DEPARTMENT OF HEALTH AND SOCIAL SERVICES
Nature of the Proceedings
The attached regulations, "State of Delaware Birth Defect Surveillance and Registry Program Regulations" are being proposed in accordance with 16 Delaware Code, Chapter 2.
The proposed regulations define birth defect reporting requirements for health care providers in Delaware. The regulations also provide for reported birth defect data to be compiled in a Statewide Birth Defects Registry. The Registry will be used to gather data to assist with identification of risk factors, including environmental and hereditary; assist in the investigation of causes and prevalence; and assist in the development of strategies to reduce the occurrence of, or prevent such defects.
Notice of Public Hearing
The Community Health Care Access Section, Division of Public Health, Department of Health and Social Services will hold a public hearing to discuss the proposed Delaware Birth Defect Surveillance and Registry Program Regulations.
The public hearing will be held on Friday, January 10, 2003 at 1:00 PM in the third floor conference room of the Jesse Cooper Building, Federal and Waters Streets, Dover, Delaware.
Copies of the proposed regulations are available for review by contacting:
JoAnn Baker, Community Health Care Access
Jesse Cooper Building
Federal and Water Streets
Dover, Delaware 19903
Telephone: (302) 744-4554
Anyone wishing to present his or her oral comments at this hearing should contact David Walton at (302) 744-4700 by Thursday, January 9, 2003. Anyone wishing to submit written comments as a supplement to or in lieu of oral testimony should submit such comments by January 10, 2003 to:
David P. Walton, Hearing Officer
Division of Public Health
P.O. Box 637
Dover, Delaware 19903-0637
Birth Defect Surveillance and Registry Program Regulations
Authority: 16 Delaware Code, Chapter 2, Section 203
1.0 Purpose
1.1 Birth defects are one of the causes of infant mortality and disabilities in Delaware. A Birth Defects Surveillance System, or Birth Defects Registry, will enable the Department of Health & Social Services (DHSS), Division of Public Health (DPH) to collect birth defects data, to create a statewide registry, and to link surveillance with tracking of individual children for the provision of services.
1.2 The purpose of the Birth Defects Registry is to provide information to Public Health officials as to the existence of previously unrecognized health and environmental hazards, help prevent certain birth defects and ultimately decrease the infant mortality rate. The Birth Defects Registry will gather data to assist with identification of risk factors, including environmental and hereditary, assist in the investigation of causes and prevalence; assist in the development of strategies to reduce the occurrence of, or prevent such defects; and track and follow-up abnormal newborn hearing screening results.
1.3 The usefulness of the data collected in the Birth Defects Registry will depend upon the full and accurate reporting of such defects by health care practitioners, health care facilities, clinics and laboratories.
1.4 The Birth Defects Registry will be a component of the Newborn Screening Case Management System, including metabolic and hearing screening. All results of metabolic and hearing screens will become part of the screening record. Tracking and follow-up of incomplete and abnormal cases will be followed by the Division of Public Health Newborn Screening Program.
2.0 Definitions The following words shall have the meanings indicated:
"BIRTH DEFECT" means any structural or biochemical abnormality, regardless of cause, diagnosed at any time before or after birth, that requires medical or surgical intervention or that interferes with normal growth or development. This includes abnormal newborn hearing screening. Reportable birth defects are listed in Appendix A of these Regulations.
"DIVISION" refers to the Division of Public Health under the Department of Health and Social Services.
"REGISTRY" means a central data bank containing collected, classified, coded, and sorted data relating to defects in children under age 5, reported by health care providers.
"SURVEILLANCE" means the process of identifying and investigating birth defects in children under age 5.
3.0 Reporting Requirements
The provisions of this section shall apply to the Delaware Health and Social Services, Division of Public Health, Birth Defect Registry:
3.1 The registry shall collect information on all births after viability and any child under the age five (5) who is a resident of the state of Delaware, or whose parent is a resident of Delaware, and who is diagnosed at any time prior to age five (5) as having a birth defect. For the purposes related to the registry the Division shall have access to any medical record of the child that pertains to a diagnosed or suspected birth defect. Prenatal information on the birth mother may be obtained with prior consent.
3.2 Any diagnosed birth defects shall be reported for all infants and children up to age 5, including those who have since died (if the data is still available).
3.3 For purposes of these reporting requirements, reportable diagnoses are those diagnoses, from the International Classification of Diseases (ICD), as listed in Appendix A of these regulations. The reportable diagnoses listed in Appendix A may be revised, upon notice, to reflect changes in publications accepted for use by the Centers for Disease Control and Prevention or State.
3.4 The following persons and organizations are required to report occurrences of birth defects within 30 days of diagnosis to the Division of Public Health.
3.4.1 Any physician, surgeon, dentist, podiatrist, certified nurse midwife, or other health care practitioner who diagnoses or provides treatment, or both, for a child under age 5 with birth defects who is not known to be previously reported;
3.4.2 The designated representative of any clinical laboratory that performs any test which identifies a child or children under age 5 with birth defects not known to be previously reported; and
3.4.3 The designated representative of any hospital, dispensary, clinic, or other similar public or private institution that diagnoses or provides treatment, or both, for a child or children under age 5 with birth defects.
3.4 The administrative officer of every health care facility shall be responsible for establishing reporting procedures at that facility, using the identified Birth Defect Registry reporting form. Reporting procedures must ensure that each infant initially diagnosed as having a birth defect shall be reported to the Division. Any presumptive or actual diagnosis in a child up to the age of 5 must be reported to the Division.
3.5 Reporting sources shall complete the Division of Public Health Birth Defects Surveillance Form for each reported case, and forward the completed form to the Division of Public Health Director or designee.
4.0 Confidentiality of Reports
4.1 No report of a diagnosis or treatment of a birth defect shall be disclosed in such a way as to identify the child who is the subject of the report, or as to identify the child's family. However, patient-identifying information may be exchanged among authorized agencies as approved by the Department and upon receipt by the Department of satisfactory assurances by those agencies of the preservation of the confidentiality of such information. Agencies will maintain the confidentiality of any information exchanged for the purpose of delivery of program services, evaluation, early intervention and epidemiological investigation.
4.2 No individual or organization providing information pursuant to these regulations shall be held liable for divulging such information to the Division.
5.0 Penalties
Any person or organization required to report the diagnosis or treatment of a birth defect pursuant to these regulations, and who violates these regulations, shall be subject to a fine of up to $100 for each violation, pursuant to 16 Del.C. Sec. 206. Justices of the Peace Courts have jurisdiction over such violations.
6.0 Severability
In the event any particular clause or section of the regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effective.
APPENDIX A
October 2002
DELAWARE BIRTH DEFECTS REGISTRY REPORTABLE DIAGNOSES
Broad Categories Specific Categories ICD-9 Codes
Congenital Infections
Congenital syphilis 090.0-090.3
Congenital rubella 771.0
Congenital cytomegalovirus 771.1
Congenital toxoplasmosis
(not specific code) 771.2
Other infections specific
to perinatal period 771.80
Other congenital infections 771.x
Neoplasms
Neurofibromatosis 237.70
Endocrine, Nutritional, Metabolic, Immunological Diseases
Congenital hypothyroidism 243.00
Phenylketonuria 270.10
Galactosemia 271.1
Cystic Fibrosis 277.00.01
Other Metabolic diseases
Diseases of Blood
Sickle Cell Disease 282.60
Other hemoglobinopathies 282.63, 282.69,
282.4
Developmental Disorders
Developmental Language
Disorder 315.31-315.39
Coordination Disorder 315.40
Mental Retardation 317 – 319
Congenital Anomalies of Central Nervous System
Anencephalus 740.0-740.1
Spina bifida without
anencephalus 741.0,741.9w/o
740.0-740.10
Hydrocephalus without
spina bifida 742.3 w/o
741.0, 741.9
Encephalocele 742.0
Microcephalus 742.1
Holoprosencephaly/
Porencephaly 742.2
Other Congenital Anomalies
of Nervous System 742.4 - 742.9
Congenital Anomalies of the Eye
Anophthalmia/microphthalmia 743.0,743.1
Congenital cataract 743.30-743.34
Aniridia 743.45
Glaucoma 743.20-743.22
Coloboma 743.46*
Congenital Anomalies of the Ear
Anotia/microtia 744.01,744.23
Congenital Anomalies of the Cardiovascular System
Common truncus 745.0
Transposition of great
arteries 745.10,745.11,
745.12, 745.19
Tetralogy of Fallot 745.2
Ventricular septal defect 745.4
Atrial Septal Defect 745.5
Endocardial cushion defect 745.60,745.61,
745.69
Single Ventricle 745.3
Pulmonary valve atresia
and stenosis 746.01,746.02
Tricuspid valve atresia and
stenosis 746.1
Ebstein’s anomaly 746.2
Aortic valve stenosis 746.3
Hypoplastic left heart syndrome 746.7
Patent ductus arteriosus
>2500 gms 747.0
Coarctation of aorta 747.10
Pulmonary artery anomalies 747.3
Congenital anomalies of the Respiratory System
Anomalies of larynx/trachea/
bronchus 748.30
Lung agenesis/hypoplasia 748.5
Other respiratory anomalies
Congenital Anomalies of the Orofacial Area
Cleft palate without cleft
lip 749.00-749.04
Cleft lip with or without
cleft palate 749.1,749.2
Choanal atresia 748.0
Congenital Anomalies of the Gastrointestinal Tract
Esophageal atresia/
tracheoesophageal fistula 750.3
Atresia/stenosis of intestine
and rectum 751.10,751.2
Hirschsprung’s disease
(congenital megacolon) 751.3
Anomalies of internal fixation
of bowel 751.40
Biliary atresia 751.61
Malrotation of intestine 751.4*
Pyloric stenosis 750.5
Anorectal malformation 751.4*
Congenital Anomalies of the Genitourinary System
Renal Agenesis/hypoplasia 753.0
Bladder exstrophy 753.5
Cloacal exstrophy *
Cystic/dysplastic kidneys 753.10,753.15
Obstructive genitourinary
defect 753.2,753.6
Hypospadias and Epispadias 752.6
Ambiguous genitalia 752.9*
Polycystic kidneys 753.12-753.14
Congenital Anomalies of the Musculoskeletal Regions
Reduction defect, upper
limbs 755.20-755.29
Polydactyly/Syndactyly/
Adactyly 755.00-755.02
755.10-755.14
755.4*
Reduction defect, lower
limbs 755.30-755.39
Arthrogryposis multiplex
congenital 754.89*
Achondroplasia 756.4
Osteogenesis imperfecta 756.51
Other skeletal dysplasia
Gastroschisis 756.7
Omphalocele 756.7
Diaphragmatic hernia
(moved up) 756.6
Scoliosis/Lordosis/Kyphosis 754.0, 756.19
Congenital hip dysplasia 754.30, 754.31
754.35*
Club Foot 754.50, 51, 53,
60, 70, 79
Craniosynostosis 756.0*
Chromosomal Disorders
Trisomy 21 (Down
syndrome) 758.0
Trisomy 13 758.1
Trisomy 18 758.2
Autosomal deletion
syndromes 758.30
Other conditions due to
autosomal anomalies 758.50
Gonadal dysgenesis (Turner’s
syndrome) 758.60
Klinefelter’s syndrome 758.70
Other conditions due to sex
chromosome anomalies 758.80
Conditions due to anomaly of
unspecified Chromosome 758.90
Fragile X Syndrome 759.83
Other Congenital Malformations
Amniotic bank disruption
complex no code
Embryopathy from Toxic Exposure in Utero
Fetal Alcohol syndrome 760.71
Phenytoin 760.79*
Isotretinoin 760.79*
Warfarin 760.79*
Other toxic exposures 760.7x
Conductive hearing loss, external ear 389.01
Conductive hearing loss, middle ear 389.03
Ear disorder, unspecified 388.9
Hearing loss, noise-induced 388.12
Hearing loss, sudden, unspecified 388.2
Hearing loss, unspecified 388.9
Sensorineural hearing loss, unspecified 389.10