HB 422

                SPONSOR:
                Rep. Hilovsky & Sen. Richardson
                Reps. Shupe, Vanderwende; Sens. Lawson, Pettyjohn, Wilson
        HOUSE OF REPRESENTATIVES
        153rd GENERAL ASSEMBLY
        HOUSE SUBSTITUTE NO. 2
        FOR
        HOUSE BILL NO. 422
        AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO ENHANCED INFORMED CONSENT FOR INFANT VACCINATIONS AND DOCUMENTATION IN SUDDEN UNEXPECTED INFANT DEATH INVESTIGATIONS.
        WHEREAS, the State of Delaware recognizes the profound grief experienced by families who lose a healthy infant following routine well-child vaccinations; and
        WHEREAS, nothing in this Act should be construed to discourage vaccination, but should be used to educate the parents/guardians, transparency, and documentation; and
        WHEREAS, current federal law requires provision of Vaccine Information Statements (VIS), but Delaware law does not mandate a signed acknowledgment of a discussion covering these specific topics or require documentation of vaccination history in every SUID investigation; and
        WHEREAS, requiring enhanced informed consent and improved SUID documentation will promote transparency, empower families, support accurate cause-of-death determinations, and strengthen public trust without restricting access to recommended vaccines.
        NOW, THEREFORE:
        BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
        Section 1. Amend Title 16 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:
        “ 
        Chapter 8E. Enhanced Informed Consent for Infant Vaccinations and Document Information.
        § 801E. This Chapter shall be known as the Josie Petrone Enhanced Informed Consent for Infant Vaccinations and Document Information Act.
        § 802E. Enhanced informed consent for vaccinations administered to infants under 12 months of age.
        (a) Before administering the vaccine(s), the vaccine injector shall verify with the parent/guardian of the child whether the health care provider explained the vaccine(s) to be administered at the office visit and answered all questions. If the parent or guardian confirms the explanation occurred and all questions were answered, the vaccine injection can proceed. If unanswered questions remain, they shall be answered in full before the vaccine is administered.
        (b) The Department of Health and Social Services shall approve the form which shall include a typed line and check box, to be completed by the person administering the vaccine verifying the requirements of subsection (a) of this section have been verified. The check box shall be marked as checked only after compliance is confirmed and shall be located on the same page as the vaccine lot number verification field.
        (c) Failure to comply with this section shall not constitute a separate cause of action for damages but may be considered by the Board of Medical Licensure and Discipline or other licensing boards in any disciplinary proceeding.
        § 803E. Documentation of vaccination history in SUID investigations.
        In every investigation of sudden unexpected infant death (SUID), including those initially classified as SUID, if the death occurred within 7 days after the administration of any vaccine, the medical examiner or investigating authority shall, as part of the comprehensive investigation, document consideration was given to any temporal association between death and recent vaccination. Such evaluation shall be conducted consistent with the Centers for Disease Control and Prevention's Sudden unexplained Infant Death Investigation guidelines and may include indicated ancillary testing to assess possible contributing factors. Nothing in this section shall be construed to create a presumption that vaccination caused or contributed to the death. This documentation shall be included in the autopsy report and forwarded to the Child Death Review Commission.
         ”
        SYNOPSIS
        This Act requires enhanced informed consent before administering vaccines to infants under 12 months of age.
        This Chapter shall be used to promote transparency in informed consent and thorough investigation of Sudden Unexpected  Infant Deaths.  Nothing in this chapter shall:
        (1) Create or imply any causal relationship between vaccination and sudden unexpected infant death,
        (2)  Restrict discourage, or interfere with the administration or recommendation of vaccinations,
        (3) Alter the standard of care of the diagnosis of SUID, or
        (4) Create any new private right of action or expand existing liability for healthcare providers or medical
        examiners.
        Before a vaccine is given, the vaccine administrator must confirm with the parent or guardian that the healthcare provider fully explained the vaccine(s) and answered all questions.  If questions remain, the questions must be answered before the vaccine is administered. The form used to verify the lot number of the vaccine must be altered to include a check  box verifying discussion was completed and all questions answered.  The Act also required documentation history of every SUID investigation and when death occurs within seven days of the vaccination, documentation consideration was given of any potential association consistent with CDC Guidelines, without creating any presumption of causation.  These measures respond to the family's request for greater transparency following the loss of healthy infants while preserving access  to recommended immunizations, and affirming nothing in  this act implies a casual link between vaccination and SUID.