| Documenting Vaccination |
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| In the past,
CDC has recommended to only accept
patient-reported history for influenza and pneumococcal polysaccharide vaccines. Is the
recommendation to not accept a
patient-reported history of pneumococcal
conjugate vaccine? |
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| ACIP's General
Best Practice Guidelines for Immunization
still states that a patient's undocumented
history can be accepted as proof of
vaccination only
for influenza and pneumococcal polysaccharide
vaccines. See
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/programs.html. |
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| Where can I
find a list of vaccines currently licensed for
use in the U.S.? |
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| The Food and Drug
Administration (FDA) website has a list of all
vaccines licensed for use in the United States
at
www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM093833.
Note that some licensed vaccines may not
currently be distributed in the
United States (for example Cervarix HPV
vaccine and influenza monovalent H1N1
vaccine). |
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| When we are
giving multiple injections in a limb, what is
the best way to accurately document the injection site? |
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| One way to handle
this is to indicate if the vaccination was
given either in the "upper" or "lower" portion
of the injection area selected (e.g., DTaP:
right
thigh, upper; Hib: right thigh, lower; or
PCV13: left thigh, upper; HepB: left thigh,
lower). It is helpful if everyone in your
office or clinic uses the same sites
for each vaccine. Use of a standardized site
map can facilitate this. Here are some helpful
site maps for different ages so you can record where shots
were given: |
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| For infants and
toddlers:
www.eziz.org/assets/docs/IMM-718.pdf |
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| For adults:
www.eziz.org/assets/docs/IMM-718A.pdf |
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| We frequently
see patients, such as immigrants, who do not
have records of past vaccination or who insist they or their children are up to date. Should
we
accept their undocumented vaccination history? |
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| Vaccination
providers frequently encounter people who do
not have adequate documentation of
vaccinations. Providers should only accept
written, dated
records as evidence of vaccination. With the
exception of influenza and pneumococcal
polysaccharide vaccines, self-reported doses
of vaccine without
written documentation should not be accepted.
An attempt to locate missing records should be
made whenever possible by contacting previous healthcare
providers, reviewing state or local
immunization information systems, and
searching for a personally held record.
However, if records cannot be located or
will definitely not be available anywhere
because of the patient's circumstances, people
without adequate documentation should be
considered susceptible
and should be started on the age-appropriate
vaccination schedule. Serologic testing for
immunity is an alternative to vaccination for
certain antigens
(e.g., measles, rubella, or hepatitis A). |
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| In general,
although it is not ideal, receiving extra
doses of vaccine poses no medical problem.
Receiving excessive doses of tetanus toxoid
(DTaP, DT,
Tdap, or Td) can increase the risk of a local
adverse reaction, however. For details,
consult the ACIP's Best Practice Guidelines
for Immunization chapter
titled Timing and Spacing of Immunobiologics,
available at
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html. |
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| We sometimes
encounter patients with foreign vaccination
records. We suspect that some of these records are not valid. What should we do? |
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| If a provider
suspects an invalid vaccination, including
those from persons vaccinated outside the
U.S., one of two approaches can be taken.
Repeating
the vaccinations is an acceptable option.
Doing so is generally safe and avoids the need
to obtain and interpret serologic tests. If
avoiding unnecessary
injections is desired, judicious use of
serologic testing might be helpful in
determining which immunizations are needed.
This may be particularly helpful in
determining tetanus and diphtheria antitoxin
levels for children whose records indicate 3
or more doses of DTP or DTaP. This issue is
discussed in detail in
the ACIP's General Best Practice Guidelines
for Immunization chapter titled Special
Situations, and summarized in Table 9-1,
available at
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/special-situations.html. |
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| Where can I
find names of vaccines used outside the U.S.? |
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| Appendix B of the
CDC publication Epidemiology and Prevention of
Vaccine-Preventable Diseases ("The Pink Book")
contains a list of vaccines used
outside the U.S. You'll find Appendix B at
www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/foreign-products-tables.pdf. |
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| Since the
Health Insurance Portability and
Accountability Act (HIPAA) went into effect,
we are unsure if we can share immunization
information on our
pediatric patients with staff in schools or
daycare facilities. |
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| Healthcare
providers (or other covered entities) may
share immunization information with schools or
daycare facilities, without authorization, if
permitted or
required by state law. These state laws would
not be preempted by the HIPAA Privacy Rule [45
CFR 160.203(c)]. |
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| If a patient
or parent refuses recommended vaccinations, is
it necessary for them to sign a refusal form,
or is the provider's documentation sufficient? |
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| There is no
federal law requiring such documentation.
Several major medical organizations, including
the American Academy of Pediatrics, have
stated that healthcare providers may decide it
is in their best interest to formally document
a parent's refusal to accept vaccination for
their (minor) child. To read a discussion on
this topic and to access a prototype refusal
form, see "Decision to not vaccinate my child
– declination form" that can be accessed at
www.immunize.org/catg.d/p4059.pdf. |
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| How can I find
out if our state or locality has an
Immunization Information System (IIS), or
registry, in which I might participate? |
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| To find out the
status of the IIS in your state you should
contact your state IIS manager. CDC maintains
a listing of contact information for all state IIS
managers at
www.cdc.gov/vaccines/programs/iis/contacts-registry-staff.html. |
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| If my state
has an Immunization Information System (IIS,
or registry) do I still need to give the
patient a vaccine record card? |
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| Yes. Patient-held
cards are an extremely important part of a
person's medical history. The person may move
to an area without a registry, and the
personal
record may be the only vaccination record
available. In addition, even within a state,
all healthcare providers may not participate
in the registry, and the
personal record card would be needed. |
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| Please explain
the federal requirements for all healthcare
providers that administer vaccines under the National Childhood Vaccine Injury Act. |
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| The National
Childhood Vaccine Injury Act (NCVIA), enacted
in 1986, set forth 3 basic requirements for
all vaccination providers, which are: |
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| • |
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Providers must give the patient (or
parent/legal representative of a minor) a
copy of the relevant federal "Vaccine
Information Statement" (VIS)
for the vaccine they are about to receive. |
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| • |
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Providers
must record certain information about the
vaccine(s) administered in the patient's
medical record or a permanent office log
(see next
question). |
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| • |
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Providers
must document any adverse event following
the vaccination that the patient
experiences and that becomes known to the
provider,
whether or not it is felt to be caused by
the vaccine, and submit the report to the Vaccine Adverse Event Reporting System
(VAERS). |
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| What do we
legally need to record when giving an
immunization to a patient? |
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| It is important
to know the federal requirements for
documenting the vaccines administered to your
patients. The requirements are defined in the
National
Childhood Vaccine Injury Act enacted in 1986.
The law applies to all routinely recommended
childhood vaccines, regardless of the age of
the patient
receiving the vaccines. The only vaccines not
included in this law are pneumococcal
polysaccharide, zoster, and certain
infrequently used vaccines, such
as rabies and Japanese encephalitis. |
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| The following
information must be documented on the
patient's paper or electronic medical record
or on a permanent office log: |
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| 1. |
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The vaccine manufacturer. |
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| 2. |
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The lot number of the vaccine. |
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| 3. |
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The date
the vaccine is administered. |
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| 4. |
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The name,
office address, and title of the
healthcare provider administering the
vaccine. |
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| 5. |
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The Vaccine Information Statement
(VIS) edition date located in the
lower right corner on the back of the
VIS. When administering combination
vaccines, all applicable VISs should
be given and the individual VIS
edition dates recorded. |
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| 6. |
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The date the VIS is given to the
patient, parent, or guardian. |
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| The federally
required information should be both permanent
and accessible. |
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| Federal law does
not require a parent, patient, or guardian to
sign a consent form in order to receive a vaccination; providing them with the
appropriate
VIS(s) and answering their questions is
sufficient under federal law. |
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| Which vaccines
are covered by NCVIA? |
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| NCVIA
requirements apply to diphtheria, tetanus,
pertussis, measles, mumps, rubella, polio,
hepatitis A, hepatitis B, Haemophilus
influenzae type b (Hib),
varicella, seasonal influenza (inactivated and
live attenuated), pneumococcal conjugate,
meningococcal, rotavirus, and human
papillomavirus (HPV)
vaccine. |
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| When and to
whom is it required to give Vaccine
Information Statements (VISs)? |
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The National
Childhood Vaccine Injury Act requires that a
VIS must be given to parents, legal
representatives, or adult patients before
administering the
vaccine. A VIS must be provided prior to each
dose, not just the first dose. Providers
should be sure they are using the most current
version of each VIS.
Current VISs and their dates are available
from on the CDC's website at
www.cdc.gov/vaccines/hcp/vis/index.html
and from IAC's website at
www.immunize.org/vis. |
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| Where can I
get instructions on how, why, and when to use
the federally-mandated VISs? |
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| Instructions on
the use of VISs and many additional items are
available on the CDC website at
www.cdc.gov/vaccines/hcp/vis/index.html
or from your state
immunization program. You can also visit IAC's website at
www.immunize.org/vis for links to
many important documents about the use of
VISs. |
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| When are VISs
released for new vaccines? |
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| An interim VIS
can sometimes be released soon after licensure
of the vaccine or after the official vote by
ACIP is taken. The interim VIS is not replaced
with a final version until the ACIP
recommendations have been published and the
new VIS has been developed according to
legally-mandated procedures. |
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| Is it required
to use a VIS in an emergency room when we give
Td/Tdap to a patient? |
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| Yes. The National
Childhood Vaccine Injury Act requires that a
VIS be given to people of any age before they receive a dose of any vaccine included in
the Act. Tetanus and diphtheria toxoids (and
pertussis vaccine) are included in the Act. If
the patient is unaccompanied and unable to
clearly read and
understand the information in the VIS (e.g.,
the patient is unconscious), this should be
noted in the patient's chart. |
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| Our large
pediatric practice is struggling with the
requirement to provide VISs to the parents of
every child we vaccinate. We would like to
create a re-usable packet of laminated VIS sheets
(fastened together on a ring). We plan to
place a packet in each exam room for parents
to read prior to vaccine
administration. On the bottom of each sheet
would be a statement, "If you would like a
copy of this sheet to take home, please ask
our staff." This will
ensure that parents are given the VIS sheets
to read prior to vaccine administration. It
will also help save paper. Our experience is
that many parents throw
out the VIS documents or leave them behind in
the waiting room. Is this an acceptable
procedure? |
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| Your solution
will meet the spirit of the federal law, as
long as you make sure to encourage the patient
(or parent) to take home a paper copy of the
VIS
and to refer to it if needed (e.g., if they
need to know what to do if there is an adverse
event or how to contact VAERS). |
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| We operate an
acute care hospital and commonly give
vaccinations to our employees and patients, including our annual staff influenza
vaccination
campaign. Are we required to use VISs in all
of these settings, or does that apply only to
patients seen in outpatient settings? |
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| VISs must be
given, regardless of the setting, to all
people, including adults, before administering
HPV, Td, Tdap, MMR, varicella, hepatitis A,
hepatitis B,
meningococcal, influenza, or polio vaccine. |
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| Current VISs are
available from the CDC's website at
www.cdc.gov/vaccines/hcp/vis/index.html and
from the Immunization Action Coalition's (IAC)
website
at
www.immunize.org/vis, where you will also
find many VIS translations in other languages. |
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| When using
VISs and providing vaccines, is a
parent/guardian signature required? |
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| No. There is no
federal requirement for signed consent for any
dose of a vaccine licensed for use by the FDA.
The federal requirement is to provide all
adult patients or parents/legal
representatives of minor children with the appropriate VIS for each dose of vaccine
administered. Some clinics, agencies,
and/or state immunization programs may have
requirements for signatures. Contact
information for your state health department
is available at
www.immunize.org/coordinators. |
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| Where can I
get VISs for some of the newer combination
vaccines? |
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| CDC currently has
no plans to develop VISs for Pediarix, Twinrix,
Kinrix, Quadracel, or Pentacel. When administering these combination vaccines, use
the
VISs for all component vaccines. For certain
combination vaccines given to children, you
can use the multi-vaccine VIS (which includes
DTaP, Hib, HepB,
polio, and PCV13) and check the appropriate box(es), just as you would if you were
administering the individual vaccines. If the multi-vaccine VIS is
unavailable, you should use the individual
vaccine VISs. A VIS was developed for MMRV vaccine because of its unique adverse reaction
profile. |
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| It seems CDC
is changing the format of VISs. Do we have to
throw our old supply away and use the new ones? |
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| Not necessarily.
CDC is in the process of re-releasing all VISs
in a slightly modified format. The modified
VISs have a consistent look and use consistent
language in the sections common to all VISs.
Modified VISs will not necessarily be new, but
may simply be redesigned versions of existing
VISs and have
the same edition dates as existing VISs.
Providers do not need to discard their
existing VIS stocks when nothing but the VIS
format has been changed.
CDC posts information on its website to alert
healthcare providers when the older version of
a VIS should not be used. This information is
available on
CDC's web section titled "What's New with
VISs", available at
www.cdc.gov/vaccines/hcp/vis/what-is-new.html. |
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| Why does CDC
include 2D barcodes on VISs? |
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| CDC began adding
barcodes to VISs in 2012. The barcode is
intended to save time and prevent
documentation errors by allowing immunization
providers
to scan the name and edition date of the VIS,
information required to be documented in the
permanent record of immunization, into an
electronic medical
record, immunization information system, or
other electronic database. Scanning the
barcode instead of manually recording the
information is optional but
can be helpful. |
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| Using 2D barcodes
requires a 2D barcode scanner and software
that is programmed to accept and process data contained in the VIS barcodes.
Providers may continue to use any VISs without
barcodes as long as the VIS content is
otherwise the same. For more information about
using barcodes,
visit
www.cdc.gov/vaccines/hcp/vis/barcodes.html. |
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| Where can I
get foreign language VISs? |
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| CDC publishes
VISs in English only; all translations have
been developed by others. To access all
currently available VISs in more than 35
languages and
links to some alternative formats
(audio/video), go to IAC's website at
www.immunize.org/vis. |
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ACIP Recommendations
Vaccine Information Statements 
