Senate File 477 - Introduced SENATE FILE 477 BY GUTH (COMPANION TO HF 632 BY SHIPLEY) A BILL FOR An Act relating to information to be provided, recorded, 1 and reported by health care providers relative to certain 2 vaccinations, and providing penalties. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 2545XS (2) 89 pf/rh

S.F. 477 Section 1. NEW SECTION . 135.39E Vaccinations —— health care 1 provider requirements —— penalties. 2 1. For the purposes of this section: 3 a. “Health care provider” means any licensed health care 4 professional, organization, or institution, whether public 5 or private, including federal, state, and local departments, 6 agencies, and instrumentalities, under whose authority a 7 licensed or emergency use vaccine is administered. 8 b. “Health profession board” means a profession board 9 designated pursuant to section 147.13. 10 c. “Vaccine injury table” means the vaccine injury table 11 created and revised pursuant to 42 U.S.C. §300aa-14. 12 2. The department shall collaborate with each health 13 profession board to ensure that a health care provider under 14 the purview of the department or a health profession board 15 is aware of and complies with the requirements of 42 U.S.C. 16 §300aa-25 and 42 U.S.C. §300aa-26, including all of the 17 following: 18 a. That, prior to the patient receiving the vaccine, the 19 health care provider provides an adult patient, or the parent 20 or legal representative of a minor patient, with a copy of 21 the relevant federal vaccine information statement for the 22 vaccine the patient is to receive and verbally informs the 23 adult patient, or the parent or legal representative of a 24 minor patient, of the existence of the federal food and drug 25 administration vaccine adverse event reporting system and the 26 national vaccine injury compensation program referenced in the 27 statement, if the vaccine is included in the vaccine injury 28 table. 29 b. That the health care provider records certain required 30 information about the vaccine administered in the patient’s 31 medical record or a permanent office log or file. 32 c. That the health care provider documents any adverse 33 event following the vaccination that the patient experiences 34 within eight weeks post-administration and that becomes known 35 -1- LSB 2545XS (2) 89 pf/rh 1/ 3

S.F. 477 to the health care provider, submits the report to the federal 1 food and drug administration vaccine adverse event reporting 2 system, and provides the adult patient, or the parent or legal 3 representative of a minor patient, with a copy of the report. 4 3. The health profession board for a health care provider 5 may deny an applicant a license or suspend, revoke, or refuse 6 to renew a license, and may take other disciplinary action 7 against a licensee based on the applicant or licensee having 8 three or more verified failures to comply with the applicable 9 health care provider requirements pursuant to 42 U.S.C. 10 §300aa-25 and 42 U.S.C. §300aa-26. 11 4. A health care provider who violates a provision of 12 42 U.S.C. §300aa-25 or 42 U.S.C. §300aa-26, in addition to 13 licensee disciplinary action pursuant to subsection 3, shall 14 be subject to a fine, per violation, of a minimum amount of one 15 thousand dollars, established by rule of the department or the 16 respective health profession board, as applicable. 17 EXPLANATION 18 The inclusion of this explanation does not constitute agreement with 19 the explanation’s substance by the members of the general assembly. 20 This bill relates to the requirements established under 21 federal law for health care providers administering certain 22 vaccines. The bill provides definitions used in the bill 23 including “health care provider” which is the definition used 24 under federal law (42 U.S.C. §300aa-33(1)); “health profession 25 board”; and “vaccine injury table”. 26 The bill requires the department of public health (DPH) to 27 collaborate with each health profession board to ensure that 28 a health care provider under the purview of the department or 29 a health profession board is aware of and complies with the 30 requirements applicable to health care providers who administer 31 vaccines, including providing the relevant federal vaccine 32 information statement for the vaccine the patient is to receive 33 and verbal information regarding the federal food and drug 34 administration vaccine adverse event reporting system (FAERS) 35 -2- LSB 2545XS (2) 89 pf/rh 2/ 3

S.F. 477 and the national vaccine injury compensation program, for 1 those vaccines included in the vaccine injury table, prior to 2 the patient receiving the vaccine; recording certain required 3 information about the vaccine administered in the patient’s 4 medical record or a permanent office log or file; documenting 5 and reporting any adverse event following the vaccination that 6 the patient experiences within eight weeks post-administration 7 and that becomes known to the health care provider to the 8 FAERS; and providing to an adult patient, or the parent or 9 legal representative of a minor patient, a copy of the report. 10 The bill provides for disciplinary action by DPH or the 11 respective health profession board and for fines in a minimum 12 amount of $1,000, established by DPH or the respective board, 13 for noncompliance with the federal requirements. 14 -3- LSB 2545XS (2) 89 pf/rh 3/ 3