June 26, 2023
TNAAP appreciates your patience as we have continued to work through the implications of SB1111/HB1380 “The Mature Minor Doctrine Clarification Act” and how to remain in compliance. We know that this has been a rapid, difficult, and worrying change in the landscape of immunizations in our state and we have been working diligently to get you the most accurate and up-to-date information.
The information provided in this communication does not, and is not intended to, constitute legal advice; instead, this is for general information and discussion purposes only. Clinicians are advised to obtain an independent legal opinion on interpretation of this legislation.
While various interpretations of the law have been presented, TNAAP has been fairly reassured in our findings. The essence is that the bill removes the Mature Minor Doctrine as it applies to immunizations (for children not in DCS custody). An adolescent patient that you may have previously considered to be a Mature Minor who could consent to an immunization on their own can no longer do so. We must now treat all children and adolescents under 18 years of age the same when it comes to informed consent for immunizations. The informed consent of the parent or legal guardian is required.
The law is ambiguous as to the definition of informed consent and what type of consent must be obtained. Physicians, practices, and medical systems must consider their process for informed consent and documentation in the medical record. A key term in the law is informed consent, although the law does not clearly specify the content of what this must include. This typically includes discussing the nature of the treatment, risks, benefits, alternatives, etc.
A conservative approach could be obtaining written, informed consent for each vaccine administered at each visit. However, a process for verbal informed consent with adequate documentation in the medical record may suffice. Thus, when a patient presents with someone who is not their parent or legal guardian, under this scenario verbal informed consent may be obtained over the phone from the parent or legal guardian at the time of the visit. However, if the parent or guardian cannot be reached or informed consent cannot be obtained, then immunizations should not be administered at that visit. We realize that this point on informed consent and whether it should be written is confusing and that you may have seen differing recommendations on this. Some are strongly urging written, informed consent, while others have felt that well documented verbal informed consent is sufficient. Please consider what you, your practice, or health system are most comfortable with, how to operationalize these options, and consider legal counsel if desired for clarification.
We do recommend that this is carefully documented in your medical record each time immunizations are administered. If written consent is obtained, that should be put into the medical record. If verbal consent is obtained this should be well documented using a statement such as: Counseling was provided regarding immunizations administered at this visit. Risks and benefits were explained, and parent/guardian concerns were addressed. The CDC VIS handout was reviewed. Signs and symptoms of adverse reactions were discussed including when to seek medical attention for adverse effects; all questions were answered. Verbal informed consent obtained from parent/guardian who agreed to immunizations administered.
For children in DCS custody, the law does require written informed consent from a parent or guardian or a court order and is very clear that consent here must be written. Written informed consent can be obtained using Form 4246. If the parent or legal guardian is not available, a court order is required. In these cases, the courts cannot authorize consent for the HPV or COVID-19 vaccines- these require written, informed consent from the parent or guardian. Also, remember that the state requires written consent for the COVID-19 vaccine in all cases, even for children who are not in DCS custody.
The remainder of the Mature Minor Doctrine for the other aspects of care that it covers still stands. We realize that there may still be situations where it can be difficult or nearly impossible to get informed consent from a parent or legal guardian. DCS is in the process of obtaining court orders authorizing consent for vaccines for children in custody. TNAAP is still awaiting the promulgation of rules from the Tennessee Department of Health as to what the penalties for non-compliance may be and if some of the ambiguous aspects of the guidance can be further clarified through this process.
TNAAP will continue to work to obtain further guidance and push for an expedited rulemaking process to help our practices and our patients. Please know that we will continue to advocate for strong protections for immunizations in our state and will work to see if there are avenues for improving this new law.