CDC Vaccination Information Sheet Requirements

When consulting with clients, often we will encounter care locations that are responsible for the administration of key vaccinations that are unaware of the requirement to both provide and document the provision of the CDC Vaccination Information Statements, otherwise known as the VIS.

The National Childhood Vaccine Injury Act:

Required since the adoption of the 1986 National Childhood Vaccine Injury Act (NCVIA) by Congress, these information statements provide valuable information on the risks and benefits of each vaccine.

Vaccines requiring a Vaccine Information Sheet

As of March 2013, according to the CDC website, Vaccine Information Sheets are required for the following vaccines:

  • Diphtheria, tetanus, and pertussis containing vaccines (DTaP, DT, Td, and Tdap)
  • Haemophilus influenzae type b (Hib)
  • Hepatitis A
  • Hepatitis B
  • Human Papillomavirus (HPV)
  • Influenza (both Inactivated and Live, Intranasal vaccines)
  • MMR
  • MMRV
  • Meningococcal
  • Pneumococcal Conjugate (PCV13)
  • Polio
  • Rotavirus
  • Varicella

Note - The CDC also provides VIS documents for other vaccines, but they are not required by law to be distributed as a component of the NCVIA.

These Statement documents must be provided PRIOR to the administration of the vaccine and PRIOR to the administration of each dose when a series of vaccinations is required to achieve vaccination.

How must the VIS be provided?

The CDC also states on its website that the VIS can be provided to the patient or legal guardian via the following means:

  • Paper copies of the VIS can be printed and given.
  • Permanent, laminated office copies may be given to patients to read prior to vaccination.
  • Patients may view VISs on a computer monitor or other video display.
  • Patients may read the VIS on their phone or other digital device by downloading the pdf file from CDC’s website.
  • Patients may be given a copy of a VIS during a prior visit, or told how to access it through the internet, so they can read it in advance. These patients must still be offered a copy to read during the immunization visit, as a reminder.

VIS associated medical record documentation:

 Specific information must be recorded in the patient’s medical record or in a permanent office log.  The most common practice observed is the recording of this information in the patient’s medical record.  Regardless of where the documentation resides, it must include:

  • The edition date of the VIS. This is found on the back of the VIS in the bottom right corner of the document.
  • The date the VIS is provided to the patient/legal guardian (e.g., the date of the visit when the vaccine is administered or date of the visit when the information was proactively provided).
  • The office address and name and title of the person who administers the vaccine.
  • The date the vaccine is administered.
  • The vaccine manufacturer and lot number.

Providers may add the name, address, and contact information of their practice to an existing VIS, but may not make any substantive changes to the document(s).

In order to address any potential existing disparities, providers can provide the document for persons to read, but additionally, can read it to them, provide a videotaped or recorded version, provide the document in various translated languages, give additional printed material, or help recipients understand the disease and vaccine in any other way that will meet the patients/legal guardians need.

Providing the most current VIS

Many organizations or care locations struggle with keeping current with the VIS documents.  The VIS documents are not updated on an annual basis, they are updated when new information or a new formulation of a vaccine is developed that may carry different risks or benefits.

Organizations are encouraged to establish a routine process to ensure that the VIS documents for all vaccines are reviewed at the beginning of each new year to ensure that the most up-to-date document is being used.  Several clients have established this task to occur the last week of December, to ensure they are ready with any new documents for the new year.

Finally, always offer the patient an opportunity to ask questions about the vaccine you are giving them or their loved one.

To learn more about Vaccine Information Statements  contact the C&A team at 704-573-4535 or email us at info@courtemanche-assocs.com.

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