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Sub. S. B. No. 121As Reported by the Senate Health, Human Services and Aging Committee
As Reported by the Senate Health, Human Services and Aging Committee
124th General Assembly | Regular Session | 2001-2002 |
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SENATORS Blessing, Fingerhut, Hagan
A BILL
To amend sections 3701.23 and 3701.501 of
the Revised
Code to revise the law
regarding
required screening
of newborn children for
genetic,
endocrine, and
metabolic disorders.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 3701.23 and 3701.501
of
the Revised
Code be amended
to read as follows:
Sec. 3701.23. (A) The director of health shall have
charge
of the laboratory authorized by section 3701.22 of the
Revised
Code. The director may employ an assistant for the
laboratory who
shall be a person skilled in chemistry and
bacteriology, and
receive such compensation as
the director may allow. All expenses
of such laboratory shall be
paid from appropriations made for the
department of health. (B)(1) The public health council, in accordance with
Chapter
119. of the Revised Code, shall adopt, and may amend or
rescind,
rules establishing reasonable fees to be charged for
services that
the laboratory performs. The council
need not
prescribe fees to
be charged in any case where the council
believes that the
charging of fees would significantly and
adversely affect the
public health.
Except
as provided in
division
(B)(2)
of
this
section, all
All fees collected
for services
that
the laboratory
performs shall be
deposited into
the state
treasury
to the credit
of the "laboratory handling fee
fund,"
which is
hereby created for
the purpose of defraying
expenses of
operating
the laboratory. (2) The council, in accordance with division (B)(1) of
this
section, shall adopt a rule establishing a fee of not less
than
fourteen dollars for tests of newborn children
conducted
under
section 3701.501 of the Revised Code. Of each such fee
collected
on or after the rule's effective date, not less than ten
dollars
and
twenty-five cents shall be deposited into the state treasury
to
the credit of the genetics services fund, which is hereby
created, and not less than three dollars and seventy-five cents
shall
be
deposited into the state treasury to the credit of the
sickle
cell fund, which is hereby created. Not less than three
dollars from each fee
credited to the genetics services fund shall
be used to defray
costs of phenylketonuria programs. Not less
than seven
dollars and twenty-five
cents of each fee credited to
the genetics services fund shall be
used to defray the costs of
the programs authorized by section
3701.502 of the Revised Code.
Money credited to the sickle cell
fund shall be used to defray
costs of programs authorized by
section 3701.131 of the Revised
Code.
Sec. 3701.501. (A)
The public health council shall adopt
rules in accordance with Chapter 119. of the Revised Code for
testing of
(1) Except as provided in division (A)(2) of this
section,
all newborn children
shall be screened for the presence
of
phenylketonuria,
homocystinuria, galactosemia, and
hypothyroidism.
The person
designated in the rules shall cause a
child to be
tested in
accordance with the rules. The rules may
require tests
for other
the
genetic, endocrine,
or
and metabolic
disorders
if
the following
conditions are met: (1) A determination is made by the public health council
that the disorders cause disability if undiagnosed and untreated
and are treatable.
(2) No additional blood samples or specimens are required
to
conduct the test.
All tests required by this section or by rules adopted by
the
public health council pursuant to this section shall be
performed
by the laboratory authorized by section 3701.22 of the
Revised
Code except that if the rules adopted by the public
health council
under this section provide that retesting of
children with
abnormal test results may be performed by
laboratories other than
that laboratory, retests may be performed
by any laboratory
approved by the director of health for that
purpose.
Rules adopted by the public health council under this
section
shall prescribe a method for giving notice of the
proposed tests
and the results of the tests to the parents of the
child. The
rules shall also prescribe a method for giving notice
of the
proposed tests and the results of the tests to either the
person
who caused the child to be tested, employees designated by
the
rules of the hospital of birth, or the health commissioner
for the
health district where the birth occurred, whichever is
appropriate
as determined by the rules.
The rules also shall
prescribe laboratory methods and other
procedures for the
detection of such genetic, endocrine, and
metabolic disorders in
newborn children, including procedures for
retesting and referral
of children with abnormal test results.
With regard to tests for the
presence of phenylketonuria, the
laboratory methods and other procedures
prescribed in the rules
shall include any test that the council determines is
effective
for use in
detecting the disorder in children who are less than
forty-eight hours old.
(B)
specified in rules,
adopted pursuant to this section.
(2) Division
(A)(1) of this section does not apply if
the
parents of the child object thereto on the grounds that
such
test
the screening conflicts with their religious tenets and
practices.
(B) There is hereby created the newborn screening advisory
council to advise the director of health regarding the screening
of newborn children for genetic, endocrine, and metabolic
disorders. The council shall engage in an ongoing review of the
newborn screening requirements established under this section and
shall provide recommendations and reports to the director as the
director requests and as the council considers necessary. The
director may assign other duties to the council, as the director
considers appropriate.
The director shall appoint the members of the council. In
making appointments, the director shall select individuals and
representatives of entities with interest and expertise in newborn
screening, including such individuals and entities as health care
professionals, hospitals, children's hospitals, regional genetic
centers, regional sickle cell centers, newborn screening
coordinators, and members of the public.
The department of health shall provide meeting space, staff
services, and other technical assistance required by the council
in carrying out its duties. Members of the council shall serve
without compensation, but shall be reimbursed for their actual and
necessary expenses incurred in attending meetings of the council
or performing assignments for the council. The council is not subject to sections 101.82 to 101.87 of the Revised Code.
(C)(1) The director of health shall adopt rules in
accordance
with Chapter 119. of the Revised Code specifying the
disorders for which each newborn child must be screened.
(2) The newborn screening advisory council shall evaluate
genetic, metabolic, and endocrine disorders to assist the director
in determining which disorders should be included in the
screenings required under this section. In determining whether a
disorder should be included, the council shall consider all of the
following:
(a) The disorder’s incidence, mortality, and morbidity;
(b) Whether the disorder causes disability if diagnosis,
treatment, and early intervention are delayed;
(c) The potential for successful treatment of the disorder;
(d) The expected benefits to children and society in
relation to the risks and costs associated with screening for the
disorder;
(e) Whether a screening for the disorder can be conducted
without taking an additional blood sample or specimen.
(3) Based on the considerations specified in division
(C)(2) of this section, the council shall make recommendations to
the director of health for the adoption of rules under division
(C)(1) of this section. The director shall promptly and
thoroughly review each recommendation the council submits. If the
director agrees with a recommendation made by the council, the
director shall adopt rules that correspond with the
recommendation.
(D) The director shall adopt rules in accordance with
Chapter 119. of the Revised Code
establishing standards and
procedures for the screenings required by this section. The rules
shall include standards and procedures for all of the following:
(1) Causing rescreenings to be performed when initial
screenings have abnormal results;
(2) Designating the person or persons who will be
responsible for causing screenings and rescreenings to be
performed;
(3) Giving to the parents of a child notice of the required
initial screening and the possibility that rescreenings may be
necessary;
(4) Communicating to the parents of a child the results of
the child's screening and any rescreenings that are performed;
(5) Giving notice of the results of an initial screening
and any rescreenings to the person who caused the child to be
screened or rescreened, or to another person or government entity
when the person who caused the child to be screened or rescreened
cannot be contacted;
(6) Referring children who receive abnormal screening or
rescreening results to providers of follow-up services, including
the services made available through funds disbursed under division
(F) of this section.
(E)(1) Except as provided in divisions (E)(2) and (3) of
this section, all newborn screenings required by this section
shall be performed by the laboratory authorized under section
3701.22 of the Revised Code.
(2) If the director determines that the laboratory
authorized under section 3701.22 of the Revised Code is unable to
perform screenings for all of the disorders specified in the rules
adopted under division (C) of this section, the director shall
select another laboratory to perform the screenings. The director
shall select the laboratory by issuing a request for proposals. The director may accept proposals submitted by laboratories located outside this state. At the
conclusion of the selection process, the director shall enter into
a written contract with the selected laboratory. If the director
determines that the laboratory is not complying with the terms of
the contract, the director shall immediately terminate the
contract and another laboratory shall be selected and contracted
with in the same manner.
(3) Any rescreening caused to be performed pursuant to this
section may be performed by the laboratory authorized
by section
3701.22 of the Revised Code or one or more other
laboratories
designated by the director. Any laboratory the
director considers
qualified to perform rescreenings may be
designated, including a laboratory located outside this state.
If more than one laboratory is designated, the person responsible for causing a
rescreening to be performed
is also responsible for selecting the
laboratory to be used.
(F)(1) The director shall adopt
rules in accordance with
Chapter 119. of the Revised Code
establishing a fee that shall be
charged and collected in addition
to or in conjunction with any
laboratory fee that is charged and
collected for performing the
screenings required by this section. The fee, which
shall be not
less than fourteen
dollars, shall be disbursed as
follows: (a) Not less than ten dollars and twenty-five cents shall be
deposited in the state treasury to the credit of the genetics
services fund, which is hereby created. Not less than seven
dollars and twenty-five cents of each fee credited to the genetics
services fund shall be used to defray the costs of the programs
authorized by section 3701.502 of the Revised Code. Not less than
three
dollars from each fee credited to the genetics services fund
shall
be used to defray costs of phenylketonuria programs. (b) Not less than three dollars and seventy-five cents shall
be deposited into the state treasury to the credit of the sickle
cell fund, which is hereby created. Money credited to the sickle
cell fund shall be used to defray costs of programs authorized by
section 3701.131 of the Revised Code. (2) In adopting rules under division (F)(1) of this section,
the director shall not establish a fee that differs
according to
whether a screening is performed by the laboratory authorized
under
section 3701.22 of the Revised Code or by another
laboratory
selected by the director pursuant to division (E)(2) of this
section.
Section 2. That existing sections 3701.23 and 3701.501 of
the Revised Code are
hereby repealed.
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