Ohio Admin. Code 3701-55-02

Current through all regulations passed and filed through October 28, 2024

Section 3701-55-02 - Required screening; facility requirements

(A) All newborn children shall be screened in accordance with procedures set forth in this chapter for the presence of the following genetic, endocrine, or metabolic disorders:

(1) 2-methylbutyryl-CoA dehydrogenase deficiency;

(2) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency;

(3) 3-ketothiolase deficiency;

(4) 3-methylcrotonyl-CoA carboxylase deficiency;

(5) Argininemia;

(6) Argininosuccinic acidemia;

(7) Biotinidase deficiency;

(8) Carnitine/acylcarnitine translocase deficiency;

(9) Carnitine palmitoyl transferase deficiency type II;

(10) Carnitine uptake defect;

(11) Citrullinemia;

(12) Congenital adrenal hyperplasia;

(13) Congenital hypothyroidism;

(14) Cystic fibrosis;

(15) Galactosemia;

(16) Glutaric acidemia type I;

(17) Glutaric acidemia type II;

(18) Glycogen storage disease type II (Pompe);

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

(20) Hypermethioninemia;

(21) Isovaleric acidemia;

(22) Krabbe disease;

(23) Long chain hydroxyacyl-CoA dehydrogenase deficiency;

(24) Maple syrup urine disease;

(25) Medium chainacyl-CoA dehydrogenase deficiency;

(26) Methylmalonic acidemia;

(27) Mucopolysaccharidosis type 1;

(28) Multiple CoA carboxylase deficiency;

(29) Phenylketonuria;

(30) Propionic acidemia;

(31) Severe combined immune deficiency;

(32) Sickle cell and other hemoglobinopathies;

(33) Spinal muscular atrophy (SMA);

(34) Trifunctional protein deficiency;

(35) Tyrosinemia type-I;

(36) Tyrosinemia type-II;

(37) Tyrosinemia type-III; and

(38) Very long chain acyl-CoA dehydrogenase deficiency.; and

(39) X-linked adrenoleukodystrophy (X-ALD).

(B) All hospitals and freestanding birthing centers that are required by this chapter to cause specimens to be collected for newborn screening for genetic, endocrine, or metabolic disorders shall:

(1) Designate a newborn screening coordinator and physician responsible for the coordination of the facility's newborn screening;

(2) Notify the chief of the Ohio department of health bureau of public laboratories of the name of the individual designated as the newborn screening coordinator on a yearly basis and whenever the designated individual changes; and

(3) Develop a written protocol for tracking newborn screening activities. The protocol must include a process for documenting the dates of specimen collection, shipping, and receipt of screening results. The protocol must also include a requirement that key fields including date and time of infant birth, date and time of specimen collection, weight of infant, feeding status, transfusion history, and the name of the physician attending the child after birth or a designee be placed on the specimen demographic form sent with the specimen to the Ohio department of health public health laboratory.

Ohio Admin. Code 3701-55-02

Effective: 10/24/2022
Five Year Review (FYR) Dates: 10/3/2019 and 10/24/2027
Promulgated Under: 119.03
Statutory Authority: 3701.501
Rule Amplifies: 3701.501
Prior Effective Dates: 03/17/2003 (Emer.), 06/15/2003, 08/16/2004, 08/30/2006, 07/01/2009, 07/29/2013, 07/01/2016, 11/01/2017