130th Ohio General Assembly
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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
Sub. S. B. No. 121


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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