Liability and Risk Management

​Influenza Implementation Guidance


Updated September 2019

​Liabilit​y and Risk Management

Influenza vaccines are covered by the Vaccine Injury Compensation Program (VICP). Pediatricians and their clinic staff should follow good risk communication and documentation steps for influenza vaccination, which includes providing parents with the appropriate Vaccine Information Statement (VIS) before a vaccine is administered. The most recent versions of the VIS for both the inactivated influenza vaccine and the live attenuated influenza vaccine are interim and are dated August 15, 2019. The VICP requires vaccine administrators to use the latest editions. Registering to receive VIS update notifications via email from the CDC the day the new editions are posted is a good strategy to keep current.

An easy way to think about distribution of VIS in your practice is to follow the 5 D's.

  • Double check to make sure the correct VIS is being used. The current VIS for inactivated influenza vaccine and the current VIS for live attenuated influenza vaccine are both available online.

  • Distribute the VIS before each vaccine dose is given. It is the law. There are many acceptable ways to provide patients and parents with VISs. These are detailed on the CDC Web site.

  • Discuss the risks and benefits of the vaccine as well as the risks of not being immunized. VISs are intended to supplement, not replace, discussions about risks.

  • Document in each patient's permanent medical record:

    • that the VIS was provided at the time of vaccination;

    • the edition date of each VIS (note: 2D barcodes have been added);

    • the office address, name, and title of the individual administering the vaccine;

    • the date of vaccine administration; and

    • the vaccine manufacturer and lot number of the vaccine administered. 

  • Dialogue with those who have questions or express hesitancy about vaccination. When parents refuse immunization, it is important to try to understand their reasoning and respond nonjudgmentally with facts about the safety and effectiveness of vaccines. If they still decline the recommended vaccine, it is prudent to have parents sign an informed refusal document. Here is the link to the AAP refusal form.

Vaccinating Parents, Grandparents, and Other Adults

Some pediatricians find it helpful to offer flu shots to parents or other adults that accompany patients to the pediatric office. Many parents appreciate the convenience. While applicable vaccine injuries are covered by the VICP, it is important to consider other malpractice risks and follow important risk management strategies.

Contact your medical liability insurance company. Some insurer policies do not cover pediatricians for treating adults. Verify coverage before you decide to offer this service.

Physicians administering vaccines to adults may be exposed to other malpractice risks beyond vaccine liability. Because pediatricians do not care for adults ordinarily, they may not be able to assess contraindications. Their offices may not be equipped to deal with adverse reactions. Be sure to screen adults for contraindications and document that screening.

When a physician, or nurse or medical assistant under the supervision of a physician, administers a vaccination to an adult, a court may determine that providing such services created a physician-patient relationship. This relationship creates malpractice exposure for the physician for failure to diagnose or treat other illnesses as well as injuries or problems unrelated to the administration of the vaccine.

As with any other patient, medical records for the vaccinated adult must be created and retained in the pediatric office. Since the VICP liability protections for vaccine-related injuries apply to immunized adults, so do the requirements for record-keeping and distributing VIS. This includes documenting risk communication and informed consent, as well as the following: the vaccine manufacturer, lot number and date of administration, the name and business address of the provider administering the vaccine, the VIS version date and date it was provided. As a best practice, also consider documenting the vaccination site and route of administration, which may be helpful in the case of a local reaction, and expiration date of the vaccine.

Tools and Resources

CDC

Immunization Action Coalition


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