Senate File 2269 - Introduced SENATE FILE 2269 BY COMMITTEE ON LOCAL GOVERNMENT (SUCCESSOR TO SF 2156) 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 5897SV (3) 89 pf/rh
S.F. 2269 Section 1. NEW SECTION . 135.39F 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. “Reportable events table” means the VAERS table of 11 reportable events following vaccination specifying the events 12 reportable to the VAERS pursuant to 42 U.S.C. §300aa-25. 13 d. “Vaccine adverse event reporting system” or “VAERS” means 14 the national vaccine safety surveillance program overseen 15 by the United States food and drug administration and the 16 centers for disease control and prevention of the United States 17 department of health and human services that collects and 18 analyzes reports of adverse events following administration of 19 vaccinations. 20 e. “Vaccine injury table” means the vaccine injury table 21 created and revised pursuant to 42 U.S.C. §300aa-14. 22 2. The department shall collaborate with each health 23 profession board to ensure that a health care provider under 24 the purview of the department or a health profession board 25 is aware of and complies with the requirements of 42 U.S.C. 26 §300aa-25 and 42 U.S.C. §300aa-26, including all of the 27 following: 28 a. That, prior to the patient receiving the vaccine, the 29 health care provider provides an adult patient, or the parent 30 or legal representative of a minor patient, with a copy of 31 the relevant federal vaccine information statement for the 32 vaccine the patient is to receive and verbally informs the 33 adult patient, or the parent or legal representative of a 34 minor patient, of the existence of the vaccine adverse event 35 -1- LSB 5897SV (3) 89 pf/rh 1/ 4
S.F. 2269 reporting system and the national vaccine injury compensation 1 program referenced in the statement, if the vaccine is included 2 in the vaccine injury table. 3 b. That the health care provider records certain required 4 information about the vaccine administered in the patient’s 5 medical record or a permanent office log or file. 6 3. The department shall collaborate with each health 7 profession board to ensure that a health care provider under 8 the purview of the department or a health profession board 9 reports to the vaccine adverse event reporting system following 10 a vaccination, any adverse event listed in the reportable 11 events table that occurs within the specified interval 12 following a vaccination and any adverse event listed by the 13 manufacturer as a contraindication to further doses of the 14 vaccine. A health care provider shall be strongly encouraged 15 to report to the vaccine adverse event reporting system any 16 clinically significant or unexpected event that occurs after 17 the administration of any vaccine licensed in the United States 18 whether or not the vaccine is listed in the reportable events 19 table and even if the health care provider is not certain the 20 vaccine caused the event, to report any vaccine administration 21 errors, and to provide to an adult patient, or the parent or 22 legal representative of a minor patient, a vaccine adverse 23 event reporting system identification number within seventy-two 24 hours of reporting the adverse event. 25 4. The health profession board for a health care provider 26 may deny an applicant a license or suspend, revoke, or refuse 27 to renew a license, and may take other disciplinary action 28 against a licensee based on the applicant or licensee having 29 three or more verified failures to comply with the applicable 30 health care provider requirements pursuant to 42 U.S.C. 31 §300aa-25 and 42 U.S.C. §300aa-26, or based on the applicant or 32 licensee violating subsection 3. 33 5. A health care provider who violates a provision of 42 34 U.S.C. §300aa-25, 42 U.S.C. §300aa-26, or subsection 3, in 35 -2- LSB 5897SV (3) 89 pf/rh 2/ 4
S.F. 2269 addition to licensee disciplinary action pursuant to subsection 1 4, shall be subject to a fine, per violation, of a minimum 2 amount of one thousand dollars, established by rule of the 3 department or the respective health profession board, as 4 applicable. 5 EXPLANATION 6 The inclusion of this explanation does not constitute agreement with 7 the explanation’s substance by the members of the general assembly. 8 This bill relates to the requirements established under 9 federal law for health care providers administering certain 10 vaccines. The bill provides definitions used in the bill. 11 The bill requires the department of public health (DPH) to 12 collaborate with each health profession board to ensure that 13 a health care provider under the purview of DPH or a health 14 profession board is aware of and complies with the requirements 15 applicable to health care providers who administer vaccines, 16 including providing to the adult patient, or to the parent 17 or legal representative of a minor patient, a copy of the 18 relevant federal vaccine information statement for the vaccine 19 the patient is to receive and verbal information regarding the 20 existence of the vaccine adverse event reporting system (VAERS) 21 and the national vaccine injury compensation program, for those 22 vaccines included in the vaccine injury table, prior to the 23 patient receiving the vaccine; and recording certain required 24 information about the vaccine administered in the patient’s 25 medical record or a permanent office log or file. 26 The bill also requires DPH to collaborate with each health 27 profession board to ensure that a health care provider reports 28 to the VAERS following a vaccination, any adverse event listed 29 in the reportable events table that occurs within the specified 30 interval following a vaccination and any adverse event listed 31 by the manufacturer as a contraindication to further doses 32 of the vaccine. Additionally, a health care provider shall 33 be strongly encouraged to report to the VAERS any clinically 34 significant or unexpected event that occurs after the 35 -3- LSB 5897SV (3) 89 pf/rh 3/ 4
S.F. 2269 administration of any vaccine licensed in the United States 1 whether or not the vaccine is listed in the reportable events 2 table and even if the health care provider is not certain the 3 vaccine caused the event, to report any vaccine administration 4 errors, and to provide to an adult patient, or to the parent 5 or legal representative of a minor patient, a vaccine adverse 6 event reporting system identification number within 72 hours 7 of reporting the adverse event. 8 The bill provides for disciplinary action by DPH or the 9 respective health profession board and for fines in a minimum 10 amount of $1,000, established by DPH or the respective board, 11 for noncompliance with the federal requirements or the bill. 12 -4- LSB 5897SV (3) 89 pf/rh 4/ 4