To amend sections 3701.501 and 3701.503 of the Revised Code to codify the genetic, endocrine, and metabolic disorders screened for under the existing Newborn Screening Program and to declare an emergency.

Section 1.  That sections 3701.501 and 3701.503 of the Revised Code be amended to read as follows:

Sec. 3701.501.  (A)(1) Except as provided in division (A)(2) of this section, all newborn children shall be screened for the presence of the genetic, endocrine, and metabolic disorders specified in rules, adopted pursuant to division (C) of this section.

(2) Division (A)(1) of this section does not apply if the parents of the child object thereto on the grounds that 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 council shall consist of fourteen members appointed by the director. 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 Each hospital and freestanding birthing center shall screen a newborn born in the hospital or center for the presence of all of the following genetic, endocrine, or metabolic disorders:

(1) Argininemia;

(2) Argininosuccinic acidemia;

(3) Biotinidase deficiency;

(4) Carnitine/acylcarnitine translocase deficiency;

(5) Carnitine palmitoyl transferase deficiency type II;

(6) Carnitine uptake defect;

(7) Citrullinemia;

(8) Congenital adrenal hyperplasia;

(9) Congenital hypothyroidism;

(10) Cystic fibrosis;

(11) Galactosemia;

(12) Glutaric acidemia type I;

(13) Glutaric acidemia type II;

(14) Homocystinuria (cystathionine-beta-synthase deficiency);

(15) Hypermethioninemia;

(16) Isobutyryl-CoA dehydrogenase deficiency;

(17) Isovaleric acidemia;

(18) Long chain hydroxyacyl-CoA dehydrogenase deficiency;

(19) Maple syrup urine disease;

(20) Medium chainacyl-CoA dehydrogenase deficiency;

(21) Methylmalonic acidemia;

(22) Multiple CoA carboxylase deficiency;

(23) Phenylketonuria;

(24) Propionic acidemia;

(25) Short chain acyl-CoA dehydrogenase deficiency;

(26) Trifunctional protein deficiency;

(27) Tyrosinemia type-I;

(28) Tyrosinemia type-II;

(29) Tyrosinemia type-III;

(30) Very long chain acyl-CoA dehydrogenase deficiency;

(31) 2-methylbutyryl-CoA dehydrogenase deficiency;

(32) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency;

(33) 3-ketothiolase deficiency;

(34) 3-methylcrotonyl-CoA carboxylase deficiency;

(35) Sickle cell and other hemoglobinopathies.

(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 and giving to the child's parents information on each disorder for which the child's screening or rescreening result was abnormal;

(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 public health laboratory authorized under section 3701.22 of the Revised Code.

(2) If the director determines that the public health laboratory 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 public health laboratory 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 public health laboratory or by another laboratory selected by the director pursuant to division (E)(2) of this section.

Sec. 3701.503.  As used in section 3701.501 and sections 3701.504 to 3701.509 of the Revised Code:

(A) "Parent" means either parent, unless the parents are separated or divorced or their marriage has been dissolved or annulled, in which case "parent" means the parent who is the residential parent and legal custodian.

(B) "Guardian" has the same meaning as in section 2111.01 of the Revised Code.

(C) "Custodian" means, except as used in division (A) of this section, a government agency or an individual, other than the parent or guardian, with legal or permanent custody of a child as defined in section 2151.011 of the Revised Code.

(D) "Hearing screening" means the identification of newborns and infants who may have a hearing impairment, through the use of a physiologic test.

(E) "Hearing evaluation" means evaluation through the use of audiological procedures by an audiologist or physician.

(F) "Hearing impairment" means a loss of hearing in one or both ears in the frequency region important for speech recognition and comprehension.

(G) "Newborn" means a child who is less than thirty days old.

(H) "Infant" means a child who is at least thirty days but less than twenty-four months old.

(I) "Freestanding birthing center" has the same meaning as in section 3702.141 of the Revised Code.

(J) "Physician" means an individual authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.

(K) "Audiologist" means an individual authorized under section 4753.07 of the Revised Code to practice audiology.

(L) "Hospital" means a hospital that has a maternity unit or newborn nursery.

(M) "Maternity unit" means any unit or place in a hospital where women are regularly received and provided care during all or part of the maternity cycle, except that "maternity unit" does not include an emergency department or similar place dedicated to providing emergency health care.

(N) "Board of health" means the board of health of a city or general health district or the authority having the duties of a board of health under section 3709.05 of the Revised Code.

Section 2.  That existing sections 3701.501 and 3701.503 of the Revised Code are hereby repealed.

Section 3. This act is hereby declared to be an emergency measure necessary for the immediate preservation of the public peace, health, and safety. The reason for such necessity is that many of the disorders included in the Newborn Screening Program panel cannot be detected by merely observing a newborn and early detection of a disorder soon after birth can help prevent serious problems, including brain damage, organ damage, and even death.