An immunization registry is not the patient's legal medical record, which is maintained by the physician. While not explicit, it is easily implied from "The Standards for Pediatric Immunization Practice" put forth by the US Department of Health and Human Services (
https://www.hhs.gov/nvpo/nvac/reports-and-recommendations/the-standards-for-pediatric-immunization-practice/index.html) and the CDC (
https://www.cdc.gov/mmwr/preview/mmwrhtml/00020935.htm) (See Standards 9, 11, 12, and 14)
This was taken from the "Ask the Experts" page at Immunize.org (
http://www.immunize.org/askexperts/documenting-vaccination.asp), which states:
Please explain the federal requirements for all healthcare providers that administer vaccines under the National Childhood Vaccine Injury Act.
The National Childhood Vaccine Injury Act (NCVIA), enacted in 1986, set forth 3 basic requirements for all vaccination providers, which are:
• 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.
• Providers must record certain information about the vaccine(s) administered in the patient's medical record or a permanent office log.
• 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).
What do we legally need to record when giving an immunization to 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 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.
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, 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) and answering their questions is sufficient under federal law.
Furthermore, most states have their own requirements for vaccinations, which you can also reference, as well as your payer policies.
Hope that helps,
Jennifer M. Connell, CPC, CPCO, CPC-P, CPB, CPMA, CPPM, CPC-I, CENTC