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What
Vaccine Information Statements (VISs) must be used?
The relevant VIS must be provided to the vaccinee (or to the
parent or legal representative) for any vaccine covered by
the National Childhood Vaccine Injury Act (NCVIA). As of
January 2002, these VISs are: DTaP, Td, MMR, Polio,
Hepatitis B, Haemophilus influenzae type b (Hib), Varicella,
and Pneumococcal conjugate vaccine. Rotavirus is also
covered by the NCVIA, but the vaccine is not in use.
Use of VISs for vaccines not covered by the NCVIA is
strongly encouraged. Other VISs that are available are
Hepatitis A, Influenza, Pneumococcal polysaccharide, Lyme
diseases, Anthrax, Meningococcal, and Smallpox.
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What is
the difference between VISs, Important Information
Statements (IIS’s), and Vaccine Information Materials (VIM’s)?
Technically, the law designates statements describing
vaccines covered by the NCVIA as Vaccine Information
Statements. Important Information Statement is a term that
was used for these statements in the past, and is still
sometimes used to describe statements for vaccines not
covered by NCVIA (e.g., hepatitis A, influenza). From 1991
to 1994 multi-page “Vaccine Information Pamphlets” (VIP’s)
were used for MMR, DTP, Td, and Polio. Vaccine Information
Materials is a generic term that has been used to describe
any of these statements. For convenience sake, we now use
the term VIS for all current information statements.
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How can I
tell if the VISs I am using are the most up-to-date
versions?
Check the NIP’s website at
http://www.cdc.gov/nip/publications/VIS. The VISs posted
there will be current.
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Can
providers develop their own vaccine information materials?
All public and private providers who administer the vaccines
covered by the NCVIA are required to use the CDC-developed
VISs. In 1994, an amendment to the act deleted the language
that allowed providers to substitute their own materials for
the VISs. However, providers may still supplement the VISs
with materials of their own.
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May
immunization projects add state or local health department
identification to the VISs?
Yes. But any other addition to these documents or variations
from their language or format must have the prior written
approval of the Director of CDC’s National Immunization
Program.
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How are
VISs distributed?
Camera-ready copies and explanatory information are sent to
all Immunization Projects. The Immunization Projects are
responsible for printing and distributing VISs to their
public health clinics. They will also be asked to print and
distribute single camera-ready copies to all providers who
administer vaccine in their state or metro area. Funds have
been included in the Immunization Project grants for
printing and distribution of the VISs. Some private provider
organizations also print and sell copies of the VISs.
The VISs are also available on the internet (see “Where can
I get the VISs,” below). These are identical to the printed
VISs, and may be downloaded and printed out by Immunization
Projects or providers and used as camera-ready copy.
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Must VISs
be used for adults as well as for children?
Yes. Under the NCVIA, anyone receiving a covered vaccine
should be given the appropriate VIS.
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Are VISs
“informed consent” forms?
No. Informed consent requirements are determined by state
law. The VISs were written to fulfill the information
requirements of the NCVIA, and are not informed consent
documents. However, because the materials cover both
benefits and risks associated with vaccinations, they
provide enough information that anyone reading them should
be adequately informed.
Nevertheless, you should consult your state law to determine
if there are any specific “informed consent” requirements
relating to immunization. The requirements could include
procedural requirements (e.g., whether informed consent is
required prior to vaccinations, whether it may be oral or
must be in writing, whether state law requires a signature
prior to vaccination) or substantive requirements (e.g., the
types of information the state would require to be included
in any informed consent).
NOTE: VISs must still be used, even if state law requires
use of other informed consent materials.
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What are
the record keeping requirements regarding VISs?
Health care providers are not required to obtain the
signature of the patient, parent or legal representative
acknowledging receipt of the VISs. However, to document that
the VIS was given, health care providers must note in each
patient’s permanent medical record at the time a VIS is
provided: (1) the date printed on the VIS and (2) the date
the VIS is given to the vaccine recipient, or the parent or
legal representative.
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What does
“legal representative” mean?
A “legal representative” is a parent or other individual who
is qualified under state law to consent to the immunization
of a minor.
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Must a
VIS be given out every time a vaccine is administered?
Yes. A VIS must be given out with every vaccination,
including each dose of a multi-dose series. This is done for
several reasons. The statement might have been updated
between visits, or the health status of the child could have
changed (e.g. he or she may have an evolving neurological
disorder).
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Must the
patient, parent, or legal representative physically
take away a copy of each VIS, or is it acceptable to simply
let them read a copy and ensure that they understand it?
It is desirable for the person getting the shot or their
representative to actually take the VISs home, because they
include information that may be needed later (e.g., the
recommended schedule for the vaccines, information
concerning what to look for and do after the vaccination,
and what to do if there is a serious reaction). Even if some
patients may elect not to take the VISs home, the provider
should offer them the opportunity to do so.
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How
should we comply with the law for patients who are
illiterate
or blind?
The NCVIA requires providers to supplement the VISs with
“visual presentations” or oral “explanations” as needed. If
patients are unable to read the VISs, it is up to the
provider to ensure that they have the information. VISs can
be read to these patients, or videotapes (or other media)
can be used as supplements.
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Are the
VISs available in languages other than English?
There are currently no “official” CDC translations of the
VISs. Several states have translated them, however, and
sharing of translations among states is encouraged. Projects
or providers may translate the VISs into other languages.
These do not have to be approved by CDC. (See “Where can I
get the VISs,” below.)
Translations currently exist on the web in Arabic, Armenian,
Cambodian, Chinese, Croatian (Serbian), Farsi, French,
German, Haitian Creole, Hmong, Ilokano, Japanese, Korean,
Laotian, Portugese, Punjabi, Romanian, Russian, Samoan,
Serbo-Croatian, Somali, Spanish, Tagalog, Thai, Turkish and
Vietnamese.
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What is
LINK?
Los Angeles-Orange Immunization Network (LINK) Registry is a
confidential, computerized information system, which enable
providers to view the most up-to-date immunization record
for their child patients.
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Where can
I get more information on the Los Angeles-Orange
Immunization Network (LINK)?
You may visit the LINK website for more information at:
http://www.immunizelink.org
