Chapter 3701-57 Ohio Birth Defects Information System

3701-57-01 Definitions.

As used in this chapter

(A) "Abnormal condition" means any condition established at conception or acquired in utero which results in a morphologic (structural), metabolic (biochemical), functional or behavioral derangement necessitating medical or other intervention.

(B) "Birth defect" means an abnormal condition resulting from an error of metabolism (biochemical), morphogenesis (structural) or both, which is either established at conception or in utero including congenital tumors and birth marks (hamartoneoplasia).

(C) "Birth Defects Information System" or "system" means the collection and maintenance of information regarding abnormal conditions, birth defects and congenital anomalies of fetal deaths and of children from birth to five years of age, and the provision of referral services to families with a child from birth to five years of age with a birth defect. In Ohio, the system is named the "Ohio Connections for Children with Special Needs" or "OCCSN".

(D) "Congenital anomaly" means an error of morphogenesis (structural) which is either established at conception or acquired during intrauterine life.

(E) "Director" means the director of the Ohio department of health or his or her designee.

(F) "Freestanding birthing center" means any facility in which deliveries routinely occur, regardless of whether the facility is located on the campus of another health care facility, and which is licensed under Chapter 3711. of the Revised Code as level one, two, or three maternity unit or a limited maternity unit.

(G) "Hospital" means a hospital classified under section 3701.07 of the Revised Code as a general hospital or children's hospital.

(H) "Local health department" means a health department operated by 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.

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

(J) "Referral services" means a formal process to assure that parents or guardians of children with birth defects are informed of medical and support services for which they may be eligible in order to improve health outcomes and/or enhance the quality of their children's lives.

(K) "Stillbirth" or "fetal death" means death of a product of conception of at least twenty weeks of gestation prior to the complete expulsion or extraction from its mother which, after such expulsion or extraction, does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles.

(L) "Surveillance" means the ongoing systematic collection, analysis, interpretation and dissemination of outcome-specific data for use in the planning, implementation an evaluation of public health practice.

Effective: 12/13/2015
Five Year Review (FYR) Dates: 09/28/2015 and 11/30/2020
Promulgated Under: 119.03
Statutory Authority: 3705.30, 3705.35
Rule Amplifies: 3705.30, 3705.31, 3705.32, 3705.33, 3705.35, 3705.36
Prior Effective Dates: 6/3/2005

3701-57-02 Reporting requirements.

(A) Each physician, hospital and freestanding birthing center shall report to the birth defects information system information concerning all children from birth to five years of age with any of the following abnormal conditions, birth defects and congenital abnormalities:

(1) Anencephalus;

(2) Spina bifida;

(3) Congenital cataract:

(4) Aniridia;

(5) Truncus arterious;

(6) Transposition of great arteries;

(7) Tricuspid atresia;

(8) Tetralogy of Fallot;

(9) Pulmonary atresia;

(10) Congenital stenosis of the aortic valve;

(11) Hypoplastic left heart syndrome;

(12) Coarctation of aorta;

(13) Total anomalous pulmonary venous return;

(14) Choanal atresia;

(15) Cleft palate;

(16) Cleft lip;

(17) Cleft palate with cleft lip;

(18) Esophageal atresia;

(19) Atresia and stenosis of large intestine, rectum and anal canal;

(20) Hirschsprung disease;

(21) Biliary atresia;

(22) Intestinal malrotation and volvulus;

(23) Renal agenesis;

(24) Gastroschisis;

(25) Omphalocele;

(26) Diaphragmatic hernia;

(27) Trisomy 13;

(28) Trisomy 18;

(29) Trisomy 21;

(30) Turner syndrome;

(31) Klinefelter syndrome;

(32) Disorders of sexual development (ambiguous genitalia);

(33) Fetal alcohol syndrome;

(34) Long QT syndrome;

(35) Velo-cardio-facial syndrome (22q11 deletion);

(36) Neurofibromatosis type 1;

(37) Spinal muscular atrophy;

(38) Tuberous sclerosis;

(39) Stickler syndrome, Treacher Collins' syndrome, Pierre Robin syndrome, Goldenhar syndrome; and

(40) Osteogenesis imperfecta.

(B) Each physician, hospital and freestanding birthing center shall report cases as described in paragraph (A) of this rule in an electronic format as prescribed by the director. The report shall contain information regarding the child which includes:

(1) Medical record number;

(2) Child's name;

(3) Child's county of residence;

(4) Child's address;

(5) Phone number of child's parent or guardian;

(6) Parent/guardian name;

(7) Child's date of birth;

(8) Child's gender;

(9) Child's race;

(10) Child's hispanic ethnicity;

(11) Date of encounter or discharge;

(12) Diagnostic code for the birth defect being reported;

(13) Child's date of death, if applicable;

(14) Mother's maiden name;

(15) Mother's date of birth;

(16) Mother's race;

(17) Mother's hispanic ethnicity;

(18) Reporting hospital Ohio department of health hospital number; and

(19) Date of report.

(C) Each physician, hospital and freestanding birthing center shall report to the Ohio department of health at least quarterly, all new cases from the previous quarter unless the physican, hospital, or freestanding birthing center has evidence that the case has already been reported.

(D) All physicians, hospitals and freestanding birthing centers providing diagnostic or treatment services to individuals with birth defects as specified in paragraph (A) of this rule shall grant to the director, or those representatives authorized in accordance with division (C) of section 3705.32 of the Revised Code, access to records that identify cases of birth defects.

(E) A physician, hospital, or freestanding birthing center is not subject to liability in an action for damages, or other relief for furnishing the information including records, reports, statements, notes, memoranda or other information to the director as required by this rule, or to a qualified person or governmental entity authorized by division (C) of section 3705.32 of the Revised Code.

(F) The director shall establish a form for use by parents and legal guardians who seek to have identifying information regarding their children removed from the birth defects information system. The director shall make the form available to hospitals, local health departments and physicians.

(G) The director shall make available to the state's birth defects information system, the same information listed in paragraph (B) of this rule for newborns diagnosed with disorders on the state's mandated newborn screening panel listed in rule 3701-55-02 of the Administrative Code.

Replaces: 3701-57-02

Effective: 12/13/2015
Five Year Review (FYR) Dates: 11/30/2020
Promulgated Under: 119.03
Statutory Authority: 3705.30, 3705.35
Rule Amplifies: 3705.30, 3705.31, 3705.33, 3705.35
Prior Effective Dates: 6/3/2005, 11/1/10

3701-57-03 Referral services.

Ohio department of health birth defects information system staff or appropriate staff from community programs may contact parents and legal guardians of children reported to the birth defects information system to offer referral information for specialty physicians and other agencies and programs such as help me grow early intervention, regional comprehensive genetics centers, public health nurses at local health departments, and the " Children with Medical Handicaps Program" ( CMH).

Effective: 12/13/2015
Five Year Review (FYR) Dates: 09/28/2015 and 11/30/2020
Promulgated Under: 119.03
Statutory Authority: 3705.30, 3705.35
Rule Amplifies: 3705.31, 3705.35
Prior Effective Dates: 6/3/2005, 11/1/10

3701-57-04 Confidentiality, research.

(A) Any information, data or reports with respect to a birth defects case that is furnished to, or obtained by, the birth defects information system or by the director shall be confidential and shall be used for one or more of the following purposes:

(1) For medical research studies including demographic, epidemiologic, teratologic, or similar studies related to health and health care provision;

(2) To inform parents, guardians and custodians of children with birth defects of medical care and other services available for the child and family;

(3) To provide data regarding birth defects in Ohio to the "National Birth Defects Prevention Network"; and

(4) To distribute reports of information as required by section 3705.36 of the Revised Code.

(B) Qualified persons or government entities engaged in demographic, teratologic, epidemiologic or similar studies related to health and health care provision may be given access to confidential information if all the following conditions are met and if the project is approved by the Ohio department of health's institutional review board:

(1) The person requesting to access the data initially meets with the birth defects program administrator or other pertinent Ohio department of health staff to discuss the proposed study concept and programmatic data elements requested.

(2) Following the outcome of paragraph (B)(1) of this rule, the person conducting the study submits a complete application to the Ohio department of health's institutional review board and provides written information about:

(a) The purpose of the study;

(b) The nature of the data to be collected;

(c) How the researcher intends to analyze it;

(d) The records the researcher seeks to review, and;

(e) The safeguards the researcher will take to protect the identity of the patients whose records the researcher will be reviewing.

(C) Based on the results from the meeting and written information submitted to the Ohio department of health's institutional review board under paragraph (B) of this rule, the director shall determine that access to confidential information concerning individuals with birth defects shall be made available to persons engaged in demographic, epidemiologic, teratologic, or similar studies related to health and health care provision if the person or government entity signs an agreement to maintain the confidentiality of the information and the study meets the following standards:

(1) The study had clearly defined goals that pertain to birth defects diagnosis, prevention, treatment or service coordination;

(2) For case control studies, the research design used in the study will involve a sufficiently large sample size that any meaningful difference between cases and controls will be statistically significant. For other projects, the study will provide enough cases for meaningful analysis of the data for identification of potential risk factors and intervention strategies for birth defects treatment and prevention; and

(3) The study will be conducted by researchers who have the ability to analyze and interpret data.

(D) The director may disclose information assembled by the birth defects information system with the written consent of the parent or legal guardian of the child who is the subject of the information.

(E) The director may obtain and merge into the birth defects information system information reported to the Ohio department of health under another provision of the Revised Code or Administrative Code.

(F) Notwithstanding paragraphs (A) and (C) of this rule, the Ohio department of health may release confidential information concerning individuals with birth defects or congenital anomalies to the birth defects information system of another state, if the other state has entered into a written reciprocal agreement with the Ohio department of health and the agreement provides that the state will comply with the confidentiality provision of this rule and that information identifying a child will not be released to any person without the written consent of the individual's parent or legal guardian.

(G) This rule does not prevent the release of information assembled by the birth defects information system in summary, statistical or other form that does not identify particular individuals or individual sources of information.

Effective: 12/13/2015
Five Year Review (FYR) Dates: 09/28/2015 and 11/30/2020
Promulgated Under: 119.03
Statutory Authority: 3705.30, 3705.35
Rule Amplifies: 3705.32, 3705.35
Prior Effective Dates: 6/3/2005, 11/1/10