Vaccine staff would confirm questions are answered before babies’ shots

Before giving a shot, vaccine staff would check with the parent or guardian that a provider explained the vaccine and answered all questions. This applies to vaccines given to babies under 12 months old. Any remaining questions must be answered fully before the shot. The state health department would approve a form with a check box. Staff would mark it only after confirming the discussion, and it must be on the same page as the vaccine lot number field. A violation alone would not create a separate right to sue for damages, but a licensing board could consider it in a disciplinary case. Staff must complete the check and have any remaining questions answered before giving the shot.

The medical examiner or other investigator would document that they considered the timing between a recent vaccine and an infant’s death. This covers investigations of sudden, unexpected infant deaths, including deaths first classified that way. The review must follow federal guidelines for investigating sudden infant deaths and may include further tests if indicated. The rule would not presume that a vaccine caused or contributed to the death. Investigators would include the documentation in the autopsy report and send it to the Child Death Review Commission. The documentation requirement applies when death occurs within seven days after any vaccine is given.