Senate File 477 - Introduced
SENATE FILE 477
BY GUTH
(COMPANION TO HF 632 BY
SHIPLEY)
A BILL FOR
1 An Act relating to information to be provided, recorded,
2 and reported by health care providers relative to certain
3 vaccinations, and providing penalties.
4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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1 Section 1. NEW SECTION. 135.39E Vaccinations —— health care
2 provider requirements —— penalties.
3 1. For the purposes of this section:
4 a. “Health care provider” means any licensed health care
5 professional, organization, or institution, whether public
6 or private, including federal, state, and local departments,
7 agencies, and instrumentalities, under whose authority a
8 licensed or emergency use vaccine is administered.
9 b. “Health profession board” means a profession board
10 designated pursuant to section 147.13.
11 c. “Vaccine injury table” means the vaccine injury table
12 created and revised pursuant to 42 U.S.C. §300aa-14.
13 2. The department shall collaborate with each health
14 profession board to ensure that a health care provider under
15 the purview of the department or a health profession board
16 is aware of and complies with the requirements of 42 U.S.C.
17 §300aa-25 and 42 U.S.C. §300aa-26, including all of the
18 following:
19 a. That, prior to the patient receiving the vaccine, the
20 health care provider provides an adult patient, or the parent
21 or legal representative of a minor patient, with a copy of
22 the relevant federal vaccine information statement for the
23 vaccine the patient is to receive and verbally informs the
24 adult patient, or the parent or legal representative of a
25 minor patient, of the existence of the federal food and drug
26 administration vaccine adverse event reporting system and the
27 national vaccine injury compensation program referenced in the
28 statement, if the vaccine is included in the vaccine injury
29 table.
30 b. That the health care provider records certain required
31 information about the vaccine administered in the patient’s
32 medical record or a permanent office log or file.
33 c. That the health care provider documents any adverse
34 event following the vaccination that the patient experiences
35 within eight weeks post-administration and that becomes known
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 S.F. 477
1 to the health care provider, submits the report to the federal
2 food and drug administration vaccine adverse event reporting
3 system, and provides the adult patient, or the parent or legal
4 representative of a minor patient, with a copy of the report.
5 3. The health profession board for a health care provider
6 may deny an applicant a license or suspend, revoke, or refuse
7 to renew a license, and may take other disciplinary action
8 against a licensee based on the applicant or licensee having
9 three or more verified failures to comply with the applicable
10 health care provider requirements pursuant to 42 U.S.C.
11 §300aa-25 and 42 U.S.C. §300aa-26.
12 4. A health care provider who violates a provision of
13 42 U.S.C. §300aa-25 or 42 U.S.C. §300aa-26, in addition to
14 licensee disciplinary action pursuant to subsection 3, shall
15 be subject to a fine, per violation, of a minimum amount of one
16 thousand dollars, established by rule of the department or the
17 respective health profession board, as applicable.
18 EXPLANATION
19 The inclusion of this explanation does not constitute agreement with
20 the explanation’s substance by the members of the general assembly.
21 This bill relates to the requirements established under
22 federal law for health care providers administering certain
23 vaccines. The bill provides definitions used in the bill
24 including “health care provider” which is the definition used
25 under federal law (42 U.S.C. §300aa-33(1)); “health profession
26 board”; and “vaccine injury table”.
27 The bill requires the department of public health (DPH) to
28 collaborate with each health profession board to ensure that
29 a health care provider under the purview of the department or
30 a health profession board is aware of and complies with the
31 requirements applicable to health care providers who administer
32 vaccines, including providing the relevant federal vaccine
33 information statement for the vaccine the patient is to receive
34 and verbal information regarding the federal food and drug
35 administration vaccine adverse event reporting system (FAERS)
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 S.F. 477
1 and the national vaccine injury compensation program, for
2 those vaccines included in the vaccine injury table, prior to
3 the patient receiving the vaccine; recording certain required
4 information about the vaccine administered in the patient’s
5 medical record or a permanent office log or file; documenting
6 and reporting any adverse event following the vaccination that
7 the patient experiences within eight weeks post-administration
8 and that becomes known to the health care provider to the
9 FAERS; and providing to an adult patient, or the parent or
10 legal representative of a minor patient, a copy of the report.
11 The bill provides for disciplinary action by DPH or the
12 respective health profession board and for fines in a minimum
13 amount of $1,000, established by DPH or the respective board,
14 for noncompliance with the federal requirements.
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