The Centers for Disease Control and Prevention (CDC) acknowledges that school administrators, staff, teachers, and parents are concerned about the effects of influenza (flu), particularly on children. Educators and staff can help to reduce the spread of respiratory illnesses such as colds, enterovirus D68, and influenza (flu). According to research studies, influenza is the leading cause of hospitalization in young children, outnumbering any other vaccine-preventable diseases. The single most effective method to protect against seasonal flu and its potentially serious complications is for children to receive a seasonal influenza vaccine each year. The federal government is making significant contributions in preventing the spread of the virus and has developed a school-located influenza vaccination program to ensure adequate influenza vaccination coverage among children. Nevertheless, parents are concerned about their children being vaccinated at school. This article will discuss how the government enforces the SLV program and how parents are made aware of this method.
School Located Vaccination (SLV): Planning Considerations
i) Informing and Enlisting the Support of Healthcare Providers
In the United States, children are immunized precisely in their family doctor’s or pediatrician’s office. Some parents and guardians may be reluctant to give consent for flu vaccination at school because the concept of vaccinating children at school is unfamiliar to them. Guardians and parents are encouraged to seek the advice of medical professionals, including their child’s healthcare provider. State organizations can strengthen the concept of school-based vaccinations by enlisting the support of local medical providers, particularly pediatricians, family practitioners, gynecologists, or obstetricians (who often serve as primary care providers for adolescent girls) and community health clinics. Partnerships with institutions such as the American Academy of Family Physicians and the American Association of Pediatricians may also contribute to the SLV program’s success and assist organizations in getting support from local providers.
Hopefully, most suppliers will be supporting the SLV clinics program. But, some may be concerned about immunizations occurring outside of their clinics, particularly about maintaining patients’ data and having adequate information in case a patient seeks immediate care for potential vaccine-related adverse effects. The need for SLV programs stems from the fact that most doctors are preoccupied with treating sick patients, so separate designated providers must be available to administer influenza vaccinations to children. Keeping doctors informed about planned SLV clinics will also help them evaluate the amount of influenza dosage (vaccine) required for their patients.
ii) Creating Forms and Letters for Parents or Guardians
The following are ideas for developing materials that should be given — via mail, email, or child— to inform parents and guardians of the planned SLV clinic and request their permission to vaccinate their child. Each material listed below should be translated and available in different languages, as regionally appropriate.
Letter to Guardians and Parents:
All documents must include letters informing parents and guardians that influenza SLV clinics will be organized at their child’s school. Typically, this note is sent as a cover letter along with other materials such as the vaccine information, consent form, and the dates and times of the SLV clinics. A similar letter could be sent in advance of the scheduled SLV date, possibly even before the vaccine is available in the area.
The letter to guardians and parents must include:
- An explanation about why seasonal immunization is recommended for their children,
- An official statement that the influenza vaccine will be available at the school and the clinic,
- A request for parent’s permission, and
- Contact information in case guardians and parents have concerns or questions.
iii) Parental Consent Forms
The requirement to obtain parental consent before administering vaccines and the precise formats and elements that must be included on a basic consent form—typically are not regulated by federal government laws and policies. Instead, each state or jurisdiction establishes informed consent requirements, including the circumstances under which children and adolescents can consent to their medical treatment.
If planning on seeking advanced consent, planners should consult with state and local legal counsel before implementing it. Planners should also consider whether state and local laws require separate approvals for delivering each dose of the two-dose vaccinations.
Different templates are available on health government portals that SLV program planners can use as starting points for developing consent forms that comply with applicable state laws and requirements. Planners can modify these templates to meet state and local requirements. As influenza SLV programs do not provide students with second doses of influenza vaccine, these consent forms were created for programs that only offer one dose of influenza vaccine to students. If a second dose of the influenza vaccine is provided, additional information about previous influenza vaccinations might be collected.
While consent to get vaccinated is typically not governed by federal law, state law may govern the vaccinator’s use or disclosure of individually identifying information about the child.
The following are notes about each section of the template consent forms:
Section 1
Information about the child who will get the vaccine: This section includes suggestions for gathering personal and demographic information.
Section 2
Screening or evaluation for vaccine eligibility: This section contains typical vaccination eligibility questions for the intravenous or both intravenous and intranasal formulations of the vaccine.
Section 3
Consent: This section contains a statement and a signature line for guardians or parents to give permission or decline vaccination on behalf of the children. Additionally, planners can provide an option for guardians and parents to select the type of vaccine (e.g., injectable, intranasal, or no preference) they prefer to be given to their child, with a statement that the selection will be honored based on the child’s eligibility and vaccine availability. It’s worth noting that state laws differ regarding whether a single parental signature is sufficient for both doses.
Section 4
Vaccination record: This part outlines suggestions for gathering information about the vaccine and ways to administer it.
SLV program planners may also consider including a section for consent or authorization to disclose specific vaccination, personal, medical, and demographic information. Student information and details in the vaccine consent form will be protected by federal or state privacy laws and regulations. Requesting such consent will be recommended or required depending on regional needs and laws such as the HIPPA (Health Insurance Portability and Accountability Act) or the FERPA (Family Educational Rights and Privacy Act).
The following are some examples of authorizations that SLV program planners might seek, including a declaration with a request for a guardian or parental confirmation on the consent form:
- The disclosure of information to public health organizations (e.g., for inclusion in an immunization registry to complete influenza reporting requirements)
- The disclosure of information to a child’s healthcare provider (for example, for entry into the child’s healthcare record)
The entity in charge of the vaccination program is authorized to use and disclose a child’s health information as per state laws and requirements. For example, the entity should understand whether it must adhere to the HIPAA Privacy Rule, which applies to specific medical providers, health plans, and medical care clearinghouses. Or they are subject to FERPA, which only applies to educational institutions or agencies that receives funding from the Department of Education or other government or state laws.
Entities directed to follow the “HIPAA Privacy Rule” can use or disclose a child’s health information with the parent’s signed authorization.
iv) Timing and Procedures for Obtaining Consent
State and local officials may consider sending consent forms to parents in advance of the influenza vaccine availability. The advantages of such a method, if determined to be legally approved in the state that will offer influenza SLV clinics, are that vaccine may be given to consented children as soon as the vaccinator receives it. Also, it will help the planner to effectively manage the adequate staff, vaccine, and other resources.
To provide guardians and parents with information to make an informed consent decision, they should be given Influenza VIS (Vaccine Information Statements), which outlines the potential risks and benefits of influenza vaccines. Also, parents must be provided with an appropriate consent form to document their child’s vaccination approval.
Suppose parental consent is obtained significantly ahead of the time the vaccine is delivered to the child. In that case, a procedure must be provided for the guardian and parent to withdraw consent before vaccination, if desired. A procedure should also be provided for a guardian and parent who initially declines to grant a license for their child’s immunization but later changes that decision and gives permission to do so. Additionally, suppose LAIV is expected to be offered, in that case, plans should be in place to ensure that the child will not receive another live vaccine (e.g., mumps, measles or varicella, rubella [MMR] vaccines) within five weeks of the SLV infirmary.
Planners should consult with state and local legal counsel before implementing this method. Planners should also consider whether state or local administration requires separate consents for each dose of a two-dose vaccine series. Please review the information about using the consent form template before designing your customized forms.
Vaccine Information Statements
Vaccine Information Statements (or VISs) are information sheets created by the CDC that explain the benefits and risks of influenza vaccines to recipients, their parents, or legal representatives. They also contain information about eligibility and indications for each immunization. An appropriate VIS should be included among materials provided to guardians and parents before and after vaccine administration.
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