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Required Use
1. Provide VIS when vaccination
is given.
As required under the National
Childhood Vaccine Injury Act (42 U.S.C. §300aa-26), all health care providers in
the United States who administer
to any child or adult
any vaccine containing diphtheria, tetanus, pertussis, measles, mumps, rubella,
polio, hepatitis A (use of hepatitis A VIS required effective July 1, 2006), hepatitis
B, Haemophilus influenzae
type b (Hib), trivalent
influenza, pneumococcal conjugate, or varicella (chickenpox) vaccine shall,
prior to administration of
each dose of the vaccine,
provide a copy to keep of the relevant current edition vaccine information materials
that have been produced by the Centers for Disease Control and Prevention (CDC):
- to the parent or legal representative
of any child to whom the provider intends to administer such vaccine,
and
- to any adult to whom the provider
intends to administer such vaccine. (In the case of an incompetent adult, relevant
VISs shall be provided to the individual’s legal representative.* If the incompetent
adult is living in a long-term care facility, all relevant VISs may be provided
at the time of admission, or at the time of consent if later than admission, rather
than prior to each immunization.)
If there is not a single VIS
for a combination vaccine, use the VISs for all component vaccines.
The materials shall be supplemented
with visual presentations or oral explanations, as appropriate.
2. Record information
for each VIS provided.
Health care providers shall
make a notation in each patient's permanent medical record at the time vaccine information
materials are provided indicating:
(1) the edition date of the
Vaccine Information Statement distributed and
(2) the date the VIS was provided.
This recordkeeping requirement
supplements the requirement of 42 U.S.C. §300aa-25 that all health care providers
administering these vaccines must record in the patient's permanent medical record
(or in a permanent office log):
(3) the name, address and title
of the individual who administers the vaccine,
(4) the date of administration
and
(5) the vaccine manufacturer
and lot number of the vaccine used.
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