HF 2005

as introduced - 90th Legislature (2017 - 2018) Posted on 03/14/2018 01:52pm

A bill for an act
relating to health; requiring health care providers administering vaccines to disclose
certain information to patients; requiring reports of adverse reactions to vaccines;
specifying content of an informed consent form; proposing coding for new law in
Minnesota Statutes, chapter 144.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [144.3353] ADMINISTRATION OF VACCINES.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) The definitions in this subdivision apply to this section.
new text end

new text begin (b) "Health care provider" or "provider" means a Minnesota-licensed physician, physician
assistant, nurse, pharmacist, dentist, or other provider authorized by law to administer
vaccines.
new text end

new text begin (c) "Minnesota vaccine adverse reaction database" or "MVARD" means a
Minnesota-specific database that is maintained by the Vaccine Safety Council of Minnesota
and that contains reports of adverse reactions that occur after the administration of a vaccine.
new text end

new text begin (d) "Vaccine adverse event reporting system" or "VAERS" means the national vaccine
event surveillance program administered by the Centers for Disease Control and Prevention
and the Food and Drug Administration.
new text end

new text begin (e) "Vaccine information" means information provided by the vaccine manufacturer
regarding a specific vaccine, including the package insert and the vaccine information
statement created by the Centers for Disease Control and Prevention.
new text end

new text begin Subd. 2. new text end

new text begin Required disclosures; consent. new text end

new text begin (a) Before administering a vaccine to a patient,
a health care provider must provide the following information to the patient, or to the patient's
parent or guardian if the patient is a minor:
new text end

new text begin (1) that the patient, or the patient's parent or guardian if the patient is a minor, may
decline some or all vaccines according to section 121A.15, subdivision 3, or 135A.14,
subdivision 3;
new text end

new text begin (2) that the health care provider administering the vaccine is not liable for harm to the
patient caused by the vaccine or its administration;
new text end

new text begin (3) that the vaccine manufacturer is not liable for harm to the patient or the death of the
patient caused by the vaccine, even if the harm or death was caused by the manufacturer's
negligence in the design of the vaccine;
new text end

new text begin (4) if a health care provider is administering more than one vaccine in a single visit, that
no safety studies have been performed, before or after approval of the vaccine, on the
combination of vaccines the provider plans to administer;
new text end

new text begin (5) vaccine information, for each vaccine being administered; and
new text end

new text begin (6) if a health care provider plans to administer a vaccine containing mercury, that an
alternative vaccine is available that is mercury-free.
new text end

new text begin (b) After providing the disclosures required in paragraph (a) and before administering
a vaccine to a patient, a health care provider must obtain written, informed consent for each
vaccine from the patient or the patient's parent or guardian if the patient is a minor. Informed
consent must be obtained using a form that is substantially similar to the Minnesota vaccine
consent form in subdivision 5.
new text end

new text begin Subd. 3. new text end

new text begin Required reporting of adverse reactions following vaccination. new text end

new text begin Any health
care provider who witnesses an adverse reaction to a vaccine or is made aware that a patient
had or may have had an adverse reaction to a vaccine must immediately report complete
information regarding that adverse reaction to VAERS and to MVARD. Within five days
of reporting the adverse reaction to VAERS and MVARD, the provider must provide to the
commissioner of health a copy of the reports submitted to VAERS and MVARD.
new text end

new text begin Subd. 4. new text end

new text begin Health care provider protections. new text end

new text begin A health care provider shall not be subject
to retaliation from an employer or subject to disciplinary action from an employer, the
commissioner of health, or the provider's professional licensing board for:
new text end

new text begin (1) providing a patient, or the patient's parent or guardian if the patient is a minor, with
the provider's professional opinion on the documented or possible side effects of a vaccine;
new text end

new text begin (2) reporting an adverse reaction to VAERS, MVARD, or the commissioner of health;
or
new text end

new text begin (3) signing a statement that a vaccine is contraindicated for a patient for medical reasons.
new text end

new text begin Subd. 5. new text end

new text begin Required form for informed consent. new text end

new text begin Informed consent from a patient, or a
patient's parent or guardian if the patient is a minor, for each vaccine to be administered
must be obtained on a form substantially similar to the form in this subdivision.
new text end

new text begin "Minnesota Vaccine Consent Form
new text end

new text begin (one must be filled out for each vaccine administered)
new text end

new text begin *The patient or guardian must read and initial each item and sign and date the form BEFORE
any vaccines are administered. The provider must also sign and date below BEFORE any
vaccines are administered.
new text end

new text begin Date: . new text end
new text begin Name of Patient: . new text end
new text begin Address: . new text end
new text begin Phone Number: . new text end
new text begin Social Security Number: . new text end
new text begin Parent or Guardian's Name: . new text end
new text begin Provider Name and License Number: . new text end
new text begin Facility Where Vaccine Will be Administered: . new text end
new text begin Address and Telephone Number of Facility: . new text end
new text begin Name of Vaccine to be Administered: . new text end
new text begin Manufacturer and Lot Number of Vaccine to be Administered: . new text end
new text begin . 1. new text end	new text begin I, ......................... (patient or parent/guardian) have been informed by my provider that I am within my legal rights to decline any and all vaccines, and that Minnesota law simply requires that I submit a vaccination record to my school district. (A vaccination record is either a notarized statement of exemption from one or more vaccines, or a list of which vaccines were administered and when.) new text end
new text begin . 2. new text end	new text begin My vaccine provider has given me a copy of the manufacturer's package insert for the vaccine as well as the CDC Vaccine Information Sheet and allowed me to read them and ask any questions. new text end
new text begin . 3. new text end	new text begin If planning to give me or my child more than one vaccine at this visit, my provider has informed me that there have been no safety studies performed on the combination of vaccines he/she plans to administer. new text end
new text begin . 4. new text end	new text begin I understand that by receiving this vaccine, I may endanger the health or life of myself or my child, and others I/they come in contact with. new text end
new text begin . 5. new text end	new text begin I understand that if I or my child is harmed or killed by this vaccine, I cannot sue the provider listed on this form, nor can I sue the vaccine manufacturer. new text end
new text begin . 6. new text end	new text begin I understand that there is no guarantee that by receiving this vaccine, I (or my child) will be protected from the disease that it was designed to prevent. new text end
new text begin Signature of Patient . new text end		new text begin Date: . new text end
new text begin Signature of Parent/Guardian (if patient is a minor) . new text end		new text begin Date: . new text end
new text begin Signature of Provider . new text end		new text begin Date: . " new text end