Excerpt from “The Immunization Encounter: Critical Issues
satellite broadcast”, originally broadcast June 27, 2002.

Written by Donna Weaver, RN, MN, Judy Schmidt, RN, EdD, and
William Atkinson, MD, MPH, with contributions by Jean Popiak and
Robert Pless, MD, National Immunization Program, Centers for
Disease Control and Prevention

ATKINSON:
Welcome to The Immunization Encounter: Critical Issues. We're
coming to you live from the Centers for Disease Control and
Prevention in Atlanta, Georgia. I'm William Atkinson and I'll be
your host for this live satellite broadcast.

Today's broadcast is the first for the National Immunization
Program in 2002, and the thirty first we've produced since 1995.
It's unique in that we won't be talking very much about vaccines
or vaccine recommendations. Instead, we will concentrate on many
of the OTHER immunization related issues that you face every day
in your office or clinic, such as vaccine storage and handling,
vaccine administration, and screening for contraindications.

We have two instructors for today's program. Donna Weaver is a
nurse educator in the National Immunization Program at CDC. Ms.
Weaver has a masters degree in nursing, and has been working in
immunization programs since 1996. Our second instructor is Dr.
Judy Schmidt. Dr. Schmidt is a Public Health Educator in the
National Immunization Program at CDC. She holds degrees in
nursing and education and has been with the National Immunization
Program since 2000.

In this program we will address issues that immunization
providers encounter every day. We will begin with a discussion of
activities that should occur before your patient arrives. In this
section we will concentrate on vaccine storage and handling, and
preparing for an emergency. The second section of the program
will cover activities that should occur DURING the immunization
encounter. In this section we will discuss parent and patient
education and the use of Vaccine Information Statements,
screening for contraindications and precautions, and vaccine
administration. In our third section, we will discuss post
encounter activities, including documentation and record keeping,
the Vaccine Injury Compensation Program, and the Vaccine Adverse
Event Reporting System.

Let's look at the objectives for this program. After this
program, we hope you will be able to do these things and much
more: describe two recommended activities in preparation for the
immunization encounter. List critical issues involved in patient
and parent education, screening, and vaccine administration
during the immunization encounter, and: describe recommendations
and responsibilities related to post- vaccination care and record
keeping.

Our program will begin with a discussion of pre encounter
activities right after this pause.

[UNSCRIPTED VIDEO PROMO]

ATKINSON:
This program is divided into 3 main sections: the pre encounter
phase, before the person arrives; the encounter phase, when the
person is in the office; and the post encounter phase, after the
person leaves the office. For each of these immunization
encounter phases, we've prepared a checklist of activities that
should be part of your routine during that phase. We will then
discuss some of these activities in detail. Donna, would you
review the pre encounter checklist for us?

WEAVER:
Yes, Bill, I will. There are many activities that should take
place BEFORE the patient arrives at your office. Most of these
activities are not specific for one patient, but are components
of a good immunization delivery system in your office or clinic.
Let's go through some of them.

One of the most important pre encounter activities for your
office is staff training and education. Competency- based
orientation and continuing education for staff are critical to
providing safe, effective and caring immunization services.
Training and education is not a one shot event but a systematic
ongoing program.

Patient reminders are one of the most effective strategies for
raising and maintaining high immunization coverage levels. Call
or send patients a note to remind them about their upcoming
appointment and remind them to bring their immunization card.
Make your life easier by participating in an immunization
registry if one is available in your area.

Adequate clinic supplies and patient education materials. Check
your inventory first thing in the morning. Be sure that you have
adequate materials and supplies on hand before your clinic day
begins. You certainly don't want to run out of syringes- or
vaccine- before the day is over.

Patient record pre-screening for recommended immunizations. We
strongly recommend that medical records be screened BEFORE the
patient arrives to assess the need for recommended immunizations.
You should do this even if the patient is scheduled for something
other than immunizations. This will help you to avoid a missed
opportunity and can save time on the appointed day.

Every person to whom you administer a dose of vaccine is
dependent on your vaccine storage and handling procedures. There
is very little room for error when it comes to proper storage of
your vaccine supply.

Likewise, every person to whom you administer a dose of vaccine
is potentially dependent on your offices' emergency preparedness
- the procedures and protocols you have in place in the unlikely
event of a medical emergency, such as an allergic reaction.

These last two activities - vaccine storage and handling, and
emergency preparedness, are critical components of good
immunization practice. We would like to discuss both of them in
ore detail, beginning with vaccine storage and handling.

ATKINSON:
Proper storage and handling procedures are critical to a safe and
effective vaccination program. Inattention to vaccine storage
conditions can lead to damaged vaccine and reduced protection.

Most live vaccines, in particular MMR, varicella and yellow fever
vaccines, are sensitive to light and increased temperatures.
Inactivated vaccines can be damaged by exposure to freezing
temperatures. Some products may show physical evidence of altered
integrity, like clumping in the solution that doesn't go away
when the vial is shaken. But other vaccines may look perfectly
normal, giving no indication of loss of potency.

All staff working with vaccines in an office or clinic setting
should be familiar with proper storage and handling to minimize
the risk of damage to your vaccine supply. During this segment we
will cover general guidelines for proper vaccine storage and
handling. Specific storage and handling recommendations for each
vaccine are available in the manufacturer's package insert and
several other resources, which will be included on the resource
web page for this broadcast. Judy?

SCHMIDT:
Thanks, Bill . There are few immunization issues more important
than the appropriate storage and handling of your vaccine supply.
This is also one of the most common vaccine delivery problems
that we encounter at the National Immunization Program. A vaccine
storage or handling failure can affect large numbers of your
patients, and result in embarrassment, expense, and potential
liability for your practice.

Every facility that stores vaccines should develop and maintain a
detailed written protocol on vaccine storage and handling. This
protocol should include information for accepting vaccine
deliveries and guidelines for storage and handling. Each facility
should assign one person primary responsibility for ensuring that
vaccines are carefully handled in a safe, documented manner.

Since no one works every single day, a back-up person should also
be designated. All office staff working with vaccines should be
familiar with storage and handling guidelines. Post temperature
guidelines for vaccines on or near the refrigerator and freezer
where vaccines are stored.

Your responsibility for proper vaccine storage and handling
begins the moment the vaccine arrives. Vaccine shipments should
be examined on arrival. Examine the shipping container and its
contents for any evidence of damage during transport. Cross-
check the contents with the packing slip to be sure they match.

Finally, check the shipment date to determine how long the
package was in transit to you. If the interval between shipment
from the supplier and arrival of the product at your office was
more than 48 hours, it could mean the vaccine has been exposed to
excessive heat or cold that might alter its integrity.

Each shipment should be recorded on an inventory log. This log
should include the name of each vaccine; the number of doses for
each vaccine received; the date it was received; the condition
of the vaccines upon arrival; the name of the vaccine
manufacturers; the lot numbers; and the expiration dates for each
vaccine.

If there are any discrepancies with the packing slip or concerns
about the vaccine shipment, store the vaccine under proper
conditions and mark, "Do NOT Use" until the integrity of the
vaccine is determined. You will then need to contact the
manufacturer or your state immunization program for further
guidance. Who you contact will depend on who shipped the vaccine
to you and on your agency or state policy.

In order to store vaccines correctly in your office, you must
have the right equipment. Vaccines must be stored in a properly
functioning household- or commercial- style refrigerator- freezer
unit. The refrigerator and freezer compartments must have
separate doors. This is particularly important if you stock
varicella vaccine.

We discourage the use of small single door refrigerators like
this. This type of unit may be OK for storing small quantities of
inactivated vaccines, if the refrigerator compartment can
maintain a constant temperature. But the freezer compartments of
these units are incapable of maintaining temperatures cold
enough to store varicella vaccine, so they are totally
unacceptable for offices that use varicella vaccine. You have a
lot of money invested in your vaccines. So do the right thing,
and invest in a quality refrigerator freezer to store them in.
Use the dorm refrigerator to store your salads and snacks.

The refrigerator and freezer compartments should have their own
thermometers. The thermometers should be placed in the central
part of the storage compartment, not against the wall. There are
several types of thermometers you can use. Here are 3 types of
certified calibrated thermometers. The thermometer on the left in
biosafe liquid is available for refrigerators and freezers. The
one in the center is a continuous graphic thermometer, which
records temperatures on graph paper. The thermometer on the right
records the upper and lower extremes of temperature during the
observation period. This is referred to as a minimum- maximum
thermometer. These thermometers provide a means of establishing
if vaccines have been exposed to potentially harmful
temperatures. Get the best thermometer you can afford.

Temperature readings should be taken and recorded on a
temperature log like this, twice each day, once when the office
or clinic opens and again at the end of the day. Also, the
back-up person should review the log on a weekly basis to assure
proper temperature recording. The date and time of any mechanical
malfunction or power outage should also be noted. Some
temperature logs have a place to record this information on the
back of the temperature log. Temperature logs should be kept on
file for a minimum of three years.

One very important point to remember is that it's not enough to
just record the temperature of the refrigerator and freezer units
twice daily. If a temperature outside of the recommended range is
found, then IMMEDIATE action should be taken to correct the
problem. It may be a problem that can be solved easily, such as a
door that was left open, or a unit was unplugged. On the other
hand, there may be a more serious problem with the unit- after
all, all refrigerators eventually fail. It could also be a power
failure or some type of emergency or disaster situation that will
require alternative storage for the vaccine until the situation
is corrected. It's very important that staff know whom to
contact in case of a malfunction or disaster. If the problem is
short- term, usually 2 hours or less, you can probably maintain
the temperature in the unit by adding ice or ice packs and
keeping the door closed. If there is an extended period of time
before the situation can be corrected, then you should move the
vaccine to another cooling unit.

It's a good idea to have an agreement with another clinic,
hospital or agency where you can store your vaccine in an
emergency. If the vaccine can be moved to this site within 30
minutes, it can be transported in insulated containers or
coolers. If the location is more than 30 minutes away and you
have a large quantity of vaccine, you should consider renting a
refrigerated truck to transport your vaccine. Also, remember
whenever there is a question about the integrity of the vaccine,
contact the vaccine manufacturer and/or your state immunization
program for guidance.

The BEST recommendation we can make is to take precautions to
PREVENT problems. In addition to the twice daily monitoring of
the refrigeration unit, install a plug guard or safety lock plug
to reduce the chance of someone inadvertently unplugging the
unit. Post warning signs above the plug and on the storage unit
to remind staff not to unplug the unit. Label fuses and circuit
breakers with information that clearly identifies power to the
vaccine storage unit, and the immediate steps to be taken if
power is interrupted. Install a temperature alarm that is audible
and, if possible, connected to a remote or automated telephone
system.

Here's a simple technique that will tell you if your freezer has
thawed. Fill a plastic cup with water, freeze it, and place a
penny on TOP of the frozen ice in the cup. Place the cup in the
middle of the freezer compartment. Check the placement of the
penny each morning when you record the freezer temperature. If
the penny is IN the ice you know the freezer temperature was not
maintained while the office was closed. You will need to talk
to the manufacturer or state immunization program before using
any of the vaccine stored in the freezer.

Another point to remember is to learn from previous situations or
mistakes. Whenever there is a violation of the vaccine handling
protocol or another vaccine storage problem, document the
occurrence. Use the experience as a learning opportunity for all
clinic or office personnel and when training new staff so that a
similar situation can be avoided in the future. Donna, will you
tell us more about storing vaccines?

WEAVER:
Thank you Judy. It's critical that your vaccine supply be stored
carefully. All vaccines, with the exception of varicella and
yellow fever vaccines, should be stored in the refrigerator
section.

The refrigerator must maintain a temperature between 35 and 46
degrees Fahrenheit. That's 2 to 8 degrees Celsius. We suggest
that you set your refrigerator temperature to an average of 40
degrees Fahrenheit, or 5 degrees Celsius. This will allow your
refrigerator to fluctuate within the recommended range of 35 to
46 degrees Fahrenheit. Your freezer must maintain an average
temperature of 5 degrees Fahrenheit, or minus 15 degrees Celsius
or colder. This temperature is necessary to assure proper storage
of varicella vaccine. Lyophilized, or freeze dried, vaccines are
in a powder form and must be reconstituted before use. Vaccine
diluents can be stored in the refrigerator or at room
temperature. Do NOT freeze vaccine diluent.

Vaccine should be stored in the middle of the refrigerator
compartment away from the walls and coils. This allows air to
freely circulate around and through the vaccine stacks and
provide even cooling to all stored vaccine. To avoid confusion,
the vaccine should be stacked in rows with vaccine of the same
type. Bottles or jugs of water stored next to the walls or on an
empty shelf will help maintain an even temperature in the
refrigerator compartment.

Vaccine stored in the freezer compartment should also be located
in the center of the compartment and away from sides of the unit.
Ice trays or ice packs can be used in the freezer to help
maintain an even temperature.

Never store vaccines in the door of the refrigerator or freezer,
or on the bottom or near peripheral areas of the unit. There is
greater temperature fluctuations in these areas, and temperature
fluctuations are bad for vaccine.

Check and rotate vaccine stock weekly so that vaccines with the
shortest expiration dates are in the front to be used first. If
the expiration date on the vial is identified only as month and
year, the vaccine does not expire until the LAST day of the
month indicated on the vial.

Expired vaccine - even if only one day after the expiration
date- should NEVER be administered. Promptly remove expired
vaccine from the refrigerator or freezer and dispose of it
appropriately. If the expired vaccine is VFC vaccine, you should
contact your state immunization program so that the expired
vaccine can be accounted for.

Keep opened vials of vaccine in a tray, so that they are readily
identifiable. Indicate on the label of each vaccine vial the
date and time it was reconstituted or first opened.

Pediatric DT, adult hepatitis B, influenza, meningococcal,
pneumococcal polysaccharide, IPV, Td and tetanus toxoid are
manufactured in multi-dose and single dose vials. A multi dose
vial of vaccine contains a bacteriostatic agent, usually
thimerosal. This vaccine can be used until the date of expiration
unless it becomes visibly contaminated. Single dose vials do not
contain a bacteriostatic agent and are meant for one time use
only. Once opened, they must be discarded after 24 hours.

Once a lyophilized vaccine has been reconstituted, the clock is
running. Reconstituted vaccines must be used within a specified
time frame or they must be discarded. Varicella and ActHIB brand
of Hib vaccine must be used within 30 minutes. Yellow fever
vaccine must be used within one hour of reconstitution. MMR must
be used within 8 hours, and PedvaxHIB must be administered within
24 hours. Vaccines reconstituted beyond these limits should NOT
be administered. The best way to avoid such waste is to
reconstitute and draw up vaccines immediately before
administration.

Varicella vaccine that has not been reconstituted can be stored
in the refrigerator compartment for up to 72 hours. If not used
within 72 hours at refrigerator temperature, it must be
discarded. Varicella vaccine should not be refrozen.

We are often asked about prefilling syringes, or drawing up
vaccine into syringes in advance of the need for it. We STRONGLY
discourage this practice. Loading vaccine into syringes before
you are ready to use it increases the risk for medication
errors, vaccine contamination, and vaccine wastage. When time and
staff are limited and demand is high, most commonly- used
vaccines are available in prefilled syringes from the
manufacturer. Manufacturer prefilled syringes are prepared under
sterile conditions that meet standards for proper handling and
storage and they are individually labeled. Varicella, MMR, and
yellow fever vaccines must NEVER be drawn up ahead of time. But
there may be situations in which a single vaccine is going to be
administered- such as a large influenza campaign- and
manufacturer's prefilled syringes are not available. In these
situations, each person giving injections may choose to prefill a
few syringes shortly before administration.

In keeping with nursing medication administration guidelines, we
recommend that the person who prepares the medication should be
the same person who administers the medication. We recommend that
any prefilled syringes should be properly stored and should be
used on the same day they are filled. Label each syringe
carefully, and keep the filled syringes cool.

Vaccines should always be stored in the refrigerator or freezer
until they are needed. Even if you anticipate using vaccines
throughout the day, do not leave them sitting out on a medicine
tray or counter.

If your clinic situation permits, open only one vial, or box, of
a particular vaccine at a time to control vaccine usage and allow
easier inventory control. We also recommend that all opened
vaccine vials be kept in a tray in the refrigerator separate from
other medications and biologics to avoid medication errors. Do
NOT store food and beverages in the same refrigerator or freezer
with vaccines. This practice leads to more frequent opening of
the unit and greater chance for temperature instability and
excessive exposure to light. It's advisable to keep MMR,
varicella and yellow fever vaccines in their boxes with the top
on until ready to use to avoid unnecessary light exposure. If
other medications and biologics MUST be stored in the same unit
with vaccine, then store the vaccines on a different shelf. This
will help reduce the chance of a medication error, or
contamination of the vaccine in the event the other medications
or biologics spill.

Occasionally vaccines must be transported between clinics or
administered at sites where there is no permanent storage unit.
In these situations, you must still maintain appropriate storage
temperatures. Always use insulated containers for vaccine
transport. A thermometer must be placed in each container so that
the temperature can be monitored and documented hourly. Craft
paper, newspaper, or bubble wrap should be used to keep the
vaccine from coming in direct contact with the ice and
inadvertently freezing. Varicella vaccine can only be transported
and temporarily stored using dry ice. Other vaccines should be
stored in separate containers with regular ice. And remember
NEVER touch dry ice without wearing heavy-duty gloves and eye
protection.

Inventory control is an important quality control measure.
Conduct a monthly vaccine inventory. This helps you avoid running
out of vaccine or over-ordering. If you work in a satellite
clinic, avoid stocking excessive amounts of vaccine because of
the possibility of a power failure. Whenever conducting a monthly
inventory, check the expiration dates. Rotate your stock to
assure that the vaccine with the earliest expiration date is
being used first to minimize waste. NEVER use expired vaccine. If
a dose of expired vaccine is given by mistake, the dose should be
repeated.

Sometimes vaccine just seems to disappear. To avoid the
inappropriate removal of vaccine, limit access to the vaccine
storage refrigerator to authorized personnel. When the unit is
not being used, keep it closed and locked.

We recently had the opportunity to talk with Jean Popiak, one of
our vaccine management experts here at the National Immunization
Program. We asked Jean to share with us some of the most common
errors in vaccine storage and handling.

POPIAK:
As a state vaccine manager and now with the National Immunization
Program, I have seen my share of costly vaccine management
errors. Here is my Top Ten list of vaccine storage and handling
no-no's, boo-boo's, transgressions, errors, offenses, violations,
treasonistic acts, and absurdities.

Number 10: Only one person in the office is responsible for
vaccine. Now let's face it, everyone gets sick or takes a
vacation. It's important to train a backup person to learn your
job, specifically when it comes to storage and handling of
vaccines. Your backup should be well versed in recording
refrigerator and freezer temperatures and recording them
properly. Your backup should also know what to do in case of an
equipment problem or power outage, but more on that later.

Number 9: Vaccine stored in the wrong part of the refrigerator
like the vegetable bins, plastic containers, the door or the
bottom of the refrigerator. This is a major vaccine no-no. The
temperature in these areas will be higher than the temperature in
the body of the refrigerator. Take the vegetable bins and
loc-tight plastic containers out of the refrigerator. Also, don't
store vaccine on the bottom of the refrigerator. The
refrigerator motor is there, and it=s the warmest location in the
refrigerator. Place the vaccines on the shelves in open, labeled
containers, so that air can circulate around the vaccine. And,
remember, don't store vaccine in the refrigerator or freezer
doors because the temperature will fluctuate.

Number 8: No emergency plans for a power outage or natural
disaster. Every practice should have a written Disaster Recovery
Plan. The most important item in this plan is to identify a
location with a backup generator to take your vaccine to in the
event of a power outage or natural disaster. Consider contacting
your local hospital, Red Cross, elder care facility and contact
them now! An example of a mock Disaster Recovery Plan is
available on the NIP broadcast resource website - you can just
fill in the blanks. What you want to do is pre-arrange
everything that way, when you take vacation, your backup person -
remember the backup person? - will know what to do.

Number 7: Discarding multi-dose vials after they are opened for
30 days. This issue has been around for years. All multi-dose
vials of vaccine have preservatives in them. Unless you see
contamination in the vial, the vaccine should be used until the
expiration date.

Number 6: Leaving the refrigerator or freezer door open
overnight. This baffles me. In all my years, I've never left my
home refrigerator or freezer door open overnight. Yet this
happens every week in an office. To prevent this, check the seals
on the doors, and if there is ANY indication the door seal may be
cracked or not sealing properly, have it replaced. The cost of
replacing a seal is much cheaper than the cost of replacing a box
of pneumococcal conjugate or varicella vaccine.

Number 5: Storing varicella vaccine in a dorm-style refrigerator.
Varicella must be stored in a refrigerator with a separate
freezer door. No matter how hard you try to adjust the
temperature to +5 F in a dorm-style refrigerator's freezer, there
is no possible way to keep the refrigerator portion between 35 -
46 F! I've seen the freezer section enclosed with in everything
from aluminum foil to cardboard. It doesn't keep the freezer
section frozen. BUT you WILL freeze the vaccine in the
refrigerator.

Number 4: Recording temperatures once per day. Temperatures
fluctuate throughout the day. Temperatures in the refrigerator
and freezer should be checked at the beginning of the day to
determine if the unit is getting too cold overnight and at the
end of the day to determine if the unit is not holding a constant
temperature throughout the day. This is an all-inclusive
temperature log. Note that is has space for refrigerator
temperatures AND freezer temperatures, to be documented twice per
day. Some temperature logs also have a space for room
temperature. This is good information to know if there is a
problem with the refrigerator. Also note that the correct
temperature range is noted on the temperature log: 35 to 46 F or
2 to 8 C for the refrigerator, and colder than +5 F or -15 C for
the freezer.

Number 3: Recording temperatures for only the refrigerator or
freezer. If your facility administers varicella vaccine, you
should have a thermometer in the refrigerator AND the freezer.
That means two thermometers. Not one thermometer that you can
move from refrigerator to freezer and back, but two thermometers.

Here are examples of calibrated, certified accurate
thermometers. Rather than buying a cheap thermometer that
doesn't accurately measure the temperature six months after you
purchase it, consider a quality thermometer that will last for
years.

Number 2: Throwing away temperature logs at the end of every
month or year. It's important that you keep temperature logs for
3 years. As the refrigerator ages, you can track recurring
problems. If temperatures have been documented out of range, you
can determine how long this has been happening and take
appropriate action. It's also a great way to prove to your boss
you need a new refrigerator!

And the Number 1 Storage and Handling faux pas is: Documenting
out of range temperatures on vaccine temperature logs and not
taking action. Documenting temperatures is not enough. Processing
the information is just as - or even more important! Your job is
not done if you document 28 F consistently in the refrigerator.

This temperature log shows the correct temperature range to be 35
to 46 F. Here are some hints on what you should do if the
temperature is out of range. To begin with, notify your
supervisor. Someone else should be aware of the problem. Attempt
to adjust the thermostat. Check the condition of the unit for
problems. Are the seals tight? Is there excessive lint on the
coils? After you have made the adjustment, document the date,
time, temperature, what the problem was, the action you took, and
the results of this action. Recheck the temperature every two
hours. Call maintenance or a repairman if the temperature is
still out of range. And move contents to your designated
location, which will be found in your Disaster Recovery Plan.

Those are the Top Ten vaccine storage and handling errors. We've
now come full circle. See how everything fits together?

ATKINSON:
The final item on the pre-encounter checklist relates to
emergency preparedness. Unfortunately, we can't eliminate all
unexpected events. So it becomes crucial to plan and prepare for
emergencies. We all want to perform flawlessly when an emergency
occurs, and a familiar, practiced plan helps that happen.

There are a variety of emergency situations that can arise in a
day in the life of an office or clinic. Storms and other natural
disasters can damage your facility or knock out your power. You
should have a contingency plan for this sort of situation,
particularly loss of power. Protecting your vaccine supply should
be a high priority.

Then there are medical emergencies. Anything can happen in a
medical provider's office, from heart attacks to delivery of
babies to injuries. For this program we will forego a discussion
of emergency C-section and focus on two office setting
emergencies that could be vaccine related - syncope and allergic
reactions.

Prevention of an emergency is the first consideration in
developing an emergency plan. Screening for allergies and
reactions following prior vaccine doses can prevent an emergency
from occurring. We will discuss screening for contraindications
and precautions later in the program.

Serious allergic reactions are very uncommon following
vaccination, but syncope is not uncommon. Judy, could you talk
about syncope?

SCHMIDT:
I'd be happy to. Syncope is a sudden loss of consciousness,
commonly known as a vaso-vagal response, or fainting.
Syncopal episodes are rare in infants and young children, they
are most common in older children and adolescents. Every person
who has given vaccines for a few years has seen a 200 pound high
school tackle faint after receiving a shot. Serious injury can
result from a syncopal episode, including broken bones, head
trauma, and brain injury.

One way to prevent a syncope related emergency relates to the
patient's posture or position during vaccine administration.
Infants and young children are usually held by a parent or
sitting during their immunizations. It's a good idea for older
children, adolescents and adults to sit during vaccination.
Sitting during vaccine administration may either prevent syncope
or prevent an injury caused by a fall.

Most syncopal episodes occur less than 5 minutes after vaccine
administration, and nearly 90 percent occur within 15 minutes. As
a result, you should consider observing older children,
adolescents, and adults for 15 to 20 minutes after vaccination,
if possible.

Office staff should be aware of and watch for warning signs that
syncope could occur - a patient who is highly anxious, pale, or
perspiring. If you think a syncopal episode is about to occur- or
has occurred- have the patient lie down and elevate his or her
legs 10 to 12 inches. Make sure the person's airway is open.
People who experience a syncopal episode should be observed until
their symptoms resolve.

Just a reminder- a syncopal episode is NOT a contraindication for
future doses of the vaccine. Syncope is NOT an allergic reaction.
If indicated, the person should receive subsequent doses on
schedule.

Another potential vaccine related emergency is a severe allergic
reaction or anaphylaxis. Severe allergic reactions are rare, but
you need to be prepared to deal with it should it occur. Donna,
could you give us details about emergency preparation for
allergic reactions?

WEAVER:
Yes I will, Judy. You're right- anaphylactic reactions following
vaccination are very rare when people are screened appropriately.
It's critical that a vaccination provider be aware of their
patient's allergies to components of the vaccine such as gelatin,
eggs, or an antibiotic. The components of each vaccine are listed
in the package insert that comes with the vaccine. So if you
discover that a person has had a severe allergic reaction to egg,
you could look through all the package inserts of vaccines you
intend to administer that day, and look for ones that contain egg
protein. Or, you could do this an easier way.

Here is a table that lists vaccine components, and lists which
vaccines contain that component. The table was published by the
company Facts and Comparisons in their monograph called Immuno
Facts. Facts and Comparisons agreed to allow us to distribute it
from the National Immunization Program website. It's a valuable
tool when a patient reports an allergy to a specific substance
that may be included as a minor component of a vaccine. You
should definitely have a copy of this table in your office.

Of course, it's possible that there can be allergies unknown to
the patient or provider until symptoms are experienced. When a
reaction unexpectedly occurs, EARLY detection of allergic
symptoms and management of anaphylaxis can be lifesaving.

When the symptoms of facial flushing and edema, hives, swelling
of the mouth, wheezing, and shortness of breath begin, immediate
recognition and treatment may avoid a more severe and life
threatening reaction. It sounds simple, but when the flushed face
of an upset, crying child becomes more than expected, the child
may, in fact, be in the initial stages of an allergic reaction.

The facial flushing may increase and progress to facial edema,
wheezing, and shortness of breath.

When office staff perform their regular review of the emergency
plan, it's also an opportunity to be sure the emergency contact
information is current. Emergency phone numbers should be posted
on or near each telephone and kept up to date. The staff
responsible for calling emergency assistance should know what to
say and how to describe their office location. Emergency response
personnel tell us that time spent in finding a provider's office
inside of a building can be critical. It's very beneficial to
assign a staff member the responsibility of meeting ambulance
personnel at the building entrance, and securing an elevator. All
office personnel should have current CPR certification, and know
where the emergency equipment is located.

Judy, will you tell us more about emergency equipment?

SCHMIDT:
Sure Donna. Every office should have an emergency kit, and it
should be inspected periodically to be sure it's up to date and
functioning properly.

Emergency kits come in many sizes and shapes. Every office should
have an emergency kit or box of equipment that is kept in a
specific, centrally located place. The equipment should be placed
in the box in a way that is easily seen and retrieved.

What should be in your kit? An important piece of equipment is
the oral airway. More than one size of airway should be in the
emergency box. The sizes and number of airways depend upon the
provider's patient population. For example, a pediatric office
will most likely have a fewer number of airway sizes than a
Family Practice office that sees patients of a greater range of
sizes.

One or more resuscitation bags should be included depending upon
the ages of the patient population. A demonstration on how to use
the equipment given by the vendor representative or other expert
along with regularly scheduled practice is vital. A stethoscope
and blood pressure cuff should be in the emergency equipment
supply along with ammonia capsules, and at least three syringes,
needles, and some alcohol swabs. Your kit should contain
emergency drugs, particularly epinephrine and diphenhydramine.

Some emergency kits include these medications in prefilled
syringes supplied by the manufacturer.

Epinephrine is administered SUBCUTANEOUSLY in a limb opposite the
immunization site and is usually massaged after injection to
promote absorption. The dose is determined by either the body
weight or age of the person. It's helpful to have a table in your
kit that lists these dosages. The dose can be repeated in 10 to
20 minutes if indicated by symptoms.

Diphenhydramine hydrochloride, commonly known by it's brand name
of Benadryl, may shorten an allergic reaction. But its effect is
delayed rather than immediate. Depending upon the severity of the
symptoms, it may or may not be useful. Diphenhydramine
hydrochloride is also given by body weight.

One final point concerning emergency preparation. No matter how
well a protocol is written, it's helpful only when office staff
are well prepared and ready to act. Office staff should keep
their CPR certifications current. Emergency procedures should be
reviewed periodically, and training updates provided to staff.

Documenting training in a personnel folder may be helpful in
promoting staff competency. Of course, training new staff in the
office emergency plan is critical, and should be part of their
orientation. Severe allergic reactions are rare events. But
because they can be fatal if not managed properly, your staff
must be ready to respond.

ATKINSON:
Excellent advice. Thanks Judy. We will be back to discuss
immunization encounter activities in just a moment.

[UNSCRIPTED VIDEO PROMO]

ATKINSON:
That video, "Ice, Champagne and Roses," is an excellent refresher
on vaccine storage and management. The tape was originally
produced by the California Immunization Program, then revised by
the Minnesota Immunization Program to include information on
newer vaccines, such as DTAP, hepatitis A, and varicella. You can
order a copy of the tape from the National Immunization Program
website. If you didn't catch the address, it will be listed on
our broadcast resources website.

In this segment of the program we will discuss activities that
occur during the immunization encounter- while the person is in
the office or clinic. The critical issues during the encounter
phase include screening- primarily for contraindications and
precautions to vaccination, patient and parent education, vaccine
administration, and after-care instructions. We will discuss each
of these issues, beginning with screening.

ATKINSON:
Screening is an important part of the immunization encounter.
This activity should include eligibility screening as well as
medical screening. If your office or clinic is enrolled in the
Vaccines for Children Program, or VFC, then it's important to
screen children and adolescents for VFC eligibility.

Children, birth through 18 years of age, are eligible for VFC
vaccines if they are: eligible for Medicaid; or have no health
insurance; or are Native American or Alaska native. Children who
ave health insurance, but immunization is not a covered benefit
are eligible if they go to a Federally Qualified Health Center.
Depending on your state immunization program, other children may
also qualify.

There's a VFC eligibility screening form that should be completed
by the parent and kept as part of the child's permanent medical
record. This is what it looks like. This eligibility form does
not need to be completed at each visit, but should be updated if
there are any changes in the child's eligibility. If you have
questions about a patient's eligibility, then we recommend that
you contact your state immunization program for clarification.

There is also general information about the VFC program for both
parents and providers available on the NIP website.

Another important aspect of patient screening is screening for
contraindications and precautions to vaccination. Donna, would
you tell us more about medical screening?

WEAVER:
Bill, not only does thorough screening provide an opportunity to
prevent possible adverse reactions, but it also provides an
opportunity to build rapport with the patient and parent, address
their concerns, and answer any questions.

The first information you will want to obtain is the patient's
prior immunization history. This information should be located on
one page in the patient's medical record. If not, encourage
parents or patients to bring their personal record so that you
can include this information in each person's chart.

A verbal history of previous immunizations is not sufficient
evidence. You should accept as valid only immunizations that are
documented in writing and dated.

If a written record isn't immediately available, we recommend
that you consider giving the vaccines that are indicated at that
visit based on the person's age. This avoids a missed opportunity
while the patient or parent continues to search for the
immunization records.

Once you have the immunization history, it's time to screen for
medical contra- indications or precautions. When the setting
allows, we recommend that you provide patients or parents with
the screening questionnaire, and the Vaccine Information
Statement, or VIS, while they are waiting to be seen. The VIS
includes information that will help the patient or parent respond
to questions on the screening form. We'll talk more about VISs in
a few minutes.

The key to reducing the risk of a serious adverse reaction is
SCREENING. Every person who administers vaccines should screen
EVERY patient for contraindications and precautions before giving
the shot. Effective screening isn't difficult or complicated. It
can be accomplished with just a few questions.

Many states have developed screening questionnaires for use in
their clinics. You can develop your own sheet, or you can adapt
one that has already been developed. The Immunization Action
Coalition has developed a good one page screening sheet for
children and another for adults.

It's important for you to understand the reasons for the
questions on the screening form. We asked Doctor Deborah Wexler,
Executive Director of the Immunization Action Coalition, to
review the screening form with us, and explain the rationale for
the questions.

WEXLER:
The key to reducing the risk of a serious adverse reaction is to
identify contra indications and precautions to vaccination BEFORE
giving the shot. Contraindications to vaccination can change from
one dose of a vaccine to the next dose. So everyone should be
screened prior to EVERY dose, even if they were screened during a
prior visit. Screening for contraindications and precautions
isn=t difficult or complicated. This is the screening form we
developed for children and teens. We suggest you use a
standardized screening form like this one, so you ask the same
questions every time. Let=s go through the 9 screening questions
and talk about why you are asking them.

ANNOUNCER:
Is the child sick today?

WEXLER:
The first question addresses whether the child has a moderate or
severe acute illness, which is a precaution to vaccination. If
the child has been examined, this question may not be necessary,
or already may have been answered. There=s no evidence that acute
illness reduces vaccine efficacy or increases vaccine adverse
events. But with moderate or severe acute illness, vaccines
should be delayed until the illness has improved. This avoids
confusing a symptom of the illness - such as fever - with a
vaccine adverse event, or vice versa. Mild illnesses, such as
otitis media or an upper respiratory infection, are NOT
contraindications to vaccination. Nor is taking antibiotics a
reason to withhold a vaccine in a person who is otherwise not
very sick.

ANNOUNCER:
Does the child have allergies to medications, food, or any
vaccine?

WEXLER:
A severe allergic reaction to a vaccine or vaccine component is a
contraindication to subsequent doses of that vaccine, or to a
vaccine containing that component. An anaphylactic reaction to
eggs is a contraindication to influenza vaccine, and an
anaphylactic reaction to yeast is a contraindication to hepatitis
B vaccine. We suggest you inquire about allergies in a generic
way, rather than read the parent a list of every component of
every vaccine. Most parents won=t recognize most of these
components names anyway. But they WILL know if the child has
ever had an allergic reaction severe enough to seek medical
attention, which is what you're getting at. If you do identify a
person who has had a severe allergic reaction to a product that
may be in a vaccine, the next challenge is to figure out which
vaccines might contain that product. To make this task easier,
you need a listing of vaccine contents. A comprehensive table of
vaccine components is available free from the National
Immunization Program website. Remember that a local reaction,
such as redness or swelling at the site of injection, is NOT a
contraindication to subsequent doses of that vaccine.

ANNOUNCER:
Has the child had a serious reaction to a vaccine in the past?

WEXLER:
This open ended question is intended to identify allergic
reactions following previous vaccine doses. It can also help
identify conditions following pertussis vaccine. Under normal
circumstances, vaccines are deferred when precautions are
present. But situations may arise when the benefit of the
vaccine outweighs the risk. For instance, a child who had a
temperature of 105 following a prior dose of DTP or DTAP might
still be vaccinated if there were an outbreak of pertussis in the
community.

ANNOUNCER:
Has the child had a seizure or a brain problem?

WEXLER:
DTAP is contraindicated in children who have a history of
encephalopathy within 7 days following whole cell DTP or DTAP
vaccine. An undiagnosed neurologic problem is a precaution to the
use of DTAP. For children with a STABLE neurologic disorder,
including seizures, unrelated to vaccination, or for children
with a family history of seizure, you should vaccinate as usual.
In these children, you should consider the use of acetaminophen
or ibuprofen to minimize the fever.

ANNOUNCER:
Does the child have cancer, leukemia, AIDS, or any other immune
system problem?

WEXLER:
Live virus vaccines, such as MMR and varicella, are usually
contraindicated in persons with severe immunodeficiency. However,
MMR and varicella are recommended for persons infected with HIV
who do not have evidence of severe immunosuppression. Varicella
vaccine is contraindicated in persons with cellular
immunodeficiency, but may be administered to persons with humoral
immunodeficiency. All inactivated vaccines may be given to
immunosuppressed persons, although the response to the vaccine
may be suboptimal. Also remember that having an immunosuppressed
person in the household is NOT a contraindication to vaccination
of a healthy child.

ANNOUNCER:
Has the child taken cortisone, prednisone, other steroids, or
anticancer drugs, or had x-ray treatments in the past 3 months?

WEXLER:
High daily doses of corticosteroids for more than 14 days can
cause significant immunosuppression and increase the chance of an
adverse reactions following a live vaccine. Live vaccines should
not be administered for at least one month following prolonged
high-dose steroid therapy, or for at least 3 months following
cancer chemotherapy.

Persons receiving aerosolized steroids, such as inhalers for
asthma, topical preparations, or low or moderate daily or
alternate- day doses of steroids for fewer than 14 days can
receive live vaccines during treatment. For those receiving high
dose daily or alternate day courses for fewer than 14 days, the
American Academy of Pediatrics recommends that live vaccines be
deferred until steroid therapy is discontinued. Similar to other
immunosuppressive conditions or therapies, inactivated vaccines
may be administered to a person receiving high dose steroid
therapy, although the response to the vaccine could be reduced.

ANNOUNCER:
Has the child received a transfusion of blood or blood products,
or been given a medicine called immune or gamma globulin in the
past year?

WEXLER:
Passively acquired antibody may reduce the effectiveness of MMR
and varicella vaccines. MMR and varicella vaccines generally
should not be given to people who have recently received
antibody containing blood products. Depending on what product was
administered, and the dose, it may be necessary to defer MMR and
varicella vaccines for up to 11 months after the blood product.

The 2002 General Recommendations on Immunization includes a table
that lists the most commonly used antibody containing
preparations in the United States. It also lists the recommended
waiting period between the blood product and administration of
MMR or varicella vaccine. Every office should have a copy of this
table, which can be obtained from the National Immunization
Program. This question might also uncover unreported illnesses
that might not have been revealed in earlier questions, since
blood products are usually given for specific indications.

ANNOUNCER:
Is the child or teen pregnant, or is there a chance she could
become pregnant during the next month?

WEXLER:
This question should be asked of all women of child bearing age,
including young adolescents. MMR and varicella vaccines are
contraindicated shortly before and during pregnancy due to the
theoretical risk of virus transmission to the fetus. Sexually
active women who receive MMR or varicella vaccine should be
instructed to practice careful contraception for one month
following receipt of either vaccine. Inactivated vaccines
generally may be given to pregnant women when indicated. On the
other hand, it=s not necessary to inquire about pregnancy in
household contacts. Having a pregnant woman living in the
household is NOT a contraindication to administration of ANY
vaccine to other household members.

ANNOUNCER:
Has the child received any vaccinations in the past 4 weeks?

WEXLER:
The intent of this last question is to identify persons who
recently received a live virus vaccine. The Advisory Committee on
Immunization Practices recommends that two live virus vaccines
not given on the same day be separated by at least 28 days. If
the vaccine given recently was an INACTIVATED vaccine, such as
DTAP or hepatitis B vaccine, it=s not necessary to defer ANY
vaccine. In addition to the child and teen screening form, we
have also developed a screening form for adults. It contains the
same questions that are on the child and teen form, except for
the question about a history of seizures. The seizure question is
included on the child and teen form to identify potential
precautions for pertussis vaccine. Since pertussis vaccine is not
given to people older than 7 years of age, it isn=t needed on the
adult form.

Both these screening forms, as well as other vaccine related
material for providers and patients are available free from the
Immunization Action Coalition website. But whether you use our
form, or some other form, the important thing is that you to ask
these questions before administering vaccines to people of any
age. Your patients are depending on you to make vaccines as safe
as they can be. Screening every patient is one way to do this.

ATKINSON:
Another critical component of the immunization encounter is
patient and parent education. As health care providers, we know
that immunizations are among the most cost effective and widely
used public health interventions. We also know that no
medication, not even a vaccine, is 100 percent safe or effective.

As the incidence of vaccine preventable diseases is reduced, the
disease threat is less visible. Public focus has changed from the
risk of disease to concerns associated with the vaccines
themselves. Before you administer any vaccine, you have a
responsibility to discuss each vaccine's benefits and risks with
the patient or parent. Judy, could you expand on this?

SCHMIDT:
Bill, risk and benefit communication between the provider and the
person receiving the vaccine is essential. The cornerstone of
immunization patient education is the Vaccine Information
Statement, or VIS.

Every health care provider, public or private, who administers a
vaccine covered by the National Childhood Vaccine Injury Act is
required by law to provide a copy of the most current VIS with
EACH DOSE of vaccine administered. Not only the first dose, but
EVERY dose. In addition, CDC encourages health- care providers to
use all available VISs, whether the National Childhood Vaccine
Injury Act covers the vaccine or not. It's just good practice.

Health care providers are not required by Federal law to obtain
the signature of the patient or their representative
acknowledging receipt of the VIS. The VISs are not designed as
informed consent documents.

Because the materials cover both benefits and risks associated
with vaccinations, they provide enough information that anyone
reading them should be adequately informed. You should, however,
consult your agency or state immunization program to determine if
there are any specific informed consent requirements.

Documentation that the VIS was given is required. Health care
providers must note in each patient's permanent medical record
the date printed on the VIS and the date the VIS is given to the
vaccine recipient, or their legal representative.

Every VIS is dated. The date is usually located in the corner of
the second page of the document. This is the date that must be
recorded in the patient's chart. VISs change periodically. Paying
attention to this date also helps to ensure that your office
always has the most current version of each VIS.

VISs are available in over twenty languages on the Immunization
Action Coalition website. State Immunization Programs have single
camera- ready, or master copies available and some private
provider organizations also print and sell copies of the VISs. If
patients or parents are unable to read the VISs, it's up to the
provider to ensure that they have the information. This can be
done by reading or paraphrasing the VISs, and confirming that
they are understood. Health care providers should also encourage
the patient or their representative to take the VIS home. This is
important because the VIS includes information that may be needed
later. This includes: the recommended schedule for that vaccine;
information concerning what to look for and do after the
vaccination; and what to do if there is a serious reaction. The
health care provider's patient education responsibilities don't
end with the Vaccine Information Statement. That's just the
beginning.

Donna, will you tell us more?

WEAVER:
Sure, Judy, I would be glad to. Education involves more than
telling pieces of information to someone. Education is an
interactive process, an exchange of information. We need to
listen, hear our patient's concerns and then be prepared to
address those concerns. If you are not willing to do this, then
the parent will go elsewhere for their information and elsewhere
may not be a reliable source of good, scientific based
information.

Let's talk about parents' vaccine information needs. Based on
several recent surveys, we know that the majority of parents
think positively about immunizations. We also know that many
parents rely on and trust their health care provider's
recommendations. As we would expect, many parents don't have
experience with or knowledge about vaccine preventable diseases
because we no longer see these diseases in epidemic proportions.

Many questions are generated by the vaccine education materials
we provide. Parents also get information from the news media,
from their friends and family, and increasingly, from the
Internet. Unfortunately, some of these sources have lead to
misconceptions and fears in a significant number of parents.

As health care providers, our goal should be to provide parents
with the basic information that they are looking for about
vaccines. Research has identified seven questions that parents
need to ask about childhood vaccinations. They are: What shots
will my child get this visit? Why should my child get these
shots? Is there any reason I should not give my child these
shots? What side effects should my child have? What should I do
if my child has a side effect? What should I do if my child has a
severe side effect? And, finally, When is my child's next shot?

We have a couple of suggestions that may help you respond to
these questions. First, help parents prepare for the immunization
encounter in advance. If possible, provide parents with
information ahead of time, before the immunization encounter.

This information may answer some of their questions. If you don't
have the opportunity to provide parents with information before
they come to your clinic or office, then consider having
information available in the waiting area, like brochures,
pamphlets, VISs and videos.

Our second suggestion- be prepared to respond to parents'
questions and concerns. Consider doing some vaccine safety
communication in- services, maybe over lunch. Staff can even
role- play various scenarios based on situations that have arisen
in your office or clinic.

These in-services can help to ensure that all staff have the same
vaccine safety information and that there are no confusing mixed
messages being given to parents. Role playing can help staff be
less defensive, more empathetic to parents' concerns, and
sensitive to cultural influences. Be clear who in your
organization will give out VISs, who will elicit the parents'
questions, and who will discuss the benefits and risks. Also
remember to praise parents for doing their homework and bringing
their children to be immunized. Hopefully parents will realize
that ultimately you both have the same interest at heart, the
health and safety of their child. Bill?

ATKINSON:
Thanks, Donna. There are several excellent patient education
resources available to you, including websites, videos, books,
and information sheets for your office. We also have a video
devoted solely to vaccine safety and risk communication that you
may want to consider for staff orientation and training. More
information on all these resources is included on the broadcast
resources web page.

ATKINSON:
Appropriate vaccine administration is critical to vaccine
effectiveness. The recommended site, route and dosage for each
vaccine are based on clinical trials, practical experience and
theoretical considerations. Vaccines may not protect your patient
if they are administered incorrectly. If the wrong site or needle
length is used to administer a vaccine, there may be an increased
risk of a local adverse reaction. So an education plan that
includes competency based training on vaccine administration
should be considered for everyone in your office who administers
vaccines. Judy, will you get us started with some vaccine
administration fundamentals?

SCHMIDT:
Thanks, Bill. Delivering vaccine into the appropriate tissue
promotes optimal antibody response to a vaccine and reduces the
risk of local adverse reactions. So let's talk a little more
about route, site and needle length.

This is a list of vaccines that should be administered by the
subcutaneous route. Those vaccines are anthrax; inactivated
polio; Japanese encephalitis; measles, mumps and
rubella-containing vaccines; meningococcal; pneumococcal
polysaccharide; varicella; and yellow fever.

This is a list of vaccines that should be administered by the
intramuscular route. Vaccines given IM include diphtheria,
tetanus and pertussis- containing vaccines; Haemophilus
influenzae type b; hepatitis A; hepatitis B; inactivated polio;
influenza; pneumococcal conjugate; pneumococcal polysaccharide;
rabies and typhoid Vi.

Inactivated polio and pneumococcal polysaccharide vaccines are
listed on both tables because they can be administered by either
the subcutaneous route or the intramuscular route. Neither the
vaccine manufacturer nor the ACIP recommends one route over the
other for either vaccine. With IPV and pneumococcal
polysaccharide, it's the clinician's choice.

Subcutaneous injections are administered into the fatty tissue
found below the dermis and above muscle tissue. Subcutaneous
tissue is present all over the body. The usual subcutaneous sites
for vaccine administration are the thigh and the upper outer
triceps of the arm. The upper outer triceps area can be used to
administer subcutaneous injections to infants. The recommended
needle size for subcutaneous injections in all age groups is a
23- to 25-gauge 5/8 inch needle. A longer needle could penetrate
the muscle, particularly if given at an incorrect angle. To avoid
reaching the muscle, the fatty tissue is pinched up and the
needle is inserted at a 45-degree angle. A more perpendicular
approach is used for IM injection.

The majority of vaccines administered by injection are given by
the intra muscular route. Incorrect intramuscular technique can
reduce vaccine effectiveness and increase local adverse
reactions, so proper technique is critical. Intramuscular
injections are administered into muscle tissue below the dermis
and subcutaneous tissue. The amount of overlying subcutaneous
tissue depends on the person and the site. Although there are
several IM injection sites on the body, the recommended IM sites
for vaccine administration are the vastus lateralis muscle in the
antero-lateral thigh and the deltoid muscle in the upper arm.

Injection at these sites reduces the chance of involving neural
or vascular structures. The site depends on the age of the person
and the degree of muscle development. The deltoid muscle is most
commonly used in older children and adults. The deltoid muscle
can be used in toddlers if the muscle mass is adequate. It's
important to use anatomical landmarks to locate the site so that
the injection is given into the center of the muscle. The buttock
should NEVER be used to administer vaccines, although it can be
used to administer large doses of immune globulin. Injection in
the gluteus risks damage to nerve tissue. The recommended needle
for intramuscular injections is 22 to 25 gauge. The needle length
must be adequate to reach the muscle and is based on the size of
the individual. The recommended needle length for an infant is
7/8 to 1 inch. The recommended needle length for toddlers and
older children is a 7/8 to 1 and one-fourth inch. Adults will
typically need a 1 to 1 and a half inch needle. To avoid
injection into subcutaneous tissue, the skin of the selected site
can be spread 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. The needle should be inserted fully into the muscle at a
90-degree angle.

There are a few other issues related to vaccine administration
that seem to generate a lot of questions. Donna, could you review
these issues?

WEAVER:
Yes, Judy, I will. We do receive a lot of questions about vaccine
administration. Many of them concern infection control.
Handwashing is recommended between each patient. When working at
a site where it's not feasible to wash your hands before each
patient, an alcohol-based waterless antiseptic can be used
between patients and in situations where your hands become
soiled.

Gloves are not mandatory for vaccine administration unless there
is the potential for exposure to blood or body fluids, the person
giving the shot has open lesions on the hands, or it is an agency
policy. But remember, gloves cannot prevent a needle- stick
injury.

In November 2000, to reduce the risk of needle-stick injury and
the potential for blood-borne diseases acquired from patients,
the Needle- stick Safety and Prevention Act was signed into law.

The act directs the Occupational Safety and Health
Administration, better known as OSHA, to strengthen its existing
bloodborne pathogen standards. Those standards were revised and
became effective in April 2001. These federal regulations require
use of safer injection devices and documentation of injuries
caused by medical sharps. They also require nonmanagerial staff
involvement in the evaluation and selection of safer devices
before they are purchased. Needle- shielding and needle- free
devices that may meet these OSHA requirements for vaccine
injections are available and are listed on several websites. We
will include these websites on the broadcast resource web page.

Of course, you should never EVER detach, recap or cut a used
needle before disposal. All used syringe and needle devices
should be placed in puncture proof containers to prevent needle
sticks and reuse. Empty or expired vaccine vials are considered
infectious medical waste and should be disposed of according to
state regulations.

Here are a few more points about vaccine administration. It's not
necessary to change the needle between reconstitution or drawing
the vaccine and administering it unless the needle is
contaminated or bent. Modern steel needles are not dulled by
entry into a vaccine vial.

When administering multiple vaccines, NEVER mix vaccines in the
same syringe unless they are approved for mixing by the Food and
Drug Administration. Very few vaccines are approved for mixing.
Those that are will be packaged together or indicated in the
package insert. Use a new syringe and needle to draw up each
vaccine to be administered.

If more than one vaccine is to be administered in the same limb,
the injection sites should be separated by at least an inch, if
possible. This separation allows any local reactions to be
differentiated. Vaccines that contain tetanus and diphtheria may
cause more soreness than other vaccines, so you may want to give
this vaccine alone or in the limb with a subcutaneous injection.

Aspiration is the process of pulling back on the plunger of the
syringe prior to injection to ensure that the medication is not
injected into a blood vessel. Although this practice is advocated
by some experts, and most nurses are taught to aspirate before
injection, there is no evidence hat this procedure is necessary.

If your procedure includes aspiration and blood appears, the
needle should be withdrawn, and a new site selected.

Many people, particularly health care providers, claim to have
latex allergies. Latex allergy is most often a contact- type
allergy. There has only been one published report of an
anaphylactic allergic reaction following vaccine administration
in a patient with known severe allergy to latex. A person with
an anaphylactic allergy to latex should not generally receive
vaccines supplied in vials or syringes that contain natural
rubber, unless the benefit of vaccination outweighs the risk of
an allergic reaction to the vaccine. People with latex allergies
that are not anaphylactic allergies, such as contact allergy to
latex gloves, can be vaccinated with vaccines supplied in vials
or syringes that contain dry natural rubber or natural rubber
latex.

With the number of injections that we are giving in immunization
practice today, both health care providers and parents are
concerned about adequate pain control. Comfort measures and
distraction techniques may help children cope with the discomfort
associated with vaccination. Remember that pain is a subjective
phenomenon influenced by multiple factors including a person's
age, anxiety level, previous health care experiences, and
culture. A variety of measures ranging from topical anesthetics
to diversionary techniques are discussed in both the recently
updated ACIP General Recommendations on Immunization, and a
vaccine administration document available on our broadcast
resource website. Bill?

ATKINSON:
Donna, just to clarify this issue- does ACIP recommend that
providers aspirate or not aspirate before injection?

WEAVER:
Bill, ACIP doesn't recommend anything about aspiration. Without
data indicating the need for aspiration, ACIP is basically
leaving this decision to the person giving the vaccine.

ATKINSON:
OK. Thanks Donna. Judy, we've talked about administering the
vaccines, now what about after the shots?

SCHMIDT:
Bill, care of patients after the shots and instructions for
patients and parents are an important part of the vaccine
administration process. We have already discussed safety measures
to avoid injury if someone faints and emergency procedures should
an allergic reaction occur. Let's discuss after-care
instructions. We recommend that you go over these instructions
and provide a written copy BEFORE the vaccines are administered.

It's unlikely that patients who have just received injections or
parents who are trying to comfort a child are able to concentrate
on after- care instructions.

Here is an example of written after- care instructions. This
document was produced by the Immunization Action Coalition and
the California Department of Health Services. You can find these
instructions on the broadcast resource web page.

Parents should be prepared to give their child a little extra TLC
and patience after immunization. Young children need reassurance
that everything is all right, and parents are encouraged to
cuddle and soothe their baby. An infant may also be comforted by
a bottle, pacifier or breast feeding. Older children often
respond positively to hugs, praise and little rewards.

Some vaccines can cause discomfort for a few days after the shots
are given. Children- and adults- may be fussy, experience some
redness, warmth, and tenderness at the injection site and have a
low grade fever following vaccination. MMR and varicella vaccines
may cause a rash or fever about a week after vaccination. The
Vaccine Information Statement for each vaccine will tell parents
and patients what kind of adverse reactions to expect. Encourage
patients and parents to take the VIS home with them.

Parents should be instructed on how to manage fever and pain that
may occur following vaccination. Either acetaminophen or
ibuprofen can be given if necessary. Aspirin should NEVER be
given to a child because of the risk of Reye Syndrome.

Other things the parent can do if the child has a fever include
giving plenty of fluids to drink; dressing the child in light
clothing, and not covering or wrapping the child tightly. The
parent can also sponge the child in a few inches of lukewarm
water. If the patient's arm or leg is swollen, warm and red, they
can wet a clean washcloth with cool water and place it on the
tender area to ease the discomfort. Let the parent know that the
child may not eat as much as usual for the next day or two, but
not to be alarmed as long as an adequate amount of fluids are
tolerated.

Parents also should be given clear instructions about when to
contact the health care provider. Parents should call if the
child is fussy for more than 24 hours; has a rectal temperature
of 105 degrees Fahrenheit or higher; is pale or limp; has been
crying continuously for more than 3 hours; if the crying isn't
normal, like a high-pitched cry; if the child is shaking,
twitching or jerking; or if the parent has any other concerns
about the way the child looks or acts.

Serious adverse events following vaccination occur infrequently,
but minor events, such as pain and redness at the injection site
re common. Good after care instructions will prepare the parent,
reduce their anxiety, and reduce the number of telephone calls
you need to handle. Bill?

ATKINSON:
Thanks, Judy. We will be back to talk about post encounter
activities after this brief pause.

[UNSCRIPTED VIDEO PROMO]

ATKINSON:
That clip was from a video on vaccine administration produced by
the California Immunization Program. It's called Immunization
Techniques - Safe, Effective, Caring. The video is 35 minutes
long and covers all aspects of vaccine administration, including
reconstitution and drawing vaccine, anatomic sites, needle
length, administration techniques, and more. The video includes
presenter's notes, a skills checklist, immunization site maps,
and other materials. It's a great competency-based training tool
for your office. The video and associated material cost 25
dollars. It's available from the California Distance Learning
Health Network, and from the Immunization Action Coalition. We
have a link to this excellent package on our broadcast website.
We will give you that address in a few minutes.

Now we are ready to move to the Post- Encounter Phase of the
Immunization Encounter. Let's look at activities for you to
consider. Documentation and record- keeping and vaccine adverse
event reports. We frequently receive questions about required
documentation, record maintenance and how to report adverse
events. We're going to spend the remainder of our time discussing
these topics. But first, let's review OTHER post- encounter
activities. Clinic clean-up and medical waste disposal. It's
important for you and other staff to be knowledgeable about OSHA
guidelines regarding infection control and waste disposal.

Adequate clinic supplies. Take time to restock your materials and
supplies so that you won't be caught short during your next
immunization encounter. Patient recall. We strongly recommend
that you contact patients who missed their appointment to
reschedule. Quality assurance and improvement activities
typically include peer and record reviews. There is information
on our resource web page about a software program called Clinic
Assessment Software Application, better known as CASA. CASA is a
software package that can help with your quality assurance by
measuring vaccination coverage in your pediatric population.

ATKINSON:
Documentation and record keeping is a critical post encounter
activity. A medical record is the backbone of a patient care
plan. Healthcare providers need access to information about a
person's medical history and vaccination status before
immunizations are scheduled and given. Accurate documentation
allows timely immunizations and helps prevent unnecessary
disease. A complete list of past immunizations also avoids the
cost and inconvenience associated with over- immunization and
laboratory testing.

Judy, tell us more about maintaining immunization records.

SCHMIDT:
Bill, there are TWO immunization records that providers should
maintain- the record in the office medical chart, and the record
held by the person being vaccinated. The information that should
be included on these records is similar. Let's talk first about
the office immunization record.

An immunization record is considered part of the person's
permanent medical record and should be maintained as part of each
patient's chart. The immunization record should be located in the
FRONT of the patient's chart for quick review at each visit.

Providers report that by simply keeping documentation on one
record placed at the front of the chart, vaccine coverage
improves and missed opportunities are eliminated. Placing the
immunization record at the front of the chart avoids this crucial
information being out of sight and out of mind.

When a provider sees the record, it's a reminder to review it to
be sure the patient is up to date. Placing the immunization
record at the front of the chart applies to everyone, from
children to senior adults.

Although there may be some variation from one practice to
another, or one state to another, all records- print and
electronic- should include the following information: the entry
begins with the type of vaccine, dose number, and dose amount.

The manufacturer is noted as well as the vaccine lot number, the
date the vaccine was administered, and the anatomic site and
route. Finally, the name of the person giving the vaccine, the
office address, and publication date of the Vaccine Information
Statement should be noted. The publication date is printed on
each VIS.

There is one footnote to charting vaccine lot numbers. A diluent
that is licensed separately has a separate lot number that must
be noted. Currently, this applies only to the combination vaccine
TriHibit, because the diluent is a vaccine- DTAP, used to
reconstitute Hib vaccine.

You may be wondering why the lot number of a vaccine needs to be
charted at all. The answer is that if a particular lot of
vaccine is ever recalled, the lot number in your chart will
indicate which of your patients may need to be notified.

How long should your office retain medical and immunization
records? The length of time medical records should be kept by
each office or clinic varies by state. We believe immunization
records should be kept indefinitely.

Donna, what about lost immunization records?

WEAVER:
Yes, we often get questions about reconstructing immunization
records that are either lost or incomplete. Let's talk about
incomplete immunization records first. Families change vaccine
providers for a variety of reasons. This may result in one person
having several medical records located in different provider
offices, with each record showing an incomplete series of
immunizations. When the person's medical records are located,
it's perfectly acceptable to review all dated, properly
documented doses and consolidate the information into a single
immunization record.

It's wise for all of us to keep a personal immunization record,
separate from the office medical record. Parents need to know
that a personally held record for each of their children is
critical in documenting vaccines required for day care or school
entry. Adults need a personally held immunization record for
employment or international travel.

When a record documenting one or more immunizations is lost, the
history of having the vaccine is lost. The National Immunization
Program frequently receives requests for copies of personal
immunization records. There is no national database of
immunization records so we can't help individuals obtain their
immunization histories. If the patient or parent doesn't have a
personal held immunization record, you should contact other
health care providers to obtain the history. Day cares or schools
may also have a record of their immunizations.

If a reasonable search does not locate a record, the person
should be vaccinated according to age. Administering doses that
may have already been given is safe and assures protection.

Serologic testing for some antigens, such as diphtheria and
tetanus, can be considered. This is a good opportunity to talk
about the advantages of immunization registries. Having a readily
accessible, central repository of immunization records helps
assure that people get the vaccines they need. Registries
ultimately save time, money, and inconvenience for everyone.

We are seeing the need for registries today more than ever
before. We know that nationally, 20 percent of children move by
the age of two and change providers for this or other reasons.

This leads to incomplete documentation in a single medical
record. The childhood immunization schedule is complex. A
registry can help simplify the process of deciding which vaccine
is due at a visit. Parents and patients become complacent about
returning for vaccination appointments when the disease rate is
low. A registry can help generate reminder and recall notices for
your patients who miss appointments. Finally, a registry can
facilitate the exchange of vaccine information among providers
and improve continuity of care.

We strongly encourage all providers to participate in a local or
state immunization registry if one is available in your area.

Much more information on this topic is available on our website.

Office policies that place a priority on maintaining immunization
records provide benefits to the provider staff as well as the
patients. For example, patients receive the benefit of timely,
age- appropriate immunization each time they visit the office.

The provider practice staff benefit when they are able to
demonstrate a high level of vaccination coverage among their
patient population, and the satisfaction of knowing their
patients are protected from dangerous diseases.

To summarize immunization record keeping: remember that a single
complete immunization record in the FRONT of the chart will act
as a reminder to check vaccination status of your patient at
every visit, and facilitate review. All information about the
vaccines administered, and the Vaccine Information Statements
given to the patient should be recorded. You should retain these
records indefinitely. And be sure to emphasize the need for the
patient to keep and maintain their personally held immunization
record.

ATKINSON:
Our last topic is vaccine adverse events and the Vaccine Injury
Compensation Program. We- YOU- administer millions of childhood
vaccines each year, and millions more to adults. Only a tiny
fraction of these results in potentially serious adverse events.

The Vaccine Injury Compensation Program, or VICP, is in place to
address legal claims for these rare, but serious, events.

Judy, will you tell us more about the VICP?

SCHMIDT:
Sure Bill. The VICP is a no- fault federal compensation program.
It serves as an alternative to the traditional tort legal system
for resolving vaccine injury claims. VICP was established by the
National Childhood Vaccine Injury Act of 1986, and began
operation in 1988. It is jointly administered by the Department
of Health and Human Services, the United States Court of Federal
Claims, and the Department of Justice.

There are eleven specific antigens included in the Vaccine Injury
Compensation Program. They are tetanus, pertussis, measles,
mumps, rubella, polio, Haemophilus influenza type B, hepatitis B,
varicella, and rotavirus. A combination vaccine containing any of
these antigens is also covered, such as DTAP or MMR. Pneumococcal
conjugate vaccine is currently covered under the broad category
of New Vaccines.

The types of injuries covered by VICP are published in a Vaccine
Injury Table. Here is the most current version of the table. For
each vaccine listed in the first column, there are specific
adverse events named in the second column. Each of these events
is associated with a time period shown in the last column. For
instance, tetanus containing vaccines list the adverse event of
anaphylaxis occurring within a 4 hour time frame. This means that
there must be evidence that anaphylaxis caused by a tetanus
containing product occurred within 4 hours of receiving the
vaccine in order to qualify for this particular compensation.

When a specific vaccine injury occurs that appears on the table
and meets the time criteria, there is a "presumption of cause".
That means the vaccine is presumed to have caused the injury,
unless the Court determines the event was due to a cause
unrelated to the vaccine. If the specific injury does not appear
on the Vaccine Injury Table, proof must be shown that the vaccine
caused the condition or significantly aggravated a pre-existing
condition.

There are specific time frames for filing a claim. The claim for
injury must be filed with the court within 36 months after the
first symptoms appeared. The injury must have lasted at least six
months after the vaccine was given. OR the injury must have
resulted in a hospital stay and surgical intervention. If a death
occurs, the claim must be filed within 24 months of the death and
within 48 months of the vaccine event that caused death.

In addition to the information in the table, there are detailed
definitions, descriptions, and instructions that accompany the
table. This information is extremely useful for health care
providers as well as the person filing the claim.

There is an important point about reporting adverse events I want
to mention here. The National Vaccine Injury Act REQUIRES health
care professionals and vaccine manufacturers to report adverse
events that appear on the Vaccine Injury Table. These adverse
events should be reported as soon as possible after their
occurrence.

In 1990, a reporting system was put into place to assist
providers and families with this requirement. The system is
called the Vaccine Adverse Events Reporting system, or VAERS.
VAERS accepts spontaneous reports of all the required events. But
it will also accept any event a health care professional,
patient, or parent suspects may be related to the vaccine. It's
important that you understand how VAERS works and what it does.

We asked Doctor Robert Pless, a vaccine safety expert in the
National Immunization Program, to tell us about the system.

PLESS:
The Vaccine Adverse Event Reporting System, or VAERS is a program
co-managed by the Centers for Disease Control and Prevention, and
the Food and Drug Administration. I hope you will remember two
important take home messages. First, VAERS is the cornerstone of
efforts to monitor the safety of vaccines, and second, your
contributions to VAERS are absolutely vital. VAERS is a unique
surveillance system that relies most on health care providers,
but also patients and parents, to report cases of adverse events
that they think might be related to vaccination. The CDC and FDA
continually monitor the safety of vaccines by collecting and
evaluating these cases.

VAERS is really the only system in place that does safety
surveillance on an ongoing basis. It is automatic, unlike a
clinical trial or a study, it does not need to be set up to
monitor a new vaccine. VAERS relies on reporting from the users
and recipients of vaccines, so it cannot work without you!

VAERS was established in 1990 after Congress passed the National
Childhood Vaccine Injury Act. VAERS merged two different systems
that had been collecting case reports separately from private
and public health care providers. Although, the Childhood Vaccine
Injury Act mandates that health care providers report the events
listed on a table of designated Reportable Events.

VAERS depends on the reporting of ALL clinically significant
events, most of which are not listed on the Table of Reportable
Events and are therefore voluntary. Any event that you suspect
MIGHT have been due to a vaccination, or if you are not SURE but
feel it is important to let VAERS know, should be reported.

Now let's talk about how VAERS works. I hope that most vaccine
providers have heard of VAERS and have seen a copy of the VAERS
reporting form. Almost 200,000 copies are sent each year to
pediatricians, nurses and family physicians.

The form can be obtained from the VAERS website at www.vaers.org
or by calling the telephone number found on every Vaccine
Information Statement. The VAERS form is self-mailing and
postage-paid, with the address and instructions on the back.
When folded and sealed, it, in fact, becomes its' own envelope.
The completed form can, of course, be faxed to a toll free
number. In addition, reporting through a secure web site is
available at www.VAERS.org. This website provides excellent
information about VAERS including a continuing education module.
The module gives continuing education credits for physicians,
nurses, and other professionals.

Once VAERS receives a report, a letter is sent out to the person
who submitted it. The letter provides a thank you, the assigned
VAERS ID number, and, if needed, requests additional information.

A team of nurses conducts personal follow up on all reports
considered serious. This follow up is done to obtain more
complete clinical information about the reported event. In
addition to the VAERS form, VAERS welcomes hospital or clinic
summaries or other additional medical information. The additional
medical information is useful informing a complete history.

To show you how VAERS works, let me give two examples of why
collecting reports that are merely suspected to be related to a
vaccination, is important.

In the past, there was a concern that Sudden Infant Death
Syndrome, or SIDS, was related to vaccination. When parents and
physicians reported cases of SIDS within a few days of a
vaccination, they thought that this close timing between the
vaccination and SIDS suggested an association. Careful studies
were conducted with control groups, and repeatedly showed that
the risk of SIDS following a vaccination is no greater than if
the vaccination had not been given. We now know that vaccines do
not cause SIDS. Reports of SIDS are still submitted and followed
up, but reassurance is given to parents that this tragic event
was not because they had their baby vaccinated.

Now, let's examine the story of the rotavirus vaccine. Before the
rotavirus vaccine was licensed in the fall of 1998, investigators
did note a few cases of a bowel disorder called intussusception
in both vaccine recipients and those who received a placebo.

Although the rate among vaccine recipients was slightly higher,
it was not significant. Therefore, the vaccine was licensed, but
intussusception was included in product information among the
list of reported adverse reactions.

Once the vaccine was widely distributed, VAERS began to receive
adverse event case reports, including cases of intussusception.
The number of cases reported relative to the number of doses
distributed turned out to be high compared to what was expected.
This suggested, but did not confirm, a problem that we call a
signal. Subsequent rigorous studies did confirm that the risk of
intussusception was higher after vaccination, and the rotavirus
vaccine was withdrawn. VAERS did its' job! The rotavirus
problem was uncovered through VAERS and confirmed, and then
appropriate action was taken. These stories of SIDS and Rotavirus
highlight the importance of reporting events even when the person
reporting may be unsure that the vaccine was responsible. 
Vaccine safety concerns raised by VAERS will be carefully
evaluated before any action is taken.

So, as the cornerstone of the country's vaccine safety monitoring
system, VAERS is always "on call" to receive case reports of any
adverse event suspected to be related to any vaccine distributed.
A few important points: VAERS accepts all reports of adverse
events. Events that are related, as well as those that are
unrelated to vaccination, end up in VAERS. VAERS reports are
screened and evaluated as they are received. Concerns are flagged
and further assessed, as illustrated by the examples of
intussusception and SIDS.

VAERS relies on the astute health care provider to notice and
report adverse events that may be related to vaccination. VAERS
is a focal point of all sorts of questions related to vaccine
safety. By being that focal point, it ensures that concerns have
a much better chance to be heard and evaluated. This is like when
a restaurant outbreak occurs. Everyone may go to a different
emergency room, but the different hospitals all call the public
health department! That way the pieces are put together and the
outbreak is discovered and managed.

Thank you for this opportunity to discuss the Vaccine Adverse
Event Reporting System. Because in the end, it relies on you to
help make sure that vaccines continue their exceptional track
record of safety. The VAERS program welcomes feedback on what can
be done to make the reporting process easier. And remember: when
in doubt, report it!

SCHMIDT:
Now that we have reviewed the vaccine adverse event reporting
system as well as the vaccine injury compensation program, it's
important to remember that these are two separate systems,
managed by different agencies. Filing a VAERS report is not the
same as filing a vaccine compensation claim. A VAERS report is
NOT a compensation claim. A compensation claim is filed
separately from the VAERS report. A VAERS report may be
appropriate where a compensation claim is not. There is more
information about the Vaccine Injury Compensation Program and
VAERS on the broadcast resource website.

ATKINSON:
Thank you Judy. We would like to give you a few additional
resources you can use to get more information about the topics we
covered in today's program.

We have created a special page on the National Immunization
Program website to provide one stop shopping for many of the
documents and forms we have discussed today. There are also links
to information on other vaccine related topics and resources. The
address is www.cdc.gov/nip.

If you have questions that we didn't answer on the air, or wish
to order materials and don't have Internet access you can call
the National Immunization Information Hotline at 800-232-2522.
The Hotline is staffed Monday through Friday from 8 AM until 11
PM eastern time.

You can use the Internet to E-mail questions, comments, or
requests directly to the National Immunization Program. The
address is nipinfo@cdc.gov. That Email address again: is
nipinfo@cdc.gov.

Finally, if you would like to find out more about upcoming Public
Health Training Network courses, visit the PHTN website at
www.phppo.cdc.gov/phtn.

Thank you for joining us for The Immunization Encounter: Critical
Issues. We've enjoyed bringing it to you. Please join us on
August 15 for our annual broadcast of Immunization Update. We'll
see you then. Goodbye.