Technically Speaking: Recording Vaccinations – What is Required by Federal Law?

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Technically Speaking: Recording Vaccinations – What is Required by Federal Law?
March 27, 2012

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 covered under this law are pneumococcal polysaccharide, zoster and certain infrequently used vaccines, such as rabies and Japanese encephalitis.)

By law, the following information must be documented on the patient’s paper or electronic medical record (or on a permanent office log):

  1. The vaccine manufacturer.
  2. The lot number of the vaccine.
  3. The date the vaccine is administered.
  4. The name, office address, title and signature (electronic is acceptable) of the person administering the vaccine. Initials of the vaccine administrator will suffice as long as the office keeps a record of the person to whom the initials refer.
  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 permission statement to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient.

Here is some additional information you may want to permanently record even though it is not required by law:

  1. Anatomic site: RA (right arm), LA (left arm), RT (right thigh), LT (left thigh)
  2. Route: IM (intramuscular), SC (subcutaneous), ID (intradermal), IN (intranasal), or PO (oral)
  3. The funding source of your vaccine: federal (F), state (S) or private (P)

Finally, for long-term clarity in documenting vaccinations, it is preferable to record the generic abbreviation (e.g., Tdap) in addition to or instead of the trade name (e.g., Adacel® or Boostrix®). It can be difficult to ascertain the components a vaccine contains if only the brand name is recorded, particularly when a specific brand is no longer used. When administering combination vaccines, record all components in the combination (e.g., DTaP-HepB-IPV).

Before the patient leaves your office, be sure to provide a record of the vaccines administered during that visit.

The Immunization Action Coalition has created free, downloadable vaccine administration records for medical charts. They include space for all federally required information and can be used "as is" or altered as per practice needs. Sample pages that demonstrate how to fill them out are also included.

Additional resources regarding vaccine documentation: