SF 2269 (LSB 5897SV (3) 89)

SENATE FILE 2269

BY  COMMITTEE ON LOCAL GOVERNMENT

(SUCCESSOR TO SF 2156)

A BILL FOR

An Act relating to information to be provided, recorded, and reported by health care providers relative to certain vaccinations, and providing penalties.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  135.39F  Vaccinations —— health care provider requirements —— penalties.
   1.  For the purposes of this section:
   a.  “Health care provider” means any licensed health care professional, organization, or institution, whether public or private, including federal, state, and local departments, agencies, and instrumentalities, under whose authority a licensed or emergency use vaccine is administered.
   b.  “Health profession board” means a profession board designated pursuant to section 147.13.
   c.  “Reportable events table” means the VAERS table of reportable events following vaccination specifying the events reportable to the VAERS pursuant to 42 U.S.C. §300aa-25.
   d.  “Vaccine adverse event reporting system” or “VAERS” means the national vaccine safety surveillance program overseen by the United States food and drug administration and the centers for disease control and prevention of the United States department of health and human services that collects and analyzes reports of adverse events following administration of vaccinations.
   e.  “Vaccine injury table” means the vaccine injury table created and revised pursuant to 42 U.S.C. §300aa-14.
   2.  The department shall collaborate with each health profession board to ensure that a health care provider under the purview of the department or a health profession board is aware of and complies with the requirements of 42 U.S.C. §300aa-25 and 42 U.S.C. §300aa-26, including all of the following:
   a.  That, prior to the patient receiving the vaccine, the health care provider provides an adult patient, or the parent or legal representative of a minor patient, with a copy of the relevant federal vaccine information statement for the vaccine the patient is to receive and verbally informs the adult patient, or the parent or legal representative of a minor patient, of the existence of the vaccine adverse event reporting system and the national vaccine injury compensation program referenced in the statement, if the vaccine is included in the vaccine injury table.
   b.  That the health care provider records certain required information about the vaccine administered in the patient’s medical record or a permanent office log or file.
   3.  The department shall collaborate with each health profession board to ensure that a health care provider under the purview of the department or a health profession board reports to the vaccine adverse event reporting system following a vaccination, any adverse event listed in the reportable events table that occurs within the specified interval following a vaccination and any adverse event listed by the manufacturer as a contraindication to further doses of the vaccine. A health care provider shall be strongly encouraged to report to the vaccine adverse event reporting system any clinically significant or unexpected event that occurs after the administration of any vaccine licensed in the United States whether or not the vaccine is listed in the reportable events table and even if the health care provider is not certain the vaccine caused the event, to report any vaccine administration errors, and to provide to an adult patient, or the parent or legal representative of a minor patient, a vaccine adverse event reporting system identification number within seventy-two hours of reporting the adverse event.
   4.  The health profession board for a health care provider may deny an applicant a license or suspend, revoke, or refuse to renew a license, and may take other disciplinary action against a licensee based on the applicant or licensee having three or more verified failures to comply with the applicable health care provider requirements pursuant to 42 U.S.C. §300aa-25 and 42 U.S.C. §300aa-26, or based on the applicant or licensee violating subsection 3.
   5.  A health care provider who violates a provision of 42 U.S.C. §300aa-25, 42 U.S.C. §300aa-26, or subsection 3, in addition to licensee disciplinary action pursuant to subsection 4, shall be subject to a fine, per violation, of a minimum amount of one thousand dollars, established by rule of the department or the respective health profession board, as applicable.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill relates to the requirements established under federal law for health care providers administering certain vaccines. The bill provides definitions used in the bill. 
   The bill requires the department of public health (DPH) to collaborate with each health profession board to ensure that a health care provider under the purview of DPH or a health profession board is aware of and complies with the requirements applicable to health care providers who administer vaccines, including providing to the adult patient, or to the parent or legal representative of a minor patient, a copy of the relevant federal vaccine information statement for the vaccine the patient is to receive and verbal information regarding the existence of the vaccine adverse event reporting system (VAERS) and the national vaccine injury compensation program, for those vaccines included in the vaccine injury table, prior to the patient receiving the vaccine; and recording certain required information about the vaccine administered in the patient’s medical record or a permanent office log or file. 
   The bill also requires DPH to collaborate with each health profession board to ensure that a health care provider reports to the VAERS following a vaccination, any adverse event listed in the reportable events table that occurs within the specified interval following a vaccination and any adverse event listed by the manufacturer as a contraindication to further doses of the vaccine. Additionally, a health care provider shall be strongly encouraged to report to the VAERS any clinically significant or unexpected event that occurs after the administration of any vaccine licensed in the United States whether or not the vaccine is listed in the reportable events table and even if the health care provider is not certain the vaccine caused the event, to report any vaccine administration errors, and to provide to an adult patient, or to the parent or legal representative of a minor patient, a vaccine adverse event reporting system identification number within 72 hours of reporting the adverse event.
   The bill provides for disciplinary action by DPH or the respective health profession board and for fines in a minimum amount of $1,000, established by DPH or the respective board, for noncompliance with the federal requirements or the bill.