DEPARTMENT OF HEALTH AND SOCIAL SERVICES
Statutory Authority: 16 Delaware Code,Section 203 (16 Del.C. §203)
ORDER
Adoption Of The State Of Delaware Birth Defect Surveillance and Registry Program Regulations
Nature of The Proceedings:
Delaware Health and Social Services (“DHSS”) initiated proceedings to adopt State of Delaware Birth Defect Surveillance and Registry Program Regulations. The DHSS proceedings to adopt regulations were initiated pursuant to 29 Delaware Code Chapter 101 and authority as prescribed by 16 Delaware Code, Chapter 2.
On December 1, 2002 (Volume 6, Issue 6), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Delaware Code Section 10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by January 10, 2003, or be presented at a public hearing on January 10, 2003, after which time DHSS would review information, factual evidence and public comment to the said proposed regulations.
Verbal and written comments were received during the public comment period and evaluated. The results of that evaluation are summarized in the accompanying “Summary of Evidence.”
Findings Of Fact:
The Department finds that the proposed regulations as set forth in the attached copy should be adopted in the best interest of the general public of the State of Delaware.
The proposed regulations include minor modifications from those published in the December 1, 2002, Register of Regulations, based on comments received during the public comment period. These modifications are deemed not to be substantive in nature.
THEREFORE, IT IS ORDERED that the proposed State of Delaware Birth Defect Surveillance and Registry Program Regulations are adopted and shall become effective March 10, 2003, after publication of the final regulation in the Delaware Register of Regulations.
Vincent P. Meconi, Secretary, DHSS, 2/14/2003
Summary Of Evidence
A public hearing was held January 10, 2003 at 1:00 p.m., in the Third Floor Conference Room of the Jesse Cooper Building, Federal and Water Streets, Dover, Delaware before David P. Walton, Hearing Officer, to discuss the proposed Department of Health and Social Services (DHSS) Birth Defect Surveillance and Registry Program Regulations. Announcements regarding the public hearing were published in the Delaware State News, The News Journal and the Delaware Register of Regulations in accordance with Delaware Law. JoAnn Baker from the Community Health Care Access (CHCA) Section of the Division of Public Health (DPH) made the agency’s presentation. Attendees were allowed and encouraged to discuss and ask questions regarding all sections of the proposed regulations. Although there was no testimony given at the public hearing, four letters were received commenting on the proposed regulations during the public comment period (December 1, 2002 through January 10, 2003). Organizations that commented on the proposed regulations included:
• Delaware Healthcare Association
• State Council for Persons with Disabilities
• Delaware Developmental Disabilities Council
• March of Dimes Delaware Chapter
All comments and the DHSS (Agency) responses are as follows:
Sections 3.4.1 & Section 3.4.3, Reporting Requirements. These sections state that those responsible for diagnosis or treatment, or both for a child or children under the age 5 with birth defects shall be required to report required information to the registry. To have every health care provider who is treating the patient report the defect to the registry would duplicate information being provided to the registry. It is suggested that the physician, surgeon, dentist, podiatrist, certified nurse midwife, or other health care provider who initially diagnosis the birth defect should be the one to report the information to the registry.
Agency Response: After careful review of the law (16 Del.C., Chapt. 2, §203), the Department has determined that the law requires reporting of every occurrence of a birth defect by those who diagnose or treat, or both, any child under age 5. Section 3.4.1 of the regulation has language (“who is not known to be previously reported”) that will lessen the possibility of duplicative birth defect reporting and based on this comment, Section 3.4.3 was amended to also include such language.
Section 2.0, Definitions; Section 3.0 Reporting Requirements. Defects discovered prior to birth are included in the Section 2.0 definition of “birth defect”. Section 3.4 would require reporting of such prenatal defects within 30 days. However, Section 3.1 contemplates that the registry only includes information on “all births after viability”. There is some “tension” between the regulations suggesting inclusion of prenatal birth defects in the registry versus those suggesting inclusion only after viable birth. The Division may wish to clarify its intent.
Agency Response: As a result of this comment, Section 3.1 was amended for clarification purposes.
Reporting Requirements in Section 3.4 may benefit from a specific recital that providers treating through spiritual means alone are not covered by the reporting requirements [please refer to Title 16 Del.C. Sec. 203(b)]. Otherwise, a mental, spiritual or alternative health provider is literally required to comply with reporting requirements under Section 3.4.1.
Agency Response: As a result of this comment and after careful review of the law, the Department added Subsection 3.4.4 to the regulations citing this reporting exemption.
The statute requires covered providers to submit follow-up information at least once annually [please refer to Title 16 Del.C. Sec. 203(a)(4)]. The regulations do not address this requirement. It is recommended that the Division insert a conforming regulation.
Agency Response: As result of this comment and after careful review of the law, the Department added Section 3.7 to the regulations citing this requirement.
The statute ostensibly authorizes a parent to withhold a child’s name and identifying information based on religious tenets or practices [please refer to Title 16 Del.C. Sec. 203(c)]. The regulations contemplate that all reporting will not include the identity of the child or family [Section 4.1]. However, the second sentence in Section 4.1 suggests that the patient-identifying information will be compiled and shared under certain circumstances. The regulations do not address the parental right to not have personally identifying information collected/reported based on religious tenets or practices.
Agency Response: As a result of this comment and after careful review of the law, the Department added Section 4.2 citing this part of the law.
General Comment. There were concerns raised regarding the quantity of reportable diagnoses, and the necessity of reporting some of them. The concerns were centered around the possible effect of the quantity of reportable diagnoses impacting negatively on the quality of the reporting.
Agency Response: The law requires the Department to collect birth defect information in accordance with recommendations from the Centers for Disease Control and Prevention (CDC). The reportable diagnoses list included as part of the regulation is recommended by CDC.
Additionally, minor corrections were made to the proposed regulations due to formatting errors.
The public comment period was open from December 1, 2002 to January 10, 2003.
Verifying documents are attached to the Hearing Officer’s record. The regulations have been approved by the Delaware Attorney General’s office and the Cabinet Secretary of DHSS.
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 [any] birth[s] [defect diagnosed in utero and postpartum after viability and on anyone 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 [who is not known to be previously reported].
[3.4.4 This section of the regulations shall not apply to any person or private institution that, as an exercise of religious freedom, treats the sick or suffering by spiritual means through prayer alone.]
3.5 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.
3.6 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.
[3.7 Reporting sources are required to submit annual follow-up information as requested through Birth Defect Program.]
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 Any parent, custodian or guardian of any infant having any birth defect may refuse disclosure to the surveillance system and registry of the infant’s name and identifying information on the grounds that such birth defect identification is contrary to the religious tenets and practices of the infant’s parent, custodian or guardian.]
[4.2 4.3] 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