mL or 3 mL syringe as long as the prescribed dosage is delivered.
Needle Selection
Vaccine must reach the desired tissue site for optimal immune response. Therefore, needle
selection should be based upon the prescribed route, size of the individual, volume and
viscosity of the vaccine, and injection technique. Typically, vaccines are not highly viscous,
and therefore a fine gauge needle (22-25 gauge) can be used.
Each vaccine vial should be carefully inspected for damage or contamination prior to use. A
description of the vaccine, its color and appearance is noted in the manufacturers product
monograph.
The expiration date printed on the vial or box should be checked. Vaccine can be used
through the last day of the month indicated by the expiration date unless otherwise stated on
the package labeling. Expired vaccine should never be used.
Reconstitution
Some vaccines are prepared in a lyophilized form that requires reconstitution, which should
be done using a blunt fill needle. Diluent solutions vary; use only the specific diluent
supplied for the vaccine. Once reconstituted, change the blunt fill needle to a safety needle,
and the vaccine must be either administered within the time guidelines provided by the
manufacturer or discarded.
Prefilling Syringes
SWNDHA strongly discourages filling syringes in advance, because of the risk of decrease in
potency of the vaccine and an increased risk of administration errors. Once the vaccine is in
the syringe it is difficult to identify the type or brand of vaccine. Other problems associated
with this practice are vaccine wastage, and possible bacterial growth in vaccines that do not
contain a preservative. Furthermore, medication administration guidelines state that the
individual who administers a medication should be the one to draw up and prepare it.
Syringes other than those filled by the manufacturer are designed for immediate
administration, not for vaccine storage. Under no circumstances should MMR or varicella
vaccines ever be reconstituted and drawn prior to the immediate need for them. These live
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virus vaccines are unstable and begin to deteriorate as soon as they are reconstituted with
diluent.
Administration
Routes
Administering a vaccine by the recommended route is imperative. Deviation from the
recommended route of administration might reduce vaccine efficacy or increase the risk of
local reactions.
1. Subcutaneous (Subcut) injections are administered into the fatty tissue found below
the dermis and above muscle tissue. Subcutaneous tissue can be found all over the
body.
a) Site: The upper outer triceps of the arm (for people older than 12 months of age).
b) Needle Gauge & Length: 5/8 inch, 23 to 25 gauge needle
c) Technique:
 Follow standard medication administration guidelines for site
assessment/selection and site preparation.
 To avoid reaching the muscle, using the thumb and index finger pinch up
the fatty tissue, insert the needle at a 45° angle and inject the vaccine into
the tissue.
 Before administering an injection, it is not necessary to aspirate, i.e. pull
back on the syringe plunger after needle insertion.
 Withdraw the needle and apply light pressure to the injection site for
several seconds with a dry gauze.
2. Intramuscular (IM) injections are administered into muscle tissue below the dermis
and subcutaneous tissue.
a) Site : The recommended IM sites for vaccine administration are
 the vastus lateralis muscle (anterolateral thigh) and
 the deltoid muscle (upper arm).
For infants less than 12 months of age is the vastus lateralis (anterolateral thigh). It should
also be considered for older children with a small deltoid muscle mass.
For children 12 months of age or over and for adults, the preferred site is the deltoid muscle.
When the deltoid muscle is used for children 12 months of age or over, first assess the
adequacy of the muscle mass.
NOTE: Do not inject more than 2 ml of immunizing agent into the deltoid
To make it easier for the deltoid to relax during the injection, have the client either adopt the
supine position, with the arm stretched out along the body, and the elbow slightly bent or the
sitting position, with the elbow bent and the forearm resting on the arm of a chair. Another
option would be to have the client place one hand on the opposite shoulder to the arm
receiving the injection.
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b) Needle Length & Gauge: 1 inch (2.5 cm); 21 to 25 gauge needle
The needle should be long enough to reach the muscle mass and prevent the vaccine from
seeping into subcutaneous tissue, but not so long as to involve underlying nerves, blood
vessels, or bone.
c)
Technique
 Follow standard medication administration guidelines for site
assessment/selection and site preparation.
 To avoid injection into subcutaneous tissue, spread the skin of the selected
vaccine administration site taut between the thumb and forefinger, isolating the
muscle. Another technique, acceptable mostly for pediatric and geriatric
patients, is to grasp the tissue and "bunch up" the muscle.
 Insert the needle fully into the muscle at a 90° angle and inject the vaccine into
the tissue.
 Withdraw the needle and apply light pressure to the injection site for several
seconds with a dry gauze.
Aspiration:
Before administering an IM or subcutaneous vaccine injection, it is not necessary to
aspirate. i.e., pull back on the syringe plunger after needle insertion. The CDC (Center
for Disease Control and Prevention) does not recommend aspiration when administering
vaccines because no data exist to justify the need for this practice. Given the size of the
needle and the angle at which you inject the vaccine, it is difficult to cannulate a vessel
without rupturing it and even more difficult to actually deliver the vaccine intravenously. We
are aware of no reports of a vaccine being administered intravenously and causing harm in
the absence of aspiration. (CDC- MMWR Weekly report, 2006).
Multiple Vaccinations
When administering multiple vaccines, NEVER mix vaccines in the same syringe. If more
than one vaccine must be administered in the same limb, the injection sites should be
separated by 1-2 inches so that any local reactions can be differentiated. Vaccine doses
range from 0.2 mL to 1 mL. The recommended maximum volume of medication for an IM
site, varies among references and depends on the muscle mass of the individual. However,
administering two IM vaccines into the same muscle would not exceed any suggested
volume ranges for either the vastus lateralis or the deltoid muscle in any age group. The
option to also administer a subcutaneous vaccine into the same limb, if necessary, is
acceptable since a different tissue site is involved. If a vaccine and an immune globulin
preparation are administered simultaneously (e.g., Td/Tdap and tetanus immune globulin
[TIG] or hepatitis B vaccine and hepatitis B immune globulin [HBIG]), a separate anatomic
site should be used for each injection. The location of each injection should be documented
in the patient’s medical record.
Nonstandard Administration
Deviation from the recommended route, site and dosage of vaccine is strongly discouraged
and can result in inadequate protection.
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Documentation
All vaccines administered should be fully documented in the patient’s permanent medical
record.
Documentation should include:
1. Date of administration
2. Name or common abbreviation of vaccine
3. Vaccine lot number
4. The trade name
5. Administration site, dose, route given
6. Patient response/outcome
7. Name and professional designation.
Any adverse events following immunization must be reported to the Yarmouth Public Health
Office using the Adverse Event Following Immunization (AEFI) form, which is available online
at the Public Health Agency of Canada website at http://www.phac-aspc.gc.ca/im/aefi-formeng.php
Complete the form and fax to (902) 742-3083.
V. STORAGE AND HANDLING OF VACCINES
Vaccine storage and handling is a key component in maintaining the efficacy of immunization
programs. It is a shared responsibility from the time the vaccine is manufactured until it is
administered.









Protect immunizing agents from light at all times by keeping them in the manufacturersupplied box.
Remove immunizing agents from the refrigerator only when they are to be used
immediately and put them back in the refrigerator immediately after each use.
Transportation on vaccines must be performed as outlined in the Medication Cold
Chain policy.
Do not use any immunizing agents that have not been stored according to standards.
Do not use any immunizing agents that are beyond their expiration date.
The optimum temperature for refrigerated vaccines is between +2 to +8° C.
For frozen vaccines, the optimum temperature is below -15° C.
NEVER leave vaccines unattended.
Adhere to strict aseptic technique when handling vaccines.
VI. COLD CHAIN
The cold chain refers to the process used to maintain optimal conditions during the transport,
storage, and handling of vaccines, starting at the manufacturer and with administration of the
vaccine. The optimum temperature for refrigerated vaccines is between +2°C and +8°C. For
frozen vaccines the optimum temperature is –15°C. In addition, protection from light is a
necessary condition for some vaccines. Refer to product monographs/ manufacturers’
package inserts. Proper storage temperatures must be maintained at every link in the chain.
Importance of Maintaining the Cold Chain
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Vaccines are sensitive biological products that may be less effective, or even destroyed,
when exposed to temperatures outside the recommended range. Vaccines exposed to
temperatures above or below the recommended temperature range experience some loss of
potency with each episode of exposure. Cold-sensitive vaccines experience an immediate
loss of potency following freezing. Repetitive exposure to heat episodes results in a
cumulative loss of potency that is not reversible. Information on vaccine degradation is
sparse, and multi-point stability studies on vaccines are difficult to perform. Information from
manufacturers is not always available, so it can be difficult to assess the potency of a
mishandled vaccine.
The Effective Cold Chain
Three main elements combine to ensure proper vaccine transport, storage, and handling:
• trained personnel
• transportation and storage equipment
• efficient management procedures
VII.
PROCEDURE
1)
2)
Once an immunization is ordered by the physician, the script is sent to pharmacy.
When nursing is ready to administer the immunization agent ordered, nursing will
make arrangements to obtain the agent from pharmacy.
3) When immunization is obtained from pharmacy, the immunization is removed from the
controlled environment (refrigerator with temperature alarms) and packed in a cooler
with an ice pack to maintain the recommended temperature during transport.
Note: Department /Nursing Units with temperature monitoring on their refrigerators
need to be monitored for proper functioning. If continuous electronic monitoring is not
available while the vaccine is in the fridge, staff are to monitor the temperature twice
daily. The temperature daily log form, located on the fridge door, is to be filled out.
4) Transport of the immunization agent may be done by an RN, LPN, CCA, ward clerk or
porter.
5) Once the immunization reaches the nursing unit it is administered as soon as possible.
6) Required amount of the immunization is drawn up for injection and the remainder of
the vial is returned immediately to the cooler and lid closed to maintain the “Cold
Chain”.
7) The remainder of the immunization agent is to be returned to the Pharmacy
immediately.
DO NOT store it in the medication fridge on the nursing unit.
Stability
The stability of various immunizing agents can vary considerably. For example, some can
tolerate long periods of exposure to heat without exhibiting a serious lack of activity. But for
others, exposure to a higher temperature translates into degradation in their activity, and
each exposure produces a cumulative effect. Most immunizing agents are unstable when
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exposed to freezing. When immunizing agents are exposed to temperatures of less than
+2°C or more than +8°C, the result is a break in the cold chain.
*****IF THERE IS A SUSPECTED OR ACTUAL BREAK IN THE “COLD CHAIN”*****
1. Return the immunization agent to Pharmacy immediately and fill out an Incident
Report detailing the suspected or actual break in the “Cold Chain”.
2. Pharmacy will isolate the Immunization agent involved, review the incident and
determine if the “Cold Chain” was in fact broken, and discard immunizations effected.
**When a cold chain break has been identified after a vaccine has been administered, the
type of vaccine and the duration and temperature of the exposure will be taken into account
when assessing the situation. Serological testing and/or revaccination may be suggested.**
Maintaining the potency of vaccines is important for several reasons:
1. There is a need to ensure that an effective product is being used. Vaccine failures
caused by administration of a compromised vaccine may result in the re-emergence
or occurrence of vaccine- preventable disease.
2. Careful management of resources is important. Vaccines are expensive and can be in
short supply. Loss of vaccine may result in the cancellation of immunization clinics,
resulting in lost opportunities to immunize.
3. Revaccination of clients who received an ineffective vaccine is professionally
uncomfortable and may cause loss of public confidence in vaccines and/or the healthcare system.
The Shake Test
The shake test is not a reliable method of testing vaccine potency because a positive shake
test may or may not occur after a liquid has been frozen.
The “shake test” is one method that was previously used as an indicator that a liquid vaccine
had been inappropriately frozen. A positive shake test is the formation of granular particles
that show up in the liquid upon shaking the vaccine after the vaccine has been frozen and
thawed.
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REFERENCES
Evidence-based recommendations for immunization - Methods of the National Advisory
Committee on Immunization http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/09pdf/acs1.pdf January, 2009. Ottawa, Canada
Public Health Agency of Canada Immunization Guide Green Edition. Ottawa:PHAC
http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php Retrieved April 9,2012
College of Registered Nurses of Nova Scotia (2011). Immunization Guidelines for Registered
Nurses. CRNNS Halifax: Nova Scotia
Columbia University Press (2000)
The Columbia Electronic Encyclopedia (Immunity), Columbia University Press
Public Health Agency of Canada Canadian Immunization Guide Green Edition. Ottawa: PHAC.
http://www.phac-aspc.gc.ca/cd-mc/index-eng.php Errata and Clarifications (2008)
Retrieved April 9, 2012.
Capital Health: Learning Module for Immunization Administration (MM 20-010). QEII
Learning Module
South Shore Health Immunization Competency Guide, Contributor: Edna Matheson B.N.
Feb, 2012
Patient Immunization Policy For Nurses at the IWK Health Centre
http://policy.nshealth.ca/Site_Published/Provincial/document_render.aspx?docu
mentRender.IdType=6&documentRender.GenericField=&documentRender.Id=408
45 , retrieved Feb25, 2013.
The Nova Scotia Immunization Manual (2008). www.gov.ns.ca/hpp, retrieved March 8, 2013
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Page 22 of 43
SOUTH WEST NOVA DISTRICT HEALTH AUTHORITY
NURSING REFERENCE MANUAL
POLICY
TITLE: Immunization
NUMBER: 100.240
Effective Date:
Page (1 of 3)
August 2014
Applies To: Nursing
POLICY:
1. The Medical Directive/Delegated Medical Function Competency Table (I-205) indicates
the Unit Specific, RN and/or LPN approved by the Nursing Program to perform the
designated procedure.
2. Nurses in SWH are accountable to be competent to administer immunizations that are
ordered for the patients in their specific practice setting.
3. Competencies will be reviewed based on scope of practice during initial orientation and
assessed annually during performance appraisal using the Immunization Guidelines
for Registered Nurses.
http://www.crnns.ca/documents/Immunization%20Guidelines%20WEB%202011.pdf
4. Use only up-to-date information from the Nova Scotia Immunization Manual available at
http://www.gov.ns.ca/hpp/cdpc/info-for-professionals.asp
5. There must be a written order by a physician to administer immunizations; including an
order to implement Immunization Anaphylaxis Protocol (I-241)
6. Nurses must have anaphylaxis supplies (kit) on hand when administering vaccine.
Refer to The Canadian Immunization Guide Ever Green Edition :
http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php
7. All vaccine recipients will be kept under supervision for 15 minutes after immunization,
unless they exhibit signs of hypersensitivity, then they must be supervised for 30
minutes.
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Title:
100.240 Immunization
8. All moderate and severe reactions are reported to the Communicable Diseases Control
Nurse at Public Health Services. See Appendix A.
NOTE:
Currently, LPN’s working for SWNDHA are not authorized to perform this
procedure
9. The patient’s eligibility for immunization will be determined:





All patients being admitted to SWH will be assessed for eligibility for influenza
and pneumococcal immunizations during admission and/or prior to discharge.
Patients presenting to Outpatient Clinics will be assessed for eligibility for
influenza and pneumococcal immunizations.
OBS Clinic patients will also be screened for MMR, varicella antibody and
pertussis.
Patients presenting in ER with trauma will be assessed for eligibility for diptheria
and tetanus immunization booster.
Pediatric patients’ immunization status will be assessed for possible updates
10. An exemption may be granted in specific circumstances for the clinical component
based on the assessment of the Nurse Manager or his/her designate.
11. Contents of Anaphylaxis Kit will include the following and should be checked monthly
for expiration dates:
• 4 x 1-mL syringes and 4 needles ( 25-G 1"and 1 ½”)
• 3 x 1 mL amps epinephrine 1:1000
• 1 (50 mg/ml) vial of diphenhydramine
• 2 x 25 mg tablets oral diphenhydramine
• 20 mL(12.5 mg/5 ml) oral diphenhydramine suspension
• alcohol swabs
• copy of the most up-to-date SWNDHA anaphylaxis protocol algorithm I-241-1E
12. Use the Omnicell stock to refill Anaphylaxis Kit as soon as possible after use.
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Title:
100.240 Immunization
References:
Information for Immunization Providers. Retrieved Feb 28, 2012 from
http://www.gov.ns.ca/hpp/publications/Influenza-Control-Immunization-info-Provider.pdf
Anaphylaxis Campaign (2010). Retrieved from www.anaphylaxis.org.uk
Nova Scotia Department of Health and Wellness: Public Health Services Immunization
Manual 2008. Retrieved from www.gov.ns.ca/hpp
Canadian Immunization Guide Ever Green Edition . Vaccine Safety and Adverse Events
Following Immunization. Retrieved May 13,2012 from Guide Errata and Clarifications,
March 2008 (PDF Version, Full Document – 105 KB-9 pages) http://www.phacaspc.gc.ca/publicat/cig-gci/index-eng.php
Public Health Agency of Canada. Immunization and vaccines. Retrieved Nov 6, 2012 from
http://www.phac-aspc.gc.ca/im/index-eng.php
College of Registered Nurses of Nova Scotia (2011). Immunization Guidelines for Registered
Nurses. Halifax, NS: Author. Retrieved May 13, 2012 from
http://www.crnns.ca/documents/Immunization%20Guidelines%20WEB%202011.pdf
Capital Health District: Pharmacy-Immunization: Initial Management of Anaphylaxis Following
Immunization MM 20-005 and Immunization Administration MM 20-010 (2011).
Retrieved May 24, 2012.
Nova Scotia Department of Health and Wellness. 2012. 2011-2012 Seasonal Influenza
Vaccine . Retrieved from www.gov.ns.ca/hpp/.../Influenza_Surveillance_Report_20112012.pdf
The Public Health Agency of Canada Centre for Immunization and Respiratory Infectious
Diseases: Immunization Competencies for Health Professionals, 2008. Retrieved from
http://www.phac-aspc.gc.ca/im/pdf/ichp-cips-eng.pdf.
National Advisory Committee of Immunization: Retrieved from www.phacaspc.gc.ca/im/index.html.
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SOUTH WEST NOVA DISTRICT HEALTH AUTHORITY
NURSING REFERENCE MANUAL
PROCEDURE
TITLE: Immunization
NUMBER: 100.240.1
Effective Date:
Page (1 of 7)
August 2014
Applies To: Nursing
Equipment
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Vaccine (maintained at +2ºC to+8ºC)
Sterile syringe (1mL or 3mL)
Needle (5/8″, 1″ to 1.5″; 25 gauge)
Blunt fill needle (if reconstituting)
Alcohol swab
2x2 gauze
Band-Aid
Sharps container
Privacy screen (setting dependant)
Alcohol-based hand sanitizer for routine hand hygiene
Anaphylaxis Kit (as per Immunization Policy 1-240)
Procedure:
1. Assessment and Consent
Complete a health assessment and immunization history, with careful consideration to the
following:







Allergy to any component of the vaccine
Reactions to a previous dose of vaccine
Pregnancy
Immunocompromised state, in particular for a live vaccine
Receipt of live vaccine in previous 4 weeks (if administering a live vaccine )
Vaccine specific contraindications (see product monograph)
Previous or incomplete immunization history
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Page 26 of 43
Title: 100.240.1 Immunization


If a clear decision to immunize cannot be made based on assessment, consult or
refer to an authorized prescriber as needed.
Obtain informed consent for immunization, giving consideration to the patient’s current
condition and providing verbal and/or written information regarding the vaccine
including:
 Purpose of vaccine
 Risks and benefits of the vaccine
 Constituents
 Recommended schedule for the vaccine, i.e. series of doses
 Potential adverse events or reactions
 Management of adverse events or reactions, and
 Other issues which may be identified by the patient.
 Respond to any questions from the patient/parent/SDM.
2. Vaccine Administration
NOTE: The vaccine should be withdrawn from the vial by the person administering the
vaccine
A. Review vaccine immunization. (Refer to Canadian Immunization Guide Ever Green
Edition)
B. Ensure anaphylaxis kit is accessible
C. Prepare vaccine
D. Check the characteristics of the product for the following:
 Unusual appearance (particulate matter, damage or contamination)
 Expiry date (multi-dose vials are to be used within 30 days of opening
with proper storage)
 Vaccines requiring reconstitution with a dilutent should be mixed only
with the diluents supplied by the manufacturers for the vaccine, unless
otherwise permitted by the manufacturer. Vaccines should be mixed with
a careful swirling motion until a uniform suspension is achieved prior to
administration.
E. Select appropriate syringe and needle:
Syringe selection: A separate, sterile syringe should be used for each injection.
Different vaccines should not be mixed in the same syringe unless specified by the
manufacturer as part of the reconstitution and administration procedure. Depending
on the dosage, a 3 mL or 1 mL syringe should be selected.
Needle selection: Needle selection should be based on the route of administration,
individual's age, size of the muscle mass and viscosity of the vaccine
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Page 27 of 43
Title: 100.240.1 Immunization
Guidelines for Needle Gauge Selection:
 For intradermal (ID) injections, a 26-27 gauge needle is recommended.
 For subcutaneous (SC) injections, a 25 gauge, 1.6 cm (5/8") needle is
recommended.
 For intramuscular injections (IM) a 22-25 gauge needle that is long enough to
reach muscle is recommended:
Guidelines for Needle Length Selection:
 2.2cm (7/8"') to 2.5 cm (1") for infants
 2.2cm (7/8") to 2.5 cm (1") for toddlers and older children
 2.2 cm (1") to 3.8 cm (1½") for adolescents and adult
NOTE:
Regardless of the site, route or technique, always uncap the vaccine vial, wipe
with a suitable disinfectant (e.g., isopropyl alcohol) and allow to dry prior to
withdrawal of vaccine into the syringe.
Clean the skin with a suitable antiseptic and allowed to dry before injection.
Use a separate, sterile needle and syringe for each injection .
Dispose of all needles as per Infection Control procedure
INJECTION SITE, ROUTE AND TECHNIQUE
F. Vaccines and other biologic products are injected via ID, SC or IM routes.
ID injections:

ID injections are usually administered on the flexor surface of the forearm.

The bevel of the needle should be turned upwards and at an angle parallel to
the forearm.

The needle is inserted so that the bevel penetrates the skin. If done correctly, a
small bleb should be observed at the injection site upon injection of the vaccine.
Subcut injections:
Subcut injections are usually given at a 45o angle into subcutaneous tissue of the
upper triceps area of the arm.
Intramuscular injections:
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Page 28 of 43
Title: 100.240.1 Immunization

IM injections are administered at a 90o angle into the vastus lateralis muscle
(anterolateral thigh) in infants less than 1 year of age and the deltoid muscle of
anyone greater than or equal to 1 year of age (unless the muscle mass is not
adequate). Appropriate site selection is important to avoid inadvertent injection into
a blood vessel or injury to a nerve.

The needle should be inserted as far as possible into the muscle. A larger bore
needle (e.g., 22 gauge) may be required when administering viscous or larger
volume products such as immune globulin

The buttock should not be used for active immunization. Immunogenicity is lower to
hepatitis B and rabies vaccines if given in the buttock, probably because of injection
into adipose tissue where the vaccine is not well mobilized. The buttock is an
acceptable site for administration of immune globulin when large volumes are
administered, but appropriate site selection of the dorsogluteal muscle is necessary
to avoid injury to the sciatic nerve.

Vaccines containing adjuvants are to be injected intramuscularly. If inadvertently
injected subcutaneously or intradermally, increased inflammation, induration or
granuloma formation may occur
3. Post-Immunization Management
A. Observe the patient for a minimum of 15 minutes after immunization, unless they exhibit
any signs of hypersensitivity, then they must be supervised for 30 minutes.
Assessment includes:
 Level of consciousness (impairment might reflect hypoxia)
 Upper and lower airways [observe for hoarse cry/voice, stridor (a high-pitched noisy
sound occurring during inhalation or exhalation), cough, wheezing, or shortness of
breath]
 Respiratory rate
 Pulse rate (assess for rapid, weak pulse). Examine for pallor or cyanosis around
perioral area
 Skin (observe for facial flushing, itching, hives or welts)
 Gastrointestinal system (nausea, vomiting, or diarrhea)
 Injection site(s). Observe for redness, swelling, or hives.
B. A mild local reaction resolving by itself within a few minutes does not require special
observation. If swelling and hives occur at the injection site(s):
 Keep client under direct observation for at least 30 minutes to ensure the reaction
remains localized
 Observe for any deterioration in condition
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Page 29 of 43
Title: 100.240.1 Immunization



If hives or swelling disappears, or there is no evidence of any progression to other
parts of the body or any other symptoms within the 30-minute observation period, no
further observation is necessary. Release the client from observation.
If any other symptoms arise, even if considered mild (e.g., sneezing, nasal
congestion, tearing, coughing, facial flushing) or if there is evidence of any progression
of the hives or swelling to other parts of the body, administer epinephrine
Apply ice for comfort.
C. Should the patient experience an anaphylactic reaction, the RN will implement the
Immunization Anaphylaxis Protocol Procedure Number (I-241).
D. Any moderate and severe reactions are reported to the Communicable Disease Control
Nurse at Public Health Services. See Appendix A of the Immunization Anaphylaxis
Protocol (Procedure I-241)
4. Documentation and Reporting
A. Document the consent process in the health record including:
1.
Pre-Immunization Assessment findings (E.g.: assessment of contraindications)
2.
Discussed benefits and risks of not getting immunized, possible common and
expected side effects of vaccine and possible serious side effects of vaccine
and frequency
3.
Patient teaching provided
4.
Potential need and consent for anaphylaxis management
5.
Any questions posed by patient and their written consent to the immunization
and potential anaphylaxis management
B. Document the administration of and response to the vaccine in the health record,
including:
1.
Date and time
2.
Product: generic & trade name
3.
Lot Number
4.
Route
5.
Site
6.
Dose
7.
Adverse event or reaction
8.
Signature
C. Complete the required Public Health Services forms and send via interoffice mail to
Public Health Services (i.e. Reciprocal Notification or Aggregate Form).
D. If a patient experiences an adverse event following immunization, complete the
Adverse Events Following Immunization (AEFI) Form and send it to the Yarmouth
Public Health Office [ (T)742-7141 or (F)742-3083].
Note: Form can be found in the back of the CPS or at the Public Health Agency of Canada
link: http://www.phac-aspc.gc.ca/im/pdf/hc4229e.pdf
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Page 30 of 43
Title: 100.240.1 Immunization
REFERENCES
National Advisory Committee on Immunization. Retrieved from http://www.phacaspc.gc.ca/naci-ccni/index-eng.php
Canadian Immunization Guide, Ever Green Edition: Retrieved from http://www.phacaspc.gc.ca/publicat/cig-gci/index-eng.php Ottawa, Canada.
College of Registered Nurses of Nova Scotia (2011). Immunization Guidelines for Registered
Nurses. CRNNS Halifax: Nova Scotia
The Columbia Electronic Encyclopedia (Immunity), Columbia University Press (2000)
Tabers Cyclopedic Medical Dictionary (20th ed.) (2005) F.A. Davis: Philadelphia
http://www.tabers.com/tabersonline
Routine Practices and Additional Precautions for Preventing the Transmission of Infection in
Health Care, Retrieved Feb 21, 2012 from www.phac-aspc.gc.ca/nois-sinp/guide/acsa-eng.php
B.C. Centre for Disease Control retrieved from http://www.bccdc.ca/dis-cond/commmanual/CDManualChap2.htm.
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Page 31 of 43
Exhibit- 100.240.1E
POST IMMUNIZATION MANAGEMENT
Observe the patient for a minimum of 15 minutes after immunization
Any signs of hypersensitivity, supervise for 30 minutes
Observe for any deterioration in condition
Mild local reaction resolving by itself
within a few minutes
Swelling and hives occur at the injection site(s):
Direct observation for at least 30 minutes to
ensure the reaction remains localized
Hives or swelling disappear, or
No evidence of any progression to other
parts of the body or any other symptoms
within the 30-minute observation period
If any other symptoms arise, even if considered mild
(e.g., sneezing, nasal congestion, tearing, coughing, facial
flushing) or
If there is evidence of any progression of the hives or
swelling to other parts of the body:
INITIATE SWNDHA IMMUNIZATION ANAPHYLAXIS
PROTOCOL
Release from observation.
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Page 32 of 43
SOUTH WEST NOVA DISTRICT HEALTH AUTHORITY
NURSING REFERENCE MANUAL
PROTOCOL
TITLE: Immunization Anaphylaxis Protocol
NUMBER: 100.241
Effective Date:
Page (1 of 5)
August 2014
Applies To: Nursing
POLICY STATEMENT:
In the event that patient experiences a mild to severe anaphylactic reaction following
immunization, the RN will treat the patient based on the SWNDHA Immunization Anaphylaxis
Protocol (I-241-1).
System Affected
Mild to Moderate
Severe Anaphylaxis
Anaphylaxis
(life threatening)
Gastrointestinal
Respiratory
Cardiovascular
Cutaneous




















Abdominal pain
Diarrhea
Difficulty swallowing
Vomiting
Increased mucous
Nausea
Coughing
Wheezing
Dyspnea
Stridor
Rhinitis
Dizziness
Hypotension
Tachycardia
Headache
Syncope
Substernal chest pain
Generalized urticaria
(hives) and/or
angioedema (welts)
Flushing or pallor
Puritis (itchiness with or
without rash)



Bronchospasm
Laryngeal edema
Respiratory distress

Loss of consciousness
(Glasgow Coma Scale
<15)
Hypotension
(Systolic BP <90mmHg)

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Page 33 of 43
Exhibit- I-241-1E
SWNDHA Immunization Anaphylaxis Protocol Algorithm
Steps 1,2,3 should be
done promptly and
simultaneously
1.
Do not leave the patient
Call Code Blue
2. Position person recumbent with legs elevated
above their head
If all limbs
used for
immunization,
Epinephrine
can be
administered
2.5 cm from
immunization
site
Alternate right
and left thigh
or arm sites
for repeat
doses of
Epinephrine
(to maximize
absorption of
Epinephrine).
3.
GIVE EPINEPHRINE (1:1,000) IM
(Epipen® can be used)
Administer into opposite limb from immunization.
Dosage (0.01 mL per kg to a maximum of 0.5 mL per dose)
AGE
2 - 6 months***
12 months
18 months - 4 years
5 years
6 – 9 years
10 – 13 years
Equal to or more than 14 years
EPINEPHRINE 1:1,000
0.07 mL
0.1 mL
0.15 mL
0.2 mL
0.3 mL
0.4 mL
0.5 mL
4.
Breathing worse OR decreased LOC
Repeat Epi @ 5 min. intervals, (Max 3 doses)PRN
Benadryl® 1-2mg/kg (Max 50mg) Orally preferred (IM, PRN) x 1 dose only.
AGE
Less than 2 years
2 – 4 years
5 – 11 years
Equal to or more than 12 years
5.
INPATIENT: TREAT AS
PER PHYSICIAN ORDERS
BENADRYL
Injected
(50mg/mL)
0.25mL
0.5mL
0.5 – 1mL
1mL
ORAL 12.5mg/5mLs
5mLs
10mLs
10-20mLS
20mLs
Provide CAB’s of resuscitation
OUTPATIENT:
TRANSPORT TO ED
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Page 34 of 43
Title: Immunization Anaphylaxis Protocol
References
Canadian Immunization Guide Ever Green Edition Vaccine Safety and Adverse Events
Following Immunization. Retrieved May 13, 2012 from Guide Errata and
Clarifications, March 2008 (PDF Version, Full Document – 105 KB- 9 pages)
http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php
South Shore District Health Authority Policy and Procedure : Immunizations NU -200-550.
Retrieved Nov. 6, 2012 from
http://policy.nshealth.ca/Site_Published/DHA1/document_render/aspx?documentRen
der.IdType=6&documentRender.GenericField=%documentRender.Id=35611
College of Registered Nurses of Nova Scotia (2011). Immunization Guidelines for Registered
Nurses. Halifax, NS: Author. Retrieved May 13, 2012 from
http://crnns.ca/documents/Immunizsation%20Guidelines%20WEB%202011.pdf
BC Centre for Disease Control. The Immunization Manual (2012).
http://www.bccdc.ca/NR/rdonlyres/52EA275F-0791-4164-ABA907F0183FF103/0/SectionV_Anaphylaxis_Apr2013.pdf
Retrieved Nov. 27, 2013.
British Journal of Nursing, 2010, Vol 19, No 16 Recognition and treatment of anaphylaxis in
hospital. Author Phil Jevon is Honorary Clinical Lecturer, Resuscitation
Officer/Clinical Skills Lead, Manor Hospital, Walsall. Retrieved Feb. 29,2012.
Capital Health District: Pharmacy-Immunization: Initial Management of Anaphylaxis Following
Immunization MM 20-005 and Immunization Administration MM 20-010 (2011).
Retrieved May 24, 2012
Public Health Agency of Canada. Immunization and vaccines. Retrieved Nov 6, 2012 from
http://www.phac-aspc.gc.ca/im/index-eng.php
Evidence-based recommendations for immunization – Methods of the National Advisory
Committee on Immunization January 2009 • Volume 35 • ACS-1. Retrieved Nov. 8,
2012.
U.S. Department of Health and Human Services. Centre for Disease Control and Prevention:
Vaccines and Immunizations : vaccine safety and adverse effects Retrieved April 9,
2012 from http://www.cdc.gov/vaccines/vac-gen/safety/default.htm
Medical Management of Vaccine Reactions in Adult Patients www.immunize.org •
www.vaccineinformation.org Immunization Action Coalition • 1573 Selby Ave. • St.
Paul, MN 55104 • (651) 647-9009
Simons FE, Camargo CA. Anaphylaxis: Rapid recognition and treatment. In: UpToDate,
Bochnew BS (Ed). UpToDate: Waltham, MA, 2010. Retrieved Nov 6, 2012
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Page 35 of 43
Title: Immunization Anaphylaxis Protocol
National Vaccine Storage and Handling Guidelines for Immunization Providers
www.phac-aspc.gc.ca/publicat/2007/nvshglp-ldemv/index-eng.php.
Retrieved Nov. 27, 2012
Nova Scotia Immunization Manual: October 2013 Retrieved from
http://www.gov.ns.ca/hpp/cdpc/docs/TableofContents.pdf
College of the Registered Nurses of Nova Scotia Standards of Practice for Registered
Nurses (Effective January 16, 2012), ,
http://www.crnns.ca/documents/RNStandards.pdf. Retrieved Nov 27, 2012.
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Page 36 of 43
Title: Immunization Anaphylaxis Protocol
Appendix A: Reporting Adverse Effects Following Immunization. Retrieved from
http://www.gov.ns.ca/hpp/cdpc/info-for-professionals.asp
Do Not Report:
•
Local redness, pain, and/or inflammation at injection site
•
Fatigue, loss of appetite, irritability
•
Swelling of lymph nodes near injection site
NOTE:
It is the law to report moderate to severe reactions following immunization.
MODERATE ADVERSE EVENTS
REPORT: Within 5 working days:
• Fever as high as 40ºC
• Chills/shivers
• Hives
• Pronounced drowsiness
• Prolonged crying or irritability
• Significant nodules/lumps
• Abscesses at injection site
SEVERE ADVERSE EVENTS
REPORT: Within 1 working day:
• Anaphylaxis
• Acute encephalopathy
• Paralysis
• Guillain Barré Syndrome
1. Consult local public health office to determine is an Adverse Effect Following
Immunization (AEFI) form needs to be completed.
2. If so, download and complete the form at www.phac-aspc.gc.ca/im/aefi-form-eng.php
and send it to your district public health office:
Public Health Services
Yarmouth Regional Hospital
60 Vancouver St., 4th Floor
Yarmouth, NS B5A 2P5
Tel: 742-7141
Fax: 742-3083
Adapted from: Nova Scotia Department of Health: Public Health Services. 2012. It’s the
Law: Reporting Adverse Events Following Immunization.
http://www.crnns.ca/documents/news/AdverseEventsPoster.pdf
Appendix B:
Canadian Adverse Events Following Immunization Surveillance System
www.phac-aspc.gc.ca/im/vs-sv/caefiss-eng.php
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Page 37 of 43
SWNDHA – NURSING PROGRAM
COMPETENCY- PROCEDURE – LEARNING MODULE
IMMUNIZATION-CLINICAL EVALUATION GUIDE
PART II CLINICAL COMPONENT
Upon successful completion of the theory component (Part I), the learner may progress to the
application of the acquired knowledge in the clinical setting.
Clinical Objective
Properly implement the procedure according to the Policy and Procedure guidelines of the SWNDHANursing Program required for immunization as determined by the designated supervisor(s) authorized
to provide supervision and approval for certification.
Learner’s Name:
Primary Assignment Unit:
Designated Supervisor(s):
SKILL EVALUATED
COMPETENCY
DESIGNATED
DEMONSTRATED( ) SUPERVISOR’S INITIALS
1. Verifies physician’s order.
2. Assess patient (allergies and type reactions).
Patient history and present condition.
3. Obtains immunization Anaphylaxis Protocol
procedure and supplies
4. a. States what the vaccine is for.
b. States what reactions may occur.
c. States if there are any contraindications to
administration of vaccine.
d. States why immunization is recommended.
e. States if and when booster shots are
recommended.
5. Identifies the patient correctly and explains
procedure to patient.
6. Administers correct dosage.
7. Administers immunization via recommended
route of the manufacturer using proper route and
proper injection technique.
8. Instruct patient to report any adverse reactions that
occur.
9. Maintains the “cold chain”.
10. Dispose of needle/syringe per Infection Control
policy.
11. Documents procedure correctly on patient’s cMAR
and chart if required.
Date:
Date Clinical Component Successfully Completed
Signature of Designated Supervisor
Signature of Learner
Date CRC/Designated Personnel receives _____________Date sent for computer input________
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Page 38 of 43
SOUTH WEST NOVA DISTRICT HEALTH AUTHORITY
COMPETENCY
Letter of Competency
This is to certify that
(Please Print)
has successfully completed the educational requirements and training and is recognized to perform
Immunization
Date
Signature of Designated Supervisor
Signature of Learner
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Page 39 of 43
SWNDHA – NURSING PROGRAM
COMPETENCY -PROCDURE – LEARNING MODULE
QUIZ – IMMUNIZATION
INSTRUCTIONS:
1.
DO NOT WRITE ON QUIZ – USE ANSWER SHEET.
2.
Candidate must successfully complete test (pass mark 80%) prior to initiation of Part II –
Clinical Component.
3.
Reference material (learning module, text, etc.) may not be referred to while writing test.
4.
No time limit has been assigned for completing test, however, thirty (30) minutes should
provide adequate time for completion of test.
5.
Please return both test questions and answer sheet following completion of test.
6.
Date CRC/Designated Personnel receives.
Part I
1.
Multiple choice questions (select the most appropriate answer).
Value 8 points each
Immunization is the process of inducing a state of:
1. Immunity or resistance in a donor against a virus.
2. Immunity or resistance in a host against a disease.
3. Immunity or resistance against a host.
2.
The individual being immunized is known as the
1. Donor
2. Host
3. Immuner
.
3.
Acquired immunity is identified as:
1. Artificial immunity
2. Active
3. Active or passive
4.
The recommended sites for subcutaneous or intramuscular immunization in adults are:
a. Deltoid area
b. Anterolateral surface of the thigh
c. Abdominal area
d. Gluteus maximus
1. a & b
2. a
3. b & c
4. d
5.
The recommended site of choice for immunization for infants below the age of one (1) year is:
1. Deltoid
2. anterolateral surface of the thigh
3. Buttock
Part I con’t
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Page 40 of 43
6.
If an individual is receiving a dosage of an immunization agent for the first time:
1. Observe patient for five (5) minutes after administration
2. Observe injection site after administration for approximately ten (10) minutes.
3. Observe patient injection site for 12 hours q 15 minutes.
4. Observe the patient for at least 15 minutes.
7.
Health Care personnel providing immunization procedures should be aware of which of the
following information:
a. Contraindications to administration of specific vaccines.
b. The disease the immunization is for.
c. Why immunization is recommended.
d. Reactions that may occur.
e. If and when booster shots are recommended.
f. Correct method and route of administration.
1. a,b,d
2. b,d,e,f
3. a,b,c,d
4. all of the above
8.
The medications used to treat a serious allergic reaction (anaphylaxis) are
1. Epinephrine (1:10,000) and Benadryl
2. Benadryl
3. Epinephrine (1:1000) or Benadryl if individuals do not respond to epinephrine
9.
Prior to administering an immunization agent an RN must have a physician order to
administer the immunization agent, as well as:
1. A physician order to implement the immunization anaphylaxis protocol in the event a
patient has an anaphylaxis reaction.
2. A physician order to administer Narcan in the event a patient has an anaphylaxis
reaction.
3. A physician order to administer anexate in the event a patient has an anaphylaxis
reaction.
10.
In the event that a patient experiences an anaphylaxis reaction,
1. RN contact physician immediately
2. RN will treat patient based on the SWNDHA Immunization Anaphylaxis protocol.
3. RN will monitor patient for 15 minutes.
11.
Contraindications to administration of immunization vaccines may include:
a. Anaphylaxis to a specific component in the vaccine.
b. Moderate to severe illness.
c. Individuals with immunosuppression induced by therapy
d. Live viral vaccines to pregnant women.
1.
a
2. a, b
3.
a, c
4.
All of the above
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Page 41 of 43
12.
The term “cold chain” refers to:
1. The polypetide chain in the vaccine.
2. Procedures and equipment used to ensure vaccines are protected from inappropriate
temperature and light, from transport from the manufacturer to the time of administration.
3. The maintenance of refrigeration of vaccines to a temperature of + 8 degrees Celsius to +
12 degrees Celsius during transportation.
Part II Identify the following statements as being True (T) or False (F).
Value 3 points each
1.
Immunity may be natural or produced by acquired stimulation of the
person’s immune system through disease or immunization.
2.
Artificially acquired active immunity can be induced by a vaccine.
3.
Naturally acquired active immunity occurs when the person (host) is
exposed to a live pathogen, develops the disease and becomes immune
as a result of the primary immune response.
4.
Passive immunity is a long-term immunization.
5.
Patient assessment prior to immunization is imperative to identify patients
current health status and allergies that may contraindicate the administration
of immunization agent to the patient.
6.
The injection site for all immunization should be the deltoid area.
7.
Vaccines should be maintained and transported at + 2 degree C to + 8 degree C
unless otherwise specified.
8.
For infants under one (1) year of age site of choice for administration of a
vaccine is anterolateral surface of the thigh.
9.
All moderate and major reactions are to be reported to Public Health Services
10.
Administration of vaccine is documented on the cMAR.
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Page 42 of 43
SWNDHA– NURSING PROGRAM
COMPETENCY- PROCEDURE- LEARNING MODULE
ANSWER SHEET – IMMUNIZATION
Learner’s Name:
Primary Assignment Unit:
Date Test Written:
Employee I.D. Number:
PART I (8 points each)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
____________
____________
____________
____________
____________
____________
____________
____________
____________
____________
____________
____________
PART II (2 points each)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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