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S. B. No. 121 As Introduced
As Introduced
124th General Assembly | Regular Session | 2001-2002 |
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SENATOR Blessing
A BILL
| To amend sections 3701.23, 3701.501, and 3701.502 of | 1 |
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the Revised
Code to revise the law
regarding | 2 |
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required screening of newborn children for | 3 |
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genetic,
endocrine, and metabolic disorders. | 4 |
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 3701.23, 3701.501, and 3701.502
of | 5 | the Revised
Code be amended
to read as follows: | 6 |
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Sec. 3701.23. (A) The director of health shall have
charge | 7 |
of the laboratory authorized by section 3701.22 of the
Revised | 8 |
Code. The director may employ an assistant for the
laboratory who | 9 |
shall be a person skilled in chemistry and
bacteriology, and | 10 |
receive such compensation as
the director may allow. All expenses | 11 |
of such laboratory shall be
paid from appropriations made for the | 12 |
department of health. | 13 |
(B)(1) The public health council, in accordance with
Chapter | 14 |
119. of the Revised Code, shall adopt, and may amend or
rescind, | 15 |
rules establishing reasonable fees to be charged for
services that | 16 |
the laboratory performs. The council
need not
prescribe fees to | 17 |
be charged in any case where the council
believes that the | 18 |
charging of fees would significantly and
adversely affect the | 19 |
public health.
Except | 20 |
In the case of newborn screenings conducted pursuant to rules | 21 |
adopted under section 3701.501 of the Revised Code, the fee shall | 22 |
be in addition to the initial fee established under section | 23 |
3701.502 of the Revised Code. | 24 |
Except as provided in
division
(B)(2)(A) of
this section | 25 |
3701.502 of the Revised Code, all fees collected for services
that | 26 |
the laboratory performs shall be
deposited into the state
treasury | 27 |
to the credit of the "laboratory handling fee fund,"
which is | 28 |
hereby created for the purpose of defraying expenses of
operating | 29 |
the laboratory. | 30 |
(2) The council, in accordance with division (B)(1) of
this | 31 |
section, shall adopt a rule establishing a fee of not less
than | 32 |
fourteen dollars for tests of newborn children
conducted
under | 33 |
section 3701.501 of the Revised Code. Of each such fee
collected | 34 |
on or after the rule's effective date, not less than ten
dollars | 35 |
and
twenty-five cents shall be deposited into the state treasury | 36 |
to
the credit of the genetics services fund, which is hereby | 37 |
created, and not less than three dollars and seventy-five cents | 38 |
shall
be
deposited into the state treasury to the credit of the | 39 |
sickle
cell fund, which is hereby created. Not less than three | 40 |
dollars from each fee
credited to the genetics services fund shall | 41 |
be used to defray
costs of phenylketonuria programs. Not less | 42 |
than seven
dollars and twenty-five
cents of each fee credited to | 43 |
the genetics services fund shall be
used to defray the costs of | 44 |
the programs authorized by section
3701.502 of the Revised Code. | 45 |
Money credited to the sickle cell
fund shall be used to defray | 46 |
costs of programs authorized by
section 3701.131 of the Revised | 47 |
Code. | 48 |
Sec. 3701.501. (A) As used in this section and section | 49 |
3701.502 of the Revised Code:
| 50 |
(1) "CLIA certified laboratory" means a laboratory that has | 51 |
a valid certificate to perform examination of materials derived | 52 |
from the human body for the purpose of providing information for | 53 |
the diagnosis, prevention, or treatment of any disease issued | 54 |
pursuant to the "Clinical Laboratories Improvement Act (CLIA)," 81 | 55 |
Stat. 536 (1967), 42 U.S.C.A. 263a, as amended.
| 56 |
(2) "Screening"
means a process by which an individual | 57 |
undergoes a
procedure to
indicate whether the individual is at a | 58 |
greater or lesser risk of
having a specific condition. | 59 |
(B) The public health council shall adopt
rules in | 60 |
accordance with Chapter 119. of the Revised Code for
testing | 61 |
screening of
all newborn children for the
presence of | 62 |
phenylketonuria, homocystinuria, galactosemia, and
hypothyroidism. | 63 |
The person
designated in the rules shall cause a child to be | 64 |
tested in
accordance with the rules. The rules may require tests | 65 |
for other
genetic, endocrine, or metabolic disorders
if the | 66 |
following
conditions are met.
The rules
shall identify the | 67 |
disorders for which screening must be conducted; prescribe | 68 |
laboratory methods and other procedures for the detection of those | 69 |
disorders, including procedures for rescreening and referral of | 70 |
children with abnormal screening results; and
designate the | 71 |
person responsible for causing the screening to be conducted. | 72 |
In identifying the disorders for which screening must be | 73 |
conducted,
the public
health council shall consider the following | 74 |
criteria: | 75 |
(1)
A determination is made by the public health council
that | 76 |
the disorders cause
Whether the disorder causes disability if | 77 |
undiagnosed and untreated
and are treatable.
diagnosis,
treatment, | 78 |
and early intervention are delayed; | 79 |
(2)
No additional blood samples or specimens are required
to | 80 |
conduct the test
Characteristics of the disorder, including | 81 |
incidence, morbidity, and mortality; | 82 |
(3) Potential for
successful treatment; | 83 |
(4) The specimen type required
to
conduct a screening; | 84 |
(5) Characteristics of the screening, including
sensitivity, | 85 |
specificity, feasibility for mass screening, and
cost; | 86 |
(6) Expected benefits to children and society in relation
to | 87 |
the risks and costs associated with screening for the
disorder. | 88 |
(C) All
tests
screenings and any rescreenings required by | 89 |
this section
or by
rules adopted
by
the public health council | 90 |
pursuant to this
section shall be
performed by the laboratory | 91 |
authorized by section
3701.22 of the
Revised Code
except that if | 92 |
the rules adopted by
the public
health council under this section | 93 |
provide that
retesting
of
children with abnormal test
results may | 94 |
be performed
by laboratories other than that
laboratory, retests
| 95 |
may be performed by any
laboratory approved by the director of | 96 |
health for that
purpose
or a CLIA certified laboratory. | 97 |
(D)(1) Rules adopted by the public health council under this | 98 |
section shall prescribe a method for giving notice of the
proposed | 99 |
tests
screenings and the results of the
tests
screenings to the | 100 |
parents of the
child.
The | 101 |
(2)
The rules shall also prescribe a
method for giving
notice | 102 | of the proposed
tests
screenings and the results of the
tests | 103 |
screenings to
either the person who caused the
child to be
tested | 104 |
screened, employees designated by
the rules of the hospital
of
or | 105 | other facility at which the
birth
occurred, a person or
government | 106 | entity responsible for providing
medical or nursing
follow-up care | 107 | to the child, or the health commissioner
for the
health district | 108 | where the birth occurred, whichever is
appropriate
as determined | 109 | by the rules.
Parental consent is not necessary
for
giving notice | 110 | of screening results to persons or government
entities under | 111 |
division (D)(2) of this section. | 112 |
The rules also shall prescribe laboratory methods and
other | 113 |
procedures for the
detection of such genetic, endocrine, and | 114 |
metabolic disorders in
newborn children, including procedures for | 115 |
retesting
and referral
of children with abnormal test
results. | 116 |
With
regard to
tests for the
presence of
phenylketonuria, the | 117 |
laboratory methods and other procedures
prescribed in the rules | 118 |
shall include any test that the council
determines is
effective | 119 |
for use in
detecting the disorder in
children who are less than | 120 |
forty-eight hours
old. | 121 |
(B) Division (A) of this section does | 122 |
(E) The rules of
the public health council adopted under | 123 |
this section do not apply
to a
child if the
parents of the child | 124 |
object
thereto
to a screening on the
grounds that
such test
the | 125 |
screening conflicts with their
religious tenets and practices. | 126 |
Sec. 3701.502.
(A) The public health council shall adopt | 127 |
rules establishing an initial fee of not less than fourteen | 128 |
dollars for screenings of newborn children conducted pursuant to | 129 |
rules adopted under section 3701.501 of the Revised Code. Whether | 130 |
paid directly to the Ohio department of health or paid to a | 131 |
hospital, free standing birthing center, or person and transmitted | 132 |
to the department, the initial fee shall be disbursed as follows: | 133 |
(1) Not less than ten dollars and twenty-five cents shall be | 134 |
deposited in the state treasury to the credit of the genetics | 135 |
services fund, which is hereby created. Not less than seven | 136 |
dollars and twenty-five cents of each fee credited to the genetics | 137 |
services fund shall be used to defray the costs of the programs | 138 |
authorized by division (C) of this section. Not less than three | 139 |
dollars from each fee credited to the genetics services fund shall | 140 |
be used to defray costs of phenylketonuria programs. | 141 |
(2) Not less than three dollars and seventy-five cents shall | 142 |
be deposited into the state treasury to the credit of the sickle | 143 |
cell fund, which is hereby created. Money credited to the sickle | 144 |
cell fund shall be used to defray costs of programs authorized by | 145 |
section 3701.131 of the Revised Code.
| 146 |
(B)(1) Any amount charged by the laboratory authorized by | 147 |
section 3701.22 of the Revised Code for screening a newborn child | 148 |
that exceeds the initial fee shall be deposited in the state | 149 |
treasury in accordance with division (B) of section 3701.23 of the | 150 |
Revised Code. | 151 |
(2) Any amount charged by a CLIA certified laboratory for | 152 |
screening a newborn child that exceeds the initial fee shall be | 153 |
paid to the CLIA certified laboratory. | 154 |
(C)
The director of health shall do all of the following: | 155 |
(A)(1) Encourage and assist in the development of programs | 156 |
of
education, detection, and treatment of genetic diseases and | 157 |
provide for habilitation, rehabilitation, and counseling of | 158 |
persons possessing a genetic trait of, or afflicted with, genetic | 159 |
disease; | 160 |
(B)(2) Advise, consult, cooperate with, and assist, by | 161 |
contract or otherwise, agencies of this state and the federal | 162 |
government, agencies of the governments of other states, agencies | 163 |
of political subdivisions of this state, and private | 164 |
organizations, corporations, and associations in the development | 165 |
and promotion of programs pertaining to the causes, detection,
and | 166 |
treatment of genetic diseases, habilitation, rehabilitation,
and | 167 |
counseling of persons possessing the trait of or afflicted
with | 168 |
genetic disease; | 169 |
(C)(3) Accept and administer grants from the federal | 170 |
government or other sources, public or private, for carrying out | 171 |
any of the functions enumerated in divisions
(A)(C)(1) and
(B)(2) | 172 |
of this
section. All such moneys so received shall be deposited | 173 |
by the
director in the state treasury and shall be kept in a | 174 |
separate
fund by the treasurer of state. Except as otherwise | 175 |
provided in
section 3701.45 of the Revised Code, payments from the | 176 |
fund
shall be made pursuant to
vouchers approved by the director. | 177 |
Section 2. That existing sections 3701.23, 3701.501, and | 178 |
3701.502 of
the Revised Code are
hereby repealed. | 179 |
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