H.F. 2449 Section 1. NEW SECTION . 135.39E Vaccinations —— health care 1 provider requirements —— penalties. 2 1. For the purposes of this section: 3 a. “Adverse event” means any unfavorable or unintended 4 medical occurrence, including any sign, laboratory finding, 5 symptom, or disease that a child experiences within eight weeks 6 following the administration of a vaccine. 7 b. “Health care provider” means any licensed health care 8 professional, organization, or institution, whether public 9 or private, including federal, state, and local departments, 10 agencies, and instrumentalities, under whose authority a 11 vaccine set forth in the vaccine injury table is administered. 12 c. “Health profession board” means a profession board 13 designated pursuant to section 147.13. 14 d. “Vaccine injury table” means the vaccine injury table 15 created and revised pursuant to 42 U.S.C. §300aa-14. 16 2. The department shall collaborate with each health 17 profession board to ensure that a health care provider under 18 the purview of the department or a health profession board 19 is aware of and complies with the requirements of 42 U.S.C. 20 §300aa-25 and 42 U.S.C. §300aa-26, and state law including all 21 of the following: 22 a. That the health care provider provides an adult patient, 23 or the parent or legal representative of a minor patient, with 24 a copy of the relevant federal vaccine information statement 25 for the vaccine the patient is to receive and verbally informs 26 the adult patient, or the parent or legal representative of a 27 minor patient, of the existence of the vaccine adverse events 28 reporting system and the vaccine injury compensation program 29 referenced in the statement, prior to the patient receiving the 30 vaccine. 31 b. That the health care provider records certain required 32 information about the vaccine administered in the patient’s 33 medical record or a permanent office log or file. 34 c. That the health care provider documents any adverse 35 -1- LSB 5850YH (5) 88 pf/rh 1/ 3

H.F. 2449 event that the patient experiences within eight weeks following 1 administration of the vaccine and that becomes known to the 2 health care provider, submits the report to the federal vaccine 3 adverse events reporting system, and provides the adult patient 4 or the parent or legal representative of a minor patient with a 5 copy of the report. 6 d. That the health care provider provides information to 7 the adult patient or to the parent or legal representative of 8 a minor patient regarding the process to report a health care 9 provider who fails to comply with the requirements of this 10 section for licensee discipline. 11 3. The health profession board for a health care provider 12 may deny an applicant a license or suspend, revoke, or refuse 13 to renew a license, and may take other disciplinary action 14 against a licensee based on the applicant or licensee having 15 three or more verified failures to comply in one calendar year 16 with the applicable health care provider requirements pursuant 17 to 42 U.S.C. §300aa-25 and 42 U.S.C. §300aa-26. 18 4. In addition to licensee disciplinary action pursuant to 19 subsection 3, a health care provider who violates a provision 20 of 42 U.S.C. §300aa-25 or 42 U.S.C. §300aa-26, shall be subject 21 to a civil penalty in the amount of one thousand dollars, 22 at a minimum, per violation, as established by rule of the 23 department or the respective health profession board, as 24 applicable. 25 EXPLANATION 26 The inclusion of this explanation does not constitute agreement with 27 the explanation’s substance by the members of the general assembly. 28 This bill relates to the requirements established under 29 state and federal law for health care providers administering 30 certain vaccines. The bill provides definitions used in the 31 bill including “adverse event”, “health care provider” which is 32 the definition used under federal law (42 U.S.C. §300aa-33(1)), 33 “health profession board”, and “vaccine injury table”. 34 The bill requires the department of public health (DPH) to 35 -2- LSB 5850YH (5) 88 pf/rh 2/ 3

H.F. 2449 collaborate with each health profession board to ensure that a 1 health care provider under the purview of the department or a 2 health profession board is aware of and complies with the state 3 and federal requirements applicable to health care providers 4 who administer vaccines on the federal vaccine injury table 5 under the federal National Childhood Vaccine Injury Act of 1986 6 (42 U.S.C. §§300aa-1 to 300aa-34), including provision of the 7 relevant federal vaccine information statement for the vaccine 8 the patient is to receive and verbal information regarding 9 the vaccine adverse events reporting system and the vaccine 10 injury compensation program, prior to the patient receiving the 11 vaccine; the recording of certain required information about 12 the vaccine administered in the patient’s medical record or a 13 permanent office log or file; the documenting and reporting of 14 any adverse event following the vaccination that the patient 15 experiences within eight weeks of administration of the vaccine 16 and that becomes known to the health care provider to the 17 federal vaccine adverse events reporting system; the provision 18 of a copy of the adverse event report to the adult patient or 19 parent or legal representative of a minor patient; and the 20 provision of information by a health care provider to an adult 21 patient or to the parent or legal representative of a minor 22 patient regarding the process to report a health care provider 23 who fails to comply with the requirements of the bill for 24 licensee discipline. 25 The bill provides for disciplinary action by DPH or the 26 respective health profession board and a minimum civil 27 penalty of $1,000 for each violation of the federal health 28 care provider requirements relative to the administration of 29 vaccines specified under the bill. 30 -3- LSB 5850YH (5) 88 pf/rh 3/ 3