130th Ohio General Assembly
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S. B. No. 121  As Introduced
As Introduced

124th General Assembly
Regular Session
2001-2002
S. B. No. 121


SENATOR Blessing



A BILL
To amend sections 3701.23, 3701.501, and 3701.502 of1
the Revised Code to revise the law regarding2
required screening of newborn children for3
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

       Sec. 3701.23.  (A) The director of health shall have charge7
of the laboratory authorized by section 3701.22 of the Revised8
Code. The director may employ an assistant for the laboratory who9
shall be a person skilled in chemistry and bacteriology, and10
receive such compensation as the director may allow. All expenses11
of such laboratory shall be paid from appropriations made for the12
department of health.13

       (B)(1) The public health council, in accordance with Chapter14
119. of the Revised Code, shall adopt, and may amend or rescind,15
rules establishing reasonable fees to be charged for services that16
the laboratory performs. The council need not prescribe fees to17
be charged in any case where the council believes that the18
charging of fees would significantly and adversely affect the19
public health. Except20

       In the case of newborn screenings conducted pursuant to rules21
adopted under section 3701.501 of the Revised Code, the fee shall22
be in addition to the initial fee established under section23
3701.502 of the Revised Code.24

       Except as provided in division (B)(2)(A) of this section25
3701.502 of the Revised Code, all fees collected for services that26
the laboratory performs shall be deposited into the state treasury27
to the credit of the "laboratory handling fee fund," which is28
hereby created for the purpose of defraying expenses of operating29
the laboratory.30

       (2) The council, in accordance with division (B)(1) of this31
section, shall adopt a rule establishing a fee of not less than32
fourteen dollars for tests of newborn children conducted under33
section 3701.501 of the Revised Code. Of each such fee collected34
on or after the rule's effective date, not less than ten dollars35
and twenty-five cents shall be deposited into the state treasury36
to the credit of the genetics services fund, which is hereby37
created, and not less than three dollars and seventy-five cents38
shall be deposited into the state treasury to the credit of the39
sickle cell fund, which is hereby created. Not less than three40
dollars from each fee credited to the genetics services fund shall41
be used to defray costs of phenylketonuria programs. Not less42
than seven dollars and twenty-five cents of each fee credited to43
the genetics services fund shall be used to defray the costs of44
the programs authorized by section 3701.502 of the Revised Code.45
Money credited to the sickle cell fund shall be used to defray46
costs of programs authorized by section 3701.131 of the Revised47
Code.48

       Sec. 3701.501.  (A) As used in this section and section49
3701.502 of the Revised Code: 50

       (1) "CLIA certified laboratory" means a laboratory that has51
a valid certificate to perform examination of materials derived52
from the human body for the purpose of providing information for53
the diagnosis, prevention, or treatment of any disease issued54
pursuant to the "Clinical Laboratories Improvement Act (CLIA)," 8155
Stat. 536 (1967), 42 U.S.C.A. 263a, as amended. 56

       (2) "Screening" means a process by which an individual57
undergoes a procedure to indicate whether the individual is at a58
greater or lesser risk of having a specific condition.59

       (B) The public health council shall adopt rules in60
accordance with Chapter 119. of the Revised Code for testing61
screening of all newborn children for the presence of62
phenylketonuria, homocystinuria, galactosemia, and hypothyroidism.63
The person designated in the rules shall cause a child to be64
tested in accordance with the rules. The rules may require tests65
for other genetic, endocrine, or metabolic disorders if the66
following conditions are met. The rules shall identify the67
disorders for which screening must be conducted; prescribe68
laboratory methods and other procedures for the detection of those69
disorders, including procedures for rescreening and referral of70
children with abnormal screening results; and designate the71
person responsible for causing the screening to be conducted.72

       In identifying the disorders for which screening must be73
conducted, the public health council shall consider the following74
criteria:75

       (1) A determination is made by the public health council that76
the disorders cause Whether the disorder causes disability if77
undiagnosed and untreated and are treatable. diagnosis, treatment,78
and early intervention are delayed;79

       (2) No additional blood samples or specimens are required to80
conduct the test Characteristics of the disorder, including81
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 to87
the risks and costs associated with screening for the disorder.88

       (C) All tests screenings and any rescreenings required by89
this section or by rules adopted by the public health council90
pursuant to this section shall be performed by the laboratory91
authorized by section 3701.22 of the Revised Code except that if92
the rules adopted by the public health council under this section93
provide that retesting of children with abnormal test results may94
be performed by laboratories other than that laboratory, retests 95
may be performed by any laboratory approved by the director of96
health for that purpose or a CLIA certified laboratory.97

       (D)(1) Rules adopted by the public health council under this98
section shall prescribe a method for giving notice of the proposed99
tests screenings and the results of the tests screenings to the100
parents of the child. The101

       (2) The rules shall also prescribe a method for giving notice 102
of the proposed tests screenings and the results of the tests103
screenings to either the person who caused the child to be tested104
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 under111
division (D)(2) of this section.112

        The rules also shall prescribe laboratory methods and other113
procedures for the detection of such genetic, endocrine, and114
metabolic disorders in newborn children, including procedures for115
retesting and referral of children with abnormal test results.116
With regard to tests for the presence of phenylketonuria, the117
laboratory methods and other procedures prescribed in the rules118
shall include any test that the council determines is effective119
for use in detecting the disorder in children who are less than120
forty-eight hours old.121

       (B) Division (A) of this section does122

       (E) The rules of the public health council adopted under123
this section do not apply to a child if the parents of the child124
object thereto to a screening on the grounds that such test the125
screening conflicts with their religious tenets and practices.126

       Sec. 3701.502.  (A) The public health council shall adopt127
rules establishing an initial fee of not less than fourteen128
dollars for screenings of newborn children conducted pursuant to129
rules adopted under section 3701.501 of the Revised Code. Whether130
paid directly to the Ohio department of health or paid to a131
hospital, free standing birthing center, or person and transmitted132
to the department, the initial fee shall be disbursed as follows:133

       (1) Not less than ten dollars and twenty-five cents shall be134
deposited in the state treasury to the credit of the genetics135
services fund, which is hereby created. Not less than seven136
dollars and twenty-five cents of each fee credited to the genetics137
services fund shall be used to defray the costs of the programs138
authorized by division (C) of this section. Not less than three139
dollars from each fee credited to the genetics services fund shall140
be used to defray costs of phenylketonuria programs.141

       (2) Not less than three dollars and seventy-five cents shall142
be deposited into the state treasury to the credit of the sickle143
cell fund, which is hereby created. Money credited to the sickle144
cell fund shall be used to defray costs of programs authorized by145
section 3701.131 of the Revised Code. 146

       (B)(1) Any amount charged by the laboratory authorized by147
section 3701.22 of the Revised Code for screening a newborn child148
that exceeds the initial fee shall be deposited in the state149
treasury in accordance with division (B) of section 3701.23 of the150
Revised Code.151

       (2) Any amount charged by a CLIA certified laboratory for152
screening a newborn child that exceeds the initial fee shall be153
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 programs156
of education, detection, and treatment of genetic diseases and157
provide for habilitation, rehabilitation, and counseling of158
persons possessing a genetic trait of, or afflicted with, genetic159
disease;160

       (B)(2) Advise, consult, cooperate with, and assist, by161
contract or otherwise, agencies of this state and the federal162
government, agencies of the governments of other states, agencies163
of political subdivisions of this state, and private164
organizations, corporations, and associations in the development165
and promotion of programs pertaining to the causes, detection, and166
treatment of genetic diseases, habilitation, rehabilitation, and167
counseling of persons possessing the trait of or afflicted with168
genetic disease;169

       (C)(3) Accept and administer grants from the federal170
government or other sources, public or private, for carrying out171
any of the functions enumerated in divisions (A)(C)(1) and (B)(2)172
of this section. All such moneys so received shall be deposited173
by the director in the state treasury and shall be kept in a174
separate fund by the treasurer of state. Except as otherwise175
provided in section 3701.45 of the Revised Code, payments from the176
fund shall be made pursuant to vouchers approved by the director.177

       Section 2.  That existing sections 3701.23, 3701.501, and178
3701.502 of the Revised Code are hereby repealed.179

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