What information does federal law require us to document when we immunize a patient?

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 (NCVIA) enacted in 1986. The law applies to all routinely recommended childhood vaccines, and vaccines recommended during pregnancy (except COVID-19 and RSV), regardless of the age of the patient receiving the vaccines.

The RSV preventive antibody, nirsevimab (Beyfortus, Sanofi) is not a vaccine and not covered by the NCVIA, but a VIS-equivalent, known as an immunization information sheet (IIS), should be provided to the caregiver of an infant receiving nirsevimab.

The following information must be documented on the patient’s paper or electronic medical record or on a permanent office log when a vaccine covered by the NCVIA is given, and is recommended when any vaccine is administered:

1. The vaccine manufacturer
2. The lot number of the vaccine
3. The date the vaccine is administered
4. The name, office address, and title of the healthcare provider administering the vaccine
5. 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
6. The date the VIS is given to the patient, parent, or guardian

The federally required information should be both permanent and accessible.

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), IIS, or Emergency Use Authorization (EUA) Fact Sheet (where applicable) and answering their questions is sufficient under federal law.